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Challenges of Extended Cycle Times
CRCST
CRCST Self-Study
Lesson Plan
LESSON NO. CRCST 118
(Technical Continuing Education-TCE)
Lesson Author
Susan Klacik, ACE, CHL, CRCST, FCS
CSS Manager
St. Elizabeth Health Center
Youngstown, Ohio
This series of self-study lessons on CSSD topics
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LEARNING OBJECTIVES:
1. Review traditional steam sterilization parameters recommended by the Association for the
Advancement of Medical Instrumentation (AAMI).
2. Explain common reasons why manufacturers may recommend extended steam sterilization
cycle times for medical devices.
3. Discuss common challenges that confront CSSD professionals as they monitor instruments in
extended cycles.
4. Provide an overview of how manufacturers and users verify sterilization instructions.
5. Explain the need to follow manufacturer’s instructions when processing instruments for
immediate use (flash sterilization).
Healthcare facilities have used traditional steam sterilization time, temperature and dry cycle
standards for more than three decades to process utensils, power equipment, single instruments,
and instrument sets, among other items. However, medical instrumentation manufacturers are
now incorporating routine and complex designs and materials into their devices that increasingly
lengthen these traditional recommendations. This lesson provides an overview of extended
cycle challenges that confront Central Sterile Supply Department (CSSD) personnel.
Objective 1. Review traditional steam Objective 2. Explain common reasons
sterilization parameters recommended why manufacturers may recommend
by the Association for the Advancement extended steam sterilization cycle
of Medical Instrumentation times for medical devices
AAMI has offered standard steam sterilization While the AAMI-recommended standard
cycle recommendations to produce cycle times shown in Figure 1 are used today,
efficiently-processed medical instrumentation many medical devices now require extended
with minimal errors for more than 30 years. sterilization times, and CSSD professionals
Examples of these recommended standard must rethink and revise traditional steam
cycle times for gravity-displacement and sterilization parameters.
dynamic-air removal steam sterilizers are
Extended cycle times result from the
shown in Figure 1. Note: The information
written recommendations of medical device
contained in these figures incorporate
manufacturers. They can range from up to
normal variations in sterilizer manufacturers’
one hour in a gravity-displacement steam
recommendations at different temperatures.
sterilizer and up to a 30-minute exposure in
It is always important to consult and utilize
a dynamic-air-removal sterilizer (compared
written recommendations provided by the
to the much shorter cycle times for these
manufacturers of the sterilizers used at
sterilizers shown in Figure 1).
specific healthcare facilities.
Figure 1: Examples of Standard Cycle Times
A. Gravity-Displacement Steam Sterilizers(1)
Exposure Time Exposure Time Exposure Time Minimum
Item 250°F (121°C) 270°F (132°C) 275°F (135°C) Drying Time
Wrapped 30 min. 15 min. 10 min. 45 min.
Instruments 30 min.
Textile Packs 30 min. 25 min. 10 min. 30 min.
30 min.
B. Dynamic-Air-Removal Steam Sterilizers(1)
Exposure Time Exposure Time Minimum
Item 270°F (132°C) 275°F (135°C) Drying Time
Wrapped 4min. 3 min. 30 min.
Instruments 16min.
Textile Packs 4 min. 3 min. 5 min.
3 min.
 IAHCSMM CRCST Self-Study Lesson Plan
CSSD personnel must obtain, study and
consistently follow the manufacturer’s
written recommendations for the
medical devices they process. They
must implement a policy that these
written recommendations be provided
by the manufacturers for all items
purchased, consigned or loaned to
the facility to help ensure that items
requiring extended sterilization times are
identified and properly processed. These
recommendations should be filed and used
for reference and training purposes. They
should also be available for easy access by
CSSD technicians, and a copy should be
retained in the supervisor’s office. Note:
When new medical devices are introduced
in the facility, the CSSD manager should
receive a copy of the instructions for
review when the items are evaluated.
Extended exposure times are most frequently
encountered in orthopedic and neurological
instrument sets because:
• They may be dense and heavy.
• The devices may incorporate a complex
and/or difficult-to-sterilize design.
• Instruments in these sets may contain a
narrow lumen (tubular shaft) of unusual
size or shape.
The above factors create a more significant
challenge to air-removal and steam
penetration during steam sterilization cycles.
Other common examples of instruments
requiring extended sterilization cycles
include loaner instrumentation sets with a
dense metal mass that require additional
steam contact. Also, power equipment and
instruments with lumens or crevices may
need to be processed in rigid containers,
instrument cases, cassettes, organizing trays,
or other containment devices comprised of
materials including plastic and/or metal that
increase sterilization challenges.
Extended exposure times can also be related
to the country of origin. European medical
device manufacturers may recommend an
extended (18-minute) pre-vacuum cycle of
274°F (134°C) to inactivate prions which
cause Creutzfeldt-Jakob Disease (CJD).
These recommendations do not change
when devices are imported to the United
States.
Figure 2: Examples of Extended Steam Sterilization Times2
(A)
Device Name Manufacturer
Acetabular reamer
Zimmer
system
Dupuy Moreland
Orthopedic set
Revision Instruments
(B) DePuy Recommendations For Processing Instrumentation
Minimum
Cycle Type
Temperature
Prevacuum 8 minutes/20 minutes dry time for metal or
132-134°C
(4 prevacuum pulses)
Prevacuum 5 minutes/20minutes dry time for metal or
134-137°C
(4 prevacuum pulses)
Objective 3: Discuss common
challenges that confront CSSD
professionals as they monitor
instruments in extended cycles
CSSD professionals use chemical indicators
(CIs) and biological indicators (BIs) and
corresponding challenge packs that are
designed, tested, and qualified for use
as process monitors in steam sterilizers
operating at the traditional exposure times
and temperatures indicated in Figure 1. A
BI qualified for use in a gravity displacement
sterilizer operating at 248°F (120°C) for 30
minutes should not be used in a pre-vacuum
steam sterilizer cycle at 273°F (134°C) for
4 minutes unless the BI manufacturer has
validated its use and provides label claims for
the second cycle.
CSSD personnel use a limited number of
steam cycles for routine sterilization. Their
sterilizers are validated by the manufacturer
to yield the appropriate steam sterilization
conditions for the specific cycles noted in
Figure 1, and users do not typically alter
them after installation of the sterilizer.
Significant problems occur when cycle times
recommended for new medical devices
extend beyond the traditional times. In fact,
extended times for affected devices may
Cycle time Alternative cycle
recommended by time approved by
manufacturer manufacturer
4 mins PreVac at
18 minutes 134°C. Precimed Grip-
PreVac at 132°C per handle requires
18 min. at 132°C
132°C for
None
40 minutes
Minimum Sterilization/Dry Time
metal/poly trays; 45 minutes for all poly trays
metal/poly trays; 45 minutes for all poly trays
be 5-20 minutes or even longer at 270-
275°F (132-135°C) in dynamic air-removal
sterilizers.
Sterilizer use time and daily processing
capacities are impacted by extended steam
sterilization cycles when medical devices
with specific extended cycles require a
dedicated sterilizer cycle. For example,
processing backlogs can be created that
impact other sterilization loads.
Most manufacturers require standard cycle
times (Example: 4 minutes at 270-275°F
[132-135°C] in a dynamic-air-removal
sterilizer) based on device material and
design. Damage to some items can occur
if these items are processed with other
devices requiring an extended cycle in the
same load. Also, the manufacturers’ specific
instructions must be followed, so facilities
may be legally liable if items are damaged or
compromised and then fail during a surgical
procedure. Another potential problem:
device replacement costs will also be the
facility’s responsibility.
Examples of extended steam sterilization
cycle times are shown in Figure 2.
 IAHCSMM CRCST Self-Study Lesson Plan

Objective 4: Provide an overview of Objective 5: Explain the need to Endnotes

how manufacturers and users verify follow manufacturer’s instructions 1. Association for the Advancement of
sterilization instructions when processing instruments for Medical Instrumentation. Comprehensive
Extended sterilization cycles have created immediate use (flash sterilization) guide to steam sterilization and sterility
concerns about the validation responsibilities In 2010, a position paper relating to immediate assurance in health care facilities. ANSI/
of medical device and sterilizer manufacturers, use sterilization was developed and released AAMI ST79. 2010.
and user verification is important. by stakeholders representing AAMI and other
healthcare associations including IAHCSMM.5 2. Examples shown are from:
Medical device manufacturers must validate
cleaning and sterilization processes for their It addresses flash sterilization problems and (A) - Alfa, M. et al. User Alert: Problems
instruments. To do so, BIs are placed in the provides guidance about sterilizing medical with Process Monitors for Extended
most challenging areas of the medical devices devices for immediate use. Steam Sterilization Cycles. 2006.
which have prompted the need for extended The guidelines require that medical devices
(B) - DePuy Reprocessing Instructions for
sterilization cycles. Examples of these sterilized in surgery for immediate use must
Use of Reusable Non-Sterile Instruments.
locations include the corners and centers of be processed with the sterilization times and
Rev. A1FU- 0902-05-001.
containment devices, next to a large metal temperatures specified in the medical device
mass, by lumens, and among instruments manufacturer’s written instructions. It also 3. Association for the Advancement of
on stringers. Manufacturers of containment notes that (a) cycle parameters to achieve Medical Instrumentation. Hospital Steam
devices should indicate the most challenging sterilization are determined by instrument Sterilizers. ANSI/AAMI ST8. 2001.
locations where indicators should be placed. design, load characteristics, sterilizer capabilities,
4. Readers desiring more information about
Sterilizer manufacturers use tests specified in and packaging, if used, and (b) the device product testing are referred to: Extended
the ANSI/AAMI ST8: 2001 Hospital Sterilizer manufacturer’s instructions may not be Cycles. Training Achievement Program.
Manufacturer Standard to validate that their compatible with instructions provided by the Chicago, IL. International Association of
equipment operates the way it is intended to sterilizer or the container/wrapper manufacturers. Healthcare Central Service and Materiel
perform.3 Test data for specific cycle parameters Instructions provided by the device Management. In production.
must be submitted to the U.S. Food and Drug manufacturer may be unclear, incomplete,
Administration (FDA) for clearance. or require unavailable processes or cycles. 5. Association for the Advancement of
Medical Instrumentation. Immediate-Use
CSSD sterilizer users must verify that cleaning When instructions conflict or are insufficient, Steam Sterilization. Position Paper. 1/31/11.
and sterilization processes are effective and the device manufacturer should be Note: other healthcare associations
that the methods used by their facility are contacted and, when differing instructions including IAHCSMM are represented in
consistently performed according to the medical cannot be resolved and the instrument is this position paper.
device manufacturers’ instructions and ANSI/ urgently needed, the device manufacturer’s
AAMI ST79: 2010 recommended practices.1 instructions must be followed. This includes
This verification is done by product testing. 4 the use of extended sterilization cycles, if
recommended.
Earn Continuing Education Points:
You can use these lessons as an in-service with your
Advisory Committee and Authors For Self-Study Lessons staff, or visit www.iahcsmm.org for online grading at a
nominal fee.
Scott Davis, CMRP, CRCST, CHMMC Carol Petro, CRCST, RN, BSN
Each lesson plan graded online with a passing
Materials Manager, Surgical Services O.R. Room Educator for Surgical Services
score of 70% or higher is worth two points (2 contact
University Medical Center of Southern Nevada Clarian North Medical Center • Carmel, IN
Las Vegas, NV hours). You can use these points toward your
Technical Editor: re-certification of CRCST (12 points).
Susan Klacik, ACE, CHL, CRCST, FCS
Mailed submissions to IAHCSMM will not be graded
CSS Manager Carla McDermott, RN, ACE, CRCST
St. Elizabeth Health Center Clinical Nurse III and will not be granted a point value.
Youngstown, OH South Florida Baptist Hospital Purdue mail-in, self-study lesson subscription
Plant City, FL (6 lessons/2 points each) for $75. Call (800) 830-0269.
Patti Koncur, CRCST, CHMMC, ACE
Corporate Director, CSPD For grading of individual lessons, send completed quiz
Series Writer/ Editor: and $15 to: CE Business Office, Purdue University,
Detroit Medical Center • Detroit, MI
Jack D. Ninemeier, Ph.D. Stewart Center Room 110, 128 Memorial Mall, West
Natalie Lind, CRCST, CHL
IAHCSMM Educational Director Michigan State University • East Lansing, MI Lafayette, IN 47907-2034.
Moorhead, MN Sponsored By: Each 20-question quiz with a passing score of
70% or higher is worth two points (contact hours)
David Narance, RN, CRCST
Nurse Manager, Sterile Reprocessing toward your CRCST re-certification (12 points). Two
Med Central Health System • Mansfield, OH attempts to achieve a passing score are permitted per
examination.


Quiz No. CRCST 118 (CIRCLE THE CORRECT ANSWER)
Lesson 118 • May 2011 • Lesson expires May 2014
CRCST

Objective 1
1. Current AAMI recommendations for standard
steam sterilization cycles have been in place
for more than ________ years.
a. 10
b. 20
c. 30
d. 40
2. Exposure times for gravity-displacement steam
sterilizers ________ as temperatures increase.
a. Increase
b. Decrease
3. AAMI cycle time recommendations for gravity
displacement steam sterilizers indicate that the
exposure time for wrapped instruments at 270°F
(132°C) is greater for wrapped instruments than
for textile packs.
a. True
b. False
4. Which of the following statements is true
about exposure times for dynamic-air-
removal steam sterilizers?
a. Exposure times increase as sterilization
temperatures increase
b. Exposure times for textile packs are greater
than for wrapped instruments at the same 11. Processing requirements for medical devices with
exposure temperature
c. Exposure times for wrapped instruments and back logs that impact other sterilization loads.
textile packs are the same at specific exposure a. True
temperatures
d. None of the above statements is true
5. Textile packs have a shorter minimum drying
time than wrapped instruments in a
dynamic-air-removal steam sterilizer.
a. True
b. False
Objective 2
6. Extended cycle times result from the written
recommendations of:
a. Sterilizer manufacturers
b. Container manufacturers
c. Facility quality committees
d. Medical device manufacturers
7. Which of the following is not a potential
reason for extended sterilization times for
instrument sets?
a. They may be heavy
b. The devices may incorporate a complex design
c. Instruments may be recently introduced to b. False
the marketplace
d. Instruments may contain a narrow lumen
8. Which of the following is a reason that
loaner instrumentation sets may have
extended sterilization cycles?
a. Past usage rates are unknown
b. They may have a dense metal mass
c. Conservative sterilization parameters are
needed because equipment is not owned by
the facility
d. Sterilization cycle parameters are mandated
by The Joint Commission
9. Processing recommendations of instrument
manufacturers outside of the United States
________ change when devices are imported
to the United States.
a. Do
b. Do not
Objective 3
10. Steam sterilizers are validated by their
manufacturer to yield the steam sterilizer
conditions for the cycle times recommended
by the Association for the Advancement of
Medical Instrumentation.
a. True
b. False
extended sterilization cycles can create processing
b. False
12. Which of the following is/are potential
problems that can occur if devices requiring
standard cycle times are processed with items
requiring an extended cycle in the same load?
a. Instrument damage can occur
b. There may be legal liability if instruments fail
c. Replacement costs will likely be borne by the b. Those of container/wrapper manufacturer, if
facility
d. All of the above
Objective 4
13. Medical device manufacturers verify and
CCSD personnel validate sterilization processes.
a. True
b. False
14. The most challenging areas of medical devices
are those which prompted the need for
extended sterilization cycles.
a. True
15. The most challenging locations for the placement
of BIs include:
a. Corners and centers of containment devices
b. Next to a large metal mass
c. By lumens
d. All of the above
16. Sterilizer manufacturers must submit test
data for a specific cycle parameters to:
a. AAMI
b. APIC
c. AORN
d. FDA
17. Sterilizer users in CSS departments must
verify that cleaning and sterilization
methods are consistently performed
according to:
a. Medical device manufacturers’ instructions
b. ANSI/AAMI ST79
c. Both of the above
d. Neither of the above
Objective 5
18. Medical devices to be sterilized for
immediate use should be processed
according to instructions from the:
a. Sterilizer manufacturer
b. Medical device manufacturer
c. Both of the above
d. Both of the above if instruments have lumens
or a dense metal mass
19. When processing instructions of the device
manufacturer differ with those provided by
the sterilizer manufacturer, which
instructions should be followed?
a. Those of the sterilizer manufacturer
applicable
c. Those of the device manufacturer
d. Those suggested by the physician
20. Devices that require extended
sterilization times can never be processed
for immediate use.
a. True
b. False

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