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© 3M 2015. All Rights Reserved
3M Health Care AcademySM
© 3M 2015. All Rights Reserved
Questions and Answers from the 3M Sterilization Tech Line
December 10, 2015
© 3M 2015. All Rights Reserved
Welcome!Topic: Questions and Answers from the 3M Sterilization Tech Line
• Facilitators: Christophe de Campeau, 3M Susan Flynn, 3M
• Speakers: Dorothy Larson, Sandra Velte
• For more information: www.3m.Com/3MSterileU
© 3M 2015. All Rights Reserved 3
House Keeping
From the GoToWebinar page:• Click on the orange box with a
white arrow to expand your control panel (upper right-hand corner of your screen).
• Type a question in the question box and click send.
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House Keeping
Continuing EducationEach 1 hour web meeting is approved by IAHCSMM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour.
Post webinar email• Link to Course Evaluation• CS Tech CE Certificate Included• Forward eMail to others in attendance
© 3M 2015. All Rights Reserved 5
Learning Objectives
• Discuss hot topics from the 3M Sterilization Tech Line
• Discuss solutions based on applicable standards and recommended practices
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Disclosure
Dorothy Larson, Sandra Velte
3M Company
Infection Prevention Division
Sterilization Technical Services
Tech Line 1-800-441-1922 option 2
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Common Questions
• BI PCDs for large and small steam sterilizers• Documentation - terminal and IUSS loads• Steps to take following a positive BI result• Phases of a steam sterilization cycle• Verifying a cycle printout tape• Cycle to use for IUSS• EO sterilization of endoscopes• Placement of internal chemical indicators• Bowie-Dick testing
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Quality control recommended practices
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 & A4:2013 (Consolidated Text)
Association of Perioperative Registered Nurses (AORN)• AORN Guideline for Sterilization (2015)
• AORN Guideline for Selection and Use of Packaging Systems for Sterilization (2015)
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First, a few key terms...
• Terminal sterilization• Immediate use steam sterilization• Routine sterilizer efficacy testing• Process challenge device
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Terminal Sterilization• “terminal sterilization: process whereby
product is sterilized within its sterile barrier system.” (ST79, section 2.133)
• “The process of sterilizing a packaged item.” (CSSD Dictionary and Reference Guide)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2014 (Consolidated Text), Section 2.133
Mixed load - a combination of wrapped packs, rigid containers, peel pouches, with proper packaging and dry time
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Immediate Use Steam Sterilization“Immediate use steam sterilization (IUSS): Steam sterilization of patient care items intended for immediate use. Formerly known as “flash sterilization.” (AORN 2015)
Multi-society Position Statement on IUSS• Used during the procedures for which it was sterilized • Transported in a manner that minimized exposure to air and
other environmental contaminates• Not stored for later use, nor held for later case
AORN 2015 Guideline for Sterilization, Glossaryhttp://www.aami.org/publications/standards/ST79_Immediate_Use_Statement.pdf - accessed 11/11/2015ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013
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Routine Sterilizer Efficacy Monitoring
Establishing a regular pattern of testing the efficacy of the sterilization process
Frequency of using BI PCDs Weekly, preferably daily
• Every load containing implants
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Table 6 Section 10.5.3.2, 10.4, 10.7
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Process Challenge Device (PCD)“Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process.” Representative of load Create 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 & A4:2013, Section 2.103
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Process Challenge Device (PCD)
Depending on the application (type of testing being done) the PCD may contain:•A BI
•A Class 5 Integrating CI
•A BI and a Class 5 Integrating CI
•A Class 6 Emulating CI
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.4
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Process Challenge Device (PCD)Commercially available,
FDA Cleared•Not available for IUSS •Not available for table top sterilizers
User assembled•Challenge test pack or tray (e.g., AAMI 16-towel pack, IUSS containment device)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.4
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Can we run the same Biological Indicator Process Challenge Device (BI PCD) in both our large, and small table-top steam sterilizers?
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Biological Indicator Process Challenge Device (BI PCD)
• Large Sterilizers – greater than 2 cubic feet
• Small - Table-top Sterilizers
Immediate Use Steam Sterilization Cycles
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10
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Biological Indicator Process Challenge Device Routine Efficacy Testing• Sterilizers > 2 cubic feet - Terminal, “mixed” loads
Commercial, FDA cleared BI PCD AAMI 16 towel pack
Place BI PCD in full load, bottom shelf over drain
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.2, 10.7.2.1, 10.7.2.2
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Biological Indicator Process Challenge Device Routine Efficacy Testing
• Small, Table-top sterilizers User-assembled BI PCD BI PCD in full load
If routinely processing: User-assembled BI PCD:Peel pouches BI + CI inside peel pouch
Peel pouches &Wrapped instruments
BI + CI inside wrapped tray
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.2, 10.7.3.1, 10.7.3.2
© 3M 2015. All Rights Reserved 20
Polling Question
According to ANSI/AAMI ST79, for sterilizers larger than 2 cubic feet and table-top sterilizers, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done:a. In an empty chamberb. With a load
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Biological Indicator Process Challenge Device Routine Efficacy Testing• Sterilizers > 2 cubic feet – IUSS cycles Representative BI PCD – Place BI(s) and
CI(s) in empty tray configuration• Rigid sterilization container system,
Perforated, mesh bottom, open surgical tray; Protective organizing case; Single-wrapped surgical tray
BI PCD in otherwise empty chamber, bottom shelf over drain.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.3.2, 10.7.4.1, 10.7.4.2
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Polling Question
According to ANSI/AAMI ST79, for Immediate Use Steam Sterilization, routine sterilizer efficacy monitoring with a biological indicator process challenge device is done:a. In an empty chamberb. With a load
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What does it mean to verify a cycle printout tape?
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Types of Steam Sterilization Processes
Gravity Displacement- Incoming steam displaces air
Dynamic-Air-RemovalPrevacuum
- Series of pressure and vacuum excursions
Steam-flush pressure-pulse (SFPP) - A series of steam flushes and pressure
pulses above atmospheric pressure
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.25, 2.26
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Profile of a Gravity Displacement Cycle
Vac
uum
Pres
sure
Time
Conditioning phase (come-up time)
Set point(exposure temperature)
Drying (Exhaust) phase
Sterilization Phase
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Profile of a Prevacuum Cycle
Time
Vac
uum
Pres
sure
Set point(exposure
temp.)
Come-up phaseSterilization Phase
Drying (Exhaust) Phase
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•“Physical Monitors” (e.g., cycle printout tapes) verify that parameters of sterilization cycle are met
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.1
Physical Monitors
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•Marked with correct date and sterilizer identification at beginning of cycle
• Read & verified by initialing at end of cycle
• If not correct, do not release load
Physical Monitors
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 , Section 10.5.1
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Surveyors are paying close attention to sterilization record keeping today. What needs to be documented, and how?
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DocumentationWhat?• Materials that have been processed • Results of the sterilization process
monitoring
How?• Load labels/package• Paper log systems• Electronic log systems • Filed as individual document
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.3.1, 10.3.2
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Labeling on product• Lot or load control number―Date of processing―Sterilizer number―Cycle number
• Expiration date or statement: “ Contents sterile unless
package is open or damaged. Please check before using.”
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.3.1, 10.3.3
Documentation
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Record Keeping
• Product recall• Determining reason for sterilization
process failure
Provides a permanent record
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.3
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Sterilizer and load records• Load contents• Date and time of cycle• Exposure time and
temperature• Initials of operator• Biological results• Chemical indicator resultsRecords of sterilizer repair, maintenance and calibrationMaintain records for time determined by risk manager
Documentation
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.3.2
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IUSS Sterilization AORN DocumentationLog or database to trace sterilized items used on patients should include:• Information on each load― Item(s) processed―Patient on whom the items
were used―Type of cycle (e.g., gravity-
displacement, dynamic-air-removal)
―Cycle parameters used (e.g., temperature, duration of cycle)
AORN 2015 Guideline for Sterilization VII.g.1
―Monitoring results―Day and time cycle was run―Operator information (i.e.,
person who initiated the cycle, person who retrieved the item from the sterilizer)
―Reason for IUSS
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Each monitoring tool …“… plays a distinct and specific role in sterilization process monitoring, and each is indispensable to sterility assurance.”
Results• Integrate results of all monitoring controls
•Determine if an effective sterilization process
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.4
Sterilization Process Monitoring
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Polling Question
Documentationa. establishes accountabilityb. demonstrates compliance with regulatory
and accrediting agency c. Identifies trends and quality improvement
opportunitiesd. all of the above
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What does the expiry date on a sterilization monitoring device mean, post sterilization?
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3M™ Comply™ Instrument Protector Example: Lot No. 2017-03AZ
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In the O.R., sometimes we need to run an Immediate-Use Steam Sterilization (IUSS) cycle. Should we run a gravity or prevacuumcycle?
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Cycle SelectionGravity or Dynamic-air-removal?
“The reusable medical device manufacturer is responsible for ensuring that the device can be effectively cleaned and sterilized.”
“The written IFU of the device manufacturer should always be followed.”
IUSS Cycles – “Unless a device manufacturer specifically recommends the use of gravity cycles, dynamic air removal cycles should be the cycle of choice.” (8.6.2.1)
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.2.2, 8.6.2.1
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Immediate-Use Steam SterilizationAORN recommends the use of rigid sterilization
containers that are designed and intended for IUSS cycles– Reduce risk of contamination during transport to point of use– Ease of presentation to sterile field
• Reconcile differences• “Manufacturers of reusable medical devices intended
to be sterile have the responsibility to support label claims by providing complete, validated and comprehensive written instructions for sterilization of their products.”
AORN 2015 Guideline for Sterilization, Rec. VII.eANSI/AAMI ST79:2010 & A1:2010 & A2:2011, A3:2012 & A4:2013, Section 8.4, 8.6
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Sterilization ParametersST79, Section 8.6 – Table 5, Minimum cycle times for dynamic-air-removal steam sterilization cycles > 2 cubic feet
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, A3:2012 & A4:2013, Section 8.6.2
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Sterilization Parameters• IFUs are provided with new medical devices upon purchase, and
can also be received by calling the manufacturer of the medical device.
• Obtain Current IFU Documents:• Build your own library of documents• Subscribe to an online database to access a library of
manufacturers’ IFU documents• e.g. www.oneSOURCEdocs.com
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What are the steps to take when we have a positive BI result following a steam sterilization cycle?
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IS immediately identified and confined to one load or item (e.g., used incorrect sterilization cycle)• Correct problem and
reprocess load
Figure 12 – Decision Tree → Investigating Steam Sterilization Process Failures
IS NOT immediately identified • Quarantine load, recall all items
processed since last negative BI
• Take sterilizer out of service
• Determine cause of failure
• Minor repair→ return sterilizer to service
• Major repair→ re-qualify sterilizer
If cause of failure:
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10, Figure 12 — Pg. 116
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• Determine Cause of Failure• Figure 12 – Decision tree for
conducting investigations of steam sterilization process failures
• Table 8 – Checklist for identifying reasons for steam sterilization process failures
Troubleshooting Steam Sterilization Process Failures
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.7.5.1
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SterilizerRepairs outside the scope of normal maintenance • Examples:
– Weld repairs of pressure vessel
– Replacement of chamber door or piping assembly
– Rebuilds or upgrades of controls
Sterilization Process Failures
UtilitiesChanges to the utilities connected to the sterilizer• Examples:
– Water-main break
– Annual boiler maintenance
– Additional equipment loads
– Installation of new boilers
Major Repairs
ANSI/AAMI ST79:2010 & A1:201 & A2:2011 & A3:2012 & A4:2013, Section 10.6.4
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Actions to take following a positive BI
Qualification Testing: To determine if the sterilizer is working after an ‘event’ that could effect its ability to perform
After sterilization process failures when the cause is not immediately identifiable
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 (Consolidated Text), Section 10.5.3.2, 10.8
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Qualification TestingPrevacuum sterilizers > 2 cubic feet
3 Biological Indicator Process Challenge Devices (BI PCDs); no load
3 Bowie-Dick tests; otherwise empty chamber
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text), Section 10.5.3.2, 10.8
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Polling Question
Steam sterilizer qualification testing is necessarya. when the cause of the sterilization process failure is
immediately identifiable and confined to one loadb. after a sterilization process failure when you cannot
immediately identify the cause of the failure
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Why is it recommended to run a warm-up cycle before the Bowie-Dick test?
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Bowie-Dick Test
•The Bowie-Dick Test monitors efficacy of air removal and steam penetration in 270-275ºF (132-135ºC) dynamic-air removal sterilizers (i.e., vacuum-assisted sterilizers)
•An improperly heated sterilizer could cause false Bowie-Dick test failures
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Bowie-Dick Test
Bowie-Dick tests can detect: •Air leaks•Inadequate air removal•Inadequate steam penetration•Presence of non-condensable gases: air or gases from boiler additives
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, A3:2012 & A4:2013, Section 10.7.6
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Bowie-Dick Test
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, A3:2012 & A4:2013, Section 10.7.6
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Bowie-Dick Test
• The Bowie-Dick Test should be run in an otherwise empty chamber to maximize the potential for detecting any air that enters the sterilizer chamber.
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011, A3:2012 & A4:2013, Section 10.7.6
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Does Ethylene Oxide sterilization damage endoscopes?
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Does Ethylene Oxide sterilization damage endoscopes?
• “[EO] Can sterilize heat or moisture-sensitive medical equipment without deleterious effects on the materials used in medical devices” (2008 CDC Guideline)
Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 http://www.cdc.gov/hicpac/pubs.html
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Follow Endoscope Manufacturers IFUs before sterilization• Leaking testing• Damage inspection• Connection of ventilation adaptors - ventilation caps,
when applicable• Removal of water resistant caps – soaking caps,
when applicable
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Where do we place internal chemical indicators inside of an instrument tray?
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Chemical Indicators – Class 3, 4, 5 or 6Pack control – ANSI/AAMI ST79
ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.2.2
“An internal CI should be used within each package, tray, or rigid sterilization container system to be sterilized… the CI should be placed in that area of the package, tray, or containment device… considered least accessible to steam penetration.
“For a containment device, the manufacturer’s written IFU for placement of the CI should be consulted. This location might or might not be the center of the package, tray, or containment device.”
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Chemical Indicators – Class 3, 4, 5 or 6AORN
• CI should be placed in area within package presenting a challenge for air removal and sterilant contact (V.a.2., V.b.)
• More than one CI may be required for multilayered trays- Place according to tray manufacturer’s IFU (V.a.3.)
Appropriate number/placement of internal CIs (V.b.)• Consult CI manufacturer, device manufacturer, and
containment device manufacturer for additional information
AORN 2015 Guideline for Selection and Use of Packaging Systems for Sterilization V
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Chemical Indicator Placement
Wrapped fabric packs
Wrapped instrument sets• Place CI in geometric
center, not on the top
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For rigid container systems, ask the manufacturer where the greatest challenge is
Chemical Indicator Placement
Rigid container• Place two CIs inside
rigid containers
• Place one in each of two opposite corners
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Chemical Indicator Placement
Multi-layer rigid container
• Place two CIs in each level of multi-level rigid container
• Place one in each of two opposite corners on each level
For rigid container systems, ask the manufacturer where the greatest challenge is
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Chemical Indicator Placement
For all these trays, ask the medical device manufacturer where the greatest challenge is
Multi-level container• Supplied by the
manufacturer
• Holes in tray
• Has to be wrapped
• Place a CI in center of each level
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ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 10.5.2.2.2
Chemical Indicators – Class 3, 4, 5, 6
• Internal chemical indicators• The contents of a package with
a non-responding chemical indicator should not be used
• Quarantine remainder of load until BI results are known
• If no BI, decide on recall based on physical monitors and other CI results
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Thank you
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Questions?
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Next Live Webinar
Date: Thursday January 21, 2016Title: Improving the Quality Control of Flexible
GI Endoscope Reprocessing