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Vibration Response Imaging Fibre Optic Plethysmography Quality Assurance in Surgery

Issue 12 2007 £5.95 €8.00 $8.95 www.asianhhm.com

Socially responsible
behaviour across the value
chain of private hospitals
ensures that their role
as legitimate healthcare
providers is accepted.

John Zinkin
Deputy Chairman
CSR Malaysia
Visiting Fellow
International Centre for Corporate
Social Responsibility
Nottingham University Business School
UK

Corporate
Social
Responsibility Published by

in Private Hospitals
In association with

M e d i c a l S c i e n c e s | S u r g i c a l S p e c i a l i t y | Te c h n o l o g y, E q u i p m e n t & D e v i c e s | F a c i l i twi ewsw .&a s iO


a nphehrma.tci o
omn s
w w w. a s i a n h h m . c o m 
Contents

HEALTHCARE MANAGEMENT
New Drugs in 23
Cover Story Anaesthesia
14 A review
Corporate Swati Daftary, Consultant Anaesthesiologist,
Jaslok Hospital & Research Centre,

Social
India

Responsibility
Stem Cell Therapy 27
The good, the bad and the confusing
Michael Marber, Professor, Cardiology, Divisional Lead
Mrinal Saha, Specialist Registrar, Cardiology,
in Private Hospitals St. Thomas Hospital,
UK

Socially responsible behaviour across


the value chain of private hospitals
SURGICAL SPECIALITY
ensures that their role as legitimate Integrated Operating Rooms 29
healthcare providers is accepted. Enabled by Richard Wolf’s ‘CORE’ system: A case study
Henning Baldauf
Project Manager - Core, Richard Wolf GmbH, Germany

Quality Assurance Programmes for Surgery 30


John Zinkin, How and why in Asia?
Deputy Chairman Malcolm J Underwood, Professor, Department of Surgery
CSR Malaysia CA van Hasselt, Professor, Department of Surgery
Visiting Fellow Hong Fung, Cluster Chief Executive, New Territories, East,
International Centre for Chinese University of Hong Kong,
Corporate Social Responsibility
Nottingham University
Hong Kong SAR
Business School
UK
Advances in 32
Cardiac Surgery
Safe and Reliable Healthcare 07 Yoshihiro Suematsu, Assistant
Supporting strategy and structure Professor, Division of Cardiothoracic
Michael Leonard, Physician Leader, Patient Safety, Surgery, University of Tokyo,
Kaiser Permanente Japan
Allan Frankel, Director, Patient Safety, Partners Healthcare,
USA
DIAGNOSTICS
In the Passionate Pursuit of Healthcare Oral-based Diagnostics 35
Excellence 09 Oral diseases and beyond
Peter A Gross, Chairman, Internal Medicine,
Antoon J M Ligtenberg, Assistant Professor, Department of Oral
Hackensack University Medical Center,
Biochemistry, Academic Centre for Dentistry Amsterdam (ACTA),
USA
The Netherlands
Healthcare in New Zealand 11
Innovations 37
Learning from complaints
Ron Paterson, Health and Disability Commissioner,
Vibration
New Zealand Response Imaging
A new methodology for
Leadership and Strategy in Healthcare 17 measurement of lung vibrations
Delon Wu, President, Taiwan Hospital Association,
Taiwan Igal Kushnir, President and CEO,
Deep Breeze Ltd, Israel

MEDICAL SCIENCES
Point-of-care Diagnostics 39
Cancer Nanomedicine 19 Tapping the potential
Emerging opportunities Neil Butt, Consultant,
Matthew Dennis, Cancer Market Specialist, Richard Owen, Consultant,
Espicom Business Intelligence, Product and Process Engineering, PA Consulting Group,
UK UK

w w w. a s i a n h h m . c o m 
 Asian Hospital & Healthcare Management ISSUE-12 2007 Circle 02
CONTENTS

TECHNOLOGY, EQUIPMENT & DEVICES


Fiber Optic Plethysmography for
Non-invasive Cardiac Monitoring 42 Issue 12 2007
Andy T Augousti, Professor, Applied Physics and
Instrumentation, Faculty of Science,
Kingston University, Chief Editor Rajeshwer Chigullapalli
UK Healthcare Editorial Team Grace Jones
Akhil Tandulwadikar
Prasanthi Potluri
Networking Implanted Feroz Zaheer

Medical Devices Copy Editors Kiran BV


Jagadeesh N
Ensuring effectiveness 45
and security Art Director M A Hannan
Visualiser Narsingoji Raju
George D Jelatis,
Security Architect, Project Coordinators Sunny Roger
Parkway Associates, Yuvraj Sahni
USA Project Associates Stella Powell
N Sweta
Madhubabu Pasulla
Santosh Kumar Dasari
CyberKnife Radiosurgery 48 Anthony M
An emerging surgical revolution Circulation Manager Gagan Kumar Vallabhaneni
John R Adler, Jr., Professor, Neurosurgery and Director, Circulation Executives Kevin Smith
Radiosurgery and Stereotactic Surgery,
Kranti Kalidindi
Stanford University School of Medicine,
Abhishek Jain
USA
Chigarapati Diwakar
China’s Medical Device Industry 51 Advertising Support Team Manoranjan Luke
Expansion time Rajkiran Boda
Andrew Wee, Research Analyst, APAC Healthcare, Frost & Sullivan, L Vandana Chowdary
Singapore P Venkata Nagendra Reddy

FACILITIES & Operations


Marketing Manager Ahmed Tariq

Hospital of 53
Asian Hospital & Healthcare Management is published by
Tomorrow SPG Media Limited in association with Frost & Sullivan
The design perspective
Henning Lensch, Managing Partner,
RRP architects+engineers,
Germany CEO, SPG Media Group Keith Sadler
Head, SPG Media, India Sanjay Manglik
INFORMATION TECHNOLOGY
SPG Media Group Plc SPG Media Private Limited
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Lessons from Taiwan 55-57 North Wharf Road 6-3-907 –912, Rajbhavan Road
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w w w. a s i a n h h m . c o m 
 Asian Hospital & Healthcare Management ISSUE-12 2007
Foreword

Socially responsible, efficient healthcare


Healthcare organisations, whether owned by the state or privately, either for-profit or not,
shall provide incentives for efficiency, emphasise on safety, and have measures to practice
and communicate socially responsible behaviour.

I
t has been the fundamental premise that business or- The role of privately owned healthcare organisations
ganisations exist to create wealth for their sharehold- is likely to increase in the future as state-owned healthcare
ers ever since Adam Smith’s Wealth of Nations laid systems are under severe strain in several regions. Asia’s
the foundations of classical free market economic theory two emerging economies, India and China, which have
in the 18th century. Several countries began building experienced stupendous economic growth as a result of
their economies on the free market model under which, reforms, too, still lag in the area of healthcare for all. The
business organisations regard their customers as impor- economic success achieved on the strength of countries’
tant stakeholders. At the economy level, this model en- human resources will be sustainable on the strength of
sures that the most efficient users of shareholders’ money improved healthcare systems.
receive their capital investments.
Therefore, the message is loud and clear for the lead-
The concept of corporate social responsibility in the ers of healthcare, whether the organisations are owned by
context of businesses, in general, adds another dimension the state or privately, either for-profit or not; they shall
to this scenario. It postulates that business organisations provide incentives for efficiency, emphasise on safety, and
should consider the society as a stakeholder in addition to have measures to practice and communicate socially re-
their shareholders and customers. In doing so, corpora- sponsible behaviour. As an IBM study predicts, the fu-
tions ensure their long-term survival. This is supported ture customers of healthcare will increasingly pay out of
by the views of Peter Drucker, who argued that every their pocket for healthcare, be more informed on account
organisation must be able to state that its business exists of proliferation of information enabled by information
to serve public good (Practice of Management), in order to technology, and are likely to comparison-shop for the
survive and thrive. best healthcare providers just as they do when they buy a
consumer durable.
Unlike other businesses, however, a hospital’s
raison d’etre is healthcare, which directly fits with no- Organisations that strive to be socially responsible
tions of public good. Therefore, the dimensions of cor- will build brands that would be strong enough to sustain
porate social responsibility acquire a slightly different their performance over the long term.
colour in the context of hospitals. More so, if the hos-
pitals are privately owned, for-profit organisations. It is
this aspect that is analysed in depth, in the cover story
“Corporate Social Responsibility in Private Hospitals”,
by John Zinkin, Deputy Chairman, CSR Malaysia and Rajeshwer Chigullapalli
Managing Director, Zinkin Ettinger Ltd., Malaysia. Chief Editor

Essential reading for the


healthcare professional

Subscribe / register online at

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 Asian Hospital & Healthcare Management ISSUE-12 2007
H E A L T H C A R E M anagement

Safe and
Reliable
Healthcare
Supporting
strategy and
structure
Effective leaders translate their strategic
goals into a few simple statements that
everyone working in the organisation can
understand and to which they can align
their behaviour.

everyone working in the


organisation can under- Michael Leonard
stand and to which they Physician Leader
can align their behaviour. Patient Safety
If too many, or, made too Kaiser Permanente

T
o consistently deliver superior complex, front line workers can neither Allan Frankel
clinical quality and value, health- remember the goals nor, while providing Director
Patient Safety
care organisations must ensure care, consistently align their behaviour to
Partners Healthcare
that their strategy and structure are well them. By contrast, Ascension Healthcare,
USA
coordinated. Organisations that succeed the largest faith-based American health sys-
will be able to deliver superior clinical care tem with 67 hospitals, espouses 3 goals for
and outcomes, and will have market advan- everybody everyday: care that is safe, care
tage in brand reputation and operational that works (reliable delivery of evidence rounds, a scribe’s sole job is to record every
efficiency. Success requires work in four ar- based medicine), and care that leaves no issue brought forth and by whom, so it can
eas: 1. Leadership—senior, administrative one behind (fulfilling their social mission of be evaluated, and feedback given to every
and clinical 2. human factors 3. reliable providing care to disenfranchised patients staff member who contributes. The topics
care systems and 4. patient–centric care. without health insurance or other care op- discussed during WalkRounds are evaluated
tions). The mantra at Ascension is that “by for risk, assigned to appropriate individu-
Leadership the year 2008, we will have no preventable als, and tracked to ensure resolution. After
Leaders must model and live organisational patient harm or deaths.” If achieved, this six years and hundreds of rounds, employ-
values everyday. If there is notable difference mission will be a competitive advantage as ees and physicians know that they can be
between the values inscribed on the hospital clear measures of quality and patient safety forthright in their comments without a
wall and what staff and patients experience become more readily available for patients punitive response, and that their concerns
every day, then habitual excellence is not and purchasers. will be acted upon. Visible physician leader-
possible. Cultural surveys have been use- At Brigham & Women’s Hospital in ship is critically important in the adoption
ful in American hospitals to assess the real Boston a management tool called Leader- of collaborative clinical practice necessary to
perceptions of staff as to their perception of ship Patient Safety WalkRounds engages achieve superior clinical outcomes. The tra-
management, the quality of their work ex- senior leadership on a weekly basis with ditional educational approach of physicians
perience, and how safe they feel to advocate front line staff. Through careful planning, as individual experts and vigilance as the
for safe care. the WalkRounds appear as relaxed con- mechanism to ensure safety is not an effec-
Effective leaders translate their strate- versations where staff can feel safe discuss- tive strategy given the complexity of modern
gic goals into a few simple statements that ing any topic including errors. On these medical care. Yes, we need skilled experts,

w w w. a s i a n h h m . c o m 
H E A L T H C A R E M anagement

but as we have learned from other high-risk elements are the distillation of decades of technical delivery of care, i.e. how long did
industries – such as aviation, nuclear pow- work in high risk industries and our experi- it take to successfully intervene in patients
er and military operations – the ability to ence working with medical teams in high with acute myocardial ischemia? Interest-
work collaboratively within reliable systems risk clinical areas over the past several years. ingly, we have learned that these technical
is a critical success factor. This perspective This basic communication package can markers are often invisible to patients, who
is best understood when viewing the be- be embedded within a few clinical elements process their medical care as a profound
haviour of stellar physician leaders in the that clinicians use every day to care for pa- social experience. Understanding this, we
first couple of minutes when a team comes tients. High risk clinical areas like obstet- must redefine what constitutes successful
together. They establish effective team be- rics, surgical services, emergency medicine, care. It is not adequate to intervene techni-
haviour and an environment of supportive critical care and others are natural areas for cally, we must engage patients so that they
respect by actively engaging all participants intervention, though virtually any clinical understand the care they receive and feel
in a discussion of plans, disavowing personal area can benefit from the systematic adop- supported throughout. This then highlights
perfection (“We’re all experts, but because tion of these tools and behaviours. health literacy as a major problem because
we’re human we’ll all make mistakes. That in America, the average citizen reads at an
includes me.”), and clarifying the goals and Reliability and reliable design 8th grade level, while frequently we pro-
pitfalls of the job ahead. The concept of reliability—defined as de- vide them with information formulated
fect free care over time for a patient—has at a college reading level. Patients with
Human factors evolved from high risk industries and is health literacy issues consume four times
Applied human factors science provides gaining traction in healthcare. Reliable the average resources annually, and con-
tools to support effective teamwork and systems support the delivery of consistent, sistently have poorer clinical outcomes.
communication. Communication failures superior care. For example, in surgical care, Two simple techniques from the Ameri-
are the central theme in the overwhelming infection rates are affected by administra- can Medical Association have shown great
majority of avoidable adverse patient out- tion of prophylactic antibiotics within 60 benefit: Ask Me Three—that every patient
comes. Often, healthcare providers hesitate minutes prior to incision. The tracking of and their family must understand three as-
to speak up about their concerns because antibiotic administration and surgical infec- pects of every component of care—“ what is
they don’t know the plan of care (and worry tion rates are currently required metrics in my basic medical problem, why is it impor-
they will appear ineffective) or they were American healthcare. In many ICUs ven- tant that I understand this, and what needs
previously treated with disrespect when they tilator associated pneumonias, previously to happen for me to get better?” The second
did voice concerns. The other common pit- considered an irreducible cost of long term technique is the “Teach Back”, in which in-
fall is “the assumption we’re all in the same ventilation, has virtually been eliminated stead of asking them if they understand and
movie”, rather than using structured com- by the combination of peptic ulcer disease having the patient politely nod in agree-
munication such as a read-back to ensure all and deep venous thrombosis prophylaxis, ment, we ask “you have heard us talk about
have the same understanding of the plan of elevating the head-of-the–bed 30 degrees your care, now please take a minute and tell
care. and sedation vacations. me how you will explain it to your family.”
The authors have taught human factors Many healthcare systems have adopted Often we have assumed patients and fami-
and team work training in multiple Ameri- improvement methods like Toyota Lean lies understand, but on closer inspection
can health systems. The four elements nec- or Six Sigma, which allow frontline experts their lack of understanding can seriously
essary for effective teamwork and commu- to contribute to process improvement and impact their care process and health status.
nication are: elimination of waste. The organisations that
1. Structured language – using an SBAR are making quantum leaps in quality and In summary
(Situation–Background–Assessment– safety—and are realising substantial opera- In regards the endeavour to achieve safe and
Recommendation) briefing model that tional efficiencies—have embedded these reliable healthcare, we are at best at the end
offers predictability, and closed loop com- techniques within their culture. Similar to of the beginning, but over the past decade
munication techniques like read-back Toyota, they relentlessly focus on how to the pattern, form and shape of success have
2. Critical language – “I need a little clar- improve the way they improve, rather than become clear. The tapestry of safe and reli-
ity” that allows anyone to “stop the line” if applying a solution and declaring victory. able healthcare is woven with the threads
they are concerned about the well-being of of leadership engagement, human factors
the patient Patient-centric care theory application, reliable design imple-
3. Psychological safety – an envi- Patient-centric care, ultimately the singular mentation, and understanding of patients’
ronment of respect where anyone goal of all healthcare efforts, is to deliver safe holistic needs. “Safety and Reliability” is
feels safe to speak up and voice a and reliable care for all. Leading health sys- not a series of projects, it is an overarching
concern—a significant issue in cultures that tems continuously learn about the patient strategy formulated into understandable
place emphasis on politeness and respect experience and how medical care is per- and simple goals and supported by ex-
4. Effective leadership – described previous- ceived by patients and families. In America, traordinarily elegant organisational struc-
ly as the ability to rapidly engage healthcare a common failing is that physicians and ture, all of which can be envisioned only
employees in team behaviour. These four hospitals ascertain success by assessing the by enlightened leadership.

 Asian Hospital & Healthcare Management ISSUE-12 2007


H E A L T H C A R E M anagement

In the Passionate Pursuit of


Healthcare Excellence

It’s time for healthcare organisations to adopt drastic changes in their existing systems
in order to reduce medical errors and deliver quality healthcare.

uted to this dysfunctional system has been in the healthcare institution—this would be
Peter A Gross debated, whatever is the number, it is too a structural measure. The group should be
Chairman large. The report concluded that the prob- knowledgeable and experienced in measur-
Internal Medicine lem is caused by faulty systems of care, not ing processes and outcomes. Then, we can
Hackensack University Medical Center
USA
faulty providers. To address the issue, they start with measures that have been vetted for
emphasised that new systems of care must a number of years and are evidence-based
be developed. such as the measures for acute myocardial
In their follow-up document—Cross- infarction (AMI). The AMI process mea-
ing the Quality Chasm, the IOM urged that sures include the use of aspirin and a beta-
each process of care should be safe, effective, blocker on admission and discharge, use of

T
he healthcare system in the United efficient, equitable, timely and patient cen- an ACE inhibitor or an ARB if heart failure
States is in disarray. Communi- tered. They developed 10 new rules for 21st is present, and door to balloon inflation time
cation among providers is poor. century healthcare (see Table 1). of less than 90 minutes. These are process
Providers continue to function without measures based on
adequate data, thus, preventing mid-course studies in the medical
10 New Rules for 21st Century Health Care*
corrections when the service they provide literature that show a
is off the mark. A shared organisational vi- 1. Develop healing relationships 6. Safety is a system property decrease in mortality
sion is lacking among healthcare providers. 2. Customize care to patient 7. Embrace transparency when these processes
The suffusion of information technology is 3. Patient is source of control 8. Anticipate patient’s needs are followed. In fact,
slow compared to other industries. A strong 4. Share knowledge 9. Reduce waste they are more accu-
performance improvement structure to fa- 5. Use evidence-based medicine 10. Cooperation is a professional priority rately called process-
cilitate improvement is minimal in most oriented outcome
*Crossing the Quality Chasm, Institute of Medicine, 2001 Table: 1
healthcare institutions. The use of evidence- indicators. A more
based medicine versus anecdotal experience standard outcome
to guide the practice of medicine is not often While most of the New Rules in indicator would be mortality in the hospi-
distinguished. The coup de gras is that care is Table 1 are actionable now, two will require tal or within 30 days. Mortality assessment
not centered on the patient but on the dis- special attention. The patient as the source depends on risk-adjustment and is a more
ease. As a result, awareness of the physical of control will depend on developing the difficult measure to assess accurately.
and emotional needs of the patient with a tools for creating a more informed patient If you adopt the Institute for Health-
disease is not considered and a prevention —the responsibility being shared by the care Improvement’s 100,000 lives campaign
focus is missing. provider team and the patient. The other you will have access to bundles of perfor-
Is it hopeless or can these issues be dealt knotty issue is embracing transparency. To mance measures for managing AMI, pre-
with more effectively and care coordinated deal with transparency, the legal system will venting ventilator-associated pneumonia,
around the patient’s needs? To begin to ad- have to make some adjustments so this New central venous line infections and surgical
dress the dysfunction in “modern” medical Rule doesn’t result in a malpractice quag- site infections, and reducing adverse drug
care, the Institute of Medicine (IOM) is- mire. events with medication reconciliation. All
sued its now famous report—To Err is Hu- Where do we begin? We begin by mea- of these are evidence-based. Finally, ongo-
man—in 2000. They pointed out that the suring. Using the Donabedian construct— ing studies are attempting to determine if
frequency and severity of accidental injury structure, process and outcome measures— rapid response teams can detect failing pa-
in the healthcare system is a serious prob- we can begin. First, we need to have a tients early and prevent their transfer to an
lem. While the number of deaths attrib- performance improvement group available intensive care unit or death.

w w w. a s i a n h h m . c o m 
H E A L T H C A R E M anagement

Implementation Strategies for Changing Provider Behavior* such as nurse practitioners, experts in a giv-
en medical condition such as heart failure,
Generally ineffective Variably effective Generally effective
heart attack or stroke, was critical to moni-
Research publications Audit and feedback Provider reminders
toring the care patients received and vital
Dissemination of guidelines Local opinion leaders Computer provider order entry systems
to intervening with the physicians when
Didactic lectures Local consensus conferences Clinical decision support systems performance measures were not being met.
Consumer education Academic detailing The nurse practitioner was always backed
Barrier-oriented interventions up by the specialty and department chiefs.
Collaborate with mid-level providers This approach inserted a redundancy into
*Gross et al. Medical Care 2001;39:8(Suppl II):85-92 Table: 2 the system of care and assured compliance.
Another method for achieving compli-
occasionally given be- ance is to use the tools of reliability science.
International Patient Safety Goals from Joint Commission International
fore the diagnosis of To achieve 80%-90% compliance—i.e.,
1. Identify patients correctly
CAP is made, in order 1-2 failures out of 10, use checklists and
2. Improve effective communication among providers to comply with the other standard order sheets, reminders, au-
3. Improve the safety of high-alert medications four-hour window al- dit and feedback, avoid reliance on memory,
4. Eliminate wrong-site, wrong-patient, wrong-procedure surgery lowed for antibiotic and train in quality improvement. To move
5. Time out to verify checklist before starting a procedure administration from to the 95% level—i.e., 5 or less failures out
6. Mark the precise site for surgery the time of entry to of 100, institute computerised physician
7. Reduce the risk of health care-acquired infections with hand hygiene the emergency room order entry with clinical decision support
8. Reduce the risk of patient harm from falls
to the time of antibi- that provide decision aids and reminders
otic administration. to the provider, make the desired action the
Table: 3
Because the diagnosis default action, simplify and standardise, and
Stages of acceptance of impending change of CAP is not always use redundancy as described above. Atten-
clear, making the tion to human factors engineering is also
1. Denial: “The data are wrong”
four-hour window can helpful. Finally, to reach the 99% compli-
2. Anger: “Who are you to judge my practice?”
be difficult. Therefore, ance level which is rare today—i.e., 5 or less
3. Bargaining: “My patients are sicker, so those measures just don’t apply to me.”
it is best to lower the failures out of 1,000, analyse each critical
4. Depression: “The situation is hopeless” and “I’m leaving medicine.” compliance goal from failure with the techniques of root cause
5. Acceptance: “like it or not, we must be at the table and learn to play by the new rules.” 100% to 95%, for ex- analysis in retrospect and failure mode and
6. Leadership: “We will actually help make the new rules and lead the field.” ample, to account for effect analysis in prospect.
Table: 4 those unusual cases First, enlist the support of the inno-
where the diagnosis vators at your institution, then, the early
It is of interest that compliance with is not clear on initial presentation to the adopters and early majority will follow.
process measures translates into better out- healthcare system. Gradual adoption is critical and easier than
comes. They showed that for every 10% We have a lot of work to do to correct attempting to accomplish all at once. Don’t
increase in compliance with the measures a the poor performance demonstrated by Mc- worry about the traditionalists. They typi-
10% reduction occurred in inpatient mor- Glynn et al. What are some of the imple- cally make up about 15% of the providers.
tality. The CMS-Premier Hospital Quality mentation tools that we can use to improve? They may not be worth the effort as you
Initiative Demonstration project showed Additional factors are support from senior may never convince them to change.
that in one year for community-acquired leadership to help shape the organisational Similar approaches can be applied to
pneumonia (CAP) and coronary artery culture. Involvement of the Board of Trust- improving patient safety—the other side of
bypass graft surgery among approximately ees of the institution is important. Atten- the quality coin. These international patient
3,000 hospital deaths were avoided and tion to financial aspects of quality improve- safety goals also require instituting new sys-
US$1 billion was saved. ment will make an impact on these leaders. tems mentioned in Table 3.
How well are we doing with reach- Efforts to reduce waste, bring down length As you go about improving the qual-
ing compliance with these well-described, of stay, use resources more wisely and effi- ity and patient safety at your institu-
evidence-based measures? McGlynn and ciently, and go lean by cutting 1%-3% from tion, keep in mind Kuebler-Ross’s stages
colleagues studied compliance with many the budget annually will enhance support to of acceptance of impending change
measures in 12 communities and found any investments that have to be made in the (actually, Kuebler-Ross described it in re-
that compliance reached only 55%. improvement effort. lation to acceptance of death) (Table 4).
There is a downside or potential un- Most critical is the development of Life is short; art is long. Good work takes a
intended consequences to performance new systems of care delivery. The new sys- long time to accomplish.
measurement. Human nature may lead tems will vary from one institution to the
to gaming the system to achieve compli- next. For example, in our medical centre,
Full references are available on
ance. For example, for CAP, antibiotics are we found that inserting mid-level providers www.asianhhm.com/magazine/

10 Asian Hospital & Healthcare Management ISSUE-12 2007


H E A L T H C A R E M anagement

Healthcare in New Zealand


Learning from complaints

Quality improvement measures made across the health sector as a result of complaints made
to the Health and Disability Commissioner are evidence that investigating systemic failures in
care, and recommending improvements, is making a positive difference in New Zealand.

providers and institutional providers such as Commissioner forms an opinion as to


Ron Paterson hospitals and rest homes. whether the provider has breached the Code.
Health and Disability Commissioner The Health and Disability Commis-
New Zealand sioner complaints process ensures that the Improvements in quality of care
rights set out in the Code are enforced. One There is growing evidence that investigating
of the primary objectives of the Health and systemic failures in care, and recommend-
Disability Commissioner is to “secure the ing improvements, is making a positive
fair, simple, speedy and efficient resolution difference in the health and disability sec-

T
here is a growing international of complaints”. The complaints system en- tors. Landmark research has recently been
interest in using patient com- sures a degree of accountability for health- published on the relationship between
plaints to address problems with care providers, but also allows consumers to complaints and quality of care in New
quality in healthcare. In New Zealand, the express their concerns, facilitates the resolu- Zealand. Dr Marie Bismark compared 398
complaint mechanisms under the Health tion of complaints, triggers an investigation complaints to the Commissioner relating
and Disability Commissioner Act 1994 in appropriate cases, and ensures action is to public hospital admission in 1998 with
have become the primary vehicle for deal- taken to reduce the risk of harm to other a nationally representative sample of non-
ing with complaints about the quality of patients. complainants who suffered adverse events
healthcare and disability services. Anyone can make a complaint to the in the same year. Bismark concluded that
Commissioner alleging that any action of “complaints offer a valuable portal for ob-
The complaints system a healthcare or disability services provider serving serious threats to patient safety and
New Zealand has had a health and disability appears to be in breach of the Code. Essen- may facilitate efforts to improve quality”.
service complaint system in place for over tially, this means complaints may be made The following Commissioner’s reports
a decade. This complaints system is headed about anything related to the quality of ser- are illustrative of the way in which com-
by the Health and Disability Commis- vices (including the way in which they were plaints can be influential in bringing about
sioner, who has the role of promoting and provided, and the handling of a complaint quality improvements in healthcare:
protecting the rights of health and disability about them). The Commissioner may also
consumers, and facilitating the resolution undertake investigations on his or her own Medication mix-up
of complaints. The Commissioner’s spe- initiative, without waiting for a complaint A report released in November 2005
cific complaints investigation role relates to be made, allowing the Commissioner to highlighted the systemic issues regarding
to alleged breaches of the statutory Code of fulfil a “consumer watchdog” role and to medication safety in public hospitals. The
Health and Disability Services Consumers’ ensure public safety. Commissioner received a complaint from
Rights (the Code). The Commissioner’s investigation is Mrs Anderson’s daughter about the care her
Consumers of health and disability ser- an impartial and independent process to mother received at a hospital. 91 year old
vices have ten rights under the Code, which which the rules of natural justice apply. Mrs Anderson presented to the hospital’s
cover basic principles such as the right to re- Investigations often involve liaison with the Emergency Department with a suspected
spect, the right to an appropriate standard of other bodies with an interest in the subject lower respiratory tract infection. At some
care and the right to full information and to matter of the complaint. Where the qual- time during the course of her clinical
give informed consent, and places duties on ity of care is in issue, the Commissioner assessment or admission, a computer-
providers regarding complaint procedures. will obtain independent expert advice from generated patient identification label was
Consumers in both the private and public a peer of the provider with knowledge affixed to the top of a completed drug chart
sector are covered, and the duties apply to of, and experience in the matters under intended for another patient. Due to this
health professionals, unregistered healthcare investigation. After an investigation, the error, Mrs Anderson received incorrect

w w w . a s i a n h h m . c o m 11
H E A L T H C A R E M anagement

medications (and did not receive her found that the nurse had inadvertently set the pharmacy in breach of the Code for fail-
own regular medications) for a period of the pump to deliver 20mm of diluted medi- ing to have adequate systems in place to pre-
four days. cation per hour instead of 2mm per hour. vent such mistakes. The report was sent to
While the error was perpetuated by a Accordingly, the nurse was found in breach the Pharmacy Council, the Pharmaceutical
number of individuals in the medical and of the Code. A factor contributing to the Society, the Pharmacy Guild, and Medsafe
nursing teams, the critical issue identified error was confusion about the operation of (New Zealand Medicines and Medical De-
in the investigation was that various or- two different types of Graseby pump—a vices Safety Authority). The Commissioner
ganisational and system factors outside of “green” one, which delivered medication at also made a recommendation that Roche
the individual providers’ control ultimately millimetres per 24 hours and a “blue” pump and Jansen-Cilag Pty Ltd review labelling of
conspired to create a dangerous situation for set at millimetres per hour. medication to assist pharmacists to clearly
Mrs Anderson. Accordingly, the hospital was The Commissioner’s report recom- identify different strengths of medication.
held to have breached Right 4 of the Code. mended that to reduce the risk of error, The report was also published on the Com-
A copy of the report was sent to the Minister where practicable, palliative care services missioner’s website.
of Health, the Director-General of Health, move towards using one type of pump for In addition to systems changes imple-
the Medical Council, the Nursing Council, the administration of subcutaneous medi- mented at the individual pharmacy, the
the Royal Australasian College of Physi- cation. The recommendation was sent to Pharmacy Council of NZ reported that
cians, the Accident Compensation Corpora- all DHBs, Hospice New Zealand, and the it is “actively addressing” the issues raised,
tion, the Coroner, and the national Quality Society of Palliative Medicine. They were including standardisation of dispensing
Use of Medicines Group. The report was subsequently contacted to see what follow- procedures and mechanisms for sharing
also posted on the Commissioner’s website, up action they had taken. Only six of the procedural changes made as a result of
www.hdc.org.nz. Following the report, the 21 DHBs reported that they were still using errors. In a recent survey, 83% of pharma-
Commissioner visited the hospital to follow two types of pump (and they were either cists said that the media attention to this
up on his recommendations that the report phasing out one model, or had responded to case had prompted action in their pharmacy
be circulated for orientation and training the recommendation by instituting tighter (Pharmacy Today, Sept 2006).
purposes, and that a number of changes be protocols, new labels, or training to reduce
made to the policies and practices in place. the potential for error). All DHBs indicated Conclusion
This report has been widely used for that they had carefully considered the con- These cases are part of a body of evidence on
teaching purposes in the health sector, and cerns raised by the Commissioner, and had the use of complaints to improve the qual-
prompted one metropolitan DHB to write: drawn them to the attention of appropri- ity of healthcare. The Health and Disability
“This DHB has taken the key messages from ate staff. The Society of Palliative Medicine Commissioner complaints system plays a
your review very seriously indeed. The mea- supported the Commissioner’s recommen- key role in linking dispute resolution with
sures we have put in place since receiving dation and Hospice New Zealand advised improvements in patient safety and quality
your report include: redesigning the drug its members of the risks involved in holding of healthcare. The Commissioner’s reports
chart so that the patient’s name is handwrit- and using different types of the pump. It are widely reported in the media and are
ten; assigning a common area for patient asked the manufacturer to consider devel- used for educational purposes throughout
records and drug charts in all wards; keep- oping a standard pump with a single scale the health sector. The complaints system is
ing the patient labels with the drug charts; setting. The company, Graseby Internation- linked to other strategies for improving the
and deploying a ‘10 rules of safe prescribing’ al, replied that this would be considered as quality of care, such as continuing profes-
document to all medical officers and senior part of its product development process. sional development, audit, risk manage-
nurses.” The report has prompted medica- ment, and critical incident reporting, which
tion safety audits and improvements in hos- Pharmacy error promotes learning from complaints and
pitals throughout New Zealand. Another recent complaint has resulted in the implementation of quality improve-
widespread changes in the systems in place ment measures. Leading safety experts Alan
Graseby pump at pharmacies to reduce the risk of errors. In Merry and Mary Seddon recently com-
In another case, the Commissioner’s rec- March 2005 the Commissioner received a mended the New Zealand Health and Dis-
ommended changes regarding the use and complaint from the mother of a 10 year old ability Commissioner on “a world-leading
manufacture of a medical device are be- girl who had been dispensed the incorrect focus on addressing aspects of the system
ing adopted nationally. A complaint was strength of medication on two separate oc- which contribute to patient harm, rather
received from the Police on behalf of the casions at her local pharmacy. An investiga- than only seeking to identify individual
family of a woman who died while receiv- tion revealed that there had been a failure to scapegoats when things go wrong”. This
ing palliative care at home for end-stage check the medications before they were dis- focus on investigating systemic failures in
lung cancer. The woman’s death followed pensed. Staff also failed to accurately record care, learning from complaints, and recom-
the administration of an overdose of mor- who was responsible for those checks, so it mending quality improvements, is making
phine by a palliative care nurse. The mor- was not possible to establish the identity of a positive difference to the quality of health
phine was administered subcutaneously, the responsible pharmacist. The Commis- care in New Zealand.
References are available on request from:
using a Graseby pump. The Commissioner sioner’s report found the pharmacists and
rpaterson@hdc.org.nz

12 Asian Hospital & Healthcare Management ISSUE-12 2007


H E A L T H C A R E M anagement

Healthcare Recruitment: The B. E. Smith way


“Improving Lives through Healthcare Recruitment.” • Ongoing communication with client and placed
How does B. E. Smith live up to its tag line? candidate following the search to ease potential transition
As quoted by Doug Smith, B. E. Smith’s CEO and Presi- issues for candidate such as family relocation etc
dent, “when we say Improving Lives through Health- • Closing procedures involving communication with non
care Recruitment, we are talking of improving the lives of selected candidates as well as a client satisfaction
patients through better leadership of hospitals and their survey
departments, the lives of healthcare leadership candidates
[and their colleagues and families] through better career How does the Interim Management recruitment
opportunities, and the lives of community members when service of B. E. Smith help hospitals?
we bring good families in. In summary, we positively impact Not only is B. E. Smith able, in a timely and affordable fash-
the whole ecology of lives by what we do, recruiting quality ion, to provide its clients with qualified, highly experienced
healthcare leadership”. individuals who will perform the every day function of the
open positions, they also benefit from the following added
What is the biggest challenge in recruitment for the value:
healthcare industry? • The interim executive is an employee
There is only one [worldwide] overall of B. E. Smith thus alleviating our cli-
challenge: the demand-supply imbal- ents from all people management ac-
ance of quality leadership talent due to tivities typically associated with their
the increasing aging population in the own employees
developed economies and booming • This interim “on loan” works in
population of developing economies. tandem with a B. E. Smith executive
The development of hospital facilities project manager giving the client the
without proper leadership affects quality benefit of two professionals’ expertise
of care negatively. and experience
• Once the client organization has
What are Best Practices that B. E. defined its requirements, our interims
Smith follows? follow the predictable B. E. Smith
B. E. Smith’s Best Practices involve not process: assessment, action plan
only the process outlined below but also development and plan implementation
our team approach. These teams work • The interim executive arrives therefore
intimately to find the best talent for our with a client specific objective which
clients and are comprised of our busi- may involve, among other duties, be-
ness development executives along ing a change agent, management tran-
with our executive consultants (all with sitioning, mentoring, activities involving
healthcare leadership experience and regulatory compliance and any other
expertise) and their research colleagues. project management. These services,
• Comprehensive understanding of the as performed by our executives, are
client’s needs during initial discussions with key stake- typically not performed by our client’s permanent em-
holders ployee often because of lack of time and resources
• Preparation of the position profile based on client’s need
and presentation for approval by client How can Asian hospitals benefit from B. E. Smith's
• Development of a marketing plan and attractive cam- services?
paign to our target potential candidates They can benefit from the full array of services we have de-
• Identification, screening, evaluation and narrowing of the veloped but mainly from the expertise we have acquired
pool of candidates based on client’s specifications over the years by focusing only on hospital leadership
• Agreement with client on the final list of best candidates talent, unlike our competition. Deployed through the high
and development of comprehensive profiles caliber talent employed at B. E. Smith, our consultants are
• Comprehensive background and reference checks on experienced healthcare executives who have walked in their
selected candidates clients’ shoes. Finally, the most beneficial service we can
• Travel arrangements and interview scheduling for presen- tangibly provide Asian hospitals is the access to American
tation of candidates to client healthcare educated leadership from C-level executives to
• Negotiation of terms of employment with client and directors of all departments in a hospital. No one delivers
candidate to ensure all expectations are communicated healthcare leadership talent like we do.
before an offer is made Advertorial

For more details about B. E. Smith’s services, visit www.besmith.com or contact Doug Smith, President or Caroline Krause, Vice President at 001-913-752-4528

w w w . a s i a n h h m . c o m 13
Cover story H E A L T H C A R E M anagement

Corporate Being responsible means


finding the right balance
between what patients want

Social and what governments


can afford, and that staff
are willing to provide the

Responsibility
care needed. Doing this
affects the entire hospital
value chain. Doing this
well, ensures the long term

in Private Hospitals success that shareholders


demand.

John Zinkin
Deputy Chairman
CSR Malaysia
Visiting Fellow
International Centre for Corporate
Social Responsibility
Nottingham University Business School
UK
and
Managing Director
Zinkin Ettinger sdn bhd
Malaysia

A
“A business that does not show a profit at least t the heart of delivering good pri- pitals. The advantage profit-making hospi-
equal to its cost of capital is irresponsible; it vate healthcare lies an apparent tals have, is that normally profits are a good
wastes society’s resources. Economic profit per- contradiction. Hospitals for profit signal that what is being provided is valued
formance is the base without which business are expected to make money, arguably and being done efficiently. Yet in this area
cannot discharge any other responsibilities, capitalising on patients’ misfortune and too, there is a problem because some treat-
cannot be a good employer, a good citizen, suffering. Some may feel that being so- ments cannot be justified on grounds of
a good neighbour. But economic performance cially responsible means providing unlim- profits.
is not the only responsibility of a business… ited healthcare without paying attention
Every organization must assume responsibil- to profit. Yet as Peter Drucker’s quotation Who are the stakeholders?
ity for its impact on employees, the environ- above shows, they would be wrong because So what do we really mean by corporate
ment, customers, and whomever and what- being socially responsible is first and fore- social responsibility (CSR) in the private
most about using scarce resources well and hospital context? Perhaps the easiest way
ever it touches. That is social responsibility.”
this applies to not-for-profit hospitals just to answer the question is to consider who
The Daily Drucker, Peter Drucker as much as it does to profit-making hos- the stakeholders of private healthcare are.

14 Asian Hospital & Healthcare Management ISSUE-12 2007


H E A L T H C A R E M anagement

First and foremost they are customers


CSR and the Hospital Value Chain
(patients and families) served by hospitals,
Outpatient Marketing Management
employees working in hospitals and gov- R&D Purchasing Production
Care & Sales Policies
ernments who have a vital interest in pub-
lic health of electorates that can vote them Natural Capital
> Biopiracy > Environmental > Pollution/Spills > 3 'R's
out of office if they are dissatisfied with the > Patenting damage > Emissions/GHGs -- Reduce

traditional > Waste > Use of water -- Reuse


health service they receive. Shareholders remedies > Pollution > Use of energy -- Recycle

are also primary stakeholders, but in many > GHGs > Bandage/parts

disposal
countries are regarded as less important be- Social Capital
> Compution Corruption Corruption No comption
> > > Corruption > Corruption >
cause much of society still has to come to > Intellectual > Social inequity > Social inequity > Social inequity > Social inequity > Obey the law
terms with the idea of making money from property
> Abuse of
> Abuse of > Ethical > Ethical > Avoid politics

indigenous marketing marketing > Support


peoples’ suffering. indigenous people > Generics v. > Generics v. education
people's > Intellectual brands brands
Customers knowledge property
In business, as opposed to healthcare
Human Capital
the focus is on creating and retaining > Discrimination > Discrimination > Discrimination > Discrimination > Discrimination > Diversity &
> Human Rights Human Rights Human Rights Inclusion
> > > Unicon Rights > Unicon Rights
loyal customers. Again in the words of > Union Rights > Unicon Rights > Unicon Rights > Health & Safety > Health & Safety > Meritocracy
Peter Drucker: > Health & Safety
> Working hours
> Health & Safety
> Working hours
> Health & Safety
> Working hours
> Working hours > Working hours > Respect Union

Rights
“It is the customer who determines what > Good Health &

Safety
a business is. For it is the customer, and he > Good working

alone, who through being willing to pay for a hours


> Pay for
good or a service, converts economic resources performance
into wealth, things into goods. What the busi-
Figure: 1
ness thinks it produces is not of the first im-
portance—especially not to the future of the cilitate patient care then, in the words of laws and acceptable business practices) and
business and to its success. What the customer Hippocrates, staff will be motivated to: to invest in human capital (by empowering
thinks he is buying, what he considers ‘value’ "Declare the past, diagnose the present, and training staff). If we look at CSR in this
is decisive—it determines what a business is, foretell the future; practice these acts. As to way, we can see how it affects the hospital
what it produces and whether it will prosper. diseases, make a habit of two things—to help, value chain in figure 1: As can be seen, there
The customer is the foundation of a busi- or at least to do no harm." are a number of issues hospitals must ad-
ness and keeps it in existence. He alone gives Governments dress if they are to behave responsibly across
employment. And it is to supply the consumer Governments need to be re-elected and the value chain.
that society entrusts wealth-producing re- so their interest is quite simply making sure Natural capital
sources to the business enterprise.” that healthcare does not a become political The issues appear in R&D where private
Drucker, The Practice of Management ‘hot potato’. Governments welcome private medicine needs to be careful to avoid
There are, however, problems when we ap- healthcare as long as it is politically accept- charges of abetting biopiracy and encourag-
ply this thinking to healthcare: able and so private hospitals that forget this in ing the patenting of traditional medicines.
1. Patients demand the best care regardless their search to be profitable put themselves at They also appear in "purchasing" and “pro-
of economic justification and are often risk of losing their “Licence to Operate”. duction” (the processes, by which patients
unable to pay for it, looking to govern- Shareholders are admitted, diagnosed and treated) and
ment to meet the bill A fair return on capital employed is all that relate primarily to the environmental im-
2. Governments are finding they can no shareholders can ask for, and they need to pact hospitals can have through waste, pol-
longer afford to do this remember that unlike many other busi- lution, emissions and the use of water and
3. Successful healthcare reduces the nesses, the provision of healthcare is an energy. From a policy perspective, hospi-
number of patient visits; it does not try emotional and moral issue that may mean tals need to think about adopting the ‘3Rs'
to maximise loyalty or retention, unlike they have to live with a lower rate of return designed to reduce, re-use (if possible) and
business. We cannot, therefore, adopt a than they might otherwise like. If they are recycle (again if possible) necessary inputs.
customer focused approach designed to perceived to be “scalping” their patients, Social capital
maximise repeat purchase! they will lose their “Licence to Operate”. The key issues here are to ensure that all the
Employees way through the value chain, business is un-
Without good, caring doctors and nurses, CSR equals capital stock renewal dertaken so as to avoid, or at least minimise
hospitals cannot deliver the care patients Another way of looking at CSR is to regard the opportunities for corruption. The issues
expect. If they provide the best terms and it as a form of Capital Stock Renewal re- involving intellectual property are more
working conditions, recognising in a world flecting the need to preserve natural capital complicated because they require careful
short of medical talent, they compete (by minimising the hospital’s environmen- cost-benefit analysis of the value of generics
globally to keep their best people; and if tal footprint), to improve social capital (by versus patented brands. From a marketing
they ensure administrative procedures fa- supporting the institutional framework of perspective, hospitals should adopt a policy

w w w . a s i a n h h m . c o m 15
H E A L T H C A R E M anagement

The Business Case


of truthful selling and ethical marketing, tients will not feel ‘scalped’ CSR Pathways to Shareholder Value
lest they become associated with capitalis- 2. Guarantee the supply of willing and mo- Product and
Tangible
ing on the suffering of others. tivated staff because employees will feel process innovation
outcomes
Increased
Reduced waste and profitability
Human capital the hospital is doing what is ‘right’ to emission Improved capital
Here the issues that run right across the patients and staff Efficient use of utilisation
resources
value chain all are associated with how best 3. Keep governments ‘on side’ as they will Occupational health
to recruit, retain, upgrade and motivate not have political repercussions to fear and safety Intangible Customer satisfaction
Shareholder
Stakeholder assets value
scarce qualified staff who are in demand 4. As a result, provide access to qual- engagement Intellectual capital
everywhere in the world. ity partners and investors from around Value to society Licence to operate
This approach recognises the fact the world, happy to be associated with Employees
Reputation and brand
satisfaction
image
that for organisations to be truly so- organisations that respect the environ- Environmental
protection Reduced risk
cially responsible, they must focus on: ment, the laws and conventions of the
Community quality
1. What they exist to do countries in which they operate and of life Source: GEMI Figure: 2
2. How they go about doing it and provide good care for both patients and
3. Only lastly, what they do with the staff, thus ensuring a benign political en- what patients want and governments can
money once they have made it vironment. afford, ensuring that society as a whole has
Figure 2 summarises the business case good standards of public health, and that
The business case for CSR for being socially responsible for business, staff are willing and able to provide the
Properly embedded, socially responsible and it applies equally to private hospitals. care needed. Doing this affects the entire
behaviour across the hospital’s value chain hospital value chain. Doing this well guar-
ensures that the role of private hospitals as Conclusion antees access to patient demand and em-
legitimate healthcare providers will be ac- The first responsibility is to use scarce re- ployee supply and ensures public accept-
cepted by both government and electorates sources well and private hospitals have the ability and acceptance of private medicine,
alike. It will: benefit of the profit mechanism to signal thus ensuring the long term success that
1. Preserve access to patients and their de- they are doing this. Being responsible shareholders demand if they are to get an
mand for services provided because pa- means finding the right balance between adequate return on their investment.

16 Asian Hospital & Healthcare Management ISSUE-12 2007


H E A L T H C A R E M anagement

Leadership and Strategy


in Healthcare

Hospital leaders should formulate and communicate vision for the institution.
They should also continuously keep evolving the vision and motivate the followers
to accomplish the mission.

crisis, able to stay clean about a sour mis- Eighth Army, who defeated Erwin Rom-
Delon Wu sion, and having passion, persistence and mel in Egypt were leaders with different ex-
President partnerships, and able to work with a team ecutive style. They were fully supported by
Taiwan Hospital Association and build a consensus. There is no differ- their boss with a clear-cut mission to win
Taiwan
ence for a hospital manager as compared to the war.
a business leader. Hospital leaders should The leader should shape a strategy for the
formulate and communicate vision for the institution. In early 1970s, Mr. YC Wang,
institution. They should also continuously Board Chairman of the Formosa Plastics

I
t appears that everyone knows what keep evolving the vision and motivate the Group, decided to build a non-profit hos-
leadership is. However, it is not easy to followers to accomplish the mission. The pital to serve the middle and lower income
define the word leadership. Webster’s leader should be aware of his own emo- family in Taiwan, to provide equal service to
New World English Dictionary explains tion, able to manage his own emotion, all peoples with low cost, and to become a
“leadership” as “the capacity to be a leader” able to read the emotion of his people, major center for medical education and re-
or “ability to lead”. Indeed, there are many and able to manage the relationship with search. He wished to recruit the best physi-
legendary leaders in business history, such his people. There appear to be two basic cians and to install the best equipment for
as George Eastman of the Eastman Kodak styles of leading people. Julius Caesar was a the hospital. During that period, Taiwan was
Co., Henry Ford of the Ford Motor Co., field general of the late Roman republic, who developing from an agriculture-dependent
Andrew Carnegie of the Carnegie Steel greatly extended the Roman Empire before to an industrialised society. There were only
Co., Samuel Moore Walton of the Wal- seizing power and making himself the Ro- few tertiary referral hospitals with a total of
Mart, Robert Noyce of Intel, Konosuke man emperor. As a field general, he required less than 3,000 beds capable of perform-
Matsushita of the Matsushita Electric In- the respect and support of his soldiers and ing open-heart surgery or brain surgery to
dustrial Co., and YC Wang of the Formosa needed personal charisma to win popular- serve a population of 14.84 million people.
Plastics Group. These giants are character- ity. Erwin Johannes Eugen Rommel was the Although there were 11,518 beds coun-
ised by their ability to tell the difference German Field Marshal, served in France, trywide, more than 70% of the hospitals
between the seemingly impossible and the Italy and Romania. He commanded the 7th were operated by the government with a size
genuinely impossible, by their courage to Panzer Division assisting Italians in North of less than 200 beds; less than 30% of the
bet on the vision of market potential, by Africa, which became the Africa Korps. He hospitals were operated by the private sector
their ability to shape the market vision into accomplished a series of brilliant battles and the size was very small, usually less than
the company mission and to be the mes- driving the British back hundreds of miles 50 beds. Good medical service was a luxury.
sage for customers, employees, and inves- and gained his nickname of “Desert Fox”. The university hospital or the few medical
tors, by their ability to deliver more than However, he faced shortage in supplies centers were like the white ivory tower not
what they have promised, and by their will and tanks, under constant and close sur- accessible to the ordinary people. Visiting
of not to look back. veillance of the Gestapo and Hitler and, a hospital was like visiting a bureaucratic
These giants are born with these charac- thus, required the respect and support of government office; patients had to pay a
teristics. A competent leader, nonetheless, his soldiers as well as the German people guarantee-deposit before hospital admis-
is a person who is striving for excellence, back home to accomplish his work. In con- sion, frequently requiring a special “red-en-
able to make an enjoyable atmosphere for trast, The Duke of Wellington who defeated velope” tip for service by physicians.
his people, able to hug and kick, able to Napoleon at Waterloo in 1815 and Bernard Meanwhile, there were 6 medical schools
make a quick decision, able to handle a Law Montgomery, Field Marshal of the with approximately 800 graduates annually.

w w w . a s i a n h h m . c o m 17
H E A L T H C A R E M anagement

The few university hospitals and medical 30% publicly owned. The Economist listed
BOOK Shelf
centers were not sufficient for post-gradu- Taiwan as the second healthiest country
ate training of these 800 medical graduates. in the “World Healthy Nations List” in
There appeared not much future for the new 2000. Chang Gung Medical Group con- Blue Ocean Strategy
physicians. As a consequence, the new med- sists of 6 hospitals with 8,500 beds, 2
ical graduates went abroad for opportunity. universities, 1 health village for senior citi- Authors : W. Chan Kim
Renée Mauborgne
It was under these circumstances that zens and one nursing home; the hospitals
Mr. YC Wang shaped his mission. serve 10% of the population in Taiwan Year of Publication: 2005
The first Chang Gung Memorial Hos- and share 8% of total expense of the Na- Pages: 256
pital was opened in December 1976. It was tional Health Insurance Program annually.
a “patient-centered” and “service-oriented” The success story of Chang Gung Medi- Description:
hospital with service encompassing pri- cal Group may serve as an example of lead- Based on a study of 150 strategic
mary clinic care to tertiary inpatient care. ership and strategy in hospital management. moves spanning more than a hundred
The hospital applied the 4Cs of business It fits the model of “Blue Ocean Strategy” years and thirty industries, Kim and
management to the operation: Capital, recently proposed by Kim and Mauborgne. Mauborgne argue that tomorrow's leading
companies will succeed not by battling
Corporation, Consumer and Commu- It eliminated the guarantee-deposit, the
competitors, but by creating "blue oceans"
nication. It radically revolutionised the red-envelope tip, and patient discrimina- of uncontested market space ripe for
medical practice in Taiwan and quickly tion; it reduced the price of hospital service, growth. Such strategic moves—termed
dominated the market of medical service. the patient waiting time, and the complex- “value innovation”—create powerful leaps
During 1980s, other intenders duplicated ity of paper work; it raised the accessibility, in value for both the firm and its buyers,
the strategy and eventually changed the efficacy and quality of care, and salaries of rendering rivals obsolete and unleashing
medical system in Taiwan, providing the personnel; it created ease of hospital visit, new demand.
background for the implementation of incentive of physicians, nurses and techni-
National Health Insurance Program by the cians as well as a new form of healthcare. For more books, visit Knowledge Bank
government in 1995. Presently, 70% of the Full references are available on section of www.asianhhm.com
health providers are privately owned and www.asianhhm.com/magazine/

18 Asian Hospital & Healthcare Management ISSUE-12 2007


M edical S ciences

Cancer Nanomedicine
Emerging opportunities

Nanotechnology has many advantages when applied to medicine. However, continued


research into disease processes at the molecular level is essential for its development.

and delivery techniques. In the future, a • Reporters of efficacy


Matthew Dennis nanoparticle or a set of nanoparticles may • Multi-functional therapeutics
Cancer Market Specialist be designed to search for, find and destroy a • Prevention and control and
Espicom Business Intelligence single diseased cell, driving us ever closer to • Research enablers
UK
realising the ultimate goal of disease preven- As the field of nanotechnology con-
tion. In the foreseeable future, nanotechnol- tinues to grow, an increasing number of
ogy as applied to medicine, will lead to ad- countries are developing research agendas
vancement in remote monitoring and care, with particular focus on specific areas of

D
iagnosing, treating and track- where a patient may be treated at home, a nanomedicine. This has led to some iden-
ing the progress of therapies less expensive option, and one that is more tifiable research trends and initiatives. There
for each type of cancer that ex- conducive to a successful medical outcome are however, many research programmes
ists has long been a dream of oncologists, than treatment at a hospital. with broad initiatives that are not specific to
and one that has grown recently alongside Continued research into disease process- cancer. Some trends are highlighted below
developments in genomics, proteom- es at the molecular level is essential for the that have been identified from national and
ics and cell biology. Now, a revolution in development of nanomedicine, and involves international reports.
nanotechnology is pushing personalised teams of scientists from across conventional At the CancerNano 2006 Symposium,
cancer treatment closer than ever before. disciplines, such as physics, chemistry, sur- held from 7th to 11th May, in Boston, MA,
Future techniques in medical diagnosis gery and mathematics, as well as those from researchers from around the world gathered
and treatment have often been the subject the relatively new fields of genomics, pro- to discuss the next steps for taking promis-
of science fiction and fantasy. What was teomics, metabolomics, pharmacokinetic ing cancer-fighting nanoresearch from the
once the stuff of fiction is now closer to modelling and microscope design. laboratory to clinical trials. The Symposium
becoming reality. Nature already operates Highlighted below are the six main ar- was co-produced by the Nano Science and
at the nanoscale and we are acquiring an eas under which progress in nanomedicine Technology Institute, the National Cancer
increasingly profound understanding of is expected to advance over the next five Institute (NCI) and the National Institutes
natural processes at this scale, enabled by to ten years. These areas were identified by of Health. “We have a lot of exciting nano-
a new generation of scientific instruments. the National Cancer Institute (NCI) in its technology research going on throughout
Armed with this knowledge, we are able 2004 Cancer Nanotechnology Plan, which the country, and our main goal now is to
to design devices that can either directly set out to describe how to accelerate the expand the connections between the nano-
interact with, or influence, the behaviour application of nanotechnology to cancer tech and cancer communities, and help
of living cells. As with any nascent and research and clinical care, emphasising the get today’s cancer-focused nano research
rapidly developing field, there are research, need for cross-disciplinary and cross-sector out of the labs and into clinical trials,”
technological and ethical challenges to be collaboration to develop and deliver the stated Dr Mansoor Amiji, co-chair
considered, and the approaches to these public health benefits. After each potential of the Symposium from the Depart-
constitute an integral part of this field. area for development, there is an analysis ment of Pharmaceutical Sciences at
Nanotechnology has many advantages of the specific section, with three predicted Northeastern University in Boston.
when applied to medicine. At the nanome- development scenarios over the five to ten The Symposium highlighted many
tre scale, materials often exhibit surprisingly year time course: optimistic, realistic and promising nano-driven research projects:
different physical, chemical and biologi- pessimistic. • An in-body detection system based on
cal properties, compared to the very same These six sections are: quantum dots that can safely be inserted
material in bulk form. The properties of • Molecular imaging and early detection into the human body to find, detect and
nanoparticles, such as increased chemical • In vivo imaging make images of cancer cells as early as
activity and the ability to cross tissue bar- possible (even before symptoms appear)
riers, are leading to new drug targeting   www.nano.cancer.gov/about_alliance/cancer_nanote- • In-body gene and drug-delivery systems
chnology_plan.asp

w w w . a s i a n h h m . c o m 19
20 Asian Hospital & Healthcare Management ISSUE-12 2007
M edical S ciences

that can be safely inserted into the hu- Further analysis can reveal that, of the the market. Four drugs that have already
man body to target cancer cells directly products identified: been launched are all reformulations of cur-
(with time-release delivery of treatment • 32 (59%) are nanotechnology reformu- rently approved anticancer drugs that aim
drugs or gene therapy) lations of currently approved anticancer to reduce the side effects associated with the
• In-body monitoring and surveillance sys- drugs original forms. This seems to be a common
tems that detect cancer mutations (via • 15 (28%) use nanotechnology to deliver trend for many of the companies that are de-
triggers or genetic markers) new or unapproved drugs or are treating veloping nanomedicines: trying to improve
• New nanoscale tools, protocols and cancer in another way the safety profiles of drugs that are already
methodologies for designing drugs for • 4 (7%) are nanotechnology imaging approved. This offers many advantages over
more efficient, targeted release into the agents developing novel therapeutics and is show-
system and • 1 (2%) is using nanotechnology to detect ing that nanotechnology can be used safely.
• New nano-driven diagnostics that will cancer; and Once these drugs have been on the market
enable cancer investigators to more • 2 (4%) are using nanotechnology for for a period of time then it may give other
quickly identify submolecular targets for other cancer applications companies the confidence to develop thera-
research, clinical development and/or In its report “Emerging Opportunities in pies incorporating nanotechnology from
predict drug resistance Cancer Nanomedicine” (published August the drug discovery stage. However, it will be
At the present stage, it is not possible to 2006), Espicom identified six products that some time before these start to make their
determine the amount of funding that has are employing nanotechnology in relation way through into companies’ development
been allocated to nanomedicine with respect to cancer treatments which are currently on pipelines.
to oncology. This is partly due to the emerg-
ing nature of the technology, but primarily
Examples of public funding for R&D in nanoscience and nanotechnology
because much nanotechnology R&D at this
stage is not disease-specific, being at a much
Anaesthetic Facility Expenditure on nanoscience and nanotechnologies
more basic and therefore general level. There
is however, information relating to nanotech- US The US’ 21st Century Nanotechnology Research and Development Act (passed in 2003)
allocated nearly US$3.7 billion to nanotechnology from 2005 to 2008 (which excludes a
nology funding as a whole. Nanotechnology substantial defence-related expenditure). This compares with US$750 million in 2003.
R&D spending is distributed among govern-
Europe Current funding for nanotechnology R&D is approximately EUR 1 billion, two-thirds of
ments (including national, regional, State and which comes from national and regional programmes.
local), universities, corporations and venture
capital investors. The availability and consis- UK With the launch of its nanotechnology strategy in 2003, the UK Government pledged
£45 million per year from 2003 to 2009.
tency of accurate figures varies for the differ-
ent categories. When comparing the avail- Japan Funding rose from US$400 million in 2001 to US$800 million in 2003, and was
expected to rise by a further 20% in 2004.
able data for various countries, difficulties
can arise due to differences in the definition India India’s Department of Science and Technology will invest US$20 million from 2004 to
2009 in their Nanomaterials Science and Technology Initiative.
of nanotechnology, the inclusion of private
contributions or other variations in the cal- Brazil The projected budget for nanoscience during the 2004 to 2007 period is approximately
culation of government funding, difficulty US$25 million.

in getting some private, especially venture


capital, investment data, mismatch in invest-
ment periods, and the various exchange rates Products currently on the market with oncology applications
employed.
The majority of products in develop- Product Type of nanomaterial Indication Company
ment for the treatment of cancer are still Abraxane Nanoparticle albumin Non-small cell lung cancer, Abraxis BioScience
in preclinical development, though a few breast cancer, others
are nearing approval and possible mar-
DaunoXome Liposomal formulation of Kaposi’s sarcoma Gilead Sciences
ket launch. Of the products identified by daunorubicin
Espicom Business Intelligence:
CellSearch Circulating Magnetic nanoparticles Metastatic breast cancer Immunicon
• 3 (6%) are either in Phase III or have filed tumour Cell Kit (ferrofluids)
for approval
Verigene platform and DNA-functionalised gold Diagnostics Nanosphere
• 9 (17%) are currently in Phase II devel- Bio-barcode Technology nanoparticles
opment Caelyx/Doxil Doxorubicin liposome Ovarian cancer, AIDS- Ortho Biotech (Johnson &
• 11 (20%) are currently in Phase I devel- injection related Kaposi’s sarcoma Johnson)
and recurrent breast
opment and cancer
• 31 (57%) are currently in preclinical de- Myocet Liposome encapsulated Recurrent breast cancer Zeneus Pharma
velopment doxorubicin citrate complex

w w w . a s i a n h h m . c o m 21
22 Asian Hospital & Healthcare Management ISSUE-12 2007
M edical S ciences

New Drugs in
Anaesthesia
A review
New drugs are being developed in anaesthesia, Swati Daftary
Consultant Anaesthesiologist
so as to reduce the number of side-effects and to Jaslok Hospital & Research Centre
improve patient outcome. India

T
he history of anaesthesia men- single largest group
tions use of non-pharmacological of surgeries all over
(Cold, Concussion, Carotid com- the world. Most of
pression, Nerve compression, Blood letting the new anaesthe-
and Hypnosis) and pharmacological tech- sia drugs cater to
niques (use of alcohol, opium, hyoscine, the demands of these
cannabis, cocaine) in ancient and mediae- surgeries and primarily
val times for anaesthesia. aim at an early and unevent-
1850 onwards, as anaesthesia became ful recovery. Some of these newer
popular, more and more surgeries were car- drugs which are available
ried out under general anaesthesia. At that since last decade are
time, any surgery under general anaesthe- reviewed below.
sia practically mandated a stay in the hos-
pital, often to recover not from the surgery New drugs
but from the effects of the anaesthesia used Premedication
during the operation. Patients were woozy – Dexmedetomidine
for hours, unable to get out of bed, nause- Specific, selective alpha-
ated and vomiting, and even if they wanted 2 agonist gives excellent anxi-
to eat, they couldn’t because their digestive olysis and sedation pre-operatively. Its
systems were paralysed. People receiving features include:
anaesthesia were also at risk—a significant • Haemodynamic stability, low heart rate
number died not from their disease but and anaesthesia intra-operatively.
from the anaesthetic drugs themselves. • The benefits also extend into the post- tional dis-
operative period with prophylaxis tillation of air
Present scenario against ischaemic events, analgesia and and costs 2000
With better understanding of surgery, in- reduced shivering. times more than N2O.
strumentation and devices like endoscopic • Available in parentral formulation. A Owing to environmental
equipments, there was an acute need for dosage of 1-2.5 µg/kg is given over concerns, there may be no alter-
anaesthesiologists to keep up with this 2 minutes. Short half life of 2 hours. native but to use xenon in distant fu-
pace. By the mid twentieth century, we • Ideal for perioperative use. Antagonis- ture even if it incurs an increase in cost.
had learnt to control mortality figures to a ing the sedative/hypnotic effects of • Colourless and odourless gas with no
great extent. Obviously the need then was dexmedetomidine with atipamezole will irritation to the respiratory tract. Well
to take care of disturbing morbidities like permit rapid recovery from anaesthesia, tolerated with gas induction
severe postoperative nausea vomiting, pain, regardless of the duration—a technique • Low blood/gas and oil/water partition
delayed recovery and prolonged hospitali- already widely and successfully practised co-efficients allowing rapid induction
sation. Most of these problems are greatly in veterinary anaesthesia! and eduction
reduced today thanks to some wonderful • Produces unconsciousness with analge-
drug molecules and better understanding Induction and maintenance — Xenon sia and a degree of muscle relaxation
of pharmacokinetics and pharmacody- Xenon is Greek for stranger. It was dis- • MAC of 60-70% allows a reasonable in-
namics. Day care surgeries today form a covered in 1898. Manufactured by frac- spired oxygen concentration

w w w . a s i a n h h m . c o m 23
M edical S ciences

• It does cause respiratory depression, to compound encapsulates muscle relaxant volatile agents. Supplement with N2O,
the point of apnoea and promotes dissociation from Ach recep- propofol or isoflurane.
• It is cardiac stable tor. This is revolutionary, especially when Adverse effects:
• Not metabolised in the body and is you look at its implications in a difficult 1. Anticipate and prevent postoperative
eliminated rapidly and completely via airway. pain
the lungs 2. Bradycardia may occur
• It is non-toxic and is not associated with Local anaesthetics – 3. Dose-dependent respiratory depression,
allergic reactions Levobupivacaine, opivacaine Muscle rigidity occurs
• Stable in storage, no interaction with Ropivacaine: A long-acting local anaes- 4. NOT for epidural use as the lyophilised
anaesthesia circuits or soda lime. Should thetic with less cardiac and central nervous powder contains 15mg of glycine
not be used with rubber anaesthesia system toxicity than bupivacaine, and a 5. If given alone, may cause awareness
circuits as there is a high loss through smaller tendency to cause motor block. It
the rubber is less lipid soluble than bupivacaine and New formulations
• Non-flammable more selective for A delta and C fibres than New formulations of known drugs are
• Expensive motor nerve fibres, giving a greater degree being developed to either cut down their
Muscle relaxation – Cisatracurium of separation between motor and sensory drawbacks or to improve their efficacy.
Cisatracurium besilate is a non-depo- blockade when used in concentrations be- Some of the drugs which are being worked
larising neuromuscular blocking agent low 0.25%. Minimum effective concentra- on are Propofol, Midazolam and local an-
with an intermediate duration of action, tion is 0.2%. It is highly protein-bound aesthetics.
cardiostability, and faster recovery than (94%) with terminal t1/2 111 min. and Drugs for hypnosis and sedation may
vecuronium. Hoffman degradation as for maximum allowable dose is 2 mg/kg. have problems in the form of extended du-
atracurium. Compared with atracurium, Levobupivacaine: The S(-)enantiomer ration of action, unwanted cardiovascular
less laudanosine is produced (this is then of bupivacaine, with less cardiovascular and respiratory effects and issues with their
cleared renally). Well tolerated; no sig- and central nervous toxicity, a slightly vehicle including pain on injection, hyper-
nificant histamine release. Recovery seems longer duration of sensory block, but oth- lipidaemia and vulnerability to bacterial
NOT to be prolonged with liver or renal erwise similar to its parent. Compared to growth. Three main strategies are being
dysfunction. bupivacaine it is as potent, with a trend to- employed to improve these drugs.
Rocuronium bromide: wards longer sensory block; with epidural Reformulation: to overcome issues of
• ED90: 0.3 mg/kg usage it produces less prolonged motor formulation vehicle as in Propofol. As not
– intubating dose: 0.6-1.0 mg/kg block; Differentiation not seen with pe- a single formulation is problem free, we
– onset: 1-1.5 minutes, clinical dura- ripheral placement; lethal dose 1.3 to 1.6 have multiple formulations claiming ad-
tion: 30-60 min times higher; less cardiac effect including vantages. Standard- Propofol 1% and 2%
• Maintenance dose: 0.1-0.15 mg/kg, less depression of contractility and fewer in 10% soya oil as long chain triglycerides
duration: 15-30 min arrhythmias; higher convulsive doses. It - Addition of EDTA or sodium sulphite
• Metabolised by liver, 75-80% has elimination t1/2 ‘1.3 hours’, and pro- does not support bacterial growth but
• Excreted by kidney, 20-25% tein binding > 97%. Recommended maxi- can cause allergic reaction or yellowish
• ½ life β: ~ 60 minutes mum dosage same as bupivacaine. Observe discolouration (more with sulphite).
• Mild CV effects- vagolysis, no/minimal precautions as for all local anaesthetics. - An emulsion containing long and medi-
histamine release, um chain triglycerides reduces incidence
• Prolonged duration in the elderly + Analgesics – Remifentanil of pain on injection
liver disease A typical μ opiate receptor agonist with - Propofol 6% in 10% soya oil reduces hy-
• Only non-depolariser approved for RSI ultra-rapid clearance and offset of action, perlipidaemia
that is independent of excretory organ - Propofol 1% in 5% soya oil with or
Neuromuscular block Reversal– function. It is 20 to 30 times more potent without EDTA – pain on injection ↑4
ORG 25969 / Sugammadex than alfentanil. Undergoes rapid hydrolysis times
The results of four ongoing Phase II tri- by nonspecific esterases to almost inactive - Propofol in cyclodextrin based
als indicate that a new selective relaxant remifentanil acid. This metabolism is not formulation
binding agent, a ϒ-cyclodextrin (GC) altered by end-organ function or genetic Pro-drug approaches: Focused mainly
compound, has the potential to radically variablility of specific esteraes (like plasma on propofol to achieve good water solubil-
change the way neuromuscular blockade cholinesterease); redistribution is of little ity. The inherent problem is of slow onset
is administered and reversed. Depending consequence. Context-sensitive half time and offset of action as they need to be rap-
on the dose of the GC compound, mod- is 3-5min regardless of infusion duration. idly metabolised to liberate the active com-
erate and deep neuromuscular blockade Full recovery of respiratory function oc- pound. e.g. Methyl phosphate pro-drug of
in patients receiving either rocuronium curs in ‘10 to 15 min’. Given by continu- propofol, Aquavan→ The phase III trial
or vecuronium was reversed rapidly and ous infusion, it reduces induction dose of have been halted due to high level of ad-
safely, often in less than two minutes. This thiopentone by 30%; Lowers the MAC of verse events.

24 Asian Hospital & Healthcare Management ISSUE-12 2007


M edical S ciences

The soft drug approach: This has been • Effect of intraoperative magnesium Cleofol®: Clear propofol promoted as
previously used in remifentanil, propa- infusion on perioperative analgesia ‘vegetarian’ formulation of propofol fell
nidid and mivacurium. The aim is to pro- Anaesthesiology. 1996 Feb; 84(2): in disrepute after reporting of very painful
duce metabolically-labile agent which is 340-7, Eur J Anaesthesiol. 2002 Jan; injection and increased incidence of severe
hydrolysed rapidly by blood and tissue es- 19(1):52-6. J Clin Anesth. 2004 thrombophlebitis.
terases so as to have rapid recovery profile. Jun; 16(4):262-5. The above list is obviously not compre-
TD-4756, esters of barbiturates(Aryx) and hensive. We are still looking for an ideal
benzodiazepine ligands(CeNeS) are some The rapid rise and fall of a few local, intravenous, inhalational anaesthetic,
examples of such compounds. new drugs: Rapacuronium, Cleofol a safe and a very effective pain killer.
and Rofecoxib
Novel clinical uses of known Rapacuronium bromide: FDA approval for Conclusion
drugs: clinical use of this non-depolarising muscle This disproves the concern that use of
• Intranasal Nicotine for postop. Pain relaxant came on August 8, 1999. The drug old / less expensive drugs may compromise
treatment. Anaesthesiology 101: 1417- was developed as a substitute for succinyl- patient outcome and satisfaction and that
21, 2004 choline in the setting of a rapid sequence newer and costlier drugs are always safer.
• Analgesic effects of Gabapentin on acute induction. Clinical experience with this Some suggest that national societies should
postop. Pain Anaesthesiology 100: 935- drug showed increased incidence of severe, create guidelines for cost-beneficial prac-
938,2004, Acta Anaesthesiol Scand 48: life-threatening bronchospasm in children tice. Others favour physician autonomy in
322-327.2004 with rapid injection. Nineteen months drug selection. There will be great reluc-
• Oral Amantadine (antiparkinson and later, on March 27, 2001, the manufac- tance to deny patients pharmacologically
antiviral) for postop. Pain Anaesthesiol- turer withdrew the drug from the market superior drugs based on cost alone, espe-
ogy 100: 134-141,2004 voluntarily. cially since drugs are such a small portion
• Introp use of Adenosine is associated Rofecoxib: This selective COX-2 inhib- of the total surgical costs. The aim should
with reduced opioid requirement in itor was withdrawn worldwide in October be to manage and modify drug practice in
postop period Anaesthesiology 1999; 2004 after the reports of cardiovascular anaesthesia depending on changing needs
90: 956-963. risks were published. to provide value-based care.

w w w . a s i a n h h m . c o m 25
26 Asian Hospital & Healthcare Management ISSUE-12 2007
M edical S ciences

Stem Cell Therapy


The good, the bad and the confusing

Stem cell therapies offer great potential for treating diseases. However, a lot of questions
remain to be answered before this potential can be realised.

Unfortunately, progress in stem cell sci- ments conducted in humans reported in the
ence has sometimes been in the spotlight for scientific press. The rapidity of translation
Michael Marber
Professor the wrong reasons. We believe this has two from the laboratory bench to the bedside is
Cardiology, Divisional Lead principal explanations. perhaps a reflection of the potential rewards
Mrinal Saha Firstly, some countries lack clear legisla- to pioneers in this new era of biotechnology.
Specialist Registrar, Cardiology tive measures to bolster the ethical boundar- Maybe because of this haste, scientific rigor
St. Thomas Hospital ies created by research committees. In In- has been pushed aside in favour of perceived
UK dia several reports have emerged in recent progress. As a result, there is a confusing—
years of clinics offering miraculous cures, some might say chaotic—variety of differ-
albeit with an eye-watering fee attached, ent approaches to the same problem. How
but whose results have not fallen under the can we separate the signal from the noise?

T
he number of people affected by scrutiny of peer-review. Hence, accusations To date, the main categories of cells that
coronary artery disease is staggering. have arisen of the exploitation of potentially have been investigated for their potential to
The American Heart Association’s desperate people. Perhaps it is this relative repair damaged heart tissue include skeletal
reports that in 2003 alone there were almost paucity of regulation that has attracted for- myoblasts (resident satellite stem cells of
480,000 deaths attributable to coronary dis- eign businesses, which are known to use skeletal muscle), and multipotent stem cells,
ease in the United States, representing 1 in Indian patients as a test bed for their stem derived from bone marrow.
5 of all deaths. In addition, over 13 million cell research, both in private and govern- Skeletal myoblasts were the first cells to
Americans suffer from the consequences of ment-funded institutions. Another widely be used in a clinical trial. Cells were injected
heart attack, which include angina and heart publicised case in point is that of the emi- in the scarred portions of heart muscle dam-
failure. Furthermore, cardiovascular disease nent Korean stem cell scientist, Hwang aged by heart attack. Importantly, there was
is no longer regarded as being particular to Woo-Suk, whose reputation was called into a small but significant improvement in the
developed economies: almost 80% of deaths question over the issue of whether he was pumping function after almost a year. How-
due to heart and blood vessel dysfunction aware of the donation of eggs for experi- ever, there was a significant downside. The
worldwide occur in emerging economies. mentation by one of his own researchers. pilot trial failed to demonstrate that these
Therefore, it will come as no surprise The use of embryonic or fetal stem cells cells from skeletal muscle could transform
that a great deal of effort has been made in is the most strictly regulated. Although into heart muscle cells. Moreover, 4 of the
developing new technologies for the injured these are the most powerful weapons in the 10 patients developed potentially life-threat-
heart. Possibly the most high profile scien- regenerative therapy armamentarium, they ening heart rhythm abnormalities. This was
tific endeavour in medical science over the are also the most complex from an ethical possibly due to a lack of integration at the
past 10 years has been the attempt to har- perspective. Unregulated embryo research is electrical level between the host cells and the
ness the potential of embryonic stem cells possibly the reason for much of the negative implanted cells. Patients in the latest phase
and adult progenitor cells. These cells are attention that this field has drawn, under- of this trial now require prophylactic inser-
defined by their ability to self-renew and lining the need for more exacting controls. tion of an internal defibrillator, a specialised
mature into one or more cell types. Instead Secondly, despite the presence of a strict pacemaker capable of delivering an electric
of replacing the entire damaged organ there- legislative and ethical framework, much of “shock” to revert the rhythm to normal.
fore, this approach provides precursor cells the work that has emerged from the study In 2001 came the first report of bone
that may replace damaged components. In of stem cells in heart disease has been no- marrow cells being used in the context of
theory, there are several different sources table for a lack of cohesion. Although it has a heart attack (myocardial infarction), and
from which these cells can be harvested: been less than a decade since the possibility these are now the most commonly used
foetal tissue (from terminated pregnancies), of a cell-based repair method for the heart type of cells. A 46 year old man received his
embryos, umbilical cord, bone marrow and working with animal models arose, there own bone marrow derived stem cells deliv-
possibly other sites such as fat tissue. have since been literally dozens of experi- ered by an injection into his coronary artery.

w w w . a s i a n h h m . c o m 27
M edical S ciences

Not only was the procedure safe, but at 10 is preferable to a highly selected popula- Even after these differences are taken
weeks the patient had significantly improved tion. Other investigators have used cells into account, the magnitude of improve-
the pumping capacity of his heart. These in- harvested after prior “enrichment” with ment is typically not large. REPAIR-AMI
vestigators subsequently published the first growth factors designed to expand the de- (Reinfusion of Enriched Progenitor Cells
trial of cell therapy in acute myocardial in- sired cell sub-population. However, in And Infarct Remodelling in Acute Myocar-
farction, in which patients derived a similar some experiments, patients treated in this dial Infarction) is the largest double blind,
degree of benefit. The profusion of trials way had an acceleration of re-narrowing of placebo-controlled trial to date. This rigor-
that followed all seemed to show promise. the coronary arteries which were originally ously designed and well-executed study in-
On closer inspection, however, the benefits opened to treat the myocardial infarction. vestigated 101 patients, in whom there was
observed in stem cell recipients should be The timing of delivery of stem cells has an improvement of LV function in the cell-
tempered by considering some important varied from hours to days after the heart at- treated group of 5.5% vs. 3.0% (measured
methodological criticisms. tack. The mode of delivery of cells also differs by LV angiography) at 4 months, with fewer
Some trials, such as TOPCARE-AMI between experiments. Some have been given adverse clinical events in the treated group
(Transplantation Of Progenitor Cells and Re- intravenously, some down the coronary arter- after 1 year. This result should be put into
generation Enhancement in Acute Myocar- ies, and some injected directly into the heart context, however. In a recent study, patients
dial Infarction), were not randomised, thus muscle itself. Similarly, there is no consensus were treated for their heart attack with stan-
opening the door to unwanted bias, and leav- as to the number of cells which should be dard therapy, i.e. they did not receive stem
ing the possibility that observed effects may delivered, which varies by up to 3 orders of cells. At 5 months, with just usual care,
have occurred despite the presence of stem magnitude. ejection fraction as measured by contrast-
cell infusion. Others did not include a group Another crucial factor determining the enhanced MRI (ce-MRI) had improved by
in whom a “sham” bone marrow harvest or success of a study is the method by which it 7%, with a 31% reduction in infarct size.
infusion occurred such as BOOST-(BOne is measured. Most studies have determined This is a result comparable to the best of
marrOw transfer to enhance ST-elevation the change in the function of the left ven- those from cell therapy studies.
infarct regeneration), thereby allowing for tricle (LV), the main pumping chamber of Given the current state of affairs, perhaps
a potential confounding effect of the bone- the heart, as the principal outcome measure. it is time to resolve the many unanswered
marrow harvest procedure itself. This is because LV function appears to be questions such as: Which cell to use? How
Furthermore, in BOOST, the relative one of the best indicators of prognosis after many cells to deliver? Which delivery route is
improvement in heart function seen at 6 myocardial infarction. The method of assess- best? When should cells be delivered? Which
months was no longer evident at 18 months, ment of LV function, however, encompasses endpoint is of most relevance? Offering cell
suggesting that in this case, at least, the ef- the spectrum of modalities available, includ- therapy to patients is tempting, particularly
fect of cell therapy was simply to accelerate ing, angiography, echo, magnetic resonance if no other option seems to be available. But
recovery. imaging (MRI), and single positron emission proceeding into largely uncharted territory
There are numerous other areas of con- tomography (SPECT), all of which have with contradictory scientific studies as the
tention. It is not clear, for example, which been used at variable time-points after infarc- only means of guidance, may result in a step
subset of bone marrow stem cell is the most tion, and each having different sensitivities back from, rather than in to, the future.
effective, or if a generalised “soup” of cells for detecting change.

ZOLL AutoPulse Non-invasive Cardiac Support Pump

T
References:
he AutoPulse®—the only device of its kind—delivers the consistent, uninterrupted 1. Timerman S et al. Improved hemodynamic perform-
chest compressions that new AHA/ERC Guidelines are calling for. It is an automated,
Product Showcase

ance with a novel chest compression device during


portable device with an easy-to-use, load-distributing LifeBand® that squeezes the entire treatment of in-hospital cardiac arrest. Resuscitation.
2004;61:273-280.
chest, improving blood flow to the heart and brain during car- 2. Halperin HR et al. Cardiopulmonary resuscitation
diac arrest.1-3 Additionally, it offers the benefit of freeing up with a novel chest compression device during a porcine
rescuers to focus on other life-saving interventions. model of cardiac arrest. Journal of the American Col-
lege of Cardiology. 2004;44(11):2214-2220.
A recent independent study4 conducted in the United
3. Ikeno F et al. Augmentation of tissue perfusion by a
States, using the AutoPulse, showed that survival rates of car- novel compression device increases neurologically intact
diac arrest patients dramatically improved when treated with survival in a porcine model of prolonged cardiac arrest.
Resuscitation. 2006;68:109-118.
an automated CPR device, versus manual CPR, prior to reach-
4. Ong MEH, Ornato JP, Edwards D, et al. Use of an
ing the hospital. Data showed a survival-to-hospital-discharge automated, load-distributing band chest compression
rate of 9.7 percent using automated CPR, versus 2.9 percent device for out-of-hospital cardiac arrest resuscitation.
JAMA. 2006;295:2629-2637.
using manual chest compressions. There was also a 71 percent
higher rate of return of spontaneous circulation with the use Further information:
of the AutoPulse than with conventional CPR www.zoll.com

28 Asian Hospital & Healthcare Management ISSUE-12 2007


S u rgical S peciality

Integrated Operating Rooms


Enabled by Richard Wolf's 'CORE' system:
A case study
The unrivalled advantage of this solution is shown in the
With all the complicated systems that make up today's
voice-controlled version. The simple and legible device
operating room, controlling can become a complex process.
functions displayed are used in this case as the voice-
The Wolf CORE system allows all the different devices to controlled commands to operate the system. The speaker
be controlled with one easy-to-use system. independent voice control currently used represents the
highest technological standard and guarantees efficient
Henning Baldauf
Project Manager - Core, Richard Wolf GmbH, Germany
and direct control of devices such as ENDO camera, light
and OR table from the sterile field of the operating room.
Hospital Chemnitz Muljibhai Patel Urological Hospital
Image management
CORE also combines with MEDIMAGE® to provide
clinical partners with a complete, digital patient image
and document management system. Proceeding from
stations for image acquisition, processing and archive,
it offers every form of image management, including
server, network and telecommunication possibilities,
as well as customised solutions designed specifically for
Helios Hospital Group Clinique Generale-Beaulieu, Geneva the customer. MEDIMAGE unites in this case all types
of images, films and reports from surgery, radiology,
cardiology or any other discipline. Furthermore, it offers
the possibility of intraoperative display of pre-operative
x-ray image data (x-ray, CT) on suitable monitors in the
operation field of the physician.

Training and consultation


Telemedicine has been developed with the introduction
In the modern operating room there are a large number of of the videoconference and telecommunication solutions
highly developed, specialised devices for widely different The videoconference equipment enables sharing of
applications, such as endoscopic camera systems, HF experience among specialist colleagues and consultations
devices, insufflators, OR tables and lamps. Sometimes with specialists, and can provide efficient support in the
the complicated operation of different devices leads to education and further training of medical practitioners
an increasing load for surgeons and clinical personnel. and students. It is possible for transmissions from inside
The outcome can mean unsatisfactory results. Richard the operating room to be displayed in a conference or
Wolf has therefore paid attention to keeping its products plenary hall, as well as allowing live communication from
simple and focussed on providing devices that are self-ex- hospital to hospital. It also allows a central control of such
planatory to operate. elements as video routing and videoconferencing, as well
With the introduction of the CORE integrated OR so- as peripheral components such as the operating room
lution, Richard Wolf GmbH provides a complete system lighting.
solution for minimally invasive (MI) surgery that meets the
challenges that face the surgical community. Individual tailoring
Richard Wolf GmbH, as system integrator of the CORE
A simple central system integrated operating room, offers you this service from a
CORE focuses on the highest functionality of the indivi- single source. The company is available with its exper-
dual devices coupled with the simplest operating method tise in all phases of project design and management.
for the entire system. This is achieved by simple, intuitive Richard Wolf can help determine a requirements profile
interactive guidance. All devices networked in the sys- and design professional solution proposals which con-
tem are imaged on the monitor by a uniformly designed figure your system in accordance with the tasks required
user menu. In this case the symbols normally used on the of it. Furthermore, it can organise reliable installation,
device to show its functions are displayed on the touch- commissioning and training for your system solution and
screen by simple, readable terms which can be set to provide service and maintenance programmes tailored
different national languages. individually to your needs.
Advertorial

w w w . a s i a n h h m . c o m 29
S u rgical S peciality

Quality Assurance Programmes


for Surgery
How and why in Asia?

It is inevitable that the concept of quality assurance in surgery will expand worldwide and
encompass other surgical disciplines; the process will be driven by patients, professionals
and healthcare providers alike.

general, and surgeons in particular, should and outcomes to the UK Society of Cardi-
collect their results sequentially over time, othoracic Surgeons. These are subsequently
Malcolm J Underwood
Professor in order to provide comparative data on collated by the National body, published
Department of Surgery ‘end-results’. His suggestion was that these and made available to the public. This
CA van Hasselt outcomes be made public, allowing pa- process has evolved more recently and in
Professor tients to use the information and ‘choose’ collaboration with the Healthcare Commis-
Department of Surgery their place of treatment and individual sion in the UK, institutional and individual
Hong Fung surgeon. It was his lifelong pursuit to es- surgeons' results are now published on the
Cluster Chief Executive tablish an "end results system" to track Internet. The quality assurance process is
New Territories, East the outcome of treatments, as an op- important for individual surgeons globally.
Chinese University of Hong Kong portunity to identify and resolve clinical Advances in risk-stratification allow them
Prince of Wales Hospital misadventures thus providing the foun- to compare their case-loads and outcomes
Hong Kong SAR
dation for improving the care of future with other practitioners both locally and
patients. It was a recognition that both internationally, and ensure that the facility
institutional and individual measures of within their institution is enabling them
‘performance’ need to be recorded, aspects to perform to an appropriate level. It is
which are now widely recognised as be- important for hospitals to be able to look

A
quality assurance programme in ing an important part of the provision of at individual and group surgical outcomes,
surgical practice is quite simply quality assurance in surgery. But, for surgi- ensuring that their overall institutional
a mechanism to ensure that the cal specialties in Asia, why do we need this process meets published standards. It is
patient (consumer) is subjected to the process and how can it be achieved? important that healthcare providers are re-
least threatening journey through the hos- Quality assurance programmes in assured that their financial support of surgi-
pital during a period of treatment, with surgery are essential for patients, doctors, cal programmes within institutions is being
an outcome that is deemed acceptable hospitals and healthcare providers (finan- used effectively, not only in terms of patient
by international standards. This process ciers) worldwide for a variety of reasons. outcome, but also in resource utilisation.
inherently incorporates data collection and Patients need to be reassured that the All of the above issues are pertinent and
outcome analysis, but is in fact conceptu- process of surgical treatment to which they relevant to the provision of surgical care in
ally broader and includes assessment not have agreed is appropriate, will be adminis- Asia in view of the rapid rise of treatment
only of patient outcomes, but institution- tered effectively, and results in an outcome availability, and importantly, the associated
al processes, appropriateness of care and acceptable by international standards. In or- financial burden. Whilst it is perceived that
patient and healthcare provider satisfaction. der to achieve this, individual surgeons and all of the above processes can by default lead
All of these variables inherently, but not ex- individual hospitals should be able to pro- to consequential quality ‘improvement’,
clusively, affect the patient journey. vide information regarding outcomes after there are still many areas which require in-
surgical treatment which is based upon vali- vestigation and resolution.
Historical perspectives and dated data and also ‘risk-adjusted’ for case-
importance mix. For example, in cardiac surgery in the Stratification and data collection
The concept of developing ‘quality assess- UK, a speciality which has led the way in Presenting information regarding outcome
ment’ in surgery is historically attributed providing outcome data and analyses, each to the public (patients) requires an ongo-
to the American surgeon Ernest Codman. centre providing cardiac surgical treatments ing ‘educational’ aspect as there needs to
In the 1900s, he suggested that hospitals in submits data regarding patient risk profiles be general understanding of the important

30 Asian Hospital & Healthcare Management ISSUE-12 2007


S u rgical S peciality

differences between ‘crude’ and ‘risk-ad- tality alone may not be sensitive enough as a technology are globally available, which
justed’ outcomes. A surgeon or institute ‘quality’ outcome tool and recently, the con- provide the facility for clinical data stor-
with a comparatively high mortality for a cept of recording and analysing ‘near-miss’ age and complex outcome analysis. It is es-
given procedure may actually be performing episodes rather than death has been sug- sential that along with these systems, data
exceptionally well when case-mix is consid- gested as being a more useful mechanism to validation procedures are undertaken. This
ered. This represents a challenge in Asia. identify rectifiable performance problems at will allow confidence in the accuracy of
The ‘risk-stratification’ process is well an early stage. It seems obvious that, despite outcome reporting. The provision for these
developed in cardiac surgery, but has ac- apparent difficulties in defining surgical facilities should be given priority by health-
cepted limitations and is more complicated outcomes and applying risk-stratification, care providers. The natural progression of
to establish and consequently less devel- embracing the concept of quality assurance having these resources in place would be
oped in other surgical disciplines. Despite in Asia would be of benefit to all parties the development of national databases for
this, the Veterans Affairs Medical Centers involved in the patient journey. But how different surgical specialties within the re-
in the US has produced risk-adjustment could it be achieved? gion, enabling institutional comparisons
models for 30-day mortality and morbid- The essential element for a successful and ‘benchmarking’ exercises appropriate to
ity rates for both non-cardiac and associ- quality assurance programme is without the local population. The concept of qual-
ated surgical specialities. The ability of this question, the determination and commit- ity assurance within surgery is not new. The
model to detect variations in the quality of ment of healthcare professionals (providers process will continue to be driven by pa-
care has also been shown in a validation of direct clinical care as well as financiers) tients, professionals and healthcare provid-
study. There are still, however, complexi- to embrace the concept. The most im- ers alike. The provision of comparative sys-
ties to be resolved when defining ‘outcome’. portant practical aspect is the provision tems in Asia, facilitating quality assurance,
In cardiac surgery, mortality is routinely of an appropriate institutional infrastruc- is a moral obligation of the whole healthcare
used as a measured ‘outcome’. For surgical ture (system) which allows collection of community involved in the surgical treat-
specialities where this is unlikely to be a relevant, validated data. Without this, any ment of patients and represents an ongoing
useful marker—e.g. plastic surgery—clini- attempt to provide information regard- challenge within the region.
cal indices which reflect quality in that ing patient outcome is doomed to fail.
Full references are available on
particular service need to be identified. Mor- Computerised systems and information www.asianhhm.com/magazine/

w w w . a s i a n h h m . c o m 31
S u rgical S peciality

Advances
in Cardiac
Surgery
Yoshihiro Suematsu
Assistant Professor
Division of Cardiothoracic Surgery
University of Tokyo
Japan

The combination of new intra-cardiac imaging


technology and tool-tracking systems with the
dexterity and stability of robotic instruments will
enable safe and reliable off-pump intra-cardiac
repair, including Atrial Septal Defect (ASD) closure
and the repair of mitral valve insufficiency.

I
n the past decade, minimally inva- Recently, robotically assisted surgical In 1998, Carpentier and colleagues
sive surgical techniques have become systems have been introduced to increase reported the first cardiac surgeries (several
prevalent in the field of cardiac sur- the precision of endoscopic surgery and fa- kinds of mitral valve repairs) to be performed
gery, including minimally invasive direct cilitate minimally invasive cardiac surgery. in adults using a prototype of the current
coronary artery bypass (MIDCAB), off- These computer-guided systems can control da Vinci system (Intuitive Surgical, Sunny-
pump coronary artery bypass (OPCAB), both surgical instruments and endoscopic vale, CA). These operations were performed
and minimal access atrial septal defect cameras. Robotic instrumentation provides through small thoracotomy incisions. Sub-
(ASD) closure and mitral and aortic valve access to the heart and offers the surgeon sequently, endoscopic robotic coronary op-
surgery. In addition to the development the ability to operate precisely in limited erations were described the following year;
of new technologies such as visualisation spaces, overcoming the lack of precision that soon after, a totally endoscopic, robotically
systems, specially designed retractors, sta- results from the additive effects of instru- assisted cardiac surgery procedure for the re-
bilisers, and alternative methods of vas- ment length and operator tremor by filtering pair of atrial septal defects was reported.
cular cannulation and cardiopulmonary high-frequency motion. Dexterity is further All the robotically assisted cardiac sur-
bypass, surgeons have become capable enhanced through computer motion-scal- gery procedures performed to date have ei-
of performing simple cardiac procedures ing, which allows the surgeon to make large, ther been extra-cardiac procedures or proce-
through much smaller incisions than with easy-to-perform macroscopic movements dures that were performed inside an arrested
conventional approaches. However, the at the console and have these movements heart. In the past, beating-heart procedures
limited incision size has imposed a cor- scaled down by the computer to microscopic were attempted, but these approaches fell
responding increase in the technical dif- movements of the instrument tip inside the into disfavor after cardiopulmonary bypass
ficulty of the procedure accompanied by a patient. Endoscopic magnification also im- (CPB) became available, which allowed di-
potential for a reduced safety margin due proves the accuracy of surgical maneuvers by rect visualisation of the intra-cardiac struc-
to incomplete cardiac exposure. providing enhanced visualisation. tures. Nevertheless, CPB is widely recog-

32 Asian Hospital & Healthcare Management ISSUE-12 2007


w w w . a s i a n h h m . c o m 33
S u rgical S peciality

nised as having a number of adverse effects, frequent instrument conflicts and can result
including the generation of microemboli in additional unnecessary incisions if the
and an inflammatory response associated ports must be re-positioned. Using com-
with increased cytokine production and puted tomography (CT) and magnetic res-
complement activation, which together onance imaging (MRI), preliminary efforts
can result in neurological dysfunction in toward the development of a three-dimen-
adults and neurodevelopmental dysfunction sional virtual cardiac surgical planning plat-
in children. form have been initiated for use with totally
Several investigators have recently at- endoscopic cardiac surgery to avoid these
tempted a variety of beating heart approach- problems. We have also employed a new
es for the repair of intra-cardiac pathologies, port placement planning platform for extra-
including atrial septal defects, ventricular intraoperative images overall as an image- cardiac operations in children. The planned
septal defects, and mitral valve regurgita- guided technology, but the spatial resolu- setup enables excellent exposure in addition
tion, but the results were all suboptimal and tion of the RT3DE still needs optimisation to patient positioning, with no internal or
not applicable in clinical situation. to advance from simulation into a clinical external instrument conflicts.
On the other hand, the recently in- setting. In addition, the transducer is too The absence of tactile feedback and the
troduced real-time three-dimensional large to be applied directly to the heart inability to regulate the force applied to the
echocardiography (RT3DE) system with through a small incision, since the operating tissues comprises the most endoscopic sur-
a 2D matrix array of piezoelectric crystals field of instruments is restricted. Therefore, gical techniques and instrument manipula-
(Philips Medical Systems) provides clini- further technological development of the tion by the robotic system will eventually
cians and surgeons with a new perspective RT3DE system, such as by design of a high- become comparable to that by the human
for visualising the heart non-invasively. frequency mini-transducer or trans-esopha- wrist. In addition, haptic exploration of pre-
When RT3DE is used for image-guided geal transducer, will probably be necessary operative image data sets facilitate surgeon
surgical tasks, some complex tasks required to make minimal incision RT3DE-guided intuition during the planning of complex
for intra-cardiac repair can be performed beating-heart surgery possible. reconstructions.
using echo guidance alone. This system Current robotic systems were designed
has sufficient spatial resolution and frame Other research and development to complete a simple anastomotic suture
rate to give the surgeon a “virtual surgeon’s We are simultaneously investigating the line. Gulbins et al. reported that it required
view” of the relevant anatomy. Currently, potential application of an electromagnetic 30 minutes to finish a 10 suture throw in
we have adapted RT3DE with specialised tool tracking and navigation system as a training simulators. The time required for
instrumentation to facilitate beating-heart complementary navigation tool in beat- anastomosis could be reduced using novel
repair of Atrial Septal Defect ASD and ing heart intra-cardiac surgical procedures. devices for joining tissues or anchoring
mitral valve plasty in animal experiments Similar systems are currently in use for cath- a surgical prosthesis, such as the Tacker
(Figure 1). In our preliminary experiment, eter tip tracking and navigation for arrhyth- spiral tack (US Surgical), the SaluteTM
we also examined the feasibility of robotic mia ablation. This latter system combines (Onux Medical), the Sew-RightTM and
assisted RT3DE guided beating-heart repair an electromagnetic tracking system with a Ti-KnotTM systems (LSI Solution), or
of ASD. Compared to 2-dimensional echo catheter-based sensor that can be used to the U-ClipTM Anastamotic Device (Coa-
guidance, completion times of performing create a 3D map of the atrial chamber. We lescent Surgical). Combining any of these
clipping improved by 70% (p<.0001), and have experimentally used such a tracking devices with the speed and precision of
deviation of clipping by the robotic system tool to navigate inside a beating heart. With robotic automation could make mini-
was significantly smaller (2DE: 3.5±2.2 mm, further development, this system could be mally invasive tissue fixation exponentially
3DE: 0.2±0.3 mm, p=.0002) in RT3DE used together with RT3DE to confirm con- more efficient.
guided tasks. In water bath experiment of tact with the septal wall during patch place- Further manipulation of the digital
ASD closure, RT3DE provided satisfactory ment in ASD repairs while ensuring the visual interface may also make it possible to
images and sufficient anatomical detail for avoidance of conducting tissues. work on the beating heart in “virtual still-
suturing (Figure 2). All surgical tasks were The current size of the da Vinci surgical ness”. Lately, we have also been developing
successfully performed with accuracy. We system is the most critical limitation for its integrated motion cancelling systems, in-
therefore expect that the combination of application in pediatric cardiac surgery. To cluding visual stabilisation systems and mo-
new intra-cardiac imaging technology and date, 5mm instruments and smaller 3D en- tion stabilisation systems. The movement of
tool-tracking systems with the dexterity and doscopes have been developed. In the near the robotic instruments and camera would
stability of robotic instruments will enable future, more technological advances are be synchronised with each heartbeat, ef-
safe and reliable off-pump intra-cardiac re- likely to extend the application of robotic fectively cancelling cardiac motion and in-
pair, including ASD closure and the repair surgical systems to neonates and infants. creasing surgical precision.
of mitral valve insufficiency. Determination of the optimal port place-
Indeed, there still are several limitations. ment is a significant issue. Mistakes at this
Full references are available on
Our RT3DE system provides adequate stage of the operation lead to delays from www.asianhhm.com/magazine/

34 Asian Hospital & Healthcare Management ISSUE-12 2007


D iagnostics

Oral-based
Diagnostics
Oral diseases
and beyond

Antoon J M Ligtenberg
Assistant Professor
Department of Oral Biochemistry
Academic Centre for Dentistry
Amsterdam (ACTA)
The Netherlands

cus mutans and Lactobacillus spp., resulting


into an ecological shift to a more cariogenic
plaque. Saliva secretion rate, buffering ca-
pacity and counts of mutans streptococci
With modern proteomic and genomic techniques it is
and lactobacilli, have proven to be sensi-
possible to fine-tune diagnostics of oral diseases and tive parameters in caries prediction models.
monitor other diseases by oral diagnostics. High numbers of S.Mutans and Lactobacil-
lus spp. indicate a shift in oral microflora
from healthy to more cariogenic. Diagnos-
tic kits for S. mutans and Lactobacillus spp.

I
n October 2006 the New York Acade- mon is that samples can be collected non- counting are widely used in dental practice
my of Sciences organised a conference invasively. This makes collection of saliva and can be conducted without laboratory
in Atlanta on Oral-based Diagnostics safe and patient-friendly. Since no trained facilities. They are based on traditional cul-
dealing with the diagnostic potential of sa- staff or sterile equipment is necessary, oral- turing techniques in selective media but
liva and its constituents. Although blood based diagnostics can be used quite well analysis by PCR is also possible.
is still the gold standard for diagnostics of for point-of-care diagnostics, home testing In a healthy situation, there is no cor-
diseases and drugs, oral diagnostics has the and road side applications. relation between saliva secretion rate and
same and may be an even larger diagnostic The current position of oral diagnostics dental caries. However, when the sali-
potential. Principally, all substances that can be illustrated by its role in oral diseases vary secretion rate drops below a certain
are present in blood may be monitored in like dental caries and periodontal disease. minimum, the amount of dental caries in-
saliva, since serum components leak from Dental caries is the demineralisation of creases dramatically, also at smooth den-
the gingival crevice into the oral cavity. teeth caused by acids that are produced by tal surfaces that are normally not prone
The concentration of serum components plaque bacteria. Bacteria accumulate as an to caries as well. Salivary secretion rate
in saliva may be enhanced by normal ac- oral biofilm called dental plaque, particu- is easily measured by weighing the saliva
tions like tooth brushing which results in a larly at those dental surfaces that cannot be volume that is collected by drooling or
fourfold increase of serum albumin. In ad- cleaned properly. The frequent consump- expectoration divided by the collection
dition, not only saliva and serum compo- tion of fermentable carbohydrates results in time. Low salivary buffering capacity is
nents, but also oral bacteria and epithelial the production of organic acids, primarily a risk factor for dental caries and also is
cells are present in the oral cavity. All these lactic acid, that are released into the plaque indicative for low saliva secretion. Com-
substances have their own specific diagnos- fluid. This lowers the pH in the oral biofilm, mercial kits are available for determina-
tic potential, but what they have in com- which favours the outgrowth of Streptococ- tion of the salivary buffering capacity.

w w w . a s i a n h h m . c o m 35
D iagnostics

Saliva plays an important role in the at the gingival margin and the composition enhances the chance of a positive outcome
maintenance of oral health. For that pur- of the plaque changes, inducing gingival in- of treatment. As part of the therapy, antibi-
pose, it contains a large number of differ- flammation (gingivitis). This progresses to otics are applied frequently. However, dif-
ent components that kill or inhibit bacteria, periodontal disease characterised by break- ferent periodontopathogens are susceptible
prevent their colonisation, act as nutrient for down of alveolar bone and connective tis- to different antibiotics. Therefore, prior
commensal bacteria and promote reminer- sue fibers, resulting in loss of attachment to antibiotic treatment pathogens should
alisation of the teeth. Therefore, numerous and deepening of the periodontal pocket. be determined by culturing or PCR tech-
studies have aimed at finding a correlation Progress from gingivitis to periodontal niques. Oral fluid may be used for that, but
between dental caries and saliva constituents disease is determined by genetic suscepti- since the bacterial numbers in saliva may be
with only weak correlations. Because dental bility, environmental factors like smoking, too low, small methylcellulose paper strips
caries is a multifactorial disease, there are and the presence of pathogenic bacteria. are used to collect fluid from the gingival
several reasons for the weak salivary correla- Diagnosis of periodontal disease is primar- crevice. Next to the salivary proteome,
tions. First, saliva output and composition ily based on radiographic analysis and mea- there is a salivary ‘transcriptome’ repre-
are only two links in a whole chain of events surement of the pocket depth with a sonde. sented by RNA in saliva, as was shown by
that cause dental caries. Second, whole saliva Though efficient, such clinical methods do Dr David Wong. Approximately 3,000 dif-
composition doesn’t reflect the composition not provide adequate information for iden- ferent mRNAs have been found in saliva of
of the plaque fluid at sites where dental car- tifying people at risk, disease activity, caus- which ~200 are commonly present in all
ies develops. Third, salivary proteins show ative agents, and treatment outcome. This people. Upon exploring the clinical utility
overlap in function and many proteins have information could be provided by oral-based of the salivary transcriptome in human oral
more than one function making it difficult diagnostics. There is a large, genetically de- cancer subjects it was found that 4 salivary
to correlate dental caries to a particularly termined, variation in susceptibility for peri- mRNAs (OAZ, SAT, IL8 and IL1b) collec-
one, or a few salivary components. odontal disease. Mutations in the cathepsin tively have a 91% sensitivity and specificity
Studies that have focused on functional C gene have been identified as causal for for detection of oral cancer.
aspects of whole saliva, rather than study- the Papillon-Lefèvre syndrome, including Going beyond oral diseases, oral-based
ing the quantities of individual proteins, severe forms of prepubertal periodontitis. diagnostics finds its way to other applica-
have yielded more promising results. For In addition, multiple genes have been asso- tions. A widely used test that is approved
example, high bacterial aggregation activ- ciated with less severe forms of periodontal by the FDA is an oral test for HIV that de-
ity of saliva has been associated with low disease. People at high risk for periodontal tects antibodies against the p24 antigen of
caries experience. Since there is a long list disease might be determined therefore by HIV. The applicator swab is gently rubbed
of salivary proteins that bind and may ag- genetic screening. DNA can easily be iso- along the outer gums­­—both upper and
gregate oral bacteria (e.g. S-IgA, mucins, lated from oral epithelial cells, collected by lower—and inserted into a vial contain-
agglutinin/DMBT-1/gp340, lysozyme, use of a buccal swab, one of the most com- ing the developer solution that detects the
lactoferrin, amylase, proline-rich proteins, mon oral diagnostics. antibody to p24 antigen of HIV. In about
statherin and histatins) aggregation couldn’t The loss of attachment and deepening 20 minutes, an indicator shows that it is
be correlated with a specific salivary protein. of the periodontal pocket leads to increased working. A second signal appears if it detects
It requires modern proteomic techniques to leakage of a serum-like fluid, designated the presence of the p24 antigen; those indi-
take them all into consideration. NIH is gingival crevicular fluid, into the oral cav- viduals are given a confirmatory test. Oral
investing millions of dollars in clarifying ity. Since serum has a 50 to 70 fold higher samples are also used for testing of illegal
the human saliva proteome. At the confer- protein concentration the average protein street drugs such as marijuana, cocaine, XTC
ence on Oral-based Diagnostics in Atlanta concentrations in oral fluid increases dra- and heroin. Unlike urine samples where
Dr David Wong, UCLA, announced that a matically and the concentration of a typical switching may be possible, oral samples allow
first version of the human salivary proteome serum component like albumin shows an for observed, controlled sample collection.
is available at the website of UCLA in 2007 8-fold increase. At the conference on Oral- Conclusively, it can be said that oral-
(www.hspp.ucla.edu). based diagnostics Dr Christoph Ramseier based diagnostics already plays its own
Many oral bacteria bind carbohydrate from the University of Michigan, and specific role in caries prediction and peri-
chains on salivary glycoproteins. Therefore, Dr Ira Lamster from the Columbia Uni- odontal disease classification. Since blood
the salivary ‘glycome’ might be an impor- versity, New York, showed that during ac- components are leaking into the oral cavity,
tant pre-determinant for oral disease. This is tive periods of the disease increased levels we expect that oral-based diagnostics will
illustrated by research of Paul Denny from of inflammatory markers, like interleukins, replace more and more of the current se-
the University of Southern California, who can be demonstrated both in gingival cre- rum-based tests. In addition, microchips for
showed a difference in carbohydrate com- vicular fluid and in saliva. Several important multiple saliva analytes will become avail-
position between children at low and high marker bacteria have been associated with able in the near future, bringing proteomics,
caries risk. Another oral disease for which periodontal disease such as Porphyromo- transcriptomics and genomics within reach
several aspects of oral-based diagnostics are nas gingivalis, Prevotella intermedia and of point-of-care diagnostics.
evaluated, is periodontal disease. Due to poor Acinobacillus actinomycetemcomitans.
Full references are available on
oral hygiene the dental plaque accumulates Eradication of these bacteria significantly www.asianhhm.com/magazine/

36 Asian Hospital & Healthcare Management ISSUE-12 2007


innovations

In what appears to be the first step towards


a radiation-free, non-invasive technology,
Vibration Response Imaging (VRI) has
arrived. VRITM, an innovative technology
developed by the Israel-based company,
Deep Breeze Ltd, can create images of the
lungs based on the sound of air moving in
and out of the passageways of the lungs,
thereby preventing exposure to radiation in
diagnosis.

Igal Kushnir, President and CEO, Deep Breeze Ltd


Israel

Vibration Response Imaging


A new methodology for measurement
of lung vibrations

I
n the hands of a trained physician, Future applications include the diagnosis VRIXP™ system could fall under pulmonary
the stethoscope has been an excellent and management of asthma, lung cancer, imaging or function codes. Pulmonary im-
tool to assess the air moving through lung transplants, pneumonia, COPD, aging using nuclear medicine technology
a patient’s lung. But its usefulness is lim- and the ICU management of mechani- currently reflects an average CMS payment
ited due to the range of audible frequen- cal ventilators. In the ICU setting, physi- of US$197 (APC 378, Level ll). Based on
cies as well as outside interferences. The cians will have an easy-to-use technology 1,000 procedures per year, a facility could
VRIXP™ is a unique new lung imaging to assist them in determining the lungs’ see a New Technology for Lung Function,
system developed by Deep Breeze in Is- condition, response to therapy and to Ventilator Patients profit margin of over
rael. Based on the science of Vibration evaluate optimum ventilation settings. US$740,000 at the end of a five-year term.
Response Imaging (VRI) technology, the This should result in better outcomes by Pulmonary function reflects an average
VRIXP™ produces dynamic lung images at assisting the physician in the reduction CMS payment of US$57 (APC 368, Level
the bedside without the use of radiation. of ventilator-related pathologies. This will ll). Based on 1,000 procedures per year a
The VRIXP™ is a portable system that also allow patients to be weaned off a ven- facility would see a profit margin of over
uses an array of 42 multi-use transducers, tilator more quickly—a key factor in im- US$134,000 at the end of a five-year term.
which are placed on a patient’s back. The proving outcomes for ventilated patients. This reflects a revenue generating technol-
array is used to measure the vibrations As with any technology used on an ogy that does not directly compete with
generated from the acoustic energy devel- inpatient, the cost per use is important due any existing revenue streams.
oped as air passes through the lungs. The to the capitated payment structure most
data for producing an image is acquired in hospitals face. Along with the system’s abil- Market potential
seconds; it is a quick and easy procedure ity to offer a unique, safe and new technol- Lung disease is the third most common
performed by a technician, much like an ogy for lung assessment, the VRIXP™ also reason for hospitalisation in the US alone.
ECG. Along with producing an image, has a very attractive cost per use. This is Lungs are an internal organ but are con-
the ultimate goal is to correlate that image due to the reusable sensor array and the stantly exposed to the outside environ-
with a numerical scale namely Quantita- limited labour required. Based on 1,000 ment. Because of this, they are susceptible
tive Lung Data (QLD). tests per year, a facility should expect to to multiple forms of disease. Over 35 mil-
see costs of approximately US$24 per pa- lion Americans are living with chronic
Economical overview tient. Lower use applications such as long lung diseases such as asthma, emphy-
The first target of the VRIXP™ system term monitoring would see costs of US$80 sema and chronic bronchitis. Each year
will be the monitoring of lung sounds. based on 200 tests per year over a five-year around 350,000 die from these diseases.
This will allow physicians to detect what period. The system is currently selling for These numbers will continue to grow as
is going on in a patient’s body and aid in US$50,000 in Europe. the population ages and environmental
evaluating the outcomes of procedures. Under existing outpatient codes, the factors come into play more often.

w w w . a s i a n h h m . c o m 37
D iagnostics

nosis of lung diseases. Asthma dynamics in the tumour area. Pleural fluid
alone affects 5-10% of the US results in reduced meniscus shape in the
population. This equates to lower lobes and absence of VR in the area
an estimated 14-15 million of the pleural fluid.
people in the US, including Patients having various lung patholo-
five million children. Asthma gies such as asthma and bronchiectasis,
is also responsible for over 1.8 differed from normal images in symmetry,
million emergency room vis- intensity and time sequence. In asthma pa-
Figure1: VRIXP™ Normal Image of a Figure 2: The VRIXP™ Image of a 12
its and 500,000 hospitalisa- tients the VRIXP™ image showed an asym-
19 y.o Female Healthy with Asthma. y.o Female with Bilateral Bronchiectasis tions annually. It is estimated metrical vibration response distribution
Red Dots Indicate Wheezes. and Pulmonary Hypertension.
Blue Dots Indicate Crackles. that asthma alone costs the between lungs and lung regions (Figure
US economy over US$20 1). In 5 bronchiectasis patients the VRI™
Lung disease is also very costly to treat. It billion a year in both lost of productivity revealed disturbed VR which affected the
costs Americans US$81.6 billion in direct and treatment. time sequence and symmetry (Figure 2).
healthcare expenditures plus US$76 billion Following Single Lung Transplanta-
in indirect costs. These combined factors The procedure tion, most of the ventilation and perfusion
make lung treatment and diagnosis of lung The system is designed to be portable and shifts to the transplanted side. A routine
disease a major focus of researchers. Some easy to use. This will allow it to be used ventilation and perfusion (V/Q) scan is
of the most common lung diseases are in multiple settings by a nurse, technician performed periodically to asses the graft
COPD, pneumonia and chronic asthma. or physician. As with an ECG, a physician function. In a well functioning graft, fol-
These diseases account for over 750,000 will do the interpretation. The procedure lowing single lung transplantation, most
hospitalisations each year. COPD is most takes approximately five to ten minutes of the ventilation (V) and perfusion (Q)
common in patients over 47 years of age including preparing the patient, placing shifts to the transplanted side (Figure 3a).
and treatment is reimbursed by a combi- the sensor array on the patient’s back, and Chest auscultation usually discloses a dif-
nation of Medicare and private insurance. reviewing the image. The actual recording ference between the transplanted and non-
The most serious and costly cases involve takes approximately 12 seconds. Once the transplanted lungs; however, no quantita-
the end stages of the diseases, which is array is placed over the patient’s lungs, the tive or regional assessment can be done by
more common in Medicare patients. The transducers convert the sound data to an the physical examination. The VRIXP™ of-
National Institute of Health (NIH) es- electrical signal. This is in turn digitised fers a quantification of regional assessment
timates that the direct cost of treating and converted into a dynamic image. This lung function or Quantitative Lung Data
COPD alone is US$18 billion a year. This is a simple process that offers real-time im- (QLD) function in post lung transplanta-
makes it over 2.5 times more expensive to ages of lung function and can be done in tion patients (Figure 4b and c). Vibration
treat than all other diseases affecting hos- virtually any setting without exposing the energy collected throughout the breathing
pitalised patients. One reasons for this patient to radiation. cycle can be quantified for any lung region
by integrating the vibration energy over
the 40 sensors of the V-Array.

Right Left Conclusion


Upper 4.35% 22.11% VRIXP™ provides a better understanding
Middle 5.68% 46.97% of lung function throughout the respira-
Lower 1.06% 19.82% tory cycle, for improved diagnosis of lung
Total 11.09% 88.91% condition. With the Quantitative Lung
Data function of VRIXP™, the clinician
can obtain immediately the regional as-
Figure 3a. VRIXP™ MEF of a 56 year old female 3.5 years post left lung transplantation, Figure 3b. demonstrates the VRIXP™ sessment of right and left lung function, as
QLD configuration, and Figure 3c the posterior perfusion scan (regional assessment: right lung 23%, left lung 77%).
the imaging modality quantifies the vibra-
tion distribution automatically during the
high cost is the expense of the mechani- Functional lung imaging procedure. The VRIXP™ also has the capa-
cal ventilators required to treat the latter Normal image: healthy lung images ap- bility to visualise the location and distribu-
stages of the disease. Not including criti- pear with an almost symmetrical, simul- tion on the VRIXP™ image of the crackles
cal care cost, the ventilator therapy alone taneous development of the Vibration and wheezes should it be recognised at any
expenditures start at US$325 per day. This Response (VR), which correlates with time throughout the respiratory cycle. The
makes the reduction of ventilator use a ma- airflow dynamics. quick and efficient VRIXP™ procedure may
jor focus of both healthcare providers and VRIXP™ images of lung pathology: Lung be performed repeatedly for assessment
payers. Another potential market for the tumour image results in an asymmetrical and continued monitoring of lung status,
VRIXP™ system is the assessment and diag- appearance and reduced VR and disturbed providing instant results in any facility.

38 Asian Hospital & Healthcare Management ISSUE-12 2007


D iagnostics

Point-of-care Diagnostics
Tapping the potential

Point-of-care diagnostics are a potentially profitable growth area for the healthcare
industry. However, there are several issues to be overcome before any point-of-care
instrumentation can be successfully commercialised.

Figure 1. Projected growth in worldwide in vitro diagnostics


Neil Butt
by Product Segmentation 2005-2010
Consultant
Product and Process Engineering
Richard Owen
Consultant POC - Professional/hospital
Product and Process Engineering POC OTC - Other
POC OTC - Diabetes
PA Consulting Group Flow cytometry
UK Blood grouping/typing
Nucleic acid test
Histology/cytology
Coagulation

P
Radioimmunoassays
oint-of-care diagnostics—either for Microbiology - ID/MIC
Hematology
home use or for a “near-patient”
Immuno assays - Blood banks
environment such as the general Immuno assays - Other Immuno
practitioner's surgery—are a potentially Immuno assays - Infect Dis
Clinical Chemistry
profitable growth area for the healthcare
industry. However, there are several issues -1 4 9 14 19

to be overcome before any point-of-care


instrumentation can be successfully com-
mercialised. These include the demon- smaller companies who are happy with the Barriers to success, and how to
stration of clinical benefit, arrangements steady revenue these areas can provide—this overcome them
for reimbursement, delivery at acceptable can be reflected in the disposal by Roche in The US market consists of approximately
cost, meeting regulatory requirements, as- some of their Opti blood gas analysis busi- 900,000 physicians and approximately
surance of acceptable quality, and dealing nesses to Osmetech in 2005. 25,000 offices have some level of Clini-
with stakeholder perceptions. We discuss An alternative way to extract additional cal Laboratory Improvement Amend-
each of these areas in turn and suggest ways value from mature testing technologies is to ments of 1988 (CLIA) waiver and the
of addressing them. move them closer to the patient. In this way number continues to grow. However,
For both large and small diagnostic the tests can be potentially sold in greater that still leaves at least a further 200,000
companies, today’s diagnostics market is volumes. This offers both the clinicians, and potential POC sites including physician
challenging. Large players typically have increasingly healthcare accountants, the op- offices and clinics. To enable uptake of
many products that are mature and moving portunity to identify a disease earlier and POC testing by these facilities, we sug-
into a phase where profit margins are being potentially reduce the number of days an gest that several key strategic issues must
squeezed as competition becomes more in- individual patient may be incapacitated and be addressed:
tense. A 2006 study by Kalorama Informa- therefore, avoid using expensive hospital Clinical benefit
tion projected a compound annual growth facilities. However, this area has been high- Reimbursement
rate in clinical chemistry of only 2% until lighted as a potential growth area for many
Cost
2010. Figure 1 shows predicted growth over years, but recent market surveys predict
the period 2005-2010. The slow growth growth to be only 7% over the next 5 years, Regulation
rates in some sectors has resulted in a period whereas areas such as molecular diagnostics Test quality and quality control (QC)
of divestment by the larger companies to are predicted to grow at around 16%. Perception

w w w . a s i a n h h m . c o m 39
D iagnostics

Clinical benefit collected remotely; for successful follow-up, continuing development unless reimburse-
To make a POC proposition viable, it is records need to be kept of the test readings. ment is assured. Developers should present
necessary to develop a business case that will Data collection is harder, but not impos- reimbursement bodies with a compelling
convince both regulators and reimburse- sible, in the home setting. The device might business case showing why the test will add
ment bodies of the value of the new test. need to have a wireless communications value. This can be enhanced by, wherever
As with any diagnostic test, proven clinical adapter, or to be plugged into a telephone possible, embedding reimbursement experts
benefit will provide the strongest motiva- line. Now that communication is relatively into the development team from the outset
tion for adoption. Diagnosis in general has inexpensive and governments (in the UK at of any new programme. From our experi-
an obvious clinical benefit since over 70% least) are favourably disposed to central in- ence it is not unusual for these individuals
of healthcare decisions are made following a tegration of patient data, this proposition is to have little input into a diagnostic devel-
diagnostic result; in this context, however, it quite realistic. opment until late in the process.
is necessary to show an advantage to POC Perhaps, novel means of reimbursement
diagnosis. Reimbursement may also enhance the opportunity to extract
That advantage differs somewhat de- Without reimbursement, there is no incen- maximum value from any new diagnostic.
pending on whether the condition being tive to use any diagnostic tool, and hence Different interest groups may enhance the
tested for is acute or chronic. In the case no market. This is a problem area because value of a test and therefore act as a con-
of an acute condition, POC diagnosis can in many countries there is chronic under- vincing lobby in generating reimbursement
improve the patient outcome by allowing reimbursement for diagnostic tests, with at an appropriate level. For example, home
a reduced time to result, and hence faster prices pegged so that, for example, Medi- tests may be influenced by advertising and
initiation of treatment. Group B Strepto- care is effectively paying less each year for marketing a product directly to a patient,
coccus (GBS) provides an example. One in better tests. thereby, generating a new interest body in
20 babies infected with this common con- In addition, the structure of reimburse- establishing reimbursement.
dition dies, while many others suffer long- ment is often inimical to diagnostic tests. In
term health problems. The availability of a the US and Germany, authorities reimburse Cost
15minute test in the delivery room would hospitals for the entire cost of treating a dis- POC testing brings savings that may justify
allow physicians to prescribe intravenous ease, so that if the patient stays in hospital a somewhat higher per-test cost than is ac-
antibiotics prior to delivery. Clinicians tell longer than anticipated the hospital has to ceptable for a centralised test. Laboratory
us that POC testing in this case would con- bear the cost. That structure can discourage and hospital testing usually involves expen-
fer considerable benefits. However, the use the use of diagnostic tools if they see extra sive equipment (though the consumables
of tests for STDs and H. pylori would, on testing resulting in reduced profit, or worse are cheap). A POC test usually eliminates
the surface, appear perfect candidates for still potential financial loss per patient. that high cost of equipment. In addition,
POC testing. This has not been the case and There is little doubt that reimburse- some of the overheads of monitoring by a
reasons are not totally clear, but the expec- ment practices and structures constitute a specialist physician or technician are saved
tations of a 30 minute wait could be one barrier to development of better tests—a by a POC test, especially a home test. Any
issue, along with the fact that many of these fact that arguably affects clinical practice for organisation that brings testing nearer to the
tests at this time are not as sensitive as the the worse, since it faces both a reluctance to patient may be able to argue for a higher
laboratory based methods. use diagnostics with a lack of better tests in price because of these savings, in particular
In the case of a chronic condition, the the future. In short, the global reimburse- where a rapid intervention offers a signifi-
POC advantages again include a reduced ment situation vis-à-vis diagnosis is in ur- cant clinical benefit. However, for this to
time to result in comparison with a lab test. gent need of review, something it has not ring true the Point-of-Care systems must
In addition, there is likely to be a decreased received since the 1980s. carry an inherent low manufacturing cost
use of hospital resources and a lower risk of There are already encouraging signs in to justify the placement of several systems
sampling errors. Patient compliance and sat- the US. The Lewin Group delivered a re- (for the same purpose) in a single medical
isfaction is likely to be enhanced, especially port on diagnostics for the Advanced Medi- facility. In the case of a doctor’s surgery or
with a home test. Roche reports a recent cal Technology Association in July 2005. It emergency room, an excessive hardware cost
clinical trial which has shown that patient found that diagnostics were underused half is likely to prevent market penetration. In
self-monitoring with a new coagulation test, the time in connection with diseases like conclusion, any point of care system would
Coagucheck S, “can reduce the risk of severe cancer, heart problems and diabetes, and have to be of low complexity with low hard-
complications and minor haemorrhages by that more testing would avoid many adverse ware costs.
up to 70% in patients on oral anticoagulant events and could save almost $900 million
therapy… and that it can reduce mortality in avoidable healthcare costs. Regulation
after heart valve replacement by 60%.” In the meantime, for organisations Most countries have special regulatory re-
It is also necessary for the business case that are considering developing a POC quirements for POC tests, since they must
to show how any potential disadvantages of test, it is important to communicate with be capable of accurate administration and
POC diagnosis can be offset. One possible reimbursement authorities early on in the interpretation without the aid of techni-
objection concerns the management of data development process; there is no point in cians. If a test is sufficiently reliable and easy

40 Asian Hospital & Healthcare Management ISSUE-12 2007


D iagnostics

to use, it can in the US be exempted from sicians. These experts could encourage otherwise. Finally, clinicians set a high prior-
ongoing regulatory oversight under the patients to comply with their therapy and ity on turnaround times. Again, this percep-
CLIA law. In most cases the FDA requires could adjust treatment in response to the tion mitigates in favour of POC tests since
both home and near-patient tests to have patient’s condition. they are usually designed to deliver a “while
this “CLIA waiver”. The other difficulty with new tests is you wait” result—ideal particularly in the
For tests of “moderate complexity” that they still have to be compared to “gold case of patients being tested for a condition
those not simple enough to qualify for the standards”. This means the laboratory will such as HIV, who often do not come back
waiver there is in the near-patient environ- have to continue performing upto the gold for their test results.
ment the alternative of setting up quality standard, even if it is less efficacious. This What about the perceptions of techni-
systems to ensure that the system is correctly has resulted in an environment where new cians in centralised laboratories? They are
used. However, this alternative is likely to be tests do not replace the old, but merely add concerned that decentralised tests may not
unappealing for most doctors’ surgeries, so to the menu, and result in diagnostic groups be as accurate as lab tests, a consideration
manufacturers of POC tests should aim for continuing to order the old as well as the that can be addressed by either the CLIA-
the CLIA waiver. new. This is clearly reflected in the use of waiver route or with remote monitoring,
To obtain a CLIA waiver, manufactur- CK-MB as a cardiac marker gold standard. both of which can ensure that all systems
ers have to show that POC users generate It is widely viewed that troponin is a supe- operate to the same level of safety, qual-
data equivalent to those that would be pro- rior marker but sales of CK-MB have not ity and reliability. Technicians too, may see
duced in a lab. They also have to show that diminished at all. POC tests as more expensive, but again this
the system is failsafe, that is to say that a fail- perception arises from a partial view of cur-
ure will not give any information that may Perception rent costs.
be interpreted as a data point; it is better to The attitudes of various stakeholder groups The perceptions of patients are also ex-
convey no result than a wrong result. will influence the acceptability of a POC tremely important. In general, the public
test. For a home test to be accepted, patients likes POC testing, and they could consti-
Test quality and QC must want to test themselves, while doctors tute the strongest force in pushing for ac-
In the POC environment, there are likely must be willing to relinquish control. ceptance by the medical profession. The trip
to be no technicians present to to a local hospital or clinic in order
insist on proper control and cali- to have a routine test performed
bration. Instead, it will be neces- can be more stressful than the ac-
sary (except perhaps in the case At present, clinicians tend to perceive tual output of the test in today’s
of CLIA-waivered equipment) POC tests as expensive, but this is congested cities. Maybe it is time
to instigate centralised control usually because they operate in cost to let the patient take more control
systems that communicate elec- silos and do not yet appreciate the full over their well being. However,
tronically with the equipment many of the current tests are blood
costs associated with late diagnosis or
and collect performance data. A based, and although diabetics per-
diagnostic group should have re- poor monitoring. form blood analysis daily, many
sponsibility for monitoring based find this approach unattractive.
on this data, and should also In many cases individuals are also
have the ability to manage the system, for Let us first consider the perceptions of unwilling to find out what is wrong with
example locking out individual operators, clinicians. They want to offer the best clini- them. But, like statins, marketing direct
or even shutting down the entire system, if cal option, but are starting to talk in terms of to customer may change the perception of
performance falls below an acceptable level. “the best option at the best price” a change self-testing and open up the “over the coun-
This, of course, leads to issues over systems which opens up the possibility that they will ter” (OTC) market before the technology is
potentially “being failed” in critical situa- be receptive to home tests. At present, clini- widely adopted in clinical settings. This can
tions. However, it may be less harmful to a cians tend to perceive POC tests as expen- be illustrated with OraSures move to gener-
patient to wait for a result rather than have sive, but this is usually because they oper- ate a self test HIV kit and developments is
the wrong information reported from poorly ate in cost silos and do not yet appreciate this area may open opportunities that will
performing operator or piece of equipment. the full costs associated with late diagnosis allow for the much publicised growth rates
This type of centralised monitoring requires or poor monitoring. Doctors also want to of 20-25% heralded in the late 90’s.
connectivity between POC equipment and keep control of data interpretation, an ob- All things considered, if manufactur-
a centralised facility. Such connectivity is jective which near-patient testing supports, ers can prove a clear benefit from a POC
now cheap and easy to achieve. since it can present raw data for interpre- test and ensure issues of reimbursement
For home tests in particular, remote tation by the physician rather than having and quality are satisfactorily resolved, then
monitoring could have the additional ben- it processed first by a technician. However, physicians, conservative as they are, likely to
efit of allowing the data to be interpreted, doctors often believe that the best-quality accept the test.
and the patient’s condition managed, by testing is performed in labs, and so it is up
Full references are available on
remote experts, whether clinicians or phy- to suppliers of POC tests to convince them www.asianhhm.com/magazine/

w w w . a s i a n h h m . c o m 41
T echnology , E q u ipment & D evices

Fibre Optic Plethysmography For


Non-invasive Cardiac Monitoring
Fibre optic plethysmography for cardiac monitoring is a significant advance
on previous designs.

ure-of-eight fiber optic coil, which shows light to be lost from the fiber, and hence
increased linearity of response, a wider dy- the transmitted light is attenuated. The
Andy T Augousti namic range, and reduced hysterisis. This is ends of the coil are attached to an elasti-
Professor
Applied Physics and Instrumentation a significant advance on previous designs, cated bandage that can be placed over the
Faculty of Science which utilised a series of simple coils; a subject’s torso, and as the heart beats, the
Kingston University trade-off between the attenuation charac- minute changes in chest circumference
UK teristics of individual coils, and the result- stretch or relax the bandage. This motion
ing stiffness of the overall assembly, had to is transferred into a small variation in the
be achieved in this earlier design. The prin- bend radius of the fiber coil. Fortunately,
ciple of operation of such systems is similar the transmission of light through this coil

T
he use of cardiac monitoring is an to that of the respiratory inductive plethys- can be highly sensitive to small variations
essential diagnostic tool for pa- mograph (RIP), a wire-based system that in this bend radius (this is usually a prob-
tients in a critical condition. The utilises variations in the self-inductance lem in light transmission for optical com-
most widely used modern method of car- of a metal coil looped around the torso to munication purposes!), and so the motion
diac monitoring is the electrocardiograph, monitor cross-sectional area variations, and arising from the beating heart can be de-
which produces the well known electrocar- hence infer volumetric changes in the chest. tected. This is termed the macrobending
diogram (ECG). Experienced operatives In the case of the fiber optic respiratory loss effect (MBLE), and in this particular
can interpret the ECG to reveal not only plethysmograph (FORP), it is variations in implementation of the technique a 0.4mm
the heart rate, but also subtle information the chest circumference that are measured diameter silica glass step index fiber was
relating to the condition and function of and utilised to infer volumetric changes. employed.
the patient’s heart. However, the use of The RIP, like the ECG, suffers from its One of the key advantages of the fig-
electrocardiographs in electrically hostile susceptibility to electromagnetic interfer- ure-of-eight coil, apart from improved
environments is difficult, and so an alter- ence (EMI), due to its metallic nature. optical performance in terms of linearity
native technique that is resistant to such Absolute calibration in both systems is and hysteresis, is the improved mechanical
interference is desirable. achieved by calibration against a true volu- robustness and behaviour. Previous mul-
As the heart contracts, it undergoes metric system such as a spirometer, but the tiple simple-loop coils (imagine a simple
changes in volume as well as varying in latter suffers from being an invasive system. twist in a fiber, like making a simple knot
its positions within the chest. This com- In many situations, an absolute meas- but without threading the end through
bination of movements can be detected ure of volumetric changes, such as for res- the loop), suffered from a tendency to pop
by a fiber optic plethysmograph (FOP) piratory tidal flow, is not essential; rather, out of the plane of the coil and had to be
sensor placed near the heart at the tho- it is relative measurements and their vari- confined by being sewn onto the bandage
racic level. Such a device can also de- ation with time, as well as measurement within restraining sheaths. The figure-of-
tect small variations in circumference of simple respiratory rates or cardiac rates, eight coil, due to its geometry, balances its
produced by the beating of the heart. that are the key. These variations are often out-of-plane forces internally and hence re-
Although these minute signals are also indicators or precursors of diminished res- tains its shape as it is stretched or relaxed.
detectable when superimposed on normal piratory or cardiac performance. What’s more, it provides a useful small recoil
respiratory motion of the chest, for the force upon stretching, which helps to return
purposes of simplified signal processing, Principle of operation it to its relaxed form with a minimum of hys-
only cardiac monitoring during apnoea As light from a high-power light emitting terisis or sticking. The single coil is mounted
will be discussed here. diode (LED) (operating at a peak wave- on soft, robust skin-compliant polymer rub-
A new system has recently been de- length of 950nm, in the near infra-red) ber, similar to that found in wetsuits, which
veloped for monitoring such motion. It passes through the optical fiber coil, the renders the monitor comfortable to wear,
is based on the use of a novel single fig- curvature of the loop causes some of the even over extended periods.

42 Asian Hospital & Healthcare Management ISSUE-12 2007


T echnology , E q u ipment & D evices

Performance period monitoring. Extraction of the car- liminary measurements have already
This system was tested using 4 healthy diac period involves the use of substantial indicated that a reliable cardiac signal is
subjects, 3 male and one female, with no signal processing, due to the small size achievable from other parts of the body
previous record of cardiac or respiratory of the signal and its relative irregularity where the interference arising from
disorders. All of these test subjects were of form compared to the ECG, but it is respiratory motion is eliminated.
capable of holding their breath without nonetheless achievable. The results dem-
chest convulsion for 30 seconds, but they onstrate that for individual subjects there Conclusion
had not been trained in maintaining their is a high degree of correlation between The use of optical fiber-based systems for
chest in a stable position during this pe- the period measured by the ECG and non-invasive monitoring of key physi-
riod of apnoea. Each trial consisted of 4 those arising from the TCG and ACG ological parameters such as cardiac rate
acquisition sessions of 33 seconds each in signals. This correlation is higher than is undergoing continuous development.
which the subject was required either to 90% in offline measurements, and nearly Although such systems are still not quite
breathe or to hold their breath. The subject 90% in real-time TCG measurements. In ready for introduction into a real clini-
remained quietly seated throughout the both cases there is a consistent, subject- cal environment, they are well described
experiment, and began by sitting still for 5 specific lag between the ECG signals and as near-market. Their key feature com-
minutes prior to the start of the monitor- the TCG and ACG signals, as would be pared to established techniques such as
ing period. The FOP transducers were at- expected from the effect of the motion the ECG is their potential for application
tached around the chest slightly above the of the heart propagating throughout the in electrically noisy environments, or in
xiphoid process and at navel level of the torso. The subject specificity arises from regions where the metallic composition
abdomen. Two transducing channels were the individual placement of the trans- of the ECG would itself interfere with
utilised, to investigate whether the cardiac ducer bands. The systems demonstrated other measurements; both of these con-
output could be detected farther afield at present are, however, still susceptible ditions are found in the interior of mag-
than simply nearest the heart itself. The to spurious chest wall motions (arising netic resonance (MR) scanners, and it is
signal arising from the thoracic channel from coughing, for example), and ex- envisaged that the earliest application of
we term a thoracocardiogram (TCG), and traction of the signal in real time with a FOP-based systems would be for non-in-
that from the abdomen is an abdominocar- success rate approaching 100% remains a vasive monitoring of respiratory and car-
diogram (ACG). The system was interfaced challenge. However, part of the difficulty diac rates of trauma victims undergoing
to a computer running Matlab™ to acquire lies in the use of transducing bands that MR scans. The use of related artefact-free
and process the signals. Also utilised was are optimally localised for simultaneous FOP-based systems for monitoring the
a 3-lead ECG system for recording simul- respiratory and cardiac monitoring; pre- location of the chest wall, and providing
taneous measurements for reference and feedback to subjects during repeated MR
comparison purposes. measurements, to improve image averag-
The FOP system compares very ing and reduce blurring, has already been
well against the ECG system for cardiac demonstrated.

w w w . a s i a n h h m . c o m 43
TED

44 Asian Hospital & Healthcare Management ISSUE-12 2007


T echnology , E q u ipment & D evices

Networking Implanted
Medical Devices
Ensuring security
as well as effectiveness
Implanted medical devices present different
security issues than traditional information
systems, and require different security risk
analysis and mitigation techniques.

vices (IMDs) for device and patient data. NIMD products, related services
Our model will be IMDs for cardiac-rhythm and the system view
therapy—pacemakers, cardioverter-defibril- The latest generation of (cardiac-related)
lators, resynchronisation devices, etc. NIMDs, all of which use RF telemetry to
George D Jelatis
Security Architect network with external devices, include devic-
Parkway Associates Paradigm shift from standalone to es from Biotronik, Guidant and Medtronic
USA networked IMDs (introduced in 2000, 2005 and 2006
Until 2000, IMDs were mostly isolated, respectively). Remote (usually in-home)
standalone, electronic devices, communi- monitoring enabled by NIMDs is growing,
cating infrequently with external devices, as demonstrated by the rapid deployment

O
ver the past fifty years implanted and then only by near proximity (5cm to and growth of such systems as Biotronik’s
medical devices have undergone 10cm) inductive telemetry. Some of these Home Monitoring, Medtronic’s CareLink®
at least four major, technology- IMDs can emit sounds to alert the patient Network, St. Jude Medical’s Housecall
driven paradigm shifts—major changes in to an abnormal condition, but all other Plus™ and Guidant’s LATITUDE® Patient
world-view for designers, users, and recipi- external communication requires that Management System (introduced in 2000,
ents of such devices. the IMD be “interrogated” by an exter- 2002, 2003 and 2005 respectively).
The first was the miniaturisation of elec- nal device (a programmer) under human These new NIMD products and related
tronics and batteries that allowed devices to control. External device telemetry allows services lead us to take a much broader view
be implanted entirely within the body. The a caregiver, in a clinical setting, to modify of the networked IMD as part of a large,
second was the addition of flexibility with IMD therapy parameters, check the IMD distributed information system, as illustrat-
multiple device configuration parameters status and retrieve stored device and physi- ed below. Therefore, the obvious question
settable by an external “programmer”. The ological data. this raises is: “What security measures do
third was the replacement of hard-wired The newest families of IMDs are mi- these devices actually use?”
control circuitry with programmable micro- croprocessor controlled and, most impor-
processors, making implanted devices much tant for our discussion, equipped with Information security
more flexible, powerful and sophisticated. radio-frequency (RF) transceivers allowing consequences of NIMDs
The fourth is upon us: it is the introduction them to communicate with distant (2m to A critical security consequence of the isola-
of “real-time” autonomic networking of 20m) external devices, and to do so auton- tion of IMDs within their patient’s bodies
implanted devices, allowing them to com- omously. We refer to these IMDs capable is that the effective boundary for security
municate with other medical devices at a of distant RF telemetry as “Networked” concerns, or the “security perimeter” is an
distance, and “at will”, without any action IMDs or NIMDs. imaginary envelope about 10cm outside
on the part of the patient. The newest types of external devices the patient’s body. A critical consequence of
It is the operational and design may be clinical programmers in the tradi- networking IMDs to external devices is that
consequences of this fourth paradigm tional sense, or “read-only” home moni- the effective boundary for security concerns,
shift that we will discuss here. Our fo- toring devices. They may also be in-home the security perimeter, is greatly expanded.
cus will be on the implications of the monitors with limited IMD programming These old and new security perimeters are
networking of implanted medical de- capabilities. illustrated in the figure below.

w w w . a s i a n h h m . c o m 45
T echnology , E q u ipment & D evices

This should make it clear why, in the Addressing the NIMD information • Theft of data
past, access to sensitive IMD information security risk • Corruption of data
required either very close proximity (essen- Medical device manufacturers and the car- • Injection of false data
tially, physical access) to the IMD or access egivers (who prescribe and manage medi- • Interference with data access or commu-
to printed reports or charts. Data avail- cal devices) need to understand that the nication
ability only required the patient and a suit- clinical benefits of networking IMDs (with Fortunately, information security risk
able programmer, and data confidentiality external systems) bring with them not only management is an established discipline,
and integrity were assured by operational new benefits: with methods and processes that are easily
procedures characteristic of good clinical • Surgical Implant - Monitoring of the adapted to the world of IMDs.
practice. IMD without intruding on the sterile Such an analysis will identify the high-
Today, with the introduction of RF field level information security requirements for
telemetry for device interrogation and pro- • Clinic Follow-up - “Wandless” device NIMDs and external devices, as well as
gramming, access to sensitive IMD data interrogation (and possibly program- any centralised medical information serv-
becomes much harder to control. Data ming) ers they communicate with. By identifying
availability, confidentiality and integrity • Home Monitoring - Wireless commu- and implementing technical mitigations,
depend upon the security of the RF data nication between NIMDs and external device manufacturers can eliminate or
link, the ability of the IMD itself to verify remote monitors, without patient inter- significantly reduce these information se-
the suitability of an RF external device, vention (compliance) curity risks.
and the ability of the RF external device These benefits are accompanied, how- Security relevant steps in medical
to verify that it is communicating with the ever, by new responsibilities placed mostly device development process
right IMD. The staging of device data and on device manufacturers. Foremost of All of the above risks need to be considered
programming commands in external, net- these is the responsibility to understand in the light of a thoughtful information
worked devices also raises access control and manage the information security risks security risk assessment
issues, depending upon the location and introduced by such networking. These in- • Risk concept analysis
physical control of the external devices. formation security risks could be described • Risk trade-off decisions
The result of these differences is a sig- as (broadly speaking): • Security requirements
nificant increase in the risk of data confi-
dentiality, integrity or availability com-
promise; this is precisely the definition of
IMD Firmware Dev. IMD Management Site
information security risk.
This increase in information security
risk makes information security manage-
ment a much larger concern for new
NIMDs because, as discussed above, their
sensitive data are transmitted over an open
channel (RF) and stored in (relatively) un- IMD Dev System IMD Web/App. Server
controlled external medical devices. There
are three drivers for this heightened con- The obvious question this raises is
cern with information security: “What security measures do these
• Safety of patients may depend upon the Internet devices actually use?”
security (integrity and availability) of the
NIMD and its data
• Patient data privacy has become a regu-
latory requirement (e.g., EU Directive
Programmer
on Data Protection, 1998; HIPAA Rules
on Privacy, 2003, and Security, 2005;
Japanese Data Protection Act, 2003)
• Marketability of NIMDs will depend
upon compliance with new security External Device
regulations and laws and upon public
attitudes and acceptance
The result is that the networked “medi- Patient
cal device system” (NIMDs and the external
devices they communicate with) need to be
designed not only to ensure patient safety, but
also to ensure patient and device security.

46 Asian Hospital & Healthcare Management ISSUE-12 2007


T echnology , E q u ipment & D evices

are useful parallels with safety and hazard


analysis. There is also a rich source of
New Security
Perimeter knowledge on information security risk
management in the information security
Communication Link
literature, on the World Wide Web, in
books and in magazines and journals.

Old Security Conclusions


Perimeter
In conclusion, we see that networking
implanted medical devices introduces a
new type of risk—information security
risk—that can have both safety and legal
consequences. Even as a clearly beneficial
technology advance, medical device net-
External Medical Device working must pass a marketplace accept-
ance test; that is, its benefits must be ac-
ceptable to its users, patients and caregivers.
Patients and caregivers are more aware of,
• Device implementation > Legal statutes on privacy and concerned with, risks to safety and to
• Security verification against requirements > Customer expectations regarding privacy, than at any time in the past. Ad-
These security relevant steps are very privacy dressing information security risk is, thus,
much like the safety relevant steps in the • IMD and external device hardware essential to marketplace acceptance of net-
classic IMD development process. As with changes may be needed to implement worked medical devices.
Safety Risk, information Security Risk security requirements This is why information security risk
needs to be considered early in the process. • IMD and external device firmware assessment and mitigation are becoming
changes will be needed to implement part of the networked medical device de-
Suggestions for NIMD developers security requirements velopment and approval processes. Much
(from the trenches) Which leads to my gentle suggestion like Safety Hazard Analysis, Information
Based upon my own professional expe- that early consideration of privacy and Security Risk Analysis is most effective
rience, and upon research into the ex- security issues in the device development when performed early in the device devel-
perience of others, in the management process is essential to contain the cost and opment process. In this new medical device
of security in NIMD-based systems, limit the schedule impact of implementing paradigm, patient and caregiver acceptance
I have derived the following observations: of security requirements. of information security risks follows from
• IMD Security Changes are driven by While the terminology or information the same type of assurances as their accept-
non-technical issues: security is probably new and somewhat ance of safety risk.
> Regulations on security and privacy foreign to many IMD developers, there

ZOLL AutoPulse Non-invasive


Cefepime andCardiac Support Pump
Amikacin
T
References:

C
he AutoPulse®—the only device of its kind—delivers
ombination of the theseconsistent, uninterrupted
two different antibiotics act 1.synergistically
Timerman S et al. to Improved
providehemodynamic
total solutionperform-
Product Showcase

chest compressions that new AHA/ERC Guidelines are calling for. It is an automated, ance with a novel chest compression device during
against multi resistant bacteria like P.aeruginosa, S.aureus etc. The main advantages of
treatment of in-hospital cardiac arrest. Resuscitation.
portable device with an easy-to-use, load-distributing LifeBand® that squeezes the entire
this combination: Wide range of bactericidal activity, better efficacy, safety, lesser dose, least
2004;61:273-280.
chest, improving blood flow to the heart and brain during car- 2. Halperin HR et al.
diac arrest.nephrotoxicity,
1-3 Additionally,minimization in development
it offers the benefit of freeing ofupresistance, reduction in Cardiopulmonary
hospitalizationresuscitation
time
with a novel chest compression device during a porcine
and cost. Our organization - VENUS
rescuers to focus on other life-saving interventions. REMEDIES is in grant
model of
of a patent
cardiac for
arrest. this
Journal drug
of the combi-
American Col-
lege of Cardiology. 2004;44(11):2214-2220.
A recentnation as a singlestudy
independent compound
4 which in
conducted canthe
be administered
United parentally. Our product exists as a dry
3. Ikeno F et al. Augmentation of tissue perfusion by a
States, using the AutoPulse,
powder form which showed that survival
is reconstituted ratesinjection
before of car- with anovel
suitable solvent,
compression deviceafter reconstitution
increases neurologically intact
diac arrest it
patients dramatically improved when treatedwith survival in a porcine model of prolonged cardiac arrest.
withpH in range
is sterile, colourless to light straw coloured of 3.5 to 6. It is
Resuscitation. 2006;68:109-118.
preferably twice
an automated CPR
a day device,depending
product versus manual CPR,
on the priorcondition
patient to reach- and severity of infection, Average period of
4. Ong MEH, Ornato JP, Edwards D, et al. Use of an
ing the hospital. Data showed a survival-to-hospital-discharge
treatment is 9 to 10 days. It is provided in a sealed containerautomated, load-distributing band chest compression
such as transparent glass vial capped
device for out-of-hospital cardiac arrest resuscitation.
rate of 9.7 percent using automated CPR, versus 2.9 percent
with appropriate halogenated stopper and seal. JAMA. 2006;295:2629-2637.
using manual chest compressions. There was also a 71 percent
higher rate of return of spontaneous circulation with the use Further information
of the AutoPulse than with conventional www.venusremedies.com
CPR Web: www.zoll.com
Further information:

w w w . a s i a n h h m . c o m 47
T echnology , E q u ipment & D evices

CyberKnife
John R Adler, Jr.
Professor
Neurosurgery and

Radiosurgery
Director
Radiosurgery and Stereotactic Surgery
Stanford University School of Medicine
USA

An emerging surgical
revolution

The constellation of technologies that make up a


modern CyberKnife system enable radiosurgery to
be delivered with sub-millimeter accuracy to static
lesions and better than 2 mm accuracy to targets
that move with respiration.

S
urgery on the human body is almost to the skull) with a specialised radioac-
as old as history. Evidence has been tive cobalt-charged apparatus and created
unearthed of surgery having been Gamma Knife radiosurgery. Over the past
performed in ancient Egypt, Greece, In- 3 decades, the Gamma Knife and radio-
dia and China. Throughout the millennia surgical technologies developed since have
surgical procedures have evolved into effec- literally transformed the treatment of brain
tive and precise therapeutic interventions. disorders ranging from tumours to vascular
However, the history of the surgical experi- malformations to facial pain. Despite the
ence for patients is marked by pain, blood, huge impact of the Gamma Knife on brain
and risk to life and limb. The evolution of surgery, the biologic principles of radiosur-
surgery may have been driven as much by gery are not inherently restricted to the head.
the need to reduce its fearsome accompani- Although the frame-based design of (DRRs) made from the patient’s original
ments as to improve the therapeutic out- first-generation technology restricted radi- CT scan. Because a rigidly fixed frame of
come. Nevertheless, surgery is still widely osurgery to lesions outside the cranium, if reference is not required, the CyberKnife
viewed as both a powerful form of medi- pathologic lesions could be targeted with- system is uniquely able to aim a beam of
cine and, because of the attendant suffer- out stereotactic frames, extra cranial le- therapeutic radiation at virtually any ana-
ing and risks, something of a last resort sions might also be treated radiosurgically. tomic site with radiosurgical precision.
that should be reserved for the gravest of The CyberKnife was invented at Stanford The CyberKnife system also includes
illnesses. Many of these deeply entrenched University and Silicon Valley in the early a robotic delivery mechanism, capable of
perceptions are being challenged by the 1990s grounded in the belief that radio- flexibly and accurately targeting a com-
rapidly growing scope of radiosurgery. surgical ablation could significantly benefit pact LINAC source without a defined iso-
The concept of radiosurgery is attrib- many patients with extra cranial disorders center; all other radiation delivery systems
utable to the Swedish Neurosurgeon Lars if skeletally attached frames could be elimi- are constrained to delivering radiation
Leksell, who described its basic elements nated. The invention of computerised im- beams around and through a fixed point
in the 1950s. Simply put, radiosurgery age guidance proved critical to achieving in space known as the isocenter. Taken
precisely targets many cross-fired pencil the objective of a universal targeting appa- together, these attributes make the Cy-
beams of ionising (therapeutic) radiation ratus. The CyberKnife utilises a targeting berKnife system the first device to offer
to deliver large doses to destroy diseased technology developed specifically for this autonomous image-guided radiosurgery,
tissue without injuring adjacent anatomy. instrument called x-ray image-to-image cor- a technology that was commercialised by
In the 1960s and 70s, Leksell combined relation. This localisation method automat- Accuray Incorporated (Sunnyvale, CA,
stereotactic frame-based targeting (using ically compares live orthogonal x-ray imag- USA). The CyberKnife was awarded FDA
the frame he invented which was attached es with digitally reconstructed radiographs clearance to treat tumours throughout

48 Asian Hospital & Healthcare Management ISSUE-12 2007


T echnology , E q u ipment & D evices

the head and neck region in 1999. This with sub-millimeter accuracy to static le- has been shown to result in higher rates
clearance was expanded in 2001 to al- sions and better than 2 mm accuracy to of hearing preservation among patients
low radiosurgery throughout the body. targets that move with respiration. with acoustic neuroma while a similar
Because many tumours in the chest and ab- The CyberKnife was initially approved fractionated approach permits larger le-
domen move with breathing a new system, for brain applications, and treatment pa- sions and peri-optic tumours to be treat-
the Synchrony™ Respiratory Tracking Sys- rameters were based largely on Gamma ed safely. Although such flexibility has
tem (Accuray, Inc.), was added to the Cy- Knife experience. Since similar pathologies greatly expanded the scope of neurosur-
berKnife System in 2002. This technology occur throughout the central nervous sys- gical diseases treated with radiosurgery,
correlates real-time chest wall movements tem, CyberKnife radiosurgery was rapidly the impact of the CyberKnife has been
sensed by LED camera arrays on the pa- expanded to include a broad range of le- even greater in other surgical disciplines.
tient’s chest with the position of gold seeds sions along the spinal axis. A growing body In its initial years, most CyberKnife treat-
placed in or near the tumour and detected of medical literature now demonstrates ments were intracranial. However, thanks
in orthogonal x-rays that are shot periodi- the efficacy and safety of CyberKnife spi- in part to an emerging group of participat-
cally during the procedure. The tumour nal radiosurgery for a range of intra and ing surgical specialists, such as urologists,
position is calculated based on this correla- para-spinal tumours, and such treatment is thoracic and general surgeons, an expand-
tion and fed back to the robot, which dy- entering the mainstream of clinical prac- ing percentage of CyberKnife treatments
namically adjusts the aim of the radiation tice. Because no frame is required for ac- now target tumours within the chest, abdo-
beam to compensate for the movement of curate targeting, the CyberKnife permits a men or pelvis. Moreover, there are a grow-
the tumour. The constellation of technolo- new approach to radiosurgery for certain ing number of peer-reviewed outcome stud-
gies that make up a modern CyberKnife brain lesions. For example, a multi-ses- ies that document the effectiveness of such
system enable radiosurgery to be delivered sion approach (performed over 3-5 days) treatment for non-neurological neoplasms.

w w w . a s i a n h h m . c o m 49
T echnology , E q u ipment & D evices

For example, outpatient radiosurgery for of anatomically precise ablative radiation precision radiation, one can readily envi-
unresectable pancreatic cancer achieves against small early stage lesions has much sion numerous technical improvements to
very high levels of local control and pal- in common with other forms of surgery. the CyberKnife over the next decade that
liation; some of the more important end- However, the basic use of therapeutic will facilitate this primary goal. Incremen-
points compare favourably with much radiation, the frequent necessity to site tal improvements in targeting accuracy
more invasive alternative therapies. In addi- CyberKnife systems in existing radiation combined with ever better shaping of the
tion several published studies utilising less departments, and the heavy focus on the field of radiation and appreciably faster
precise (than the CyberKnife) high dose management of cancer is more akin to the treatment times will allow continued ex-
irradiation to treat early-stage lung cancer traditional domains of radiation therapy. tension of radiosurgery into new clinical
patients now demonstrate long-term sur- Most of CyberKnife radiosurgery is prac- realms. For example, the more efficient
vival that mirrors open surgical resection. tised as a multi-disciplinary procedure treatment of metastatic disease may allow
Although the total number of prostate involving both surgical specialists and ra- radiosurgery to effectively substitute for
cancer patients treated with a 5-day course diation oncologists, thereby reflecting its chemotherapy in patients with limited me-
of CyberKnife radiosurgery to date is mod- surgical and radiation therapy dimensions. tastases, thereby precluding the complica-
estly small, recent preliminary data from At present, more than 80 CyberKnife sys- tions of systemic treatments. Furthermore,
Stanford University suggests that the inci- tems have been installed worldwide, with 24 clinical studies are being conducted that
dence of side effects and tumour control as of them in Asia, and something in excess of involve treating benign conditions ranging
judged by prostate specific antigen (PSA) 20,000 patients have been treated. Moreo- from painful facet syndrome (back pain)
compare favourably with more invasive or ver, more than 100 peer-reviewed publica- to atrial fibrillation with the CyberKnife.
lengthy procedures. The emergence of these tions have detailed both the performance If only some of these studies demonstrate
new extra cranial procedures is gradually of image-guided radiosurgery and clinical the utility of the CyberKnife, the field of
validating the CyberKnife’s original vision. outcomes for a wide spectrum of disorders. radiosurgery could expand far beyond even
As the scope of practice expands, it is clear What is the future of the CyberKnife the most ambitious of current expecta-
that the field of radiosurgery embodies likely to encompass? Reminding oneself tions, and further challenge conventional
dimensions of both surgery and radia- that the essence of radiosurgery is merely notions about the nature of surgery.
tion therapy. The aggressive application the non-invasive destruction of tissue with

50 Asian Hospital & Healthcare Management ISSUE-12 2007


T echnology , E q u ipment & D evices

China’s Medical Device Industry


Expansion time

Domestic medical device manufacturers' extensive push to raise capital is indicative of


their intention to expand. It would only be a matter of time before they start competing
outside their home turf.

patients in 2003. A growing middle class in R&D efforts to develop products ‘in-
Andrew Wee population and better medicare scheme in novated-in-China’ that could be able to
Research Analyst China is expected to provide more access compete globally. This would mean more
APAC Healthcare to medical treatments for Chinese citizens. financial investment in technological start-
Frost & Sullivan
Currently, less than a quarter of China’s ups which would include medical technol-
Singapore
population are covered under some kind of ogy companies.
medical insurance and the government is
expected to roll out a more comprehensive Domestic manufacturers:
medicare scheme which is expected to pro- Outsourcing and distribution

G
overnment healthcare expendi- vide more coverage to residents in China. partners or competitors?
ture has more than doubled in Increasing modernisation of hospitals Even though with the influx of inter-
the past decade in China, most and healthcare delivery systems across Chi- national brand name manufacturers of
of it attributed to a stable economy that na is expected to make China one of the medical devices, the local medical device
has grown at an average rate of around fastest growing markets for medical devices industry is far from dead. Due to the in-
8-10% annually. The expanding economy for the next decade. In a speech by Gerard creasing demand for medical devices from
has also enlarged available household in- Kreisterlee, CEO of Royal Phillips Elec- China’s rural area, local medical device
comes of the burgeoning middle class in tronics, he mentioned that China’s medi- manufacturers have mushroomed over the
China. Such a situation has resulted in cal device market is expected to grow up to past few years, supplying medical equip-
increasing health problems like obesity, 10% for the next 3 years and by the next 5 ments, instruments and devices to second
cardiac diseases, diabetes, and high blood to 7 years, China could become the world’s and third tier city hospitals. Figure 1 lists
pressure. According to the World Health second largest medical device market and some prominent medical device manu-
Organization, the numbers of people who Asia’s largest. facturers that are active in the Chinese
are obese in China have increased more This growth has led to many invest- market.
than 3 times from 1992 to 2006. ments in the medical device industry in Two of the most closely watched are
With the population getting signifi- China and also the rise of several new China Medical Technologies, a Beijing-
cantly richer, more Chinese are putting medical device manufacturers, which will based manufacturer of oncology therapy
increased emphasis on healthcare and are be poised to grab a slice of this rapidly devices that is listed on NASDAQ and
demanding access to medical treatments growing market. Shenzhen Mindray, a Shenzhen-based
that improve their quality of life. Cur- Healthcare is also one of the key high- patient monitoring devices manufacturer
rently, the development of the healthcare lights in China’s key 5-year plan which was which was recently listed on the New York
sector in China follows a two-pronged ap- ratified by the National People’s Congress Stock Exchange (NYSE). China Medical
proach, one geared for the urban area and (NPC) late last year. In the plan, China Technologies, is backed by General Elec-
another suited to the rural area. highlighted the need to close the gap be- tric, that holds a significant stake in the
tween the living standards of the rural company.
Driving Factor of the Chinese regions and the urban, coastal regions of In mid-2006, MicroPort Medical, a
Medical Device Industry China for the sake of a harmonious soci- cardiovascular devices manufacturer based
With a population of more than one bil- ety. This is expected to be a boost for the in Shanghai, with links to Japan-based
lion, China has seen hospital admissions healthcare sector and could signify the Otsuka Pharmaceuticals has shown keen
rising every year. In 2004, the China Statis- modernisation of medical equipment in interest to list on the US bourses as well.
tical Yearbook recorded a total of 66.7 mil- 2nd and 3rd tier cities in China. Another While these companies have most of their
lion inpatients in China’s hospitals across feature worth noting in the plan was the sales in China, their extensive push to
the country, compared to 60.9 million in- push by the government to invest more raise capital shows their desire to expand,

w w w . a s i a n h h m . c o m 51
T echnology , E q u ipment & D evices

and it would only be a matter of time tier city hospitals for them to upgrade their Figure 1: Sample List of Medical Device
before they start competing with foreign equipments. This modernisation would Manufacturers in China, 2007
medical device manufacturers outside their benefit local and foreign medical device
Name of Company Main Products
home turf. manufacturers who would be able to sup-
New medical device being manufac- ply cost-effective, quality hospital sup- China Medical Technologies Oncology Therapy

turers established in China are no longer plies. Shenzhen Mindray Patient Monitoring
confined in the development of low cost 2. Increase in the number of admissions for MicroPort Medical Co. Ltd. Cardiovascular Devices
medical disposables. Both China Medical surgeries Shandong Weigao Group Medical Disposables
Technologies and Shenzhen Mindray have General surgeries and number of inpa- Changzhou Kanghui Orthopaedic Implants
sophisticated product lines and the latest tients is expected to rise, especially in the Jiangsu Kaishou Medical Disposables
technology. China Medical Technologies eastern coastal regions. The increasing
Guangdong Well Medical Oncology Therapy
has research collaborations with Beijing household incomes in these regions will
Vascore Medical Cardiovascular Devices
University, one of China’s premier univer- bring in demand for a better standard of
Shenzhen Lifetech Cardiovascular Devices
sities. Another university spin-off is Be- living. Plastic and cardiac surgeries are
yonder Technologies which has researchers two types of surgeries that are expected to Trident Medical Hospital Beds

coming from Tsinghua University. Shen- post a jump in the number of surgeries Beyonder Technologies Surgical Systems
zhen Mindray, on the other hand has part- conducted. This would mean an increase Source: Frost & Sullivan
nered with Masimo Corporation, incorpo- in sales of ablation equipment and cardio-
rating their SET pulse oximetry technology vascular devices.
into Mindray’s variety of products. 3. Foreign investments in private hospitals of China’s hospitals. With increasing obe-
Chinese medical device companies will increase market size sity and pollution in urban areas, cardiac
have also licensed technologies to be used Private hospitals and medical centres in and respiratory diseases are expected to
in conjunction with their proprietary prod- China are expected to see a record in terms post an increase. Meanwhile, as with most
ucts. MicroPort Medical has a licensing of the number of patient visits in 2007. developing countries, malignant tumours
agreement with AST Products to use their Chindex International, a NASDAQ listed are also expected to be a rising problem
coating systems in MicroPort’s PTCA bal- healthcare company is one of the first few in China.
loon catheters. In some cases, local medical private healthcare providers in China and
device manufacturers like Trident Medical is planning its 3rd site in Xiamen. Singa- Renaissance of the Chinese
have acted as distributors and agents for pore listed Pacific Healthcare Holdings medical device industry
high-end and specialised hospital equip- has also started operations in China. This With so much changing in China’s medi-
ment manufacturers from Germany and has shown the government’s willingness cal device industry landscape, there is
Finland, while producing and selling in allowing the entry of foreign compa- much to be gained by companies who are
lower-end products. Companies like Shan- nies to invest in healthcare in China. already in this huge booming market. Sta-
dong Weigao and Changzhou Kanghui 4. Government tenders for bulk purchases of ble economic growth with a committed
have also provided OEM services to other hospital supplies government in providing quality health-
medical device companies. More public hospitals in China would be care will increase healthcare expenditure.
In other words, the growth of Chinese expected to group together for bulk pur- However, one of the most important
medical device companies has presented chases of medical disposables and equip- changes will have to be increasing access
new opportunities for technology com- ments. China could potentially look upon of China’s rural residents, which com-
panies in terms of technology licensing, Hong Kong’s Health Authority tendering prise of around 60% of the population, to
business development and manufacturing model in order to ensure a more cost-ef- quality healthcare. The medical device in-
expertise. fective procurement method. Around dustry should use this opportunity to gain
90% of China’s major healthcare provid- market share and access to more than 700
Top 5 Trends in the Chinese ers are public-owned and operated and by million new end-users.
Medical Device Industry China’s classification, these facilities are More regulation is expected to change
1. Modernisation of hospitals in 2nd and 3rd not-for-profit, which could push the need the market, albeit for the development of
tier cities for a more cost-effective procurement of the healthcare sector as a whole. Liber-
In China’s 11th five-year plan, the govern- supplies and equipments. alisation of the sector is also beginning to
ment stressed on the need to focus devel- 5. Focus on oncology, cardiac, and materialise, with more private firms en-
opment on the western and inner regions, respiratory therapeutic systems and devices tering the healthcare sector and Chinese
which are less developed than the eastern A United Nations study in China stated medical device companies listing their
coastal region of China. Thus, in an effort the increase in the diseases of the circula- firms for expansion.
to minimise the widening urban-rural gap tory system amongst Chinese residents. In All these changes contribute to a larg-
and provide steady development in terms 2003, cerebrovascular, cardiac-related and er pie and benefits all stakeholders in Chi-
of a united society, the government is ex- respiratory system-related diseases com- na’s medical device industry, which could
pected to increase funding to 2nd and 3rd prised around 37.7% of morbidity in all be undergoing a renaissance of sorts.

52 Asian Hospital & Healthcare Management ISSUE-12 2007


F acilities & O perations

Hospital of
The speciality of the Hospital
of Tomorrow will be a

Tomorrow
combination of features for
the well-being of not only the
patients and their relatives, but
the doctors, nurses and all the
The design perspective staff of the hospital as well.

growing scientific evidence supporting the


Henning Lensch view that physical environment in which
Managing Partner medical care is provided has an impact on
RRP architects+engineers health and well-being.
and
This knowledge base contains some
CEO
evidence for the health impacts of clas-
DANDCA
Design+Consult Alliance sical elements of healing environments,
Healthcare Projects such as nature, daylight, and fresh air.
Germany Hospital architecture has to create a com-
fortable space for nursing and treatment,
thus contributing to a patient’s positive
mental attitude. A healing environment
for spaces designed can affect both the

T
he field of healthcare designs is physiological and psychological well-being grades, improvements, and adaptations of
currently undergoing an excit- of the patient. the existing facility to future requirements
ing transformation that will sig- We are facing a time-shift in the de- which can not be anticipated only a few
nificantly change the appearance of our sign of modern hospitals. Hospital man- years earlier when the “new” hospital is be-
hospitals. More and more healthcare ad- agement and design teams of architects ing planned.
ministrators and medical professionals and engineers have to consider short term The Hospital of Tomorrow is supposed
are becoming aware of the need to create circumstances such as the rapidly changing to be a green hospital. Architects have to
a healing environment that supports the technical aspects of medical treatments; make developments on the site for macro
needs of patients, family and staff. The key and long term building parameters—pro- and micro expansion. The speciality of the
factor motivating this awareness has been viding space and flexibility for future up- Hospital of Tomorrow will be a combina-

w w w . a s i a n h h m . c o m 53
F acilities & O perations

tion of features for the well-being of not opportunity for architects and engineers. healing environment, for spaces designed
only the patients and their relatives, but the Integrated planning, however, goes beyond can affect both the physiological and psy-
doctors, nurses and all the staff of the hos- the long established, and at least partially chological well-being of the patient.
pital as well. Other exciting features would fulfilled, mandate of integrating building All experts, managers and planners
include good connection and way-finding, systems into architectural concepts. Here agree that flexibility must be a basic fea-
the walkway to the hospital, shopping malls integrated planning for the Hospital of ture of any healthcare facility to keep it safe
and the location where teaching facilities Tomorrow means full and unified collabo- from rapid obsolescence and ready to face
as well as natural features could be com- ration between different disciplines in the changing needs and technologies. Needs of
bined in the holistic approach of the new pursuit of truly optimum total building healthcare facilities are evolving rapidly, and
hospital. concepts. the direction of that evolution is difficult to
Environmental pollution and re- forecast with any certainty.
source exploitation are vital issues in many Hospital design - A holistic If we consider and compare the
countries as they are dependent on for- approach hospital architecture conditions today to
eign energy and resources, and are just as The architecture of a hospital is the shell tomorrow´s conditions, there are a few as-
much in need of a healthy environment for all operational processes, the room for pects which must be considered in the de-
as any other nation. The development of recovery for patients and the daily work- sign brief of the Hospital of Tomorrow:
buildings and building systems has been place for doctors and staff. You might com- • Rapidly changing needs and technolo-
gies, reason: direction of evolution is
nearly impossible to forecast
• Changing regulations (government, in-
Healing Environment surance) with direct impact on the hos-
pital design
Green Light Water
• Lifecycle-costs determining a changed
method of construction and architecture
• New standard of the inpatient wards:
Short Stay (Day-Care), Inpatient Ward
up to 5 days, low and high-class hotels,
Consult Diagnostics Special Diagnostics
nursing home, home for the elderly (long
stay)—which means more variety in in-
patient wards
• More focus on preventive medicine
• Patients with complex diseases and more
than one disease (comorbidities) will de-
termine the functions of future hospitals
• Hospitals have to be able to attract medi-
cal tourists
Operational Clinical workflow and patient path integrating the latest IT-Technical infrastructure • Hospitals must be capable of handling
(HIS, PACS, ETC) Meets an healing environment patients of all cultures and religions
• Clinical Patient Path Way Implementa-
tion is a MUST
characterised for many years by linear pare a hospital with a city—having all the • Hospitals have to cope with the imple-
thinking and planning. In the past, single functions from the residential area next to mentation of information and commu-
products and systems were targeted at spe- the park, over the workplace for hundreds nication systems, IT networks like HIS,
cific building components and is still prac- of employees up to the disposal area and RIS and PACS
tised to some degree although it has been energy central. Cities are always changing, • Changed room requirements, e.g.
proven to be unsustainable in the future. they have to adapt to new technologies and imaging PACS, due to new workflow
It is high time, therefore, to remember what new requirements, which means that the procedures (film-less / paperless / wireless
we do know, or rather what we must know hospitals have to be able to change as well. hospital)
in the future, so that we may find solu- Teaching facilities must also be designed to • Rapidly growing expectation of the pa-
tions for the problems that we face, some encourage learning and exchange of informa- tients / customers
of which are clearly of our own doing. Envi- tion with a pleasant and longer stay for teachers • The healing environment is playing a
ronmental protection, sustainable resource and students. central role
management, re-usable instead of single-use Hospital architecture has to create a • Architecture as a branding tool—archi-
buildings, utilisation of natural resources comfortable space for nursing and treat- tecture must be updated and upgraded
and flexible real estate use will be the key. ment, thus contributing to a patient’s posi- • Natural light—natural ventilation for
Integrated planning is a challenge and an tive mental attitude, in an atmosphere of a most of the buildings, especially for the

54 Asian Hospital & Healthcare Management ISSUE-12 2007


w w w . a s i a n h h m . c o m 55
F acilities & O perations

even more uncertainty. • Departments like OT, ICU, nuclear


Increasing pressures medicine, ambulant surgery, emergency
form technology, chang- department and laboratory
ing business strategies • Less installed parts like wards
and changes in the over- • Departments like administration, of-
all healthcare system fices, OPD consultation rooms with less
are, especially in parts of technical installation or medical equip-
Europe and Asia, more ment, training facilities etc.
obvious than before. To respect the compliance of the techni-
The rate of change cal environment, the diversification of the
is becoming a constant different levels for interior planning and
part of a building´s life. the life-cycle aspects of the three categories
The focus on the overall must be considered in every healthcare and
lifecycle-costs of a build- hospital project, starting with the phase of
inpatient wards and workplaces ing like a hospital is also a more static pa- the master-plan itself.
• More importance of easy way-finding rameter, not able to give predictions or exact The Hospital of Tomorrow will pay
• No more a place for sickness and sick estimates about the very important ability respect to all these issues and also define a
people but a place for health and to change departments or even whole parts new quality in hospital design—for India,
recreation! of a house. South-East-Asia and rest of the world­—by
As a first result, it is already proven that To make sure that the change of parts combining all features of hospital design,
changes in a hospital's architecture have to of the hospitals will be appropriate, in environmental protection, energy saving
be considered as a constant need and that terms of the level of change of interiors, and healing environment design, included
the flexibility of a house is a parameter of technical installation and medical equip- in an highly economic hospital follow-
economy and affects the economic success ment in general, hospital planners have to ing clinical patient path ways and defined
of a hospital directly. Today, the rate of be able to distinguish between the follow- workflow procedures, for the benefit of
change is occurring more frequently with ing categories: quality control, for patients and staff.

56 Asian Hospital & Healthcare Management ISSUE-12 2007


information technology

Building a

Min-Huei Hsu
e-Hospital
Chief Information Officer
and Consultant Neurosurgeon
Wan Fang Hospital
Lessons from Taiwan
Taipei Medical University
Taiwan

B
efore computers became popular,
calculating rulers used by engineers
and abacuses invented by Chinese
have both been used as calculating tools.
In 1943, John Mauchly led the develop-
ment of ENIAC (Electronic Numerical In-
tegrator and Calculator). ENIAC was the
first programmable electronic calculator in
the world, and it replaced the original me-
chanical components with vacuum tubes.
In February 1946, the public saw the ENI-
AC for the first time in Philadelphia, and
a new era of electronic computing began.
In the last 60 years, computers have
changed drastically. The changes were
in the form of smaller sizes, larger stor-
age, higher speed, higher accuracy,
more functions and cheaper prices.
With the advent of Internet, people
were brought into the information era.
In the last 20 years, the development
and application of information tech-
nology has deeply affected the world
economy and various industries, and the
healthcare sector is no exception to this.
The application
As a result, hospitals have implemented of information
various computer systems, such as medi- technology
cal record management systems, insur- has improved
ance claim systems, patient billing systems the quality and
and computerised physician order entry
lowered the
(CPOE) systems. At the Wan Fang Hos-
pital we divided hospital information sys-
cost of medical
tems (HIS) into 4 categories according to services in Taiwan.
their functions. The 4 letters in the word
“CARE” could stand for these 4 categories:
C for clinical care, A for administration, R medical errors, improve access to knowledge computer-based order entry. Among other
for research and E for education. and telemedicine. Our hospital has institut- functions, this system automatically sug-
ed a variety of such technologies, and they gests appropriate dosages to physicians and
Clinical care are already producing a substantial reduc- checks for drug allergies and drug-to-drug
In recent years, there has been a growth of tion in the incidence of dangerous errors. interactions.
computer-based tools to improve physician In 1999, we began to replace paper- We instituted an alert system whereby
decision-making and clinical effectiveness. based physician ordering (including orders a computer constantly scans new data, in-
There are several islands of progress, par- for drugs, diagnostic tests, and the set- cluding patient laboratory results, as they
ticularly in applications designed to reduce ting of ventilators and other devices) with are generated. If it encounters a critical

w w w . a s i a n h h m . c o m 57
information technology

value—for example, a dangerous potas- Administration We have developed the “Clinical Research
sium level in a medication—the computer In Taiwan, computers were first intro- Information Management System” to fa-
will automatically send a short message to duced into hospitals for managing ad- cilitate the data management of studies in
the mobile phone of the patient’s attending ministrative activities. Earlier systems fo- our hospital. Using this system, investiga-
physician. cused on admissions / discharge / transfer tors can integrate clinical, molecular, ge-
In 2004, we implemented a Surgical (ADT), patient billing, claims processing netic and other translational and clinical
Patient Safety System (SPSS) in our hospital and materials management. research data. This system supports collab-
to prevent three important surgery-related In 1995 the government of Taiwan orations among clinicians and statisticians
problems: wrong site, wrong procedure and introduced universal health insurance to from the design stage through analysis and
wrong patient surgery. Although only 17% cover all citizens. The policy of Bureau of final report stage.
of adverse surgical events are judged to be National Health Insurance (BNHI) has
preventable, wrong site, wrong procedure, become the biggest influence in the de- Education
wrong person surgery are totally prevent- velopment of Taiwan’s healthcare industry We opened the clinical skill center 2
able. Using computers in the operative since then. BNHI has launched a nation- years ago. The center’s mission is to pro-
room, surgeons access this system to key in wide project for replacement of its paper- mote and provide high-quality clinical
patient’s data before operation. It takes about based health insurance cards by smart education and reliable assessment of skills
two minutes to complete this procedure. cards (or NHI-IC cards) since November and procedures, with the ultimate in-
The system checks this data with the data- 1999. These cards have been used since tent being to advance patient care. This
base of operating theatre schedule. If there July 1, 2003, and they fully replaced pa- center provides simulation-based medi-
are any mismatches, an alert is displayed per-based cards after January 1, 2004. cal education. Through new approaches
on the screen. The transactions log is stored Hospitals must support the cards in order to healthcare training and practice, the
in the server. The patient safety commit- to provide medical services for insured clinical skill center strives to improve
tee of the hospital reviews the records with patients. Health smart card system has to patient-safety and the clinical skills of
mismatches on a weekly basis. Mismatches be linked into the hospital information healthcare providers. By proactively
have been detected in about 5% of all system for patient registration, billing, exposing trainees to challenging clinical
operations. A final verification of the correct examination and prescriptions. Because of and humanistic encounters, this center
site, procedure and person by this system frequent changes to the claim rules, hospi- aims to reduce errors and improve team-
helps in preventing complications. tals have to invest large resource to main- work and quality of care. This center
Telemedicine can involve technologies tain their information systems. serves the needs of all sectors of healthcare
as simple as a radio, or as advanced as a digi- Quality has become an important is- providers in our hospital and is involved
tal video and data transmission, but the key sue to the healthcare sector. Information in the development of simulation-based
aspect is that it allows physicians to practice systems are increasingly important for medical curriculum to produce courses to
medicine from a distance. The potential measuring and improving quality. The answer the needs of these sectors.
benefit for isolated areas—where the much Taiwanese government also recognises the
needed physicians, particularly specialists, need to implement a nationwide health- An IT-driven future
are unavailable—is believed to be substan- care quality indicator system to strengthen In 2003, health expenditure as a percent-
tial. Taiwan is a heavily populated country, quality surveillance. In 1999, the Depart- age of gross domestic product (GDP) was
with small land area and many mountains ment of Health funded a 2-year project 6.8% in Taiwan, which is lower than 14.6%
and isolated islands. Unequal distribution led by the Taiwan Healthcare Execu- in America, 9.6% in Canada, 7.7% in UK
of medical resources has made high-quality tive College to develop a comprehensive and 7.8% in Japan, but medical care of
accessible medical care for all a major prob- performance assessment system, later high quality was provided to all nationals.
lem in rural areas. Medical personnel are named Taiwan Healthcare Indicator Se- One important factor was the good infor-
unwilling to practice in rural areas because ries (THIS). It includes four categories of mation management in the healthcare in-
of fear of isolation from peers and lack of indicators, namely, outpatient, inpatient, dustry in our country. Medical care, hospi-
continuing medical education in those ar- emergency care and intensive care, and has tal management, health insurance, public
eas. Telemedicine provides a timeless and 139 items in total. The system was official- health and health promotion are now digi-
spaceless measure for teleconsultation and ly launched in 2001. In light of the success tised to a certain extent in Taiwan. In fact,
education. We have established computer of the indicator series, BNHI of Taiwan information technology not only raises the
networks between our hospital and 10 ru- has proposed participation in the series as efficiency but also improves medical qual-
ral primary care centers through high-speed being one of the criteria to be reimbursed ity to a great extent. Hospitals with excel-
networks and high power computer pro- for quality. lent information technology service can
cessing to electronically exchange medical have innovative processes to break through
information and to conduct clinical exami- Research the limit of traditional service, and thereby
nation and consultation. Our system pro- Information technology is responsible for save the time wasted and raise the low effi-
vides teleconsultation of good quality and data management and providing criti- ciency to effectively improve the quality of
is cost-effective. cal statistical support to research studies. medical service.

58 Asian Hospital & Healthcare Management ISSUE-12 2007


w w w . a s i a n h h m . c o m 59
spotlight

Information Technology in
Healthcare
Creating a stronger healthcare
system

While improving computer systems would not eliminate all medical errors, researchers
believe it will reduce the errors dramatically. Now is the time to share progress, challenges
and best practices to enable interoperability and link the ecosystem in the delivery of
better quality care.

isolated and disconnected. While physi- The choices left to stakeholders of to-
Madhav R Ragam cians keep their own records, they do not day’s healthcare systems are when and how.
Director - Healthcare and Life Sciences have access to information about the care If they wait too long or do not act decisively
IBM Asia Pacific
Singapore their patients receive outside their offices. enough, their systems will be unable to con-
Hospitals rarely have access to these pa- tinue on the current path. This is a frighten-
tient records and emergency room doctors ing, but very real prospect.
know little about patients’ pre-existing

R
ising costs, ageing population and conditions. This often results in redundant Which direction will the industry
antiquated healthcare systems tests and assessments, increasing the cost take?
have put pressure on governments, of care and missed diagnoses or treatment The answer is complicated. The healthcare
businesses and society to make significant resulting in injury. ecosystem is extremely complex, based on
changes in the delivery of care. Such disconnects across the world’s intricate relationships, often with differing
These challenges, combined with the healthcare systems are causing an increase motivations. Most agree the chief goal is to
emergence of a new environment driven in poor health outcomes and in some cases improve healthcare systems to provide bet-
by globalisation, consumerism, demo- even death. ter quality service to more people, more ef-
graphic shifts, increased burden of disease, A recent Institute of Medicine (IOM) ficiently and at lower cost. How to achieve
expensive new technologies and treatments report found that preventable medical er- that goal, however, varies widely by stake-
are expected to force fundamental change rors kill up to 98,000 people each year in holder. These complex factors create an
on healthcare within the coming decade. the United States alone. While improving urgent need to break down industry silos,
One of the great ironies of modern computer systems would not eliminate all establish partnerships and increase collabo-
medicine is that while many of us enjoy medical errors, many researchers believe ration to drive progress.
the benefits of scientific discovery and they will reduce them dramatically. That’s why IBM has taken a leadership
sophisticated equipment, many patients In addition to saving lives, we at IBM role in the global healthcare transforma-
across the globe do not receive adequate believe between five and 20% of all health- tion. It is working with major ecosystem
standards of quality care due to a variety care costs could be saved by eliminating stakeholders—ranging from healthcare
of issues underpinned by the application unnecessary tests. This view is supported providers and standards bodies to govern-
of insufficient resources and fundamental by The Economist, which recently reported ments and other employers—to influence
technology inefficiencies. that redundancy and inefficiency account the adoption of a consumer-driven model.
In countries where information tech- for between 25% and 40% of the US$3.3 This emerging, patient-centric model
nology is commonly used for services such trillion the world spends on healthcare eve- focuses on improved outcomes through
as banking, telecommunications and en- ry year and that this could be eliminated disease management, prevention and
tertainment, many medical organisations with proper IT implementation. well-being programmes. It gives consum-
today still rely on paper records for the Change must be made. Healthcare ers greater control over their healthcare,
delivery of their service. systems that fail to address the challenges including in the selection of primary care
Furthermore, most existing medical of the emerging environment will “hit the providers and access to information needed
electronic systems don’t interact, which wall” and require immediate and major to make better healthcare decisions.
means that important information is often forced restructuring. Clearly, technology plays a key role in

60 Asian Hospital & Healthcare Management ISSUE-12 2007


information technology

patient-centric healthcare by enabling the - There is an expanding interest in medical Pacific countries are failing to deliver servic-
fast, efficient and secure flow of digital infor- tourism across Asia with India, Thailand es of adequate quality, often using resources
mation between patients and their doctors. and Singapore paving the way inefficiently or inappropriately.
Moreover, it provides the tools to improve - Many of the leading pharmaceutical The graphs from the WHO 2005 sta-
clinical decision making, collaboration, ef- companies are moving clinical trials from tistics for Health Systems highlight the
ficiency and administrative processes. the US and Europe to India healthcare facts and figures of relevance to
Fortunately, much of the technology - The Philippines is renowned as a leading key Asia Pacific countries and compares
needed to enable patient-centric networks exporter of highly skilled nurses around them to some of the world’s most developed
is available today. But the transformation to the globe countries.
a patient-centric model will require more - The US has turned to Indian and Aus- In these graphs, India, China and Ma-
than technology—it requires innovation tralian companies for the outsourcing of laysia clearly stand out as having a significant
and a shift to more open, collaborative and radiology readings and low number of beds, physicians and nurses
integrated systems. There remains a great - Australia has enhanced the US’s Diagno- for every 10,000 people in their respective
deal of work to be done around standards, sis Related Groups (DRG) system, which
governance and workflows, which is critical was subsequently adapted by Singapore, Physicians per 10000
to the easy flow of information within the France and Germany.
Singapore
healthcare ecosystem. According to the World Health Organi- Republic of Korea
sation (WHO), the Health Systems Statis- New Zealand

An Asia Pacific portrait tics vary significantly across the world’s de- Malaysia
Japan
Asia Pacific Healthcare market is currently veloped and emerging countries. In the case
China
the smallest in size out of the 3 geogra- of Asia Pacific, WHO claims inequitable Australia

phies—the US and Europe being the other health systems are preventing many Asia India
Europe
two. However, it is exerting a tremendous Pacific nations from meeting international
North America
influence on the global healthcare scene, for goals set on health and poverty. Further- 0 5 10 15 20 25 30
example: more, the healthcare systems of many Asia Source: WHO

w w w . a s i a n h h m . c o m 61
information technology

poor communications among constituents where community constituents can experi-


Nurses per 10000
resulting in fragmented patient data and ment with new business models to address
Singapore poor coordination across the continuum of the lack of incentives or the perverse incen-
Republic of Korea
care; inadequate information on quality and tives built in the existing reimbursement
New Zealand
Malaysia outcomes; worrisome patient safety issues; system, both for their own benefits and the
Japan and misaligned financial incentives that greater good of the community.
China
focus resources on episodes of care instead To further illustrate these points,
Australia
India of preventive medicine and long-term care figure 1 indicates the typical stakeholders in
Europe outcomes. a healthcare ecosystem, the initiatives that
North America
These ecosystem issues have resulted in are of interest to them and the types of solu-
0 20 40 60 80 100
a strong interest across several countries to tions that IBM can offer.
Source: WHO
leverage technology (healthcare interoper- At the early stages of an initiative,
countries. As a result, we expect to see expo- ability) in order to create regional electronic it is key to carefully approach planning,
nential growth of the healthcare industry in patient information exchanges. The basic
these three countries while the more devel- concept is that these exchanges will provide Hospitals beds per 10000
oped countries will focus on reining in the physicians with the patient information
healthcare costs and improving quality. they need at the time treatment decisions Singapore

Republic of Korea
are made—e.g.: what prescriptions is this New Zealand
Linking the healthcare ecosystem patient on?, what tests has he/she received? Malaysia

In all of the world’s markets, the health- etc.—which in turn permits a substantial Japan

care industry functions as an ecosystem, increase in the quality of care, patient safety China

Australia
with its various constituents, rules and in- and efficiency gains. India
teractions. More than just data sharing utilities, Europe

Currently, that ecosystem is plagued these regional electronic patient informa- North America

by a number of pervasive issues including: tion exchanges are also envisioned as places 0 20 40 60 80 100 120 140 160

Source: WHO

62 Asian Hospital & Healthcare Management ISSUE-12 2007


information technology

Total expenditure on health (% of GDP) aligned incentives and rec- technology expertise to link business pro-
onciled value perspectives cesses to IT. We can help with the business
Singapore
across key stakeholders. planning, funding, solution development
Republic of Korea
The rewards of successful and delivery of a full end-to-end national
New Zealand
transformation are high, but healthcare information networks (NHIN)
will require all stakeholders initiative. We can assist with the promotion
Malaysia
to actively participate, col- and adoption of open standards to help with
Japan
laborate and change. the integration efforts of NHIN projects.
China
Much of the comput- We have the capability to build and run the
Australia
ing infrastructure for mod- infrastructure for an NHIN system.
India
ern systems already exists. More importantly, leaders in the health-
Europe
What is now required is care industry internationally are recognising
North America
leadership, accountability the value of NHINs, as evidenced at The
0 2 4 6 8 10 12 14 and collaboration among Asia Pacific National Healthcare Informa-
Source: WHO
governments, businesses tion Network Forum 2006. The forum,
and the community to em- hosted by IBM Asia Pacific from 27 to 28
brace healthcare ecosystem February 2006 in Beijing, China, brought
constituent participation/buy in, gover- integration. If governments are prepared to together international thought leaders and
nance, legal entity creation, and overall initiate change, they will need partners to practitioners in healthcare to discuss current
strategy in order to find the most effective implement it. Companies like IBM already industry challenges; the best approaches
and efficient path to success. Multiple tech- have the track record of implementing suc- to NHINs; how to develop global NHIN
nical options exist to set up a community cessful e-health integration projects. standards; and share ideas about best prac-
and regionally based information exchange IBM sees the industry progressing in tices for healthcare interoperability.
and IBM of course has strong competency steps—from today’s world of siloed pro- The change is definitely occurring. Now
in this area. cesses and technologies, toward patient-cen- is the time to share progress, challenges and
Establishing a sustainable multi-stake- tric Networks where information is shared best practice to enable healthcare interoper-
holder business model is a bit more com- seamlessly across the healthcare ecosystem. ability and link the ecosystem in the deliv-
plex, given the well known value imbalance IBM can provide end-to-end industry and ery of better quality care.
between providers and payers. Figure: 1
However, a range of potential redistri-
bution mechanisms and incentive programs Interest within the entire ecosystem to reduce cost and Improve overall value
do exist and IBM is prepared with a meth-
Healthcare Ecosystem's Primary Stakeholders
odology and financial model to assist with
these critical planning and organisational 1. Empower 2. Manage Payers 3. Incentivize 4. Encourage 5. Promote
Employees Providers Community based Legislative
milestones. Collaboration Change
IBM’s financial model assists in creat-
ing a safe way for competitive constituents 1.1 Self Benefits
within the Healthcare Ecosystem to con- Management
e-Benefits
duct meaningful and critical conversations
1.2 Influence Healthy 2.1 Decrease 3.1 Improve
regarding cost and benefits. The key and Lifestyle Administrative Pharmacy
Wellness Programs Costs e-Rx
most elusive success factor in deploying a e-Claims & Audit Pharmacy
1.3 Promote Consumer Management
community or regional network is the will Flexibility 2.2 Disease 4.1 Promote
Consumer Driven Management
and ability for multiple constituents to Health Plans (CDHP) Disease
Community Health
Clinical
& Health Savings Management
work together on a sustained basis. Accounts Programs
Outreach Programs

1.4 Self Health


Leadership, accountability and Management
e-Disease Management
collaboration for a win-win 3.2 Improve
1.5 Promote Consumer Quality of
transformation Choice Care
Provider Selection Pay for 4.2 Promote
The transformational challenge facing Incentives 2.3 Increase Buying Performance Interoperability
RHIO & National
Power
many healthcare systems globally is daunt- 1.6 Health Record Purchasing 3.3 Promote
Health Information
Network (NHN) 5.1 Promote
Portability Coalitions IT Adoption New
ing. It often needs to be achieved with Personal Health Pay for Use Legislation
Records e-MR Lobbying
limited incremental funding in an increas-
ingly competitive global economy and
Most of these initiatives exist in multiple flavors. For example, chronic disease management typically covers
healthcare environment. The task will re- 6-15 different conditions. Similarly, RHIOs vary widely based on the mix of stakeholders, or given communities’
quire the establishment of a clear, consistent priorities and approach. At this stage, the analysis remains at a high level and does not attempt to inventory
accountability framework supported by each variation of a given initiative.

Source: IBM

w w w . a s i a n h h m . c o m 63
Products & Services

Company Page No. Company Page No. Company Page No.

Diagnostics Information Technology Richard Wolf GmbH IBC2


PhenixVision 61 PhenixVision 61 Shimadzu Asia Pacific Pte Ltd 22
Synthes Asia Pacific OBC3 SEED Infotech Limited 59 Synthes Asia Pacific OBC3
Srishti Software Applications Pvt Ltd 62 Venus Remedies Ltd 02
Facilities & Operations Management ZOLL Medical Corporation 04
Dometic S.à.rl 16 Technology, Equipment & Devices
Evolution Medicals 18 Medical Sciences Bloodline SpA 25
Bloodline SpA 25 Dometic S.à.rl 16
Faber Medi-Serve Sdn Bhd 55
Eurosets s r l 33 Eurosets s r l 33
Mocom Srl 56
Global Medisafe Holdings Pty Ltd Global Medisafe Holdings Pty Ltd
Synthes Asia Pacific OBC3
(GMS) 26 (GMS) 26
Unomedical Pty Ltd 20
Shimadzu Asia Pacific Pte Ltd 22 Menfis bioMedica Srl 50
Venus Remedies Ltd 02 Synthes Asia Pacific OBC3 Mocom Srl 56
Unomedical Pty Ltd 20 PhenixVision 61
Healthcare Management
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B. E. Smith 13
ZOLL Medical Corporation 04 Shimadzu Asia Pacific Pte Ltd 22
Dometic S.à.rl 16
SMEG SpA 44
Evolution Medicals 18 Surgical Specialty Synthes Asia Pacific OBC3
Faber Medi-Serve Sdn Bhd 55 Dometic S.a.rl 16 Unomedical Pty Ltd 20
Messe Düsseldorf China Ltd IFC1 Eurosets s r l 33 Venus Remedies Ltd 02
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Suppliers Guide

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www.hospimedica-thailand.com
Bloodline SpA 25 Solvay Pharmaceuticals GmbH 06
www.bloodline.it Mocom Srl 56 www.solvay.com
www.mocom.it
Dometic S.à.rl 16 Synthes Asia Pacific OBC3
www.dometic.lu Pangiran Budi Services 31 www.synthes.com
Eurosets s r l 33 Unomedical Pty Ltd 20
PhenixVision 61
www.eurosets.it www.unomedical.com
www.phenixvision.com
Evolution Medicals 18
Richard Wolf GmbH IBC2 Venus Remedies Ltd 02
www.evolutionmedicals.com
www.richard-wolf.com www.venusremedies.com
Faber Medi-Serve Sdn Bhd 55
SEED Infotech Limited 59 Zoll Medical Corporation 04
www.mediserve.com.my
www.seedinfotech.com www.zoll.com
Global Medisafe Holdings Pty Ltd
(GMS) 26 Shimadzu Asia Pacific Pte Ltd 22
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Menfis bioMedica Srl 50 Srishti Software Applications Pvt Ltd 62


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64 Asian Hospital & Healthcare Management ISSUE-12 2007


65 Asian Hospital & Healthcare Management ISSUE-12 2007
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