Questions and Answers 3M Sterilization Tech Line · • Sterilizers > 2 cubic feet - Terminal,...

08/12/2015

1

© 3M 2015. All Rights Reserved

3M Health Care AcademySM


Questions and Answers from the 3M Sterilization Tech Line

December 10, 2015


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.

08/12/2015

2


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


Learning Objectives

• Discuss hot topics from the 3M Sterilization Tech Line

• Discuss solutions based on applicable standards and recommended practices


Disclosure

Dorothy Larson, Sandra Velte

3M Company

Infection Prevention Division

Sterilization Technical Services

Tech Line 1-800-441-1922 option 2

08/12/2015

3


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


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)


First, a few key terms...

• Terminal sterilization• Immediate use steam sterilization• Routine sterilizer efficacy testing• Process challenge device

08/12/2015

4


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


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


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

08/12/2015

5


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


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


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)


08/12/2015

6

© 3M 2015. All Rights Reserved© 3M 2015. All Rights ReservedSM

16

Can we run the same Biological Indicator Process Challenge Device (BI PCD) in both our large, and small table-top steam sterilizers?


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


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

08/12/2015

7


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



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


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.


08/12/2015

8


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


23

What does it mean to verify a cycle printout tape?


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

08/12/2015

9


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


Profile of a Prevacuum Cycle

Time

Vac

uum

Pres

sure

Set point(exposure

temp.)

Come-up phaseSterilization Phase

Drying (Exhaust) Phase


•“Physical Monitors” (e.g., cycle printout tapes) verify that parameters of sterilization cycle are met


Physical Monitors

08/12/2015

10


•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


29

Surveyors are paying close attention to sterilization record keeping today. What needs to be documented, and how?


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

08/12/2015

11


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


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


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

08/12/2015

12


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


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


Polling Question

Documentationa. establishes accountabilityb. demonstrates compliance with regulatory

and accrediting agency c. Identifies trends and quality improvement

opportunitiesd. all of the above

08/12/2015

13


37

What does the expiry date on a sterilization monitoring device mean, post sterilization?


3M™ Comply™ Instrument Protector Example: Lot No. 2017-03AZ


39

In the O.R., sometimes we need to run an Immediate-Use Steam Sterilization (IUSS) cycle. Should we run a gravity or prevacuumcycle?

08/12/2015

14


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


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


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

08/12/2015

15


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


44

What are the steps to take when we have a positive BI result following a steam sterilization cycle?


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

08/12/2015

16


• 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


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



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

08/12/2015

17


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


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


51

Why is it recommended to run a warm-up cycle before the Bowie-Dick test?

08/12/2015

18


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


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



Bowie-Dick Test


08/12/2015

19


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.



56

Does Ethylene Oxide sterilization damage endoscopes?


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

08/12/2015

20


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


59

Where do we place internal chemical indicators inside of an instrument tray?


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.”

08/12/2015

21


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


Chemical Indicator Placement

Wrapped fabric packs

Wrapped instrument sets• Place CI in geometric

center, not on the top


For rigid container systems, ask the manufacturer where the greatest challenge is


Rigid container• Place two CIs inside

rigid containers

• Place one in each of two opposite corners

08/12/2015

22



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



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


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

08/12/2015

23


Thank you


Questions?


Next Live Webinar

Date: Thursday January 21, 2016Title: Improving the Quality Control of Flexible

GI Endoscope Reprocessing

Questions and Answers 3M Sterilization Tech Line · • Sterilizers > 2 cubic feet - Terminal,...

Documents

Transcript of Questions and Answers 3M Sterilization Tech Line · • Sterilizers > 2 cubic feet - Terminal,...