Larry! 28/06/2016. House Keeping. Welcome! From the GoToWebinar page:

Size: px

Start display at page:

Download "Larry! 28/06/2016. House Keeping. Welcome! From the GoToWebinar page:"

Jasmin Lester
6 years ago
Views:

Velte 3M Speaker: Larry Talapa 3M Technical Service Specialist Larry! For more information: www.3m.

1 A Review of Sterilization Methods and Recommended Practices for Healthcare Facilities PART I June 30, 2016 Larry Talapa Welcome! Topic: A Review of Sterilization Methods and Recommended Practices for Healthcare Facilities PART I Facilitators: Christophe de Campeau, 3M Sandra Velte 3M Speaker: Larry Talapa 3M Technical Service Specialist Larry! For more information: 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. 3 1

2 House Keeping Continuing Education Each 1 hour web meeting is approved by IAHCM, CBSPD and is 3M Health Care Provider approved by the California Board of Registered Nurses CEP 5770 for one contact hour. Post webinar Link to Course Evaluation CS Tech CE Certificate Included Forward to others in attendance 4 Today s Learning Objectives Discuss the different sterilization methods available in healthcare facilities. Define the different types of steam sterilization monitoring devices and discuss their recommended use. Describe the recommended practices for routine steam sterilizer efficacy testing. 5 Part 1 Sterilization Process Options 6 2

Steam Sterilization Approximately 85% of medical item sterilization in healthcare facilities is achieved with saturated steam under pressure Fast Highly effective Reliable Relatively low cost Easy to

3 Steam Sterilization Approximately 85% of medical item sterilization in healthcare facilities is achieved with saturated steam under pressure Fast Highly effective Reliable Relatively low cost Easy to use Readily available Technology well understood No toxicity or hazardous residues Low Temperature Sterilization Steam should always be the first choice for sterilization, but many instruments are heat and/or moisture sensitive As minimally invasive surgery procedures increase, the need for low temperature sterilization is also increasing Penetration of sterilant gas and compatibility with device and packaging are primary limitations Low Temperature Sterilization Ethylene oxide Oldest LTS technology Highly penetrating Highly compatible H 2 O 2 vapor and gas plasma H 2 O 2 vapor Ozone and H 2 O 2 All are strong oxidizers All have penetration and compatibility limitations 3

10 Polling Question Number 1 Steam is close to the ideal sterilant, what is a limitation of steam sterilization? A.

4 TODAY S FOCUS STEAM STERILIZATION NOTE: STAY TUNED FOR PART II LOW TEMPERATURE STERILIZATION MONITORING WEBINAR - JULY 21! 10 Polling Question Number 1 Steam is close to the ideal sterilant, what is a limitation of steam sterilization? A. Too slow B. Technology is not understood very well C. High temperatures and moisture D. Difficult to use in healthcare facilities E. Not readily available to healthcare facilities 11 Part 2 Steam Sterilization Monitoring Tools 12 4

Sterilization Process Monitoring Tools Biological Indicators Chemical Indicators Physical Monitors Physical Monitors Verify that parameters of sterilization cycle are met Recording charts Gauges Tape

5 Sterilization Process Monitoring Tools Biological Indicators Chemical Indicators Physical Monitors Physical Monitors Verify that parameters of sterilization cycle are met Recording charts Gauges Tape Printouts Digital displays ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Physical Monitors Marked with correct date and sterilizer identification at beginning of cycle Read and verified by initialing at end of cycle If not correct, do not release load ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section

Chemical Indicators Type 1 Process Indicators Type 2 Indicators for Use in Specific Tests Type 3 Single Variable Indicators Type 4

unit has been directly exposed to the sterilization process Exposure Control / External CIs Distinguish between processed and unprocessed

6 Chemical Indicators Type 1 Process Indicators Type 2 Indicators for Use in Specific Tests Type 3 Single Variable Indicators Type 4 Multi-variable Indicators Type 5 Integrating Indicators Type 6 Emulating Indicators ANSI/AAMI/ISO :2014 (Mfrs. Standard) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Type 1 Chemical Indicators Process Indicators Use with individual units to indicate that the unit has been directly exposed to the sterilization process Exposure Control / External CIs Distinguish between processed and unprocessed units Designed to react to one or more of the critical process variables ANSI/AAMI/ISO :2014(Mfrs. Standard) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Type 2 Chemical Indicators Indicators for Specific Tests Equipment Control Testing sterilizer performance Bowie-Dick test monitors efficacy of air removal and steam penetration in ºF ( ºC) dynamic-air removal sterilizers (i.e., vacuum-assisted sterilizers) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section ,

7 Type 2 Chemical Indicators (cont.) Bowie-Dick tests can detect: Air leaks Inadequate air removal Inadequate steam penetration Presence of non-condensable gases: air or gases from boiler additives Used for routine daily testing and qualification testing ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Type 3 Chemical Indicators Single-Variable Indicators (Internal CIs) Designed to react to one of the critical variables Indicates exposure to a sterilization process at a stated value (SV) of the chosen variable Do not provide as much information as Class 4, 5, or 6 TEMPTUBE HI-SPEED TEMPTUBE HI-DRI TEMPTUBE Before After Before After Before After ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Type 4 Chemical Indicators Multi-Variable Indicators (Internal CIs) Designed to react to two or more of the critical variables Indicates exposure to a sterilization cycle at stated values of the chosen variables ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section

8 Type 5 Chemical Indicators Integrating Indicators (Internal CIs, Load Control) Designed to react to all critical variables Stated values equivalent to the performance requirements for BIs (ISO series) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Type 5 Chemical Indicators Integrating Indicators (Internal CIs, Load Control) Response must correlate to a BI at three time/temperature relationships 250ºF/121ºC 275ºF/135ºC and at one or more temperatures in between Stated value at 250ºF/121ºC must be >16.5 min ANSI/AAMI/ISO :2014 Mfrs. Standard) Type 6 Chemical Indicators Emulating Indicators (Internal CIs, Load Control) Designed to react to all critical variables Stated value generated from the critical variables of the specific sterilization process Cycle-specific indicators ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section

Type 6 Chemical Indicators Emulating Indicators

reach end point in 30 min at 284ºF/140ºC Response

stated values Does not require a stated value at

5 minutes ANSI/AAMI/ISO 11140-1:2014 Mfrs.

Indicators Integrating Indicator Emulating Indicator

containing viable microorganisms providing a defined

9 Type 6 Chemical Indicators Emulating Indicators (Internal CIs, Load Control) Pass dry heat test / not reach end point in 30 min at 284ºF/140ºC Response does not correlate to a BI Does not require three stated values Does not require a stated value at 250ºF/121ºC, >16.5 minutes ANSI/AAMI/ISO :2014 Mfrs. Standard) A comparison Type 5 and Type 6 Chemical Indicators Integrating Indicator Emulating Indicator 26 Biological Indicators Definition Test systems containing viable microorganisms providing a defined resistance to a specified sterilization process ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 2.7 9

Biological Indicators Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores.

Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs.

10 Biological Indicators Rationale: The use of BIs provides evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides the only direct measure of the lethality of a sterilization cycle. Sterilizer manufacturers validate their sterilization cycles using BIs; therefore, routine sterilizer efficacy monitoring in health care facilities should also be conducted using BIs. ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Using biological indicators Biological Indicators Formats Spore Strips Spore Ampoules Self-contained Inoculated Carriers Biological Indicators How they work Spores are exposed to the sterilization process After processing, exposed spores immersed in optimized recovery media and incubated at optimal temperature Spore strips are transferred to medium using aseptic technique Self-contained designs allow immersion without transfer Cap Cap Filter Glass Media Ampoule Spore Strip Plastic Sleeve with Label 10

Biological Indicators Positive BI Control Incubate a positive BI control each day that a test vial is incubated in each incubator or auto-reader From same lot number as test BI Purpose is to verify

11 Biological Indicators Positive BI Control Incubate a positive BI control each day that a test vial is incubated in each incubator or auto-reader From same lot number as test BI Purpose is to verify the test system is working and to ensure: Correct incubation conditions Viability of spores Capability of medium to promote growth Proper functioning of auto-reader and incubator Good Science ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections , , Process Challenge Device (PCD) Definition Process challenge device is used in place of test or challenge pack in AAMI ST79 Representative of load and creates the greatest challenge Equal to or greater than the most difficult item to sterilize Item designed to constitute a defined resistance to a sterilization process and used to assess performance of the process. 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 2.95 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

12 Process Challenge Device (PCD) User assembled Challenge test pack or tray (e.g., AAMI 16-towel pack, IUSS containment device) Commercially available, FDA Cleared Not available for IUSS sterilization ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Sterilization Process Monitoring 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 Polling Question Number 2 If your facility is running these 3 steam sterilization cycles, 270 F, vacuum assisted, 4 minutes exposure 270 F, vacuum assisted, 8 minutes exposure 250 F, gravity, 30 minutes exposure How many Type 5 or Type 6 chemical indicators might you need to have to monitor your three steam cycles? A. One Type 5 or three Type 6 chemical indicators B. Three Type 5 or three Type 6 chemical indicators C. One Type 5 or one Type 6 chemical indicators D. Three Type 5 or one Type 6 chemical indicators 36 12

Part 3 Recommended Practices for Routine Steam Sterilizer Efficacy Monitoring 37 ANSI/AAMI ST79 Section 10 Quality Control Four levels of testing Routine load release Routine sterilizer efficacy

Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform Testing of routinely processed items to ensure the effectiveness of the sterilization process

13 Part 3 Recommended Practices for Routine Steam Sterilizer Efficacy Monitoring 37 ANSI/AAMI ST79 Section 10 Quality Control Four levels of testing Routine load release Routine sterilizer efficacy monitoring Sterilizer qualification testing Periodic product testing Testing of each non-implant and implant load Establishing a regular pattern of testing the efficacy of the sterilization process Testing of the sterilizer after events occur which could affect the ability of the sterilizer to perform Testing of routinely processed items to ensure the effectiveness of the sterilization process and to avoid wet packs Routine Sterilizer Efficacy Monitoring 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 13

cycle BD test sheet with uniform color change ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections 10.7.6.

14 Routine Sterilizer Efficacy Monitoring ºF dynamic-air removal sterilizers (i.e., Prevacuum or vacuum-assisted sterilizers) Run Bowie-Dick test pack: Daily in an empty cycle Before BI PCD One pack per cycle BD test sheet with uniform color change ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections , Sterilizers larger than 2 cubic feet Routine Efficacy Monitoring with BI PCD AAMI 16-towel pack or commercially available disposable, FDA-cleared BI PCD Full load on bottom shelf over drain Weekly, preferably daily Tech Service to add photo ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections , , Routine Sterilizer Efficacy Monitoring Test each type of cycle with a BI PCD Gravity-displacement 132ºC to 135ºC 270ºF to 275ºF Gravity-displacement 121ºC 250 F Dynamic-air-removal 132ºC to 135ºC 270ºF to 275ºF IUSS 132ºC to 135ºC 270ºF to 275ºF IUSS Single wrapper or other packaging ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section

15 Routine Sterilizer Efficacy Monitoring Test each sterilization cycle type used ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section Table-Top Sterilizers Routine efficacy monitoring with a BI PCD Representative of the package or tray routinely processed Most difficult to sterilize Routinely Process: Peel pouches Wrapped instruments Peel pouches Wrapped instruments User-assembled BI PCD: BI + CI inside peel pouch BI + C inside wrapped tray BI + CI inside wrapped tray Contains items normally present during routine sterilization Full load in cold point (check with sterilizer Mfr.) Bowie-Dick Test Check with Sterilizer Manufacturer Frequency of Monitoring with a BI PCD: Weekly, preferably daily, AAMI ST79 Section 10 - Table 6 IUSS: What cycle should we use for IUSS: Gravity or Dynamic-air-removal? What s the difference? 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. ( ) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section 7.2.2,

Routine Efficacy Monitoring with BI PCD IUSS Sterilization Cycles Test each type of tray configuration that is used For sterilizers >2 cubic feet - place the BI PCD on bottom shelf over the drain in

16 Routine Efficacy Monitoring with BI PCD IUSS Sterilization Cycles Test each type of tray configuration that is used For sterilizers >2 cubic feet - place the BI PCD on bottom shelf over the drain in an otherwise, empty chamber Representative BI PCD using one or more BIs and one or more CIs - empty tray configuration Rigid sterilization container system Perforated, mesh bottom, open surgical tray Protective organizing case Single-wrapped surgical tray ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Section , , Routine Sterilizer Efficacy Monitoring IUSS Example Which cycles should be routinely tested? Cycle: Dynamic-air-removal (prevacuum), 270ºF, 4 min., rigid container system Dynamic-air-removal (prevacuum), 270ºF, 4 min., open perforated tray Gravity-displacement, 270ºF, 10 min., rigid container system BI PCD: PCD: BI + CI in empty, rigid container PCD: BI + CI in empty, open perforated tray PCD: BI +CI in empty, rigid container IUSS AORN Documentation Log 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., gravitydisplacement, dynamic-air-removal) Cycle parameters used (e.g., temperature, duration of cycle) 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 AORN 2015 Guideline for Sterilization VII.g.1 16

(AORN) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Introduction AORN 2015 Guideline for Sterilization RP V11.

17 What about Implant Loads for IUSS? Implantables should not be sterilized for immediate use. (CDC, 2008) Immediate use steam sterilization should not be used for implantable devices except in cases of defined emergency when no other option is available. (AORN) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Introduction AORN 2015 Guideline for Sterilization RP V11.f Only Biological Indicator Results Can Be Used to Release Implants Every sterilization load containing implants should be monitored with a PCD containing a BI (a BI challenge test pack). A Class 5 integrating CI should be included in this PCD. Implants should be quarantined until the results of the BI testing are available. (CDC, 2008) When IUSS of an implant is unavoidable, cycle selection should be determined by the manufacturer s written instructions for use, and a biological indicator and a Class 5 chemical integrating indicator should be run with the load (AORN) ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Sections , AORN 2015 Guideline for Sterilization VII.f.1 IUSS AORN Documentation Implants A record describing what could have been done to prevent IUSS of the implant should be completed and used as part of a quality monitoring system A record of IUSS of implants can be helpful in determining problems, trends, or circumstances that can be addressed to prevent IUSS of implants in the future AORN 2015 Guideline for Sterilization, Rec. VII.g.2 17

Polling Question Number 3 How often does your facility monitor your steam sterilizers with a biological indicator in a process challenge device

I do not know 52 Key Learnings Sterilization process monitoring is a fundamental component of sterility assurance Facility policies and procedures

18 Polling Question Number 3 How often does your facility monitor your steam sterilizers with a biological indicator in a process challenge device (PCD)? A. Weekly B. Weekly and every implant load C. Daily and every implant load D. Every Load Monitoring (ELM) E. I do not know 52 Key Learnings Sterilization process monitoring is a fundamental component of sterility assurance Facility policies and procedures on sterilization process monitoring should be based on the recommended practices and guidelines from AAMI, AORN, and the CDC Take the time to do proper documentation Questions? 18

19 Next Live Webinar Date: Thursday July 21, 2016 Title: A Review of Sterilization Methods and Recommended Monitoring Practices for Healthcare Facilities Part II: Terminal Low Temperature Sterilization Register:

Sterile U Network. Quality Control for Table-top Steam Sterilizers. Introduction: T U T O R I A L S

Sterile U Network. Quality Control for Table-top Steam Sterilizers. Introduction: T U T O R I A L S 3M Attest Products TM TM Sterile U Network T U T O R I A L S Quality Control for Table-top Steam Sterilizers Introduction: Many health care professionals in office-based settings are not aware that they