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Troubleshooting Steam Sterilization Process Failures: Education & Training
Troubleshooting Steam Sterilization Process Failures: Education & Training
Troubleshooting Steam
Sterilization Process Failures
By Gale Havrilla, BS, CSPDT,
Robin Hicks, RN, BScN,
Dorothy Larson, CSPDT, and
—A SERIES OF UNFORTUNATE EVENTS Martha Young, BS, MS, CSPDT
Objectives Introduction
After completion of this self-study activity, the learner will be able to: Steam sterilization process failures
1. dentify a steam sterilization process failure by the use of monitoring tools. are the result of a series of unfortunate
2. List 10 of the most common reasons for steam sterilization process failures. events. The causes for these failures may be
3. Ask five questions in order to identify clues about why there was a steam complex and in some cases difficult to deter-
sterilization failure. mine. Steam sterilization process failures are
4. Test the efficacy of a steam sterilizer to return into routine use. identified by observing the available
monitoring tools. These include both the
Test Questions physical monitors on the steam sterilizer and
True or False the results of various types of indicators
1. Packs should be used if the external chemical indicator or the internal such as the Bowie-Dick (BD) tests, external
chemical indicator has not reached its end point result (reject or incom- chemical indicators, the Class 5 integrating
plete color change). indicator (Class 5 CI) in a test pack or
2. A positive biological indicator initiates a recall of all packages processed process challenge device (PCD), biological
since the last negative biological indicator. indicator (BIs) in a test pack/process chal-
3. Usually there is only one cause for a steam sterilization process failure. lenge device (PCD) or internal chemical
4. Look for the obvious reasons first when trying to determine the cause for indicators (CIs) used inside each package.
a steam sterilization process failure. Each of these monitoring tools
5. Sterilizer efficacy testing is done in three consecutive full sterilization provides different information or clues
cycles to verify the sterilizer is functioning. about the effectiveness of the sterilization
6. Human errors such as using the wrong cycle time for the load, inappro- process. Not all of the tools may detect a
priate packaging and loading techniques can cause steam sterilization failure at the same time, but do not ignore
process failures. any clue that suggests a problem with the
7. A steam sterilization cycle does not need to have the correct temperature, process because the purpose of these tools is
time and steam quality for a sterilization process to be effective. to detect failures. When these tools indicate
8. An electronic record-keeping system may provide monitoring data and a steam sterilization failure, the next
other information about the sterilization load to assist in determining the steps are to determine the cause for the
reason for a steam sterilization process failure. failure by asking the right questions,
9. Running the wrong biological indicator test pack or process challenge correcting the failure, and retesting the
device in the load can create too great of a challenge for the sterilization sterilizer (sterilizer efficacy testing)
process and result in a positive biological indicator. according to the Association for the
10. Corrective action may include inservicing, sterilizer repair or correction Advancement of Medical Instrumentation
of the steam supply. (AAMI) Recommended Practices so it can
be placed back into routine use. Now put on
Many thanks to the team at 3M Health Care for working with Managing your Sherlock Holmes Hat, find your
Infection Control to provide the following accredited course. IAHCSMM has magnifying glass, and learn how the expert
awarded 1 contact point for completion of this continuing education lesson
authors look for clues as to the cause of a
toward IAHCSMM recertification. The CBSPD has pre-approved this inservice
for 1 contact hour for a period of five (5) years from the date of publication. sterilization process failure.
This inservice is approved by the California Board of Registered Nurses, CEP
5770 for 1 contact hour. This form is valid up to five years from the date of Monitoring Tools
publication. Instructions for submitting results are on page 92. The AAMI steam sterilization recom-
Managing Infection Control and 3M Health Care will be working mended practices describe how to use
collaboratively to provide continuing education courses in monthly editions of
Managing Infection Control. physical, chemical and biological monitors
on a routine basis in order to determine the
continued on page 87
Improper cycle for the load contents Poor Steam Quality or Quantity
Not following the container or instrument/ Wet steam
container manufacturers instructions for use Improperly insulated steam lines
Not verifying instrument/container Malfunctioning trap in steam line
manufactures sterilization parameters for Malfunctioning or no drain check valve
use in your sterilizers using AAMI product Steam contact with a cold load
testing protocol.1,2,3 Steam pressure too high for the temperature
Too much water in steam produced at boiler
Inappropriate packaging materials or (dryness should be between 97% and 100%)
packaging technique
Incorrect packing or container system for the Superheated steam
cycle parameters Improper chamber heat up
Not correctly preparing the container for use Desiccated packaging materials (e.g., towels)
(i.e., filters and valves or appropriate bottom tray) Steam pressure too low for the temperature
Using a peel pouch, woven or non-woven wrap, Excessive reduction of steam pressure too close
or towel in a gravity 270ºF to 275ºF (132ºC to sterilizer
to 135ºC), three-minute cycle Faulty steam control valve
Not using a mesh bottom perforated tray that Faulty pressure reducer control valve
allows air removal and steam penetration
Placing a folded peel pouch inside another Other reasons
peel pouch Variations in steam pressure due to clogged filter,
Preparing textile packs that are too dense poorly engineered piping or excessive demands
to sterilize in the cycle parameters chosen Pressure gauges and controllers out of calibration
Not placing basins in same direction Clogged steam lines
Not using non-linting absorbent material Clogged steam supply strainer
between nested basins Clogged chamber drain line, strainer or chamber
Using canisters with closed lids drain screen
Not disassembling or opening hinged Malfunctioning valves
instruments or surgical supplies Noncondensible gas level >3.5% by volume
e ffectiveness of a sterilization process failure. 1,2,3 All If a load is released prior to the results of a BI and the BI
monitoring tools must have the appropriate results for the indicates a sterilization process failure (e.g., is positive), then all
load to be released. The AAMI documents state that loads items processed since the last load showing a negative BI should
should not be released for use if the following monitoring be considered non-sterile, retrieved and reprocessed.1,2,3 This is
tools indicate a sterilization process failure: called a recall.
Physical monitors on the sterilizer itself, show the Monitoring more frequently with a BI and obtaining results
correct cycle conditions were not met (e.g., time, within a minimal incubation time (e.g., one or three hours) allows
temperature, pressure, vacuum) or that the incorrect sterilization process failures to be identified much sooner, instruments
cycle was chosen for the load; to be turned around faster, costs associated with inventory and
External chemical indicator suggests that the packages recall to be reduced and patient outcomes to be approved.4
were not exposed to the physical conditions present in
the steam sterilizer; Causes for Steam Sterilization Process Failures
Class 5 integrating indicator in a test pack/PCD used in There may be multiple causes for steam sterilization process
loads not containing implants shows an incomplete end failures. Human error can be the root cause as often as a malfunc-
point result (reject or incomplete color change); tioning steam sterilizer and other steam-related issues. Use the
Biological indicator (BI) in a test pack/PCD is positive. check list for steam sterilization process failures in Figure 1 to help
identify the causes of the failure that occurred in your healthcare
Packs should not be used upon opening if: facility. This is not all inclusive but does represent a majority of
Internal chemical indicator suggests inadequate the causes for steam sterilization process failures. (See Figure 1
steam processing. on page 84 & 86)
Did you run the correct BI and/or Class 5 integrating indicator test
pack/PCD for the type of sterilizer and load parameters?
Did you follow the BI or BI test pack/PCD instructions for use?
Do you store the BI or BI test pack/PCD according to
manufacturer’s instructions?
Do all personnel know how to handle and incubate the BI and read
BI results?
Did you follow the Class 5 integrating indicator test pack/PCD
instructions for use?
Do you store the Class 5 integrating indicator according to
manufacturer’s instructions?
Do all personnel know how to read the Class 5 integrating
indicator results?
continued on page 93
Table 1
Sterile Process and Distribution CEU Information Saturated Steam Is Assured When
the Temperature and Pressure
CEU Applicant Name ______________________________________________ Have the Following Relationship
Address________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ __ _ _ _ ________
City__________________________________________ _ _ _ _ _ _ _ ___________ Temperature Pressure Pressure
PSIG PSIA
State_________________________ Zip Code ______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
(ºF/ºC) (lbs/sq (sq in
ingauge) absolute)
The CBSPD (Certification Board for Sterile Processing and Distribution)
has pre-approved this inservice for one (1) contact hour for a period of five (5)
249.7/121.0 15 29
years from the date of publication. Successful completion of the lesson and post
test must be documented by facility management and those records 251.6/122.0 16 30
maintained by the individuals until re-certification is required. DO NOT SEND
LESSON OR TEST TO CBSPD. 253.4/123.0 17 31
For additional information regarding CBSPD certification, contact: CBSPD,
255.2/124.0 18 32
121 State Hwy 31N, Suite 500, Flemington, NJ 08822 or call (908) 788-3847 or
visit www.sterileprocessing.org. 257.0/125.0 19 33
IAHCSMM has awarded 1 Contact Points for completion of this continuing 258.7/126.0 20 34
education lesson toward IAHCSMM recertification.
260.4/126.9 21 35
262.0/127.8 22 36
Nursing CEU Application Form
This inservice is 3M Health Care Provider apporved by the California Board 263.6/128.7 23 37
of Registered Nurses, CEP 5770 for (1) contact hour. This form is valid up to five
265.2/129.6 24 38
years from the date of publication.
1. Make a photocopy of this form. 266.7/130.4 25 39
2. Print your name, address and daytime phone number and position/title.
3. Add your social security number or your nursing license number. 268.2/131.2 26 40
4. Date the application and sign.
269.7/132.1 27 41
5. Answer the CE questions.
6. Submit this form and the answer sheet to: 271.2/132.0 28 42
Workhorse Publishing
Managing Infection Control 272.6/133.7 29 43
PO Box 25310, Scottsdale, AZ 85255-9998
273.9/134.4 30 44
7. Participants who score at least 70% will receive a certificate of completion
within 30 days of Managing Infection Control’s receipt of the application. 275.3/135.2 31 45
Application 276.6/135.9 32 46
Please print or type.
278.0/136.7 33 47
Name______________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ ____________ _ ___
279.3137.4 34 48
Mailing Address________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
City, State, Country, Zip ________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
280.5/138.1 35 49
What time of the day or what day of the week or month did the
failure occur?
What are the steam boiler demands at that time?
When did they add boiler additives to the steam line?
Have the type of boiler additives changed?
What are the water pressure and temperature demands at the time?
Is there any construction at the hospital that could effect the steam
or water lines?
correcting steam quantity and quality problems and water process failure, additional testing with BI test packs/PCDs may
pressure and temperature. Periodically review the changes to need to be done and questions need to be asked about the entire
ensure they are still in place to minimize the chances of another process. Next time a steam sterilization process failure occurs,
sterilization process failure from occurring for the same reason. put on your Sherlock Holmes hat, find your magnifying glass,
and start looking for clues. If you need help, call us and we’ll
Placing the Steam Sterilizer Back Into be your Dr. Watson.
Routine Use
After the reason for the failure has been determined and References
corrected, AAMI sterilizer efficacy testing should be performed. 1. The Association for the Advancement of Medical Instrumentation.
Steam sterilization and sterility assurance in health care facilities.
See the previous section “Sterilizer Efficacy Testing” on page ANSI/AAMI ST46:2002.
88 for more details. 2. The Association for the Advancement of Medical Instrumentation.
When the sterilizer efficacy testing indicates acceptable Flash Sterilization: Steam sterilization of patient care items for imme-
diate use. ANSI/AAMI ST37:1996.
results, i.e, the BD tests show an acceptable color change and the 3. The Association for the Advancement of Medical Instrumentation.
BIs are negative, the sterilizer can be placed back into routine use. Steam sterilization and sterility assurance using table-top sterilizers
in office-based, ambulatory-care medical, surgical, and dental facili-
ties. ANSI/AAMI ST42:1998.
Summary 4. Ross, Edwin. Using Biological Monitoring to Reduce Infection, Risk,
Sterilization process failures are the result of a series of and Costs. Surgical Services Management. Vol. 4, No. 7, July:1998.
unfortunate events whose cause needs to be identified and 5. Young, Martha. Did You Know? Central Sterile Study. Managing
Infection Control. August:2004.
corrected so the sterilizer can be retested and placed back into 6. Prust, Janet. Solving Sterilization Process Problems Using New
routine use. To identify the reason for a steam sterilization Tools. Managing Infection Control. July:2004.
70-2009-7092-2
Gale Havrilla started his working career in sterile Dorothy Larson is the voice on the end of the
processing. He has clinical experience in medical laboratory 1-800-441-1922 3M Healthcare Tech Line for Sterilization
technology, microbiology and cytology. He began a career at 3M products. Ms. Larson spends her day solving sterilization
in pharmaceutical research and then worked as an engineer in p rocess failures, answering technical questions, and
medical product development and support. Mr. Havrilla is p roviding technical information and documentation
currently providing technical support for 3M sterilization as requested. She has been working in this role for eight
monitoring products. Mr. Havrilla received a BS degree in years, and is certified as a Sterile Processing and
microbiology from the University of Minnesota, has been a Distribution Technician. She is also a member of ASHCSP
frequent speaker on sterilization related topics, and is certified as and IAHCSMM.
a Central Sterile Processing and Distribution Technician. Martha Young, BS, MS, CSPDT, is a senior international
Robin Hicks, RN, BScN, is a Senior Professional Service technical service specialist in 3M Medical Products,
Advisor for 3M Medical Products in London, Ontario. St. Paul, Minn. She has more than 25 years of experience
She provides education on sterilization monitoring and in the area of sterilization and disinfection. Ms. Young
CSA standards, and assists customers across Canada with lectures around the world and has contributed to numerous
troubleshooting sterilization failures. Over the last 21 years, publications on infection prevention with an emphasis on
Ms. Hicks has worked as an OR nurse at the London Health improving the performance of the sterilization process. She is
Sciences Centre, University Hospital. She is also a member of a member of IAHCSMM, ASHCSP, and APIC and a certified
ORNAC, AAMI, CHICA and SOPIC. She has been a speaker over Central Sterile Processing and Distribution Technician.
the last year for the certification courses organized by the Central In addition she is a member of several AAMI working group
Service Association of Ontario. committees that are developing recommended practices.