Documenti di Didattica
Documenti di Professioni
Documenti di Cultura
I
n the mid-1960s, a group of pioneering physicians looked into the future
and saw possibility. They realized that breakthroughs with transistors,
plastics, and synthetic materials and modernized manufacturing pro-
cesses had the potential to launch a Golden Age for medical devices, opening
the door to treatments that only a few years earlier would not have been
possible. They also knew that without vision and leadership, the doors to this
promising future might never be fully opened. Without effective standards,
appropriate regulation, and better coordination of the chaotic medical device Dwight Harken
industry—then a plethora of small companies—brilliant medical devices
might never achieve their full potential to save lives.
e
Dwight Harken had already pushed the envelope to create new lifesaving
devices. As a captain in the U.S. Army stationed in France, he performed
successful cardiac operations by removing shrapnel and other projectiles in
and around the hearts of soldiers injured in combat. In 1948, he carried out
one of the first mitral valvuloplasties. In the 1960s, Harken developed and
implanted a device to assist the heart’s pumping and an internal pacemaker,
and was among the first to implant artificial valves.
e
At Baylor University in Houston, TX, Arthur C. Beall, Jr., was developing
an international reputation for his work. His efforts led to the creation of
prosthetic heart valves, including the Beall valve that went on to become one Arthur C. Beall, Jr.
of the most widely used prosthetic valves from 1965 until 1970. He was also
a driving force behind the concept of using cardiopulmonary bypass during
cardiac surgery, and developed filters that removed dangerous debris pro-
duced by the bypass pump.
e
In Minnesota, a struggling electrical engineer named Earl E. Bakken was
on the brink of throwing in the towel on his 10-year old company that ser-
viced medical electronic equipment when a power outage in the Twin Cities
changed the medical device industry forever. C. Walton Lillehei, MD, of the
University of Minnesota had achieved success in treating infants suffering
heart block by relying on AC-driven pacemakers, but the blackout rendered
the machines useless and a baby died. The next day, Lillehei called Bakken
and asked if Bakken’s struggling company, called Medtronic, could come up
with something better. Four weeks later the world’s first wearable, external,
battery-powered, transistorized pacemaker was handed to Lillehei. A day
later it saw its first clinical application. Earl E. Bakken
These individuals, and others like them, realized that 1965: An Idea Catches On
in order to bring new technologies and new treatments By 1965 the use of medical devices in patient care was
to patients, they would need to generate industrywide expanding rapidly. Medical devices were having a major
cooperation and interdisciplinary communication among impact on patient outcomes, and many physicians had
those who would be able to help usher in this Golden a very personal relationship with devices. Physician-
Age. They would need the help of the physicians who inventors like Beall and Harken were struggling to find
inspired, invented, and used medical devices; the manu- engineers to translate their ideas into lifesaving medical
facturing industry that would build safe devices and de- devices. At the same time, businessmen-engineers like
liver them to the point of care; engineering personnel Bakken and John Abele, who went on to found Boston
who would maintain the devices; and a government eager Scientific, needed doctors to help their fledging medi-
to bring medical devices under its regulatory watch. cal device companies refine and market their products.
Harken, Beall, Bakken, and other giants in the medi- Technicians in the armed services like Burt Dodson
cal device industry would find themselves partners in and Herman Hubbard were running organized medical
1967 in an effort to launch a fledgling organization that equipment programs, but the concept hadn’t yet made its
promised to help realize these goals. This organization, way into the private sector. Rumblings of problems with
named the Association for the Advancement of Medical equipment safety in hospitals were laying the foundation
Instrumentation, would bring together a unique alliance for the full-blown electrical safety scare of the early 1970s.
of stakeholders involved with the development, manage- The FDA was looking closely at medical devices, trying
ment, use, and regulation of medical devices. to figure out how to regulate the technologies that were
From these early efforts, through four decades of chang- having such an impact on patient care. And, in Boston,
es and challenges, AAMI has used its resources to foster MA, a group of marketers were hatching a money-mak-
collaboration, education, communication, and consensus ing scheme that involved the creation of a new organiza-
building, offering a forum where issues that threaten the tion they named the Association for the Advancement of
advancement of medical instrumentation can be discussed Medical Instrumentation.
and, in many cases, resolved so that patients can receive Robert D. Hall, Robert J. Allen, and their colleagues
the best care possible. Hundreds of initiatives have been were in the advertising business and worked for small
launched; thousands of professionals have been helped; and high-tech companies in the Boston area, recalls John
millions of patients around the globe have benefited from Post, who served as AAMI’s first executive director.
the work of AAMI and its members. “They had an idea to start an expo and a journal with
In 2007, as AAMI celebrates its 40th anniversary, we advertising, hoping to attract manufacturers of medical
find ourselves looking back. How and why did AAMI’s devices and make money,” says Post.
early leaders come together? What goals did they have, They approached Abele, who was then working for a
and how did they plant the seeds for the many programs small medical device company, with their idea. The men
that would sprout from their efforts? Please join us as we realized that they needed to create a structure to attract
take a look back and see just how far AAMI has come. physicians who could lend legitimacy to their efforts, so
28 January/February 2007
COVER STORY
Jill Schlabig Williams
Michael DeBakey
and Adrian
Kantrowitz
debated artificial
heart designs.
Fortunately for AAMI, these and other leaders in the with Bob Hall in his office. Bob said, ‘I want you to do
field came on board to help the organization get started, this,’ and I said ‘I don’t work for you anymore. I work for
taking positions as officers or directors. “These men were AAMI.’ He backed away, and the organization went on.”
very skillful at manipulating the worlds of medicine and “The real AAMI was created in 1967, despite the
politics,” says Abele. “As a result, AAMI had a dispropor- founding of the shell that existed prior to that time,” says
tionate impact for its size.” Mike Miller, who came on board as AAMI’s chief execu-
With so many huge names in medicine on its side, the tive officer in 1969 and still holds that post today.
fledgling organization got off the ground quickly. Mer- “It’s a real tribute to the strength and foresight of those
rill chaired AAMI’s medical advisory board, and Abele early founders, who cared enough and valued the idea of
chaired the manufacturers’ advisory board. A 1967 mem- AAMI enough to wrest the organization away and raise
bership directory lists nearly 600 individual members and the money to keep it going.”
nearly 100 corporate members. The transition shook up the young organization. Pub-
lication of AAMI’s journal, Medical Instrumentation, was
1967: The Doctors Take Over halted while the board found a new publisher—Williams
Through this early period, the marketing men who found- & Wilkins of Baltimore—and a new editor—Harry S.
ed AAMI were running the show behind the scenes, with Lipscomb, MD, of the Baylor University College of Medi-
help from executive director Post (on loan from Abele’s cine. The revamped journal reappeared in January 1969.
company) and his secretary. The organization, based in AAMI’s third annual meeting—no longer called MEDAC—
Boston, ran one more trade show—MEDAC ’67—and took place in Houston, TX, under Beall’s leadership.
published several issues of the bimonthly journal Medical Significant financial problems plagued the organiza-
Instrumentation, which premiered in July 1966. tion. A 1967 financial review showed that AAMI carried a
Quickly, though, the physicians became more involved $58,000 debt, which the board rallied to eliminate. Beall
and more committed to the ideals behind the organiza- and John Kimbell (from Baxter Labs) became AAMI’s
tion, and decided to take over AAMI. In 1967, the doc- chief fundraisers. “AAMI borrowed some money from
tors reorganized the association and changed its by-laws individuals, and in many cases, those debts were for-
to consolidate the power of the board. given,” recalls Abele. “Art Beall squeezed the arms of his
“The people who started AAMI rapidly lost control,” corporate friends, and Medtronic and its founder, Earl
says Post. “I was hired by them, but then Art Beall and Bakken, stepped in and saved AAMI many times.” By the
the others came on board. I remember a confrontation end of 1969, they had erased the debt.
30 January/February 2007
COVER STORY
Jill Schlabig Williams
The board also moved to position AAMI for success government regulation of medical devices was looming
in the new legislative climate that was emerging as FDA over the community and was a key driver in AAMI’s
regulation of medical devices became inevitable. In 1969, formation. While the FDA was actively regulating drugs,
they relocated the association’s headquarters to the Wash- it had not yet expanded its authority to medical devices.
ington, DC, area and began a search for a permanent By the late 1960s, though, concern about device safety
executive director. They found Mike Miller, who had a was prompting Congressional leaders to introduce bills
law degree and an association management background, on device regulation. The FDA was trying two legal
with experience in lobbying and legislation. cases, the “AMP Case” and the “DIFCO Case,” in which
In hiring Miller, the board found an executive who it was seeking authority to regulate medical devices the
would lead AAMI through the next four decades. “When way it did drugs. A 1969 consumer protection message
we interviewed Mike, we could see that he got it, that from President Nixon to Congress called for regulation
he was able to see the horizon. Mike understood how to of medical devices.
deal with all the constituencies of AAMI and their unique “We doctors knew that regulation was inevitable,”
concerns and emotional biases,” says Abele. says W. Gerald Rainer, MD, a heart surgeon and early
“During my early years, volunteer leaders were always AAMI board member. “We wanted to get in there and
there to provide guidance to a very young and inexperi- help write the regulation to ensure that it was sensible,
enced CEO,” says Miller. He describes those early days that it did not hamstring physicians, and that it spoke to
as ones of great challenge. “When I arrived at AAMI, two the issue of safety. We didn’t want politicians or bureau-
organizational lawsuits were pending. We had no money, crats writing it.”
we had no staff. Officers had to sign personal notes to AAMI, under Harken’s leadership, organized a con-
make sure payrolls were met. In a sense, AAMI existed in ference in Bethesda, MD, in 1969 to address these con-
the offices of its leaders.” cerns. The National Institutes of Health (NIH) offered
Over the next four decades, AAMI—with its volunteer start-up funding for the conference, giving AAMI a grant
leaders and growing staff—managed to have a huge im- of $20,000. Harken authored a letter to the AAMI mem-
pact on the medical device field. Building on the efforts bership and the industry outlining the importance of the
of its early leaders, the organization would go on to play event, and raised an additional $100,000. Manufactur-
key roles in regulation of medical devices, the emergence ers saw AAMI and its physician members as a means of
of the biomedical equipment technician and clinical helping to secure constructive legislation, and were eager
engineering professions, and the creation of consensus to sign on to support the conference. Doctors, heavily
standards that have taken on global importance in ensur- dependent on devices and afraid that their promise could
ing the safety of medical devices. be throttled by government regulation, were also eager
to participate.
First Up: Medical Device Regulation Leaders from all sectors were pulled into the confer-
AAMI’s board first turned its attention to the pending ence—people from the highest levels of government,
medical device regulation. In the 1960s, the specter of industry, and medicine. “This conference was a huge
event,” says Abele. “It was the first time that the presi- capitalizing on its unique membership mix—an alliance
dents of every American Medical Association-recognized of physicians, manufacturers, engineers, and others with
society were present in one room.” an interest in medical devices—AAMI was able to bring
Virginia Knauer, special assistant to President Nixon different factions together to advance the field. AAMI
for consumer affairs, opened the meeting with remarks would play this role again and again, laying the founda-
that highlighted the government’s concerns over device tion for its success on future government programs.
safety. “To put the subject in perspective,” she said, “it has In 1990, when the Safe Medical Devices Act required
been pointed out that toilet valves must undergo several user facilities to begin reporting adverse events to the
preclearances before they can be used. Yet a pacemaker FDA, AAMI commented extensively on the regulation
inserted in the body to regulate the heart need not be and, after its passage, sponsored a series of seminars to
tested or examined at all.” educate the user community about the new requirements.
The 1969 conference had an impact on device regula- Similarly, AAMI held a series of seminars on reuse of
tion like no other meeting before or since. The report single-use devices when the user community was affected
from AAMI’s conference, which included task force in the late 1990s by new FDA requirements.
recommendations on device regulation, was published The 1990s would also bring a new role for AAMI in
simultaneously in many major engineering, medical, the realm of government regulation. When the FDA is-
industrial, nursing, and other journals and trade pub- sued a new Good Manufacturing Practice (GMP) regula-
lications. Following the conference, the Department tion, which lays out strict requirements for medical device
of Health, Education and Welfare organized the Study manufacturers, the agency turned to AAMI to help with its
Group on Medical Devices, chaired by Theodore Coo- implementation. In this groundbreaking effort, AAMI and
per, MD, director of the National Heart and Lung others created a process where FDA and industry learned
Institute. The group’s report—the Cooper Committee together what meeting the new regulation would require.
Report—built on the AAMI report and laid the founda- AAMI’s government education program grew out of this
tion for the ultimate regulation. effort and is now a mainstay of the association.
Beall, Rainer, and other AAMI leaders literally wrote
sections of the legislation. They pulled in experts like The Next Step: Who’s Watching the
David Link, who would eventually become director of Devices?
the FDA’s Center for Devices and Radiological Health, AAMI’s early physician leaders knew that the engineering
and Larry Pilot, a leading attorney, to continue AAMI’s community was a hugely important partner in the effort
efforts to track the legislation as it moved forward and to ensure the safety of medical instrumentation. Their
eventually was enacted into law as the Medical Device services were badly needed in hospitals to manage the
Amendments of 1976. rapidly growing number of devices that were becoming
Throughout this period, AAMI maintained its neu- so central to patient outcomes. “Our concern was that we
trality, playing a nonpartisan role as the facilitator of had a lot of people using this complex instrumentation,
discussions and not advocating for any one position. By but nobody was maintaining it,” says Abele.
32 January/February 2007
COVER STORY
Jill Schlabig Williams
develop training programs for biomedical equipment achievement in their chosen profession,” says Michael E.
technicians and eventually institute a certification pro- Carver of Premier Inc., himself a CBET who has partici-
gram to solidify the growth of this new profession. pated in the certification process for more than 20 years.
“The defining factor in AAMI’s relationship with and “In the credential-oriented U.S. healthcare environment,
programming for BMETs was the development of the the letters CBET engender confidence, mutual respect,
BMET certification exam by Col. Burt Dodson in the and acceptance by other healthcare professionals.”
early 1970s,” says Mike Miller. “He had a major role in The electrical safety scare of the early 1970s helped
training Air Force BMETs and took his knowledge and to solidify the importance of the BMET and clinical
developed and tested the first BMET exam for AAMI.” engineering professions. While concerns about electri-
AAMI was also a leader in advancing the role of clinical cal safety in hospitals had been prevalent throughout the
engineers in hospitals. Another early AAMI leader, Cesar 1960s, it was not until 1969 that the concerns began to
Caceres, MD, coined the term “clinical engineer.” “He gain public attention. “In 1969, the electrical safety scare
realized that the term ‘biomedical engineer’ did not truly was promulgated by Dr. Carl Walter in a series of major
describe what clinical engineers were doing in hospitals,” articles and television broadcasts,” says Abele. Walter, a
says Thomas Hargest, who would eventually become the well-known surgeon at the time, asserted that 1,200 pa-
first clinical engineer certified under AAMI’s program. tients were being accidentally electrocuted in U.S. hospi-
Biomedical engineers typically work in industry, educa- tals each year. In 1971 Ralph Nader published an exposé
tion, or government, not hospitals. “Caceres felt that the on the issue in the Ladies Home Journal, and national at-
hospital needed the judgment and experience that clini- tention focused on the issue. Many hospitals developed
cal engineers provided.” in-house medical equipment management programs for
AAMI launched the BMET certification program in the first time in response to these concerns.
1971, and the clinical engineering certification program AAMI played a leading role in responding to the scare.
followed closely behind in 1973. In 1972 Herman D. Leaders launched a series of electrical safety education
Hubbard of Fitzsimons Army Hospital in Aurora, CO, programs and created a traveling electrical safety exhibit
became the first person designated a certified biomedi- to educate medical audiences about the issue. “The ex-
cal equipment technician. Hargest earned the first cer- hibit was taken to many medical meetings to educate the
tification as a clinical engineer in 1974. A certification doctors,” recalls Post. “The message was as basic as the
program for radiation equipment specialists was added importance of using a three-prong, grounded plug, some-
in 1979, and another for laboratory equipment specialists thing we all take for granted today.” In 1971, AAMI’s first
in 1981. published standard focused on electrical safety.
Today, more than 6,000 people hold AAMI certifica- The BMET profession has flourished. Today, the Bu-
tions. “The title Certified Biomedical Equipment Tech- reau of Labor Statistics estimates that 29,000 people are
nician (CBET) has long been the single most recognized employed as BMETs. With its early efforts to develop the
and universally accepted credential by which BMETs profession and the growing importance of its certification
can publicly demonstrate both their commitment and program, AAMI provided an early home for biomedical
34 January/February 2007
COVER STORY
Jill Schlabig Williams
AAMI, with its existing standards program, strong changed as growth in the engineer and technician seg-
reputation as a consensus-building organization, and ments outpaced growth in physician membership. AAMI’s
diverse membership, was ideally positioned to develop consensus orientation led to the rise of other, more par-
medical device standards. The association was accredited tisan groups that splintered off to represent the interests
by ANSI in 1977 as a standards developing organization of particular membership segments in the 1970s, but also
and quickly became a leader in the creation of U.S. Na- positioned AAMI for success in key areas like standards
tional Standards. AAMI’s first recognized American Na- and government programs.
tional Standard, “Safe Current Limits for Electromedical The success of its standards program put the organi-
Apparatus,” was published in 1978. The first AAMI stan- zation on a firm financial footing for the first time in the
dards book, published in 1985, contained 21 standards mid-1980s, and a reorganization in 1991 helped refocus
and recommended practices. AAMI’s priorities and position it for major growth. The
As the importance of international harmonization success of its more recent regulation- and standards-
of standards grew, AAMI expanded its efforts into the based education programs has added to AAMI’s stability,
global arena. A formal decision by AAMI’s board in 1989 and given the association the opportunity to consider
to expand the international standards program laid the new initiatives like those by the Technology Manage-
groundwork for this effort. By the mid-1990s, AAMI had ment Council and a possible role in cost reimbursement
assumed international secretariats in the areas of cardio- for medical devices.
vascular implants, sterilization, electromedical devices, Rainer, one of those early physicians, says that AAMI
and quality systems and had solidified the international has followed a perfectly natural evolution to what it is
reputation of its standards development program. today. “Its key focus was always to promote safety,” he
AAMI’s standards work has had a huge impact on patient says, “First through regulations, then through standards
safety in such areas as sterilization, electromedical equip- and education. By creating forums through the years in
ment, dialysis, biological evaluation of medical devices, and which people could get together and talk, AAMI has re-
cardiovascular implants. AAMI today also plays a leading mained true to its mission.”
role in the promulgation of quality systems standards for Abele, another founder, agrees. “AAMI has provided
the manufacture and development of medical devices. an amazing way of connecting people who usually don’t
AAMI now administers 110 committees and work- connect,” he says.
ing groups that develop U.S. positions on international “There are many services that can only be created by
standards and develop/approve American National engineers, industry, and the healthcare professions work-
Standards. AAMI also administers secretariats for five ing together,” says Miller. “AAMI has made diversity
international committees or subcommittees and 85 in- work for itself and others.”
ternational working groups. This diversity will continue to serve AAMI, its mem-
bers, and the medical device field in the future, says
AAMI Today: Looking to the Future Miller. As AAMI and its members look forward to the
From 1967 to 2007, AAMI as an organization has come a next 40 years, they can continue to rely on the principles
long way. From its early beginnings operating out of the that have guided the organization through its first 40.
offices of its volunteers with a skeleton staff and a large “The importance of medical technology in healthcare
debt, AAMI has grown into a stable association with a is growing, and the need for AAMI members is greater
bright future. It is now a unique alliance of more than than ever,” says Miller. “This need will take different
6,000 members united by the common goal of increasing forms in the future, but the need for interaction between
the understanding and beneficial use of medical instru- the stakeholders to ensure that resources are in place to
mentation. It relies on a staff of 35 professionals and has guide and avoid restricting technology will remain.” n
annual revenues in excess of $10 million.
Over the years, AAMI’s membership makeup has Jill Schlabig Williams is AAMI’s senior writer.
36 January/February 2007
COVER STORY
Jill Schlabig Williams