may 3msterileu webinar steam sterilization process...
TRANSCRIPT
5/24/2013
1
© 3M 2013. All Rights Reserved.1
Refresher Course!
Steam Sterilization Process Monitoring
Today’s meeting times: 9:00 a.m., 11:00 a.m. and 1:00 p.m. CST
To hear audio, call 800-937-0042 and enter access code 7333633
Phone lines are muted. Audio will commence when the webinar begins.
3M™ Sterile U Network3M™ Sterile U Web Meeting – May 16, 2013
© 3M 2013. All Rights Reserved.2
Introducing the 3M Learning Connection:
New Name, Same Great Courses
• It’s an educational resource bringing you 3M™ Sterile U and other Infection Prevention courses.
• Improved features:• “Add to my Calendar” feature• Other 3M courses will be more accessible as we expand our offerings.
• What do you need to do? • Nothing. Your current registrations remain and our Sterile U offerings have not changed.
© 3M 2013. All Rights Reserved.3
Welcome!Topic: Refresher Course! Steam Sterilization Process Monitoring
Speaker: Martha Young BS, MS, CSPDT
Facilitators: Diane Koch, 3M Susan Flynn, 3M
Housekeeping
• Questions
• Mute feature (*7 = unmute; *6 = mute)
• “Chat” feature
• Technical difficulties
• Post session follow-up
For more information: www.3M.com/3MSterileU
5/24/2013
2
© 3M 2013. All Rights Reserved.4
Next week, all of today’s meeting participants will be sent
an email containing instructions for obtaining a CE
Certificate for today’s meeting.
The email will be sent to the email address you provided
when you logged-in to today’s meeting. If there are others
listening with you today who did not log-on, you may
forward the CE certificate email to them.
How do I get a CE Certificate?
© 3M 2013. All Rights Reserved.5
Disclosures
Martha Young BS, MS, CSPDT
President of Martha L. Young, LLC
Providing SAVVY Sterilization Solutions
for Healthcare
Educational Consultant to 3M
© 3M 2013. All Rights Reserved.6
Learning Objectives
Define the different types of sterilization monitoring
devices and discuss their recommended use
Describe the recommended practices for routine
load release of implants and non-implants
Describe the recommended practices for routine
sterilizer efficacy testing
Describe the recommended practices for sterilizer
qualification testing
1
2
3
4
5/24/2013
3
© 3M 2013. All Rights Reserved.7
Refresher Course! Steam Sterilization Process
Monitoring
Risks Being Taken in Reprocessing Medical Devices
• Not following monitoring products instructions for use (IFU)
• Not following recommended practices and standards for monitoring
the steam sterilization process
© 3M 2013. All Rights Reserved.8
Evidence-Based Guidelines
� Association for the Advancement of Medical Instrumentation (AAMI)• Comprehensive guide to steam sterilization and sterility
assurance in health care facilities ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text)
�Association of Perioperative Registered Nurses (AORN)• Perioperative Standards and Recommended Practices
(2013 Edition)
�Centers for Disease Control and Prevention (CDC) • Guideline for Disinfection and Sterilization in
Healthcare Facilities, 2008
© 3M 2013. All Rights Reserved.9
Regulations & Recommended
Practices Establish
State-of-the-Art
for Sterile Processing
5/24/2013
4
© 3M 2013. All Rights Reserved.10
The Joint Commission
National Patient Safety Goals
•NPSG.07.05.01
•“Implement evidence-based practices for preventing
surgical site infections.”
�Element of Performance 3
•“Implements policies and practices aimed at reducing the risk of
surgical site infections. These policies and practices meet regulatory
requirements and are aligned with evidence-based guidelines (for
example, the Center for Disease Control and Prevention [CDC]
and/or professional organization guidelines).”
The Joint Commission. 2013 Hospital Accreditation Standards (HAS)
© 3M 2013. All Rights Reserved.11
Every Facility that Utilizes a
Steam Sterilization Process
Should Follow Recommended Practices for
Monitoring the Steam Sterilization Process
Hospitals
ASCs
Clinics
Doctor’s Offices
Dental Facilities
© 3M 2013. All Rights Reserved.12
Sterilization Process Monitoring
• Goal of sterilization process:
• Kill microorganisms
• You cannot see sterility
5/24/2013
5
© 3M 2013. All Rights Reserved.13
Sterilization Process Monitoring
•Monitoring Tools
• Physical monitors
• Chemical indicators
• Biological indicators
• Process challenge
devices (PCDs)
Test or challenge pack
© 3M 2013. All Rights Reserved.14
Objective One
14 © 3M 2013. All rights reserved.
DEFINE THE DIFFERENT TYPES OF STERILIZATION
MONITORING DEVICES AND DISCUSS THEIR
RECOMMENDED USE
© 3M 2013. All Rights Reserved.15
Biological Indicators
• Challenges the sterilizer with a large number of highly
resistant bacterial spores
• Provide the only direct measure of the lethality of a
sterilizer cycle
• Cannot be replaced by the use of Class 5 integrating
indicators or Class 6 emulating indicators
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2
Spore Strip
5/24/2013
6
© 3M 2013. All Rights Reserved.16
Biological Indicators
• Use for
• Release of non-implant and implant loads
• Routine monitoring of the sterilization process
• Qualification testing of the sterilization process
• Product testing (will not be discussed during this webinar)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2
© 3M 2013. All Rights Reserved.17
The Joint Commission
Observations
Biological indicators (BIs) and BI process challenge devices
(PCDs) not appropriate for cycle being tested
Information on appropriate BI PCDs to use is covered in
ANSI/AAMI ST79 Section 10
and
BI and BI PCD manufacturer’s IFU
This slide was prepared based on what the author learned from a Joint Commission presentation
at the annual IAHCSMM meeting in May 2012
© 3M 2013. All Rights Reserved.18
Process Challenge Device (PCD) Definition
“Item designed to constitute a defined resistance to a
sterilization process and used to assess performance of
the process.”
Representative of load and creates the greatest
challenge
• Equal to or greater than the most difficult item to sterilize
• Placed in most difficult area in sterilizer for the sterilant
to penetrate
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Definition 2.103
5/24/2013
7
© 3M 2013. All Rights Reserved.19
BI PCD Immediate-Use Steam Sterilization (IUSS)
270ºF/132ºC Dynamic-air-removal Steam Sterilization
Process
BI PCD Used Daily Packaging Used Routinely
Is this the correct BI PCD for the packaging routinely used?
© 3M 2013. All Rights Reserved.20
BI PCD Immediate-Use Steam Sterilization (IUSS)
270ºF/132ºC Dynamic-air-removal Steam Sterilization
Process
BI PCD Used Daily Packaging Used Routinely
Is this the correct BI PCD for the packaging routinely used?
Answer: Incorrect The BI PCD does not represent the packaging
routinely used which means you may miss a sterilization process failure
© 3M 2013. All Rights Reserved.21
BI PCD IUSS Sterilization
270ºF/132ºC Dynamic-air-removal Steam Sterilization
Process
BI PCD Used Daily Packaging Used Routinely
Correct BI PCD. Represents packaging routinely used
5/24/2013
8
© 3M 2013. All Rights Reserved.22
Question asked of TJC at IAHCSMM May 2012
Question:
We use a 1 hour and a 3 hour BI in our implant loads so we can release
the implant in 1 hour. Is that correct?
Answer:
• No because each of those BIs are designed and FDA cleared for
different cycles
• This is an example
• Operator error
• Not using critical thinking
• Not following the monitoring product manufacturer’s IFU
© 3M 2013. All Rights Reserved.23
Biological Indicators
• 3M™ Attest™ 1291 Rapid
Readout Biological Indicator
(Blue Cap)
• Use for 270°F/132°C gravity steam sterilization cycles
• Healthcare facility prepared
PCD that is representative
of the load
• 1 hour readout
• 3M™ Attest™ 1292 Rapid
Readout Biological Indicator
(Brown Cap)
• Use for 270°F/132°C vacuum-
assisted or 250°F/121°C gravity steam sterilization
cycles
• Healthcare facility prepared
PCD that is representative
of the load
• 3 hour readout
© 3M 2013. All Rights Reserved.24
Is this the Correct Placement of a BI PCD in a Full Load?
5/24/2013
9
© 3M 2013. All Rights Reserved.25
Is this the Correct Placement of a BI PCD in a Full Load?
Incorrect placement: The BI PCD is placed under a pack which creates
too great of a challenge for air removal and steam penetration.
© 3M 2013. All Rights Reserved.26
Process Challenge Device (PCD)
3M™ Attest™ 41382 Rapid 5
Steam-Plus Pack
“Place an Attest Rapid 5 Steam-Plus
Test Pack flat with the label side up,
in a full load in the most challenging area for the sterilant to
reach. This is generally on the bottom shelf, over the drain.
Do not place objects (i.e. another pack) on top of the Attest
Rapid 5 Steam-plus Test Pack. This will create too great of a
challenge for air removal and steam penetration.”
© 3M 2013. All Rights Reserved.27
Correct Placement of a BI PCD in a Full Load
According to AAMI ST79 andthe BI PCD manufacturer’s IFU
5/24/2013
10
© 3M 2013. All Rights Reserved.28
The Joint Commission Observations
• BI test and control results not being recorded
• Need BI test and control from same lot
These slides were prepared based on what the author learned from a Joint Commission
presentation at annual IAHCSMM meeting in May 2012
© 3M 2013. All Rights Reserved.29
Biological Indicators Positive BI Control
• Incubate a positive BI control each day a test vial is
incubated in each incubator
•Positive control BI should be from same lot number as
test BI
• Good Science
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3
© 3M 2013. All Rights Reserved.30
Biological Indicators Positive BI Control
• Purpose is to verify the test system
is working and ensure
• Proper incubation temperature
• Placed into correct incubator• Incubator is functioning
• Presterilization viability of test spores• Capability of medium to promote growth of test spores
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3
5/24/2013
11
© 3M 2013. All Rights Reserved.31
Biological Indicators Positive BI Control
• Read and record test and control results upon completion of
incubation time
• If control test BI from lot fails:
-Test spores are nonviable or dead
-Improper incubation
•Test results are invalid•Determine why and rerun BI and load
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 A3:2012 Sections 10.7.2.3, 10.7.3.3, 10.7.4.3
© 3M 2013. All Rights Reserved.32
Chemical Indicator (CI)
• Use a Class 1 CI on the outside of each package unless
the internal CI is visible
• Read CI result before issue package or open in OR
• Do not use package if “CI suggests inadequate steam
processing”
AORN Sterilization 2013 Recommendation XX.g., XX.g.1.
AORN Sterile Technique 2013 VI.f.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.2.2.1
© 3M 2013. All Rights Reserved.33
Chemical Indicator (CI)
• Use a Class 3, 4, 5, or 6 CI inside each package.
• “Class 6 emulating indicators are cycle-specific; that is, they
should be used only in the specific cycles for which they are
labeled.”
• Place in “area of package, tray, or containment device (rigid
sterilization container system, instrument case, cassette, or
organizing tray) considered least accessible to steam
penetration”
• Follow container manufacturer’s IFU for placement
AORN Sterilization 2013 Recommendation VII.c.3., XX.g.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.2.2.2
5/24/2013
12
© 3M 2013. All Rights Reserved.34
Chemical Indicator (CI)
• Use a Class 3, 4, 5, or 6 CI inside each package.
• Read CI before package is placed on sterile field
• Do not use package if “CI suggests inadequate steam
processing”
• Supervisor “should then initiate appropriate follow-up measures”
AORN Sterile Technique 2013 Recommendation VI.a.2., VI.f.4.
AORN Sterilization 2013 Recommendation XX.g.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.2.2.2
© 3M 2013. All Rights Reserved.35
Placement of Internal CIs
•Incorrect placement of CI•Not inside of tray •Not in a location to detect inadequate air removal or steam penetration
•Same tray with correct placement of CI inside of tray•In location to detect inadequate air removal or steam penetration
© 3M 2013. All Rights Reserved.36
AORN Recommendation
Chemical Indicator (CI) for IUSS
• Use a Class 5 or Class 6 CI within each sterilization
container
• “Class 6 indicators are cycle-specific and should be used only in
the specific cycles for which they are labeled.”
AORN Sterilization 2013 Recommendation VII.c.3.
5/24/2013
13
© 3M 2013. All Rights Reserved.37
Physical Monitors
• Mark with correct date and
sterilizer identification at
beginning of each cycle
• Read & verify by initialing at end
of each cycle
• If not correct, do not release load
• Remove sterilizer from service
• Investigate
AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f., XX.f.1., XX.f.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.1
© 3M 2013. All Rights Reserved.38
Bowie-Dick Test
• Testing sterilizer performance
• Bowie-Dick Test monitors efficacy of air removal and steam
penetration in
• 132-135°C/270-275°F dynamic-air-removal
sterilizers (i.e., prevacuum sterilizers)
ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.6
© 3M 2013. All Rights Reserved.39
Bowie-Dick Test
• Detects:
• Air leaks
• Inadequate air removal
• Inadequate steam penetration
• Presence of non-condensable gases
• Air or gases from boiler additives
AORN Sterilization 2013 Recommendation XX.h.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.6
5/24/2013
14
© 3M 2013. All Rights Reserved.40
Bowie-Dick Test
• Used for routine daily testing and qualification testing
• Test pack should be either
• AAMI towel pack (100% cotton towels), or
• Equivalent commercially available
BD test pack
AORN Sterilization 2013 Recommendation XX.h.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2013 Section 10.7.6
© 3M 2013. All Rights Reserved.41
Bowie-Dick Test
• Follow the sterilizer and Bowie-Dick test
pack instructions for use
• Run a warm up cycle
• Place one pack on bottom shelf of
sterilizer over drain
• Run not more than 3.5 to 4 min,
132-133°C/270-273ºF, no dry time, immediately remove
from sterilizer
AORN Sterilization 2013 Recommendation XX.h.2.
ANSI/AAMI ST79 :2010 & A1:2010 & A2:2012 & A3:2012 Section 10.7.6
© 3M 2013. All Rights Reserved.42
Incorrect Placement of Bowie-Dick Test Packs
5/24/2013
15
© 3M 2013. All Rights Reserved.43
Incorrect Placement of Bowie-Dick Test Packs
© 3M 2013. All Rights Reserved.44
ANSI/AAMI ST79 :2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.6.5
• Uniform color change – Use
• If not uniform, shut down and report to
supervisor
• Remain in use
• Retest
• Call for repair
• Re-qualify if major repair
Bowie-Dick Test
© 3M 2013. All Rights Reserved.45
Objective Two
45 © 3M 2013. All rights reserved.
DESCRIBE THE RECOMMENDED PRACTICES FOR ROUTINE
LOAD RELEASE OF IMPLANTS AND NON-IMPLANTS
5/24/2013
16
© 3M 2013. All Rights Reserved.46
Routine Load Release of Implant Loads
• Physical monitors
• Read and initial
• External process indicator (Class 1) on outside of every
package unless internal CI is available• Read before package is issued or opened in OR
• Internal CI(s) (Class 3, 4, 5, 6) inside each package• Read before package is placed on sterile field
• A PCD containing a BI and a Class 5 integrating indicator
• Quarantine implant(s) until BI results available
AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.
AORN Sterile Technique 2013 Recommendation VI.a.2., VI.f.2., VI.f.4.
ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.1,10.5.2,10.5.4,
10.6.1, 10.6.3
© 3M 2013. All Rights Reserved.47
Routine Load Release of Implant Loads
• Evaluation of all data by an experienced, knowledgeable
person
• Do not distribute load if any data suggests a sterilization
process failure
ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.6.3
© 3M 2013. All Rights Reserved.48
Routine Load Release of Implant Loads
• “Each load should be monitored if it contains implantable
objects. If feasible, implantable items should not be used
until the results of spore tests are known to be negative.”
(CDC)
• “Releasing implants before the BI results are known is
unacceptable and should be the exception, not the rule.”
(AAMI)
CDC, 2008 Guideline for Disinfection & Sterilization
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2., 10.6.3
5/24/2013
17
© 3M 2013. All Rights Reserved.49
Routine Load Release of Implant Loads
• Class 5 integrating indicator used to
release implant in emergency situations
• “Emergency situations should be defined.”
• Class 6 emulating indicators cannot be
used to release implants early or as a
replacement for a BI*
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.3.2, 10.6.1,10.6.3
© 3M 2013. All Rights Reserved.50
Early Release of Implant Loads
• Exception form for premature release of implantable device/tray in
defined emergency situations
• Name of implant
• Name of patient
• Name of surgeon
• Reason for premature release
• What could have prevented the premature
release
• Critical that this documentation
be fully traceable to the patient
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.6.3, Annex L
© 3M 2013. All Rights Reserved.51
The Joint Commission
New Emphasis for 2011
•Exception form (AAMI ST79 10.6.3 and Annex L)•Early release of implant is unacceptable; an exception form must be completed
• Exceptions guided by policy: multidisciplinary input
These slides were prepared based on what the author learned from a Joint Commission
presentation at IAHCSMM in May 2011
5/24/2013
18
© 3M 2013. All Rights Reserved.52
The Joint Commission
New Emphasis for 2011
•Exception form (AAMI ST79 10.6.3 and Annex L)
•WHO can authorize early release of implants?
•Signature not required
•Should be a department of surgery policy
•Suggest it be a surgeon
These slides were prepared based on what the author learned from a Joint Commission
presentation at IAHCSMM in May 2011
© 3M 2013. All Rights Reserved.53
Routine Load Release of Non-implants
• Physical monitors
• Read and initial
• External process indicator (Class 1) on outside of every
package unless internal CI is available• Read before package is issued or opened in OR
• Internal CI(s) (Class 3, 4, 5, 6) inside each package• Read before package is placed on sterile field
AORN Sterilization 2013 Recommendation VII.c.1., XX.d.1., XX.f.2., XX.h.1.
AORN Sterile Technique 2013 Recommendation VI.a.2, VI.f.2, VI.f.4
ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.1, 10.5
© 3M 2013. All Rights Reserved.54
Key Considerations for Use of Class 6 CIs
• “Class 6 emulating indicators are cycle-specific; that is, they should be used only in the specific cycles for which they are labeled.” (Section 10.5.2.2)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.5.3.2
5/24/2013
19
© 3M 2013. All Rights Reserved.55
Routine Load Release of Non-implants
• Optional monitoring of load with a PCD containing a • BI
• BI and a Class 5 CI
• Class 5 integrating indicator
• Class 6 emulating indicator
• Evaluation of all data by an experienced, knowledgeable person
• Do not distribute load if any data suggests a sterilization process failure
ANSI/AAMI ST79:2010 & A1:2010 & A 2:2011 & A3:2012 Section 10.5.4
© 3M 2013. All Rights Reserved.56
Objectives Three and Four
56 © 3M 2013. All rights reserved.
- DESCRIBE THE RECOMMENDED PRACTICES FOR
ROUTINE STERILIZER EFFICACY TESTING
- DESCRIBE THE RECOMMENDED PRACTICES FOR
STERILIZER QUALIFICATION TESTING
© 3M 2013. All Rights Reserved.57
Routine Sterilizer Efficacy Monitoring
Sterilizer Qualification Testing
•Divided into sections
• Sterilizers larger than 2 cubic
feet
• Table-top sterilizers
• IUSS sterilization cycles
Photo courtesy of Rose Seavey,
The Children's Hospital - Denver
5/24/2013
20
© 3M 2013. All Rights Reserved.58
Routine Sterilizer Efficacy Monitoring
Sterilizer Qualification Testing
Routine Efficacy Testing
Establishing a regular pattern of testing the efficacy of the sterilization process
• At least weekly, preferably every day that the sterilizer is in use
Every load monitoring with a BI PCD covers routine sterilizer efficacy testing
AORN Sterilization 2013
Recommendation XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 &
A:2011 & A3:2012 Section 10.7.2, 10.7.3,
10.7.4
© 3M 2013. All Rights Reserved.59
Routine Sterilizer Efficacy Monitoring
Sterilizer Qualification Testing
Routine Efficacy Testing
Establishing a regular pattern of testing the efficacy of the sterilization process
• At least weekly, preferably every day that the sterilizer is in use
Every load monitoring with a BI PCD covers routine sterilizer efficacy testing
Qualification Testing
Testing of sterilizer after eventsoccur that affect the ability of the sterilizer to perform
• Sterilizer installation
• Relocation
• Malfunction
• Major repairs of sterilizer or utilities
• Sterilization process failuresAORN Sterilization 2013
Recommendation XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 &
A:2011 & A3:2012 Section 10.7.2, 10.7.3,
10.7.4
AORN Sterilization 2013 Recommendation
XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 &
A3:2012 Section 10.8.2, 10.8.3, 10.8.4
© 3M 2013. All Rights Reserved.60
Bowie-Dick Test Pack for 270-275°F Dynamic-Air-
Removal Steam Sterilizers
Routine Efficacy Testing
•Run Bowie-Dick Test Pack:
• Daily in an empty cycle
• Before BI PCD
• One pack
Qualification Testing
•Run Bowie-Dick Test Pack:
• After BI PCDs
• One pack in three
consecutive cycles
AORN Sterilization 2013 Recommendation XX.h.2.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.6
Uniform color change – Use
If not uniform, shut down and call repair person
Re-qualify if major repair
5/24/2013
21
© 3M 2013. All Rights Reserved.61
Routine Sterilizer Efficacy Monitoring
Test each type of cycle with a BI PCD
AORN Sterilization 2013 Recommendation XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.1
Gravity-displacement 132°C to 135°C 270°F to 275°F
Gravity-displacement 121°C 250°F
Dynamic-air-removal 132°C to 135°C 270°F to 275°F
IUSS 132°C to 135°C 270°F to 275°F
IUSSSingle wrapper or other
packaging
© 3M 2013. All Rights Reserved.62
Routine Sterilizer Efficacy Monitoring
•AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.7.1
•“NOTE - If a sterilizer will run the same type of cycle (e.g.,
dynamic-air-removal at 132°C to 135°C [270°F to 275°F] for different exposure times (e.g., 4 minutes and 10 minutes), then
only the shortest cycle time needs to be tested.”
© 3M 2013. All Rights Reserved.63
Joint Commission Observations
• BI PCDs should be used for testing at least weekly and
according to policy and procedure
• Need to test both gravity and vacuum-assisted cycles
• If use an “odd cycle” still need to test at same frequency as more
common cycles
• Be prepared to use that odd cycle
• If do not use gravity cycle then turn it off
These slides were prepared based on what the author learned from a Joint Commission
presentation at IAHCSMM in May 2012
5/24/2013
22
© 3M 2013. All Rights Reserved.64
Routine Efficacy Testing
Weekly, preferably daily
BI PCD in full cycle
Qualification Testing
BI PCD in 3 consecutive empty
cycles
Sterilizers Larger than 2 Cubic Feet
© 3M 2013. All Rights Reserved.65
Sterilizers Larger than 2 Cubic Feet
Routine Efficacy Testing
•BI PCD: AAMI 16 towel pack or
commercially available
disposable, FDA cleared BI PCD
•Full load on bottom shelf over
drain
•Weekly, preferably daily
Qualification Testing
•BI PCD: AAMI 16 towel pack or
commercially available disposable,
FDA cleared BI PCD
•Empty load on bottom shelf over
drain
•Three consecutive cycles
•Follow with BD testing (empty load)
•Three consecutive cycles
AORN Sterilization 2013 Recommendation XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3: 2013 Section 10.7.2 and 10.8.2
© 3M 2013. All Rights Reserved.66
Table-Top Sterilizers
Routine Efficacy Testing
Weekly, preferably daily
BI PCD in full cycle
Qualification Testing
After major events
BI PCD in 3 consecutive full
cycles
Quarantine the loads until the BI
results are known
5/24/2013
23
© 3M 2013. All Rights Reserved.67
Examples of BI PCDs for Table-Top Sterilizers
© 3M 2013. All Rights Reserved.68
Immediate-Use Steam Sterilization Cycles (IUSS)
Routine Efficacy Testing
Weekly, preferably daily
BI PCD in empty cycle
After Bowie-Dick test if dynamic
air-removal sterilizer
Sterilizer Qualification Testing
BI PCD in 3 consecutive empty
cycles
Before Bowie-Dick tests if
dynamic air-removal sterilizer
© 3M 2013. All Rights Reserved.69
Immediate-Use Steam Sterilization Cycles (IUSS)
Routine Efficacy Testing
Representative BI PCD* using
one or more BIs and one or
more CIs in the empty tray
configuration
• Perforated, mesh bottom, open
surgical tray
• Rigid sterilization container
system
• Protective organizing case
• Single-wrapped surgical tray
Each type of tray configuration used
should be tested
Qualification Testing
Representative BI PCD* using one or more BIs and one or more CIs
•Select one representative tray configuration
• Placed on bottom shelf over the drain
• Otherwise empty chamber
AORN Sterilization 2013 Recommendation XX.h.1.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Sections 10.7.4, 10.8.4
* No commercial BI PCDs
are available for IUSS
5/24/2013
24
© 3M 2013. All Rights Reserved.70
Running a BI PCD in Every Load and Quarantining
• Standardization of BI monitoring policy
• Less chance of operator error (human factors issue)
• Ensure meeting recommended practices requirements related to
monitoring of cycles and packaging used
• Ensure monitoring all loads with implants
• Quicker detection of IUSS container failures resulting from poor
functioning mechanical filters or leaks due to damaged gaskets
• Quicker detection and correction of process failures
• Eliminates recalls
• Reduce patient risk because less patients involved
• Save money
• Peace of mind
© 3M 2013. All Rights Reserved.71
Documentation
“Documentation demonstrates compliance with regulatory and
accrediting agency requirements and identifies trends and
quality improvement opportunities.”
AORN Recommended Practices for Sterilization 2013, Recommendation XVIII
© 3M 2013. All Rights Reserved.72
Importance of Traceability of Instruments and Implants
to the Patient
“Sterilization quality control relies heavily on historical data, especially
when quality assurance measures yield conflicting evidence. Record-
keeping is needed for both epidemiological tracking and ongoing
assessment of the reliability of the sterilization process. Accountability
to the patient and surgeon for the sterility of a reprocessed device
requires documentation that can be directly traced to the patient.
Traceability of implants is especially important because the
consequences of implant-related infections are particularly severe and
result in increased morbidity and mortality.”
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 Section 10.3.1
5/24/2013
25
© 3M 2013. All Rights Reserved.73
Summary
• Don’t take risks in reprocessing medical devices
• Follow the monitoring products IFU
• Follow AAMI, AORN, and CDC recommended practices
Because Patients Are Depending On You To Do The
Right Things
74 © 3M 2012. All rights reserved.
QUESTIONS?
© 3M 2013. All Rights Reserved.75
Next 3M™ Sterile U Web Meeting:
When: Thursday, June 20, 2013
Topic: At the Helm: IAHCSMM 2013 Highlights
Register at www.3m.com/SterileU
Thank you!
5/24/2013
26
© 3M 2013. All Rights Reserved.76
References
76 © 3M 2013. All rights reserved.
© 3M 2013. All Rights Reserved.77
Evidence-Based Guidelines
• Association for the Advancement of Medical
Instrumentation (AAMI)
• Comprehensive guide to steam sterilization and sterility
assurance in health care facilities,
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012
(Consolidated Text)
© 3M 2013. All Rights Reserved.78
Evidence-Based Guidelines
• AORN Perioperative Standards and
Recommended Practices (2013)
-Recommended Practices for Sterilization
-Recommended Practices for Sterile Technique
5/24/2013
27
© 3M 2013. All Rights Reserved.79
Evidence-Based Guidelines
•Centers for Disease Control and Prevention (CDC) Guideline for Disinfection and Sterilization in Healthcare
Facilities, 2008
Available at:http://www.cdc.gov/hicpac/Disinfection_Sterilization/13_0Sterilization.html
© 3M 2013. All Rights Reserved.80
References for The Joint Commission
• The Joint Commission, Hospital Accreditation Standards 2013
© 3M 2013. All Rights Reserved.81
Thank you
81 © 3M 2013. All rights reserved.