Technical Data Monograph. VERIFY All-In-One STEAM Reusable Test Pack

Transcription

1 Technical Data Monograph VERIFY All-In-One STEAM Reusable Test Pack

2 Table of Contents 1. Introduction Product....3 Use Application...3 Device Description...3 VERIFY All-In-One STEAM Reusable Test Pack...4 VERIFY Bowie Dick Indicator Strips...4 Biological Indicators....5 VERIFY STEAM Integrating Indicators...5 All-In-One Tracker Box Regulatory Status Device Design Compliance to ANSI/AAMI/ISO :2007/(R)2012 Bowie and Dick-type Air Removal Compliance to ANSI/AAMI/ISO Type 5 Integrating Indicator...9 Pass and Fail Specification Testing Temperature Coefficient VERIFY All-In-One STEAM Reusable Test Pack Biological Testing...11 Attest Rapid Readout Biological Indicator Testing Attest Super Rapid Readout Biological Indicator Testing...12 Smart-Read EZTest Biological Indicator Testing Reuse Study Environmental Considerations References

3 1Introduction The VERIFY All-In-One STEAM Reusable Test Pack is a multipurpose reusable test pack designed to challenge vacuum assisted steam sterilizers operating at 270 F for a 4 minute exposure. Each test pack can be used 200 times as a daily air removal test, routine microbial challenge pack, biological indicator test pack for load release or a chemical indicator test pack for release of loads without implantable devices. The test pack has been validated for use with biological indicator models: Attest 1 Rapid Read Biological Indicators, Attest Super Rapid Read Biological Indicators and Smart-Read 2 EZTest Biological Indicators for Steam. The VERIFY Bowie Dick Indicator Strip is used in conjunction with the VERIFY All-In-One STEAM Reusable Test Pack to create the daily air removal test. VERIFY STEAM Integrating Indicators are included with each test pack purchased to provide compliance with ANSI/AAMI ST79 biological indicator test pack usage. The integrating indicator meets the performance specifications of a Type 5 integrating indicator as defined in ANSI/AAMI/ISO Product Use Application: The VERIFY All-In-One STEAM Reusable Test Pack is a multipurpose reusable test pack designed to challenge vacuum assisted steam sterilizers operating at 270 F for a 4 minute exposure. Each test pack can be used 200 times as a daily air removal test, routine microbial challenge pack, biological indicator test pack for load release or a chemical indicator test pack for release of loads without implantable devices. Device Description: The VERIFY All-In-One STEAM Reusable Test Pack consists of a hollow tube-shaped process challenge device (PCD) for steam sterilization. A biological indicator, chemical indicator or both a biological and chemical indicator are placed within the hollow center of the metal tube. The PCD creates a challenge for air removal and steam penetration through a small orifice located at one end of the test pack. The orifice connects with an internal spiral lumen. The chamber housing the biological and chemical indicators is accessed through a removable cap located at the opposite end of the spiral lumen pathway. 1. Attest are registered trademarks of 3M Company 2. Smart-Read EZTest is the registered trademark of MesaLabs, Inc 3

4 The VERIFY Reusable test pack comprises three models: (1) Standard Test Pack, (2) Test Pack with Step Counter, (3) Test Pack with Tracker Tag. COMPONENTS VERIFY All-In-One STEAM Reusable Test Pack (Standard) END VERIFY All-In-One STEAM Reusable Test Pack with Step Counter VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag 1. Cap 2. Stainless Steel Tube with silicone coating 3. Access vent 4. Unique Identification Number 7 5. Counter Arm 6. Number Scale 7. Tracker Chip VERIFY Bowie Dick Indicator Strips: VERIFY All-In-One BD STRIP 1 Dark bar must cover window. Insert into Pack /01 The reusable test packs use the VERIFY Bowie Dick Indicator Strips to challenge the air removal efficacy of prevacuum steam sterilizers operating at 270 F. Either the sterilizers preprogrammed Daily Air Removal Test Cycle (Bowie Dick Test Cycle) or a prevacuum cycle operating at 134 C/273 F with a 3.5 minute exposure and a 2 minute dry time may be used. During the test cycle, the steam sensitive chemical located within the strip will wick across the viewing window. The dark color will completely fill the window if all air was removed from the reusable test pack and replaced by steam. VERIFY All-In-One BD STRIP 1 Dark bar must cover window. Insert into Pack /01 UNPROCESSED VERIFY All-In-One BD STRIP 1 Dark bar must cover window. Insert into Pack /01 PROCESSED REJECT VERIFY All-In-One BD STRIP 1 Dark bar must cover window. Insert into Pack /01 PROCESSED ACCEPT 4 DARK BAR MUST COMPLETELY COVER WINDOW

5 Biological Indicators: The reusable test packs have been validated with biological indicators commonly used to monitor steam sterilizers. Table 1 lists the validated biological indicators. Table 1: Validated Biological Indicators. Biological Indicator Product Number Manufacturer 3M Attest Rapid Readout Biological Indicator M Company 3m Attest Super Rapid Readout Biological Indicator 1492V 3M Company Smart-Read EZTest Self Contained Biological Indicators for Steam SEZS/5 and SEZS/6 MesaLabs, Inc. VERIFY STEAM Integrating Indicators: The VERIFY STEAM Integrating Indicator is used on its own or in conjunction with a biological indicator for routine monitoring and release of steam sterilized loads. VERIFY STEAM INTEGRATING INDICATOR i5 REJECT (NO) ACCEPT (OK) LOT 615-A EXP DARK BAR MUST ENTER ACCEPT WINDOW During the test cycle, the steam sensitive chemical located within the strip will wick across the REJECT viewing window and enter into the ACCEPT viewing window. Sufficient steam has entered the reusable test pack when any of the dark bar is visible within the ACCEPT Viewing window. VERIFY STEAM INTEGRATING INDICATOR i5 REJECT (NO) ACCEPT (OK) LOT 615-A EXP DARK BAR MUST ENTER ACCEPT WINDOW ACCEPT VERIFY STEAM INTEGRATING INDICATOR i5 REJECT (NO) ACCEPT (OK) LOT 615-A EXP DARK BAR MUST ENTER ACCEPT WINDOW REJECT FRONT VIEW All-In-One Tracker Box: The All-In-One Tracker box is as an optional tool to allow easier tracking of the number of uses completed for the VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag. The Tracker Tag is an RFID tag used to store information on the number of uses. The tracker box reads the RFID tag, advances the number of uses indicated by the RFID tag and displays this information on a touch screen. The tracker box has a rechargeable lithium battery allowing it to be portable. The battery requires 2 hours for initial charging, and may last up to 8 hours before requiring recharging. The tracker box can also output data to a printer to allow printing of the displayed information, as well as, to a location to record the test results from the VERIFY All-In-One STEAM Reusable Test Pack with Tracker Tag. 5

6 3Regulatory Status The VERIFY All-In-One STEAM Reusable Test Packs have been cleared for release into interstate commerce as Class II Medical Devices, as defined by the US Food and Drug Administration. This includes the utilization of the 3M Attest Rapid Readout Biological Indicators, 3M Super Raid Readout Biological Indicators and Mesa Labs Smart-Read EZTest Biological Indicators. Table 2: List of VERIFY All-In-One STEAM Reusable Test Pack s 510(k) clearances with associated products. 510(k) Number Cleared Accessories for use with VERIFY All-In-One Reusable Test Pack K M Attest Rapid Readout Biological Indicator reorder 1292 K K K K M Attest Super Rapid Readout Biological Indicator reorder 1492V Smart-Read EZTest Self Contained Biological Indicators for Steam VERIFY STEAM Integrating Indicators VERIFY Bowie Dick Indicators Strips The VERIFY STEAM Integrating Indicator was cleared as a type 5 indicator under k Device Design The VERIFY All-In-One STEAM Reusable Test Pack consists of a hollow tube-shaped process challenge device (PCD) for steam sterilization. A biological indicator, chemical indicator or both a biological and chemical indicator are placed within the hollow center of the metal tube. The PCD creates a challenge for air removal and steam penetration through a small orifice located at one end and an internal spiral lumen pathway. Biological and chemical indicators are placed within the internal chamber through a removable cap located at the opposite end of the spiral lumen pathway. The reusable test pack is intended for 200 uses. The reusable test pack combines the insulative challenge of contemporary disposable packs with a unique spiral lumen pathway to create a significant challenge for prevacuum steam sterilizers. It can be used for Air Removal Testing or Routine Sterilization Load Monitoring of prevacuum sterilizers operating at 270 F/132. 6

7 Insulative Challenge: The challenge pack s hollow chamber is surrounded by aluminum housing. The aluminum provides a heat sink creating a challenge for the steam to reach the chemical or biological indicators within. A rubber outer coating and Teflon discs located at either end of the chamber insolates that chamber from external heat. This ensures that only steam that has penetrated the interior confines of the chamber will provide the necessary heated steam for the biological and chemical indicators. Spiral Lumen Pathway: The spiral lumen pathway starts at a small opening located at the end of the reusable test pack. The opening leads to a spiral channel cut in the inner plug leading to the internal chamber of the test pack. This is the only pathway for air removal and steam penetration. The spiral lumen is approximately 3 feet long with an approximate 0.6 mm diameter. This is equivalent to 3 feet of a 20 gauge needle. The spiral shape allows the lumen to fit into a small space while adding the extra challenge of a curved lumen. 7

8 Air Removal Testing: The VERIFY Bowie Dick Indicator Strips is used in conjunction with the VERIFY All-In-One Reusable test pack to test the efficacy of the vacuum phase of a prevacuum steam sterilizer. The strip is placed pellet first into the pack. Biological Monitoring: The reusable test pack has been designed to work in conjunction with three biological indicators: 3M Attest Rapid Readout Biological Indicators, 3M Super Raid Readout Biological Indicators and Mesa Labs Smart-Read EZTest Biological Indicators. The biological indicators are inserted cap first into the chamber. Additionally, the VERIFY STEAM integrating indicator may be inserted with the biological indicator. Load Monitoring and Release: The reusable test pack may be used to monitor and release steam sterilization loads. Loads that do not contain an implantable may be released on the results of the Type 5 integrating indicator. The VERIFY STEAM Integrating Indicator is placed pellet first into the test pack. Following the cycle, the cycle printout is reviewed and the integrating indicator interpreted to determine if the cycle was good. The load is then released. The reusable test pack is also used to monitor and release loads that contain implantable devices. A biological indicator and the VERIFY STEAM integrating Indicator are placed cap or pellet first, respectively, into the test pack. Following the cycle, the cycle printout is reviewed and the integrating indicator interpreted. The load is quarantined while awaiting the SCBI result. Once the biological indicator result is received, the load may be released. 5Compliance to ANSI/AAMI/ISO :2007/(R)2012 Class 2 Indicators for Bowie and Dick-type Air Removal Tests Performance Guidance The VERIFY Bowie Dick Indicator Strips in combination with the VERIFY All-In-One STEAM Reusable Test Pack are Bowie Dick-type Air Removal Tests, as identified in ANSI/AAMI/ISO Detection of Fail Condition: Test Objective: To demonstrate the VERIFY All-In-One STEAM Reusable Test Pack when utilized with the VERIFY Bowie Dick Indicator Strips as an Air Removal Test meet the requirements of ANSI/AAMI/ISO performance standards. Test Method: A fail condition was created by reducing the vacuum depth of the preconditioning phases of a standard air removal test cycle such that the temperature obtained from the sterilizer drain is 2 C higher than the center of the standard Bowie Dick Test Pack when measured in the final 1 minute of a 3.5 minute cycle using a 134 C test temperature. A single test pack was placed within the chamber and the test cycle performed. Upon completion, the indicator strip within the pack was removed and interpreted. Test Articles: VERIFY All-In-One STEAM Reusable Test Packs 3 Lots of VERIFY Bowie Dick Indicator Strips. Test Results: All indicator strips demonstrated a fail test result when exposed to the fail test condition. See Table 3. 8

9 Table 3: Fail condition testing of the VERIFY All-In-One STEAM Reusable test pack when utilized as a Bowie Dick-type Air Removal Test Demonstration of Steam Sensitivity: Test Objective: To demonstrate the steam specificity of the VERIFY Bowie Dick Indicator strips through indication of fail conditions when exposed to 140 C/284 C dry heat environment. Test Method: VERIFY All-In-One STEAM Reusable Test Packs containing VERIFY Bowie Dick Indicator Strips were placed in a dry heat oven set at 140 C. A 30 minute timer was started when the internal chamber of the packs reached 135 C. After 30 minutes, the indicator strips were removed and interpreted. Test Articles: Lot Number # passing/# tested A 0/10 B 0/10 C 0/10 VERIFY All-In-One STEAM Reusable Test Packs 3 Lots of VERIFY Bowie Dick Indicator Strips. Test Results: All indicator strips demonstrated fail test results. See Table 4. Table 4: Dry Heat Resitometer testing of the VERIFY Bowie Dick Indicator Strips. Lot Number # passing/# tested A 0/5 B 0/5 C 0/5 6Compliance to ANSI/AAMI/ISO Type 5 Integrating Indicator Chemical Indicator Performance Guidance The VERIFY STEAM Integrating Indicators were tested to demonstrate performance to Type 5 integrating indicator standards. This includes: Type 5 integrating indicator standards according to ANSI/AAMI/ISO :2014 using a steam resistometer. See Table 5. Dry heat test requirements according to ANSI/AAMI/ISO :2005. See Table 5. Integrating indicators are designed to react to all the critical process variables of a specified sterilization process. The SVs (stated values) are generated to be equivalent to or exceed the performance of biological indicators given in ANSI/AAMI/ISO Integrating indicators are designed to react to all the critical process variables of a specified sterilization process. The SVs (stated values) are generated to be equivalent to or exceed the performance of biological indicators given in ANSI/AAMI/ISO

10 Table 5: Performance requirements of Type 5 integrating indicators as identified by ANSI/AAMI/ISO Test Point Test Time Test Temperature Test Condition Steam Passing Conditions Steam Failing Condition Dry Heat Test (Failing Condition) SV* ( 16.5 minutes) SV2* ( 1.2 minutes) 121 C Saturated steam 135 C Saturated steam SV3* As selected by vendor Saturated steam SV* - 15% 120 C F Saturated steam SV2* - 15% 134 C Saturated steam 30 minutes 140 C Dry heat Additional Requirements Test Condition Expected Results Integrator Temperature Coefficient Calculated from the end points determined at 135 C, 121 C, and one time point between these. * SV (Stated Value): Exposure time as determined for the integrator at a specific temperature. 10 C to 27 C Type 5 integrating indicator Pass and Fail condition confirmation: Test Objective: To demonstrate that the integrating indicator meets the requirements of ANSI/AAMI/ISO for Type 5 integrating indicators. Test Method: Three lots were tested at the passing and failing conditions identified in ANSI/AAMI/ISO by testing them in a steam resistometer and a dry heat resistometer in the conditions specified in Table 5. Test Articles: 3 Lots for each of the following integrating indicators. Test Results: All three lots demonstrated passing conditions for all PASS tests and failing results for all FAIL tests. See Table 6. The indicators met the steam and dry heat performance criteria for Type 5 integrating indicators as defined by ANSI/AAMI/ISO Table 6: Resistometer performance verification of the integrating indicator to ANSI/AAMI/ISO Stated Values Steam 121 C 23 min Steam 132 C 2.0 min Steam 135 C 1.2 min Dry Heat 140 C 30 minutes Test Conditions Steam Pass Condition 121 C, 23.0 min Steam Fail Condition 121 C, 19.5 min Steam Pass Condition 132 C, 2.0 min Fail Condition 131 C, 1.7 min Steam Pass Condition 135 C, 1.2 min Steam Fail Condition 135 C, 1.0 min Lot 315 Result (# pass / # tested) Lot 415 Result (# pass / # tested) Lot 615 Result (# pass / # tested) 9/9 9/9 9/9 0/9 0/9 0/9 9/9 9/9 9/9 0/9 0/9 0/9 9/9 9/9 9/9 0/9 0/9 0/9 Dry Heat Fail Condition 0/9 0/9 0/9 10

11 Confirmation temperature coefficient Test Objective: To demonstrate that the temperature coefficient is between 10 C and 27 C as specified for Type 5 integrating indicators as defined in ANSI/AAMI/ISO Test Method: The correlation coefficient of the curve was established by least squares linear regression analysis of the data utilizing stated values for three lots of VERIFY STEAM Integrating Indicators. Test Articles: 3 Lots of integrating indicators Test Results: All three lots demonstrated a linear coefficient of 11.1 with an r value of See table 7. Table 7: Calculation of temperature coefficient of 3 lots of integrating indicators per ANSI/AAMI/ISO Temperature Coefficient Lot 315 Lot 415 Lot 615 r Temperature Coefficient r Temperature Coefficient 11.1 C C C r 7VERIFY All-In-One STEAM Reusable Test Pack Biological Testing Side-by-side comparison of the VERIFY All-In-One STEAM Reusable test pack employing3m Attest Rapid Readout Biological Indicators to commercially available biological indicator test packs in abbreviated 270 F prevacuum steam sterilization cycles Test Objective: To compare the performance of the VERIFY All-In-One STEAM Reusable Test Packs employing 3M Attest Rapid Readout Biological Indicators (item number 1292) to 3M Attest Rapid 5 Steam-Plus Test Packs in abbreviated steam sterilization cycles. Test Method: VERIFY All-In-One STEAM Reusable Test packs were constructed using biological indicators from three lots. Each lot of biological indicators corresponded to a test lot of 3M Attest Rapid 5 Steam-Plus Test Packs (item number ). One reusable test pack and one disposable test pack were placed over the drain in an otherwise empty steam sterilizer. An abbreviated sterilization cycle was run. Following cycle the biological indicators were removed and incubated following the manufacturer s instruction for use. Test Articles: VERIFY All-In-One STEAM Reusable Test Packs Three lots of 3M Attest Rapid 5 Steam-Plus Test Packs Three lots of 3M Attest Rapid Readout Biological Indicators Test Results: The VERIFY All-In-One STEAM Reusable Test Packs containing the Attest Rapid Readout Biological Indicators showed positive results at 20 seconds, 1 minute, 2 minutes and 3 minutes into the exposure phase of the steam sterilizer. The Attest Rapid 5 Steam-Plus Test Packs demonstrated negative growth results at all test points. See Table 8. Conclusion: The VERIFY All-In-One STEAM Reusable Test Packs containing the Attest Rapid Readout Biological Indicators provides a greater microbial challenge to a 270 F 4 minute prevacuum cycle as compared with the Attest Rapid 5 Steam-Plus Test Pack. 11

12 Table 8: Comparison of VERIFY All-In-One STEAM Reusable Test Pack utilizing Attest Rapid Read Biological indicators to Attest Rapid 5 Steam-Plus Test Pack following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer. VERIFY All-In-One STEAM Reusable Test Pack (# positive BIs/# tested) Attest Rapid 5 Steam Plus Test Pack (# positive BIs /# tested) Exposure Time Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 20 seconds 50/50 50/50 50/50 0/40 0/40 0/40 1 minute 38/50 37/50 37/50 0/40 0/40 0/40 2 minute 25/50 25/50 25/50 0/40 0/40 0/40 3 minute 2/50 0/50 0/50 0/40 0/40 0/40 4 minute 0/50 0/50 0/50 0/40 0/40 0/40 Side-by-side comparison of the VERIFY All-In-One STEAM Reusable test pack employing3m Attest Super Rapid Readout Biological Indicators to 3M Attest Super Rapid Readout Steam Challenge Packs in abbreviated 270 F prevacuum steam sterilization cycles Test Objective: To compare the performance of the VERIFY All-In-One STEAM Reusable Test Packs employing 3M Attest Super Rapid Biological Indicator (item number1492v) to 3M Attest Super Rapid Readout Steam Challenge Pack (item number 1496V) in abbreviated steam sterilization cycles. Test Method: VERIFY All-In-One STEAM Reusable Test packs were constructed using biological indicators from three lots. Each lot of biological indicators corresponded to a test lot of Attest Super Rapid Readout Steam Challenge Pack. One reusable test pack and one disposable test pack were placed over the drain in an otherwise empty steam sterilizer. An abbreviated sterilization cycle was run. Following cycle the biological indicators were removed and incubated following the manufacturer s instruction for use. Test Articles: VERIFY All-In-One STEAM Reusable Test Packs Three lots of 3M Attest Super Rapid Readout Steam Challenge Pack Three lots of 3M Attest Super Rapid Readout Biological Indicators Test Results: The VERIFY All-In-One STEAM Reusable Test Packs containing the Attest Super Rapid Readout Biological Indicators showed positive results at 30 seconds, 1 minute and 2 minutes into the exposure phase of the steam sterilizer. The Attest Super Rapid Readout Steam Challenge Pack demonstrated negative growth results at all test points. See Table 9. Conclusion: The VERIFY All-In-One STEAM Reusable Test Packs containing the Attest Super Rapid Readout Biological Indicators provides a greater microbial challenge to a 270 F 4 minute prevacuum cycle as compared with the Attest Super Rapid Readout Steam Challenge Pack. Table 9: Comparison of VERIFY All-In-One STEAM Reusable Test Pack utilizing Attest Super Rapid Read Biological indicators to Attest Super Rapid Readout Steam Challenge Pack following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer. VERIFY All-In-One STEAM Reusable Test Pack (# positive BIs/# tested) Attest Super Rapid Readout Steam Challenge Pack (# positive BIs /# tested) Exposure Time Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 30 seconds 30/30 29/30 29/30 0/30 0/30 0/30 1 minute 24/30 26/30 26/30 0/30 0/30 0/30 2 minute 9/30 7/30 9/30 0/30 0/30 0/30 4 minute 0/30 0/30 0/30 0/30 0/30 0/30 12

13 Side-by-side comparison of the VERIFY All-In-One STEAM Reusable test pack employing MesaLabs Smart-Read EZTest Biological Indicators to SteriTec Smart-Read Biological Test Packs in abbreviated 270 F prevacuum steam sterilization cycles Test Objective: To compare the performance of the VERIFY All-In-One STEAM Reusable Test Packs employing MesaLabs Smart- Read Biological Indicators for Steam to SteriTec Smart-Read Biological Test Pack (item number BI108) in abbreviated steam sterilization cycles. Test Method: VERIFY All-In-One STEAM Reusable Test packs were constructed using biological indicators from three lots. Each lot of biological indicators corresponded to a test lot of SteriTec Smart-Read Biological Test Pack (item number BI108). One reusable test pack and one disposable test pack were placed over the drain in an otherwise empty steam sterilizer. An abbreviated sterilization cycle was run. Following cycle the biological indicators were removed and incubated following the manufacturer s instruction for use. Test Articles: VERIFY All-In-One STEAM Reusable Test Packs Three lots of SteriTec Smart-Read Biological Test Pack Three lots of MesaLabs Smart-Read Biological Indicators for Steam Test Results: The VERIFY All-In-One STEAM Reusable Test Packs containing the Smart-Read Biological Indicators for Steam showed positive results at 1 minute, 1.5 minutes and 2 minutes into the exposure time. The SteriTec Smart-Read Biological Test Pack demonstrated negative growth results at all times tested. See Table 10. Conclusion: The VERIFY All-In-One STEAM Reusable Test Packs containing the Smart-Read Biological Indicators for Steam provides a greater microbial challenge to a 270 F 4 minute prevacuum cycle as compared with the SteriTec Smart-Read Biological Test Pack. Table 10: Comparison of VERIFY All-In-One STEAM Reusable Test Pack utilizing MesaLabs Smart-Read Biological Indicators for Steam to SteriTec Smart-Read Biological Test Pack following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer. VERIFY All-In-One STEAM Reusable Test Pack (# positive BIs/# tested) SteriTec Smart-Read Biological Test Pack (# positive BIs /# tested) Exposure Time Test 1 Test 2 Test 3 Test 1 Test 2 Test 3 1 minute 28/30 25/30 20/30 0/30 0/30 0/ minute 11/30 10/30 6/30 0/30 0/30 0/30 2 minute 6/30 7/30 4/30 0/30 0/30 0/30 4 minute 0/30 0/30 0/30 0/30 0/30 0/30 8Reuse Study for the VERIFY All-In-One STEAM Reusable Test Pack Test Objective: Demonstrate that the performance of the VERIFY All-In-One STEAM Reusable Test Packs employing 3M Attest Rapid Read Biological Indicators, 3M Attest Super Rapid Read Biological Indicators or MesaLabs Smart-Read Biological Indicators for Steam does not change after 200 uses. Test Method: VERIFY All-In-One STEAM Reusable Test packs were processed for 199 prevacuum cycles operating at 270 F and 4 minute exposure times. On the 200 use, the test packs were constructed using biological indicators from three lots. One reusable test pack was placed over the drain in an otherwise empty steam sterilizer. An abbreviated sterilization cycle was run. Following the cycle, the biological indicators were removed and incubated following the manufacturer s instruction for use. 13

14 The numbers of positive results were compared against the initial biological indicator test results. Test Articles: VERIFY All-In-One STEAM Reusable Test Packs Three lots of 3M Attest Rapid Readout Biological Indicators Three lots of 3M Attest Super Rapid Readout Biological Indicators Three lots of SteriTec Smart-Read EZ-Test Biological Test Pack Test Results: The positive results obtained at 200 uses were comparable to the positive results obtained at initial use of the test pack for each type of biological indicator and lot tested. See Tables Conclusion: The reusable test packs may be used for 200 tests. Table 11: Comparison of initial VERIFY All-In-One STEAM Reusable Test Pack test results utilizing Attest Rapid Read Biological Indicators to test results of reusable test packs that have been used 200 times following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer Exposure Time Initial testing % Growth Reusable test pack at 200 uses % Growth 20 seconds 100% 100% 1 minute 75% 60% 2 minute 50% 52% 3 minute 1% 0% 4 minute 0% 0% Table 12: Comparison of initial VERIFY All-In-One STEAM Reusable Test Pack test results utilizing Attest Super Rapid Read Biological Indicators to test results of reusable test packs that have been used 200 times following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer Exposure Time Initial testing % Growth Reusable test pack at 200 uses % Growth 30 seconds 95% 96% 1 minute 84% 90% 2 minute 28% 30% 4 minute 0% 0% Table 13: Comparison of initial VERIFY All-In-One STEAM Reusable Test Pack test results utilizing Smart-Read Biological Indicators for Steam to test results of reusable test packs that have been used 200 times following exposure to abbreviated exposure times in a 132 C/270 F prevacuum steam sterilizer Exposure Time Initial testing % Growth Reusable test pack at 200 uses % Growth 1 minute 81% 79% 1.5 minute 30% 33% 2 minute 19% 18% 4 minute 0% 0% 14

15 9Environmental Considerations STERIS Corporation is committed to reducing the environmental impact of its product designs. From the product to the packaging, STERIS Corporation strives to reduce waste stream and improve recyclability. The VERIFY All-In-One Reusable Test Pack is composed of recyclable materials including aluminum, stainless steel and polytetrafluoroethylene STERIS offers a return service recycling program. The packaging and product components for the reusable test pack and indicator strips do not use lead, latex or dry natural rubber in their construction. Simply by switching from a disposable test pack constructed mostly of paper to a reusable test pack, an average size hospital monitoring every steam sterilizer load will eliminate 7.2 tons of paper from its waste stream. That s equivalent to 21 trees. 10 References A. Association for the Advancement of Medical Instrumentation (2013). ANSI/AAMI ST79:2010 &A1:2010 & A2:2011 & A3:2012 & A4:2013 Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington, VA: Association for the Advancement of Medical Instrumentation. B. Association for the Advancement of Medical Instrumentation (2014). ANSI/AAMI/ISO :2014 Sterilization on Health Care Products Chemical Indicators Part 1: General Requirements. Arlington, VA: Association for the Advancement of Medical Instrumentation. C. Association for the Advancement of Medical Instrumentation (2007). ANSI/AAMI/ISO :2007 Sterilization of Health Care Products Chemical Indicators Class 2 indicators for Bowie and Dick-type air removal tests. Arlington, VA: Association for the Advancement of Medical Instrumentation. D. Association for the Advancement of Medical Instrumentation (2010). ANSI/AAMI/ISO :2006/(R) 2010 Sterilization on Health Care Products Biological Indicators Part 1: General Requirements. Arlington, VA: Association for the Advancement of Medical Instrumentation. E. Association for the Advancement of Medical Instrumentation (2015). ANSI/AAMI/ISO :2006 /(R)2015 Sterilization of Health Care Products Biological Indicators Part 3: Biological Indicators for moist heat sterilization. Arlington, VA: Association for the Advancement of Medical Instrumentation. 15

16 Document # Rev. A 2016 STERIS Corporation All Rights Reserved 16 STERIS Corporation 5960 Heisley Road Mentor, OH USA