sELf-sTudy sERiE
June 2010 QA for table-top steam
The self-study lesson on this central service topic
was developed by 3M Health Care. The lessons are
administered by KSR Publishing, Inc.
Earn CEUs
The series can assist readers in maintaining their CS
certification. After careful study of the lesson, com-
plete the examination at the end of this section. Mail
the complete examination and scoring fee to Health-
care Purchasing News for grading. We will notify you
if you have a passing score of 70 percent or higher,
and you will receive a certificate of completion within
30 days. Previous lessons are available on the Internet
at www.hpnonline.com.
Certification
The CBSPD (Certification Board for Sterile Processing
and Distribution) has pre-approved this in-service for
one (1) contact hour for a period of five (5) years from
the date of original publication. Successful completion
of the lesson and post test must be documented by
facility management and those records maintained
by the individual until re-certification is required. DO
NOT SEND LESSON OR TEST TO CBSPD.
For additional information regarding certification
contact CBSPD - 148 Main Street, Suite B-1, Lebanon,
NJ 08833 (www.sterileprocessing.org). For more infor-
mation direct any questions to Healthcare Purchasing
News (941) 927-9345, ext 202.
Learning
Objectives
1. Understand the operation of a
table-top steam sterilizer.
2. Use AAMI ST79 recommendations
for sterility monitoring to update
policies and procedures.
3. Develop a quality assurance
auditing tool to maintain best
practices.
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46 June 2010 HEALTHCARE PuRCHAsing nEWs www.hpnonline.com
sELf-sTudy sERiEs
sterilizers
by Cynthia Hubbard, RN, BS
T
able-top sterilizers are commonly
used in laboratories, dental offices,
gynecological consulting rooms,
private physicians offices, smaller clinics
and outpatient surgeries, veterinary clinics,
hygienic (manicures and pedicures) and
tattooing shops. The type and volumes of
items requiring sterilization in these set-
tings are less variable and lower in number
than in hospital settings. However, steriliza-
tion in table-top steam units is just as im-
portant as it is in larger sterilizers, especially
with increasing numbers of people using
out-patient services requiring sterilized
instruments and equipment.
Understanding table-top steam
sterilizers
AAMI ST79 defines a table-top steam steril-
izer as a compact steam sterilizer that has
a chamber volume of not more than 2 cubic
feet and that generates its own steam when
distilled or deionized water is added by the
user. This treated water prevents mineral
buildup in the steam generating system and
ensures the purity of the steam generated.1
In addition to following the sterilizer
manufacturers instructions regarding
water purity requirements, sterilizer opera-
tors must know how to fill and drain the
reservoir; perform routine, general equip-
ment cleaning; and ensure that sterilizer
maintenance is completed on a regularly
scheduled basis.
During the fill cycle water is released from
the reservoir into the sterilizer chamber
where it is electronically heated and va-
porized into steam. After the sterilization
cycle is completed, a condensation coil
turns steam back into water. The majority
of table-top sterilizers are gravity-displace-
ment units, but dynamic-air-removal units
are also available. Some models are fully
automatic and cycle through fill, sterilize,
exhaust and dry cycles, but older technol-
ogy requires manual operation to complete
the dry cycle.2
Another advantage to automated steril-
izers is the self-diagnostic software and
display codes that assist in troubleshooting.
Sponsored by
Trays and racks hold peel packs, cassettes
and instruments away from the sterilizer
sides and bottom.3 Manufacturers Pelton
& Crane, Tuttnauer, Midmark / Ritter and
SciCan have the majority of units in opera-
tion in the US.4
Table-top sterilizers typically have several
pre-programmed cycles, including cycles
operating at both 250F and at 270-275F.
It is important that the operator selects the
appropriate cycle and packaging for the
load items to be sterilized.
Personnel needs
The education of personnel involved in
sterilization is important to ensure that
they understand and follow policies and
procedures and can use critical thinking
skills to solve day-to-day issues. Applying
infection control and sterilization moni-
toring principles to the development of
policies and procedures helps to ensure safe
sterilization practices.
Its imperative that any type of steam
sterilizer be operated correctly in order
to achieve sterile outcomes, and also to
prevent injury. There are, of course, risks
involved in operating a table-top steam
sterilizer. Common concerns include:
Heat burns from hot materials and the
steam sterilizers chamber walls or door;
Steam burns from residual steam which
may escape at the completion of the cycle.
Tools for sterility monitoring
Table-top steam sterilizers are subject to
the same type of monitoring guidelines
and recommendations as larger units. This
includes qualification testing before a new
unit is put into service; qualification testing
after major equipment issues/malfunctions
and sterilization failures; routine sterilizer
monitoring and the use of load and pack
controls.
Sterility monitoring is achieved by using
these familiar tools: the physical monitors,
chemical indicators (CIs) and biological
indicators (BIs). Evaluated together they
identify in real-time that the temperature,
time, pressure, moisture conditioning, and
 Sponsored by sELf-sTudy sERiEs
the sterilizer operator
air removal parameters of steam steriliza- cycle/mode tested during
must construct a PCD
tion are accomplished for each completed the qualification process.
cycle. representative of the Run a Bowie-Dick test
Physical Monitors: The sterilizationtype of package or according to the manu-
parameters (date, time, pressure, and tray that is routinely facturers directions each
processed. See Table
temperature) must be reviewed and docu- morning if the table-top
1 for examples and Figure 1. Typical representative BI PCDs sterilizer has a dynamic-
mented after each cycle. They are digitally
Figure 1 for a picture of representative BI air-removal feature. At a minimum, check
displayed on the unit and cycle results can
be downloaded to computerized record PCDs. The prepared PCD should be placed each sterilizer load run for successful
in a full chamber in the area least favorable physical monitors (time, temperature and
keeping and/or printed after each cycle.
AAMI recommends that only sterilizers to sterilization. pressure). Use both external and internal
with recording devices be used, as it is criti- CIs on/in each item/pack/cassette, as
Qualification testing
cal for QA to document the physical condi- recommended by AAMI.1
This testing requires time and attention to
tions needed for successful sterilization of The internal CIs will be retrieved and in-
detail. In a table-top steam sterilizer qualifi- terpreted by the users, who must be trained
each load and provide an early warning of
failure conditions.1 cation testing is done in a fully loaded ster- about the performance characteristics of
Chemical Indicators (CIs): Because ilizer (use materials that will be regularly CIs. If any CI fails to show an appropriate
sterilized in the unit in the future). The BI end point response, the item should not be
physical monitors dont measure the tem-
PCD, representative of the load, is placed in considered sterile and should not be used.1
perature or conditions inside packages or
the area designated by the sterilizer manu-
between trays/packs/cassettes, CIs must Routine BI monitoring of each type of cy-
facturer as the coldest area of the sterilizer. cle/mode is recommended at least weekly,
be used on the exterior (process indicators)
Three (3) test cycles in each sterilization but preferably each day the sterilizer is used
and interior (pack control) of all items in the
mode must show negative BI results and and with every implant load. BI PCDs must
load. Internal pack control is best achieved
appropriate CI endpoint response. The be used in each type of cycle for which the
by the use of Class 5 integrating indicators,
control BI vial with the same lot number table-top sterilizer is routinely used. The BI
as they are designed to react to all critical
as the test BIs must demonstrate growth PCD is placed in a full load.
variables of the steam sterilization process.
following proper incubation. Load items
Place internal CIs in that area of the pack-
processed while conducting qualification Load control
age, tray, cassette or peel pack considered
testing should be quarantined until the BI Load control is the term used for the process
by the manufacturer to be the least acces-
sible to steam penetration.1 test results from the three test cycles are by which a load is monitored and released
available.
Biological Indicators: The only way to based on the result of a BI PCD. Using a
If the sterilizer has a dynamic-air-removal self-contained BI with a one or three-hour
directly measure the lethality of the steril-
feature, three (3) Bowie-Dick test cycles in readout for routine sterilizer efficacy test-
ization process is to use biological indica-
an empty sterilizer are run and must show ing allows time (with proper planning) to
tors with live spores of resistant Geobacillus
acceptable air removal results (check with quarantine all items pending the BI results.
stearothermophilus. AAMI ST79 states that
the sterilizer manufacturer for Bowie-Dick This is especially important for loads con-
BIs should be used in Process Challenge
Devices (PCDs) to routinely monitor testing materials and procedure). Docu- taining implants.
ment all results.1
sterilizers at least weekly, but preferably Frequent monitoring with BI PCDs helps
every day that the sterilizer is used. BIs are eliminate recalls; reduces risk to the patient;
Routine sterilizer efficacy
required to monitor every load containing decreases liability for the organization due
testing
implants; be sure to quarantine the load to the use of a nonsterile medical device;
Once qualification testing is successfully and reduces costs. Check with the sterilizer
until the BI test results are negative.1 Since
completed, set up a schedule for routine and BI manufacturers to ensure that you are
there are no universally accepted standard-
sterilizer monitoring for each specific using the correct BI for the cycles tested. Use
ized PCDs for table-top steam sterilizers,
a BI control each day a test BI is incubated
Table 1: BI PCDs for Qualification and Routine Sterilizer Efficacy to ensure that the test lot has viable spores
Testing of Table-top Steam Sterilizers and the incubator is functioning properly.1
Mode/Cycle Temperature Time* BI PCD
Unwrapped instruments on a tray, 270-275F 3 min BI and at least 1 CI on/in an unwrapped
Best practices auditing tool
in a cassette or glassware (132-135C) instrument tray, cassette or glassware
Periodic monitoring of all relevant factors
related to sterilization quality assurance in
Wrapped trays of instruments; 270-275F 4 min BI and at least 1 CI in a wrapped tray table-top steam sterilizers can be accom-
instruments in peel pouches (132-135C) or peel pouch; include typical load
plished efficiently by creating and using a
item in PCD.
Best Practices Auditing Checklist Tool. Use
Wrapped packs 250F (121C) 30 min BI and at least 1 CI in a wrapped pack the concepts identified below, which include
that is representative of the load; in- personnel, physical and procedural issues, as
clude typical load item in PCD. the basis to design your own custom-made
* Check with the medical device and sterilizer manufacturers for complete and correct cycle times for the items being processed in auditing tool.
these modes.1
See SelF-Study on page 48
Self-Study Test Answers: 1.A, 2.A, 3.A, 4.A, 5.A, 6.B, 7.A, 8. A, 9.B, 10.A

www.hpnonline.com HEALTHCARE PuRCHAsing nEWs June 2010 47

sELf-sTudy sERiEs
SelF-Study from page 47
Summary
Table-top sterilizers play a key
role in medical device steril-
ization in many out-patient
environments, such as labs,
physician and dental offices.
Monitoring of the process
deserves the same attention to
detail applied to other key ac-
tivities in patient care. AAMI
recommendations should be
used to write policies and
procedures. QA includes
monitoring of sterilization
cycles; proper documentation
of sterilization-related poli-
cies/procedures; maintenance
activities; training of person-
nel and routine operational
audits. HPn
References
1. Comprehensive guide to steam sterilization
and sterility assurance in healthcare facilities,
Association for the Advancement of Medical
Instrumentation, ANSI/AAMI ST79:2006/
A1:2008 and A2:2009.
2. http://www.statim-autoclave.com/statim-
quantum-sterilizer.asp.
3. http://www.rpiparts.com/techtalk0018.
htm
4. http://www.fisherbiomedical.com/steril-
izers.htm.
Disclosure Statement
Ms. Hubbard is a consultant
to 3M.
Cynthia Hubbard, RN, BS, is an
author and independent nurse
consultant who has worked in
health care environments for over
35 years. Her nursing experience
includes ER, occupational health,
and GI and Cardiology ambula-
tory care. Hubbard was a sterile
processing manager at the Mayo
Clinic Saint Marys Hospital in
MN and Sacred Heart Medical
Center in WA. For 14 years
she served as a consultant with
the Lerch Bates Hospital Group
of Littleton, CO on design of
US and international construc-
tion projects related to sterile
processing, materials and waste
management. Hubbard has lec-
tured internationally on quality
sterile processing with numer-
ous publications designed to help
clinicians/technicians maintain
the highest standards of practice.
48 June 2010 HEALTHCARE PuRCHAsing nEWs www.hpnonline.com
Sponsored by
Best Practices Audit Check List
Department: __________________________________________________________
Date: ____________________ Completed by: _______________________________
Findings: Satisfactory _______ Improvement needed ________________________________________________
_____________________________________________________________________________________________
Next Re-audit due: ______________________________________________________
Administrative and Personnel: __ Manufacturers written guidelines for decon-
__ Sterilizer operators training is current; tamination and sterilization are in place for each
__ Sterilizer operators are able to articulate the opera- device reprocessed;
tional principles for the table-top steam sterilizer; __ Basic microbiology and infection control principles
__ Policy and procedure manual is available for con- are incorporated into policies and
sultation; work practices.
Decontamination:
__ Cleaning solutions are appropriate for the medical __ Reusable cleaning tools are decontaminated daily;
devices and used according to manufacturers __ Waste and used PPE materials are disposed of in
instructions; appropriate receptacles;
__ Water quality for cleaning and rinsing meets __ The decontamination area is kept clean and the
instrument & equipment manufacturers require- floors dry;
ments; __ There is efficient use of space and workflow in
__ Contaminated instruments are contained and decontamination;
transported in a manner that does not contami- __ Manual cleaning processes and automated
nate the environment; cleaning equipment are routinely tested for
__ PPE is available and correctly worn by the staff; effectiveness.
Packaging and Monitoring:
__ Instrument inspection and correct assembly of __ A BI PCD is included in all loads containing
components; implants;
__ Packaging is selected and applied following pro- __ Proper incubation of the BI control and steril-
cedures; ized BIs;
__ Proper package labeling, use of dating controls __ Chemical and biological monitors are correctly
and expiration statement; interpreted;
__ Proper selection and use of external and internal __ Release of non-implant loads is verified by physical
CIs; monitors and external CIs;
__ Qualification testing is performed per AAMI __ Release of implant loads is verified by physical
recommendations and documented; monitors, external CIs and a BI PCD;
__ Routine BI monitoring is completed and docu- __ Recall of suspected non-sterile items after a posi-
mented correctly; tive BI follows procedures.
Sterilizer Operation:
__ Uses deionized or distilled water for stream gen- __ Correct interpretation is made of the sterilizers
eration; physical monitors;
__ Proper sterilizer loading technique is used; __ Load contents are listed on a daily sterilizer log
__ Correct cycle selection is made for the load; along with identification of the sterilizer, cycle
__ Dry cycle procedure (if using a manual control number/type and sterilizer operator.
sterilizer) is correctly followed;
Sterilizer Maintenance: __ Documentation of maintenance activities;
__ Cleaning of the sterilizer filters, gasket, chamber, __ Trouble-shooting and notification of the service
boiler ring and water reservoir; technician is documented for repairs.
Sterility Maintenance/Sterile Storage:
__ Sterilized packages are not placed into storage __ Stock rotation is maintained;
until they meet inspection standards; __ Record keeping is complete for all distribution
__ Sterilized packages are inspected for contamina- activities.
tion before distribution;
 Sponsored by sELf-sTudy sERiEs
COnTInUIng EDUCATIOn TEST JUnE 2010

QA for table-top steam sterilizers

Circle the one correct answer:

1. Distilled or deionized water is used in steam table-top sterilizers to help prevent 6. Using manufacturers written guidelines for decontamination and sterilization
mineral buildup in the steam generating system. parameters are not as important for instruments sterilized in table-top steam
A. True sterilizers.
B. False A. True
B. False
2. Monitoring of the sterilization process deserves the same attention to detail
applied to other key patient care activities. 7. Cleaning of sterilizer filters, gasket, chamber, boiler ring and water reservoir
A. True are part of general sterilizer maintenance performed by the sterilizer operator.
B. False A. True
B. False
3. BIs are required to monitor every load containing implants and these loads
should be quarantined until the BI results are negative. 8. Release of implant loads is verified by physical monitors, external CIs and a
A. True BI PCD.
B. False A. True
B. False
4. AAMI recommends that only sterilizers with recording devices be used as it
is critical for quality control to document the physical conditions needed for 9. Table-top steam sterilizers that are gravity displacement units require a Bowie-
successful sterilization of each load and provide an early warning of failure Dick test each day of use.
conditions. A. True
A. True B. False
B. False
10. Internal CIs are retrieved and interpreted by the users who must understand
5. Key principles that are included in a sterile processing Best Practices Auditing the correct CI end point response to ensure they will catch any sterilization
Checklist Tool for steam table-top sterilizers include personnel, physical and process failures.
procedural issues. A. True
A. True B. False
B. False

COnTInUIng EDUCATIOn TEST JUnE 2010

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