Did You Know? Education & Training. Sterilization process monitoring Part One by Martha Young, BS, MS, CSPDT

Transcription

1 Did You Know? Sterilization process monitoring Part One by Martha Young, BS, MS, CSPDT Objectives After completion of this self-study activity, the learner will be able to: 1. Identify when a Bowie-Dick test pack is run correctly. 2. Describe a process challenge device (PCD). 3. Identify the appropriate biological indicator process challenge device (BI PCD) for testing various cycle and tray configurations. 4. Develop a policy and procedure for the use of Bowie-Dick test packs and BI PCDs for routine monitoring and sterilizer qualification testing. Test Questions True or False. Circle the correct answer. 1. Two Bowie-Dick test packs can be run in the same load. 2. The Bowie-Dick test pack is placed in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber. 3. Trust the results of your monitoring tools because they define the history of your sterilizer performance. Many thanks to the team at 3M Health Care for working with Managing Infection Control to provide the following accredited course. IAHCSMM has awarded one and one-half (1.5) contact points for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one and one-half (1.5) contact hours for a period of five (5) years from the date of publication, and to be used only once in a recertification period. This inservice is 3M Health Care Provider approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 105. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. 4. For sterilizer qualification testing in F () dynamic-air-removal sterilizers, one biological indicator process challenge device (BI PCD) needs to be run in each of three consecutive empty cycles followed by one Bowie-Dick test pack in each of three consecutive empty cycles after a sterilizer is installed or relocated, after sterilizer malfunctions, after a sterilization process failure, and after major repairs. 5. Preventative maintenance is considered a major repair and requires sterilizer qualification testing. 6. A test pack is the same thing as a process challenge device or PCD. 7. Test each type of sterilization cycle used with a biological indicator (BI PCD) when performing routine sterilizer efficacy testing and sterilization qualification testing on sterilizers greater than 2 cubic ft. and for flash sterilization. 8. In flash sterilization, test each type of tray configuration when performing routine sterilizer efficacy testing but only test one tray configuration when performing sterilizer qualification testing. 9. Each load containing an implantable device should be monitored with a BI PCD containing a Class 5 integrating indicator and the implant should be quarantined until the results of BI testing are available. 10. Product testing should be part of quality assurance testing for routinely processed items and when changes are made in packaging, wraps or load configurations. Introduction Sometimes we get so busy we don t know whether we are coming or going. Healthcare systems are 88 MANAGING INFECTION CONTROL

2 demanding that sterile medical devices and items be produced quicker with fewer resources such as people and equipment. These demands require that we use critical thinking skills to optimize our processes without sacrificing quality, and that we continue to meet the most stringent recommended practices to improve patient safety. This self-study activity will highlight some practices of the sterilization process related to Bowie-Dick (BD) test pack and biological indicator process challenge pack (BI PCD) testing that you might not know or may know but are not practicing. These recommendations are based on the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Nurses (AORN) recommended practices. This inservice replaces Did You Know: Sterilization Process Monitoring published in Managing Infection Control in August, 2004 that is out of date. Bowie-Dick Testing DID YOU KNOW THAT YOU CANNOT RUN TWO BOWIE-DICK TEST PACKS IN THE SAME LOAD OR A BOWIE-DICK TEST PACK AND A BIOLOGICAL INDICATOR OR BIOLOGICAL INDICATOR PROCESS CHALLENGE DEVICE IN THE SAME LOAD? The AAMI recommended practice Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79 states in section Placement of the Bowie-Dick test pack: NOTE 1-The test pack is the only item on the sterilizer cart. Rationale: The Bowie-Dick test is conducted in an empty chamber to maximize the potential for detecting any air that enters by means of a leak or is not removed because of malfunction of the air removal system. Other packs in the chamber would entrain a percentage of the air and reduce the sensitivity of the test. 1 If you have two Bowie-Dick (BD) test packs in the same load the air left in the chamber will be divided into the two packs and it may be such a small amount of residual air that it may not be detected. This would also be true if you were running a BD test pack and a BI PCD in the same load. If you want to compare BD test pack products or different lots of the same product, run two consecutive empty cycles each containing only one of the test packs. BI PCDs will be discussed later in this inservice. DID YOU KNOW YOU CANNOT PLACE THE BOWIE-DICK TEST PACK ON THE FLOOR OF THE STERILIZER? AAMI ST79 states in section Placement of the Bowie- Dick test pack: The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber. (See Figure 13.) 1 Placement of the BD test pack on the bottom shelf over the drain is important because this is the coldest spot in the chamber. Placing the BD test pack on the floor of the chamber can lead to superheating of the pack because the pack is sitting directly on the heated metal floor. Superheating of the BD test pack should be avoided to ensure accurate results. Consult the manufacturer s instructions to ensure you are properly placing the BD test pack in the sterilizer. Not placing the BD test pack correctly on the sterilizer rack will yield invalid results. AAMI ST79 Figure 13. Placement of the Bowie-Dick Test Pack Reprinted from ANSI/AAMI ST79:2006 and A1:2008 (Consolidated text) with permission of the Association for the Advancement of Medical Instrumentation, Inc AAMI All rights reserved. DID YOU KNOW THAT YOU CANNOT RUN THE BOWIE- DICK TEST FOR MORE THAN 4 MINUTES AT 273 F (134 C) IN A DYNAMIC-AIR-REMOVAL STERILIZER? AAMI ST79 section Test procedures A cycle is run as specified by the sterilizer manufacturer. The recommended exposure time is 3.5 min, but if 90 MANAGING INFECTION CONTROL

3 half-minute exposures cannot be selected on the sterilizer, a 4 min exposure time may be used. The exposure time should never exceed 4 min at 134 C (273 F). (The specific instructions of the manufacturer should be followed). Drying may be omitted to save time without affecting the outcome of the test. When removed from the sterilizer, the test pack might still be hot and should be opened carefully to avoid thermal injury to the hands or face. The test sheet should be removed from the pack and examined by a person trained in its interpretation. Rationale: If longer exposure times are used, the test should be considered invalid and the results meaningless: even an extra minute could affect the results. 1 Follow the instructions for use from the manufacturer of the sterilizer and the BD test pack, but never exceed four minutes. Figure 1. Bowie-Dick Test Pack Instructions 1 1. Run an empty-chamber cycle right before you run the Bowie-Dick (B-D) test pack to preheat the sterilizer and purge air out of the steam lines, even if the sterilizer was not turned off. 2. Place one BD test pack horizontally in the front, bottom section of the sterilizer rack or loading cart, near the door over the drain, but not on the floor. 3. Run the test pack for 3.5 to 4 minutes at 273 F (134 C). 4. Read the physical monitors and initial the printout. 5. If the test sheet has a uniform color change, use the sterilizer. 6. If the test sheet does not have a uniform color change, retest the sterilizer. 7. If a second test sheet has a uniform color change, use the sterilizer. 8. If the second test sheet does not have a uniform color change, don t use the sterilizer until the problem is identified and corrected. 9. The supervisor needs to determine if the sterilizer should be retested, serviced or remain in use. See section on Sterilization Qualification Testing for information on how to test the sterilizer before it is placed back into routine use. Exceeding four minutes will yield invalid test results because the test sheet will reach a uniform color even in the presence of air. DID YOU KNOW YOU NEED TO RUN AN EMPTY CYCLE RIGHT BEFORE THE BOWIE-DICK TEST IS RUN? AAMI ST79 section Test procedures Rationale: A sterilizer tested from a cold start (after the sterilizer has been turned on and before a load is processed) might produce false failures unless it is preheated to operating temperature by running at least one empty-chamber cycle. 1 This is why the BD test cycle on new sterilizers asks if you want to run a warm-up cycle before you run the BD test pack. Run an empty cycle right before you run the BD test pack to warm up the sterilizer chamber and clear air out of the steam lines, even if the sterilizer has not been turned off. Use either the warm-up cycle of the BD cycle or run an empty 3.5 to 4 minute, 273 F (134 C) dynamic-air-removal cycle with no dry time. If you get a non-uniform color change (e.g., center of test sheet paler or a different color than the edges), rerun the test pack (see Figure 2). If the second test sheet is still non-uniform, then the sterilizer cannot be used until the problem is identified and corrected. Make sure that the test Figure 2. Pass (top) and Fail (bottom) Bowie-Dick Test Results Acceptance Criteria: 1. Appropriate readings from BD test sheets. 2. Appropriate readings from physical monitors. 92 MANAGING INFECTION CONTROL

4 was performed correctly, as discussed above, and the result read was interpreted correctly. 2 Seek assistance from the healthcare facility s engineer for the sterilizer and steam supply. Contact the manufacturer of the BD test pack, the sterilizer, and service technician for assistance. See Figure 1 for complete instructions on how to routinely run the BD test pack. To get accurate results: Run an empty cycle prior to running the BD test pack. Run one BD test pack in an empty load on the bottom shelf of the rack and over the drain. Do not run the BD test pack for more than 4 minutes at 273 F(134 C). WHAT IF THE STERILIZER MANUFACTURER OR SERVICE TECHNICIAN SAYS THAT THERE IS NOTH- ING WRONG WITH THE STERILIZER? BD test pack failures are a result of air leaks, inadequate air removal, inadequate steam penetration, and poor steam quality such as the presence of non-condensable gases (air). BD test failures are not always caused by sterilizer malfunction. The failure could be caused by a utilities problem and the service technician may not have the tools or training to identify or correct the problem. In this situation, it is important to be persistent and continue to investigate to identify the cause of the BD test failures. If the problem is not found and corrected, the sterilizer may deteriorate in performance to the point where biological indicator results are positive. 2 Follow these steps when trying to identify the problem: 2 1. Do not mix and match brands of BD test packs. This will introduce another variable and make the problem solving process more difficult. Trust the results of your BD test pack because it has defined the history of your sterilizer performance. 2. Check to make sure that the test was performed correctly as discussed above and the results interpreted correctly. 3. Talk to you your facility s engineering department to assure that services/utilities provided are adequate for proper performance of the sterilizer. See Figure 3 Checklist on page Consult with the BD test pack manufacturer for additional troubleshooting information related to manufacturer s instructions for use, interpretation of results, and product quality problems. 5. Consult with the sterilizer manufacturer and service provider to ensure the sterilizer is calibrated and meets stated performance criteria. 6. If needed hire a third party to independently verify the functionality of the sterilizer or assist in determining the problem. Figure 3. Facility Engineering Services/Utilities Check List for Bowie-Dick Test Pack Failure Analysis 2 Look for variations in the steam supply throughout the day due to increased demand or changes of seasons. Check the piping system that distributes the steam. Verify generator performance if a self-contained steam generator (usually part of sterilizer) is used. Determine steam quality (dryness). Measure the steam to see if it is superheated. Accurately determine if non-condensable gases (air) are in the steam supplied to the sterilizer. Steam boiler feedwater system: Perform complete water chemistry measurements; Check for accurate records of all water conditioning or treatment processes. Here are some examples of BD problems and the importance of trusting the results of your BD test pack and being persistent in solving the problem. Case Study One A hospital had a new sterilizer installed and the BD test pack (brand X) consistently showed a failure during sterilizer qualification testing. The sterilizer manufacturer service technician checked the sterilizer with his employer s BD test pack (brand Y2) that passed. Therefore, the sterilizer technician concluded that the sterilizer was installed correctly. The SPD manager was not comfortable with this assessment so it was suggested that the sterilizer technician run a different BD test pack from his company (brand Y1) that was known to be more sensitive than the first one he used (brand Y2). The more sensitive BD test pack (brand Y1) showed a failure, just like the original BD test pack (brand X), and the service tech- 94 MANAGING INFECTION CONTROL

5 nician finally acknowledged there was a problem with the sterilizer. Another service technician was sent to the site to determine the problem and found that the sterilizer was not balanced correctly allowing air to enter the chamber from the drain. The SPD manager trusted her BD test pack results and was persistent in demanding that the service company continue to look for the problem, which was finally identified. Once the new sterilizer was balanced properly, it was successfully qualified and placed into routine use. Case Study Two A hospital was experiencing sporadic failed BD tests, positive rapid readout biological indicators and failed the Class 5 Integrating Indicators. This went on for months and eventually both sterilizers were taken out of use and another hospital began processing their packs. Another brand of BD test pack and BI PCD that contained an integrator (not a Class 5 by the new AAMI Association for the Advancement of Medical Instrumentation Sterilization of health care products-chemical indicators-part 1: General requirements, ANSI/AAMI/ISO :2005 standard) yielded passing results for the BD, the BI and the integrator. The sterilizer manufacturer ran 30 thermocouples in the sterilizer chamber and detected no problems. The 3M ETS system which is a self-contained, intelligent and independent data logger (not connected to the sterilizer controller) sold in Europe as an electronic means of conducting the daily Bowie- Dick (BD) test was used at the hospital as a diagnostic tool and identified a large amount of air in the chambers of the sterilizers. A third party, Charles O. Hancock Associates Inc., was hired to test the steam quality. He determined there was approximately 20 percent air inside the sterilizer chamber and the source was related to the utilities. The problem was identified as a broken diaphragm in the steam reduction valve that had not been replaced at the appropriate time according to the preventive maintenance schedule. The valve had started to leak in the middle of December and was causing sporadic air in the steam line that got progressively worse. The hospital was persistent in identifying resources to assist in determining the problem and trusting the monitors that they used. After the diaphragm was replaced the sterilizers were successfully qualified and placed into routine use. BD test pack failures can be the result of a human error, sterilizer malfunctions or utilities problems. Do not change BD test pack products when diagnosing a failure. This will just add another variable and make the problem solving process more difficult. Be persistent in solving the problem. DID YOU KNOW YOU NEED TO TEST THE 273 F (134 C) DYNAMIC-AIR-REMOVAL STERILIZER WITH A BOWIE-DICK TEST PACK MORE THAN JUST ROUTINELY (DAILY)? AAMI ST79 section General considerations Dynamic-air-removal sterilizers should be tested using Bowie-Dick test packs after sterilizer installation, relocation, malfunctions, and major repairs and after sterilization process failures. 1 In all of these situations run a BD test pack in each of three consecutive empty cycles, one right after the other, and examine the test sheets. During qualification testing, the BD test cycles are run after the BI PCD cycles. BI PCD testing will be discussed later in this inservice. It is important to use a transfer cart that is completely cooled between cycles to avoid superheating of the BD test pack. 1 Do not place the sterilizer into use until all BD tests show a pass. Remember that the BD test pack does not need to be run in gravitydisplacement sterilizers. For steam-flush-pressure-pulse sterilizers, check with the sterilizer manufacturer s recommendations. DO YOU KNOW WHAT IS CONSIDERED A MAJOR REPAIR OF A STEAM STERILIZER AND THE UTIL- ITIES? AAMI ST79 section Sterilization process failures A major repair is a repair outside the scope of normal maintenance, such as weld repairs of the pressure vessel, replacement of the chamber door, vacuum pump, or a major piping assembly; or rebuilds or upgrades of controls. Normal preventative maintenance, such as the rebuilding of solenoid valves or the replacement gaskets, is not considered major repair. When repairs involve parts normally replaced under preventive maintenance procedures, three Bowie-Dick tests and three BI tests are not required before the sterilizer is returned to service. Verification of the sterilizer s operation according to the manufacturer s specifications is sufficient. 1 AAMI ST79 section General considerations Significant changes to the utilities connected to the sterilizer (e.g., changes necessitated by water-main breaks, annual boiler maintenance, or additional equipment loads) could affect sterilizer performance. Major repairs of or changes to the utilities (e.g., the installation of new boilers) should be treated as major repairs to the sterilizer and steril- 96 MANAGING INFECTION CONTROL

6 izer testing should be performed as defined in this section to provide the necessary qualification for use. 1 A BD test pack should be run daily and for qualification testing after sterilizer installation, relocation, malfunctions, and major repairs and after sterilization process failures. Process Challenge Devices/Test Packs DID YOU KNOW THAT THE NEW NAME FOR TEST PACKS IS PROCESS CHALLENGE DEVICES OR PCD? AAMI ST79 defines a process challenge device (PCD) as: Item designed to simulate product to constitute a defined resistance to a sterilization process and used to assess performance of the process. 1 The PCD could contain a: BI; BI and Class 5 integrating indicator; Class 5 integrating indicator. 1 So now when you hear or read the name process challenge device or PCD you know it means test or challenge pack or test or challenge tray. DID YOU KNOW THAT IN A STEAM STERILIZER THAT IS GREATER THAN 2 CUBIC FT. FOR ROUTINE STER- ILIZER EFFICACY TESTING YOU SHOULD RUN A BIOLOGICAL INDICATOR PCD (BI PCD) WEEKLY, PREFERABLE DAILY AND IN EACH TYPE OF STEAM STERILIZATION CYCLE USED? AAMI ST79, section Using biological indicators If a sterilizer is designed to be used for multiple types of cycles (gravity-displacement at 132 C to 135 C [270 F to 275 F], gravity-displacement at 121 C [250 F], dynamic-air- removal at 132 C to 135 C [270 F to 275 F], flash at 132 C to 135 C [270 F to 275 F], flash with single wrapper or other packaging), then each sterilization cycle type used should be tested. NOTE 1 The methods of biologically monitoring cycles for wrapped items and cycles for unwrapped items (flash sterilization) differ. NOTE 2 If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132ºC to 135ºC [270ºF to 275ºF] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested. 1 So what does this mean to you? It means that all cycle types used at your facility must be routinely tested with a BI PCD. For example, if you work in an area that processes mixed loads in a 270 F-273 F (132 C-134 C), 4 minute dynamic-air-removal sterilizer that is >2 cubic ft., test this process with an AAMI 16 towel pack or a disposable BI PCD of equivalent performance. 1 The BI PCD is placed in a full load, on the rack in the front, bottom section of the sterilizer, near the drain. Check with the sterilizer manufacturer to make sure that this area represents the greatest challenge to the BI. If you also run 270 F-273 F (132 C-134 C), 8 or 10 minute cycles in the same dynamic-air-removal sterilizer than you do not need to test the longer cycles routinely (see NOTE 2 above). However, if you run a 250 F (121 C) gravity cycle with mixed loads for 30 minutes, you need to test that process with the same BI PCD and at the same frequency of testing. Again if you also run a 60 minute 250 F (121 C) gravity cycle, the longer cycle does not need to be routinely tested. See Table 1 for examples of cycles that require testing. Running a BI PCD in every load will ensure that each type of sterilization cycle routinely used is tested. Keep in mind that all loads containing an implant must be tested with a BI PCD that contains a Class 5 integrating indicator and the implant should be quarantined until the BI result is negative. Table 1. Examples of Cycles to Monitor with a BI PCD for both Routine Sterilizer Efficacy Testing and Sterilizer Qualification Testing for Sterilizers Greater than 2 Cubic Ft. Cycle Dynamic-air-removal, 270 F, 4 min. cycle Dynamic-air-removal, 270 F, 10 min. cycle Gravity, 250 F, 40 min. cycle Gravity, 250 F, 60 min. cycle Monitor with BI PCD No, unless contains an implantable device No, unless contains an implantable device Test each type of sterilization cycle used with a BI PCD when performing routine sterilizer efficacy testing or test each load to ensure all required routine sterilizer efficacy testing is performed. MANAGING INFECTION CONTROL 97

7 DID YOU KNOW THAT IN A STEAM STERILIZER GREATER THAN 2 CUBIC FT. FOR STERILIZER QUAL- IFICATION TESTING YOU SHOULD RUN A BIOLOGI- CAL INDICATOR PCD (BI PCD) IN EACH TYPE OF STEAM STERILIZATION CYCLE USED? Sterilizer qualification testing is performed in the same cycles as routine sterilizer efficacy testing. See the previous question and Table 1 for a list of cycles that must be tested when performing sterilizer qualification testing. For this testing, run one BI PCD in each of three consecutive empty cycles, one right after the other. 1 BD test pack testing in a 273 F (134 C) dynamicair-removal sterilizer would follow as described earlier in this inservice. Ensure that the transfer cart is completely cooled between cycles to avoid superheating of the BI PCD test pack. 1 Test each type of sterilization cycle used with a BI PCD when performing sterilizer qualification testing. DID YOU KNOW THAT IN FLASH STERILIZATION FOR ROUTINE STERILIZER EFFICACY TESTING YOU SHOULD ROUTINELY RUN A BIOLOGICAL INDICA- TOR PCD (BI PCD) WEEKLY, PREFERABLE DAILY AND IN EACH TYPE OF STEAM STERILIZATION CYCLE USED AND IN EACH TYPE OF TRAY CONFIGURA- TIONS? In flash sterilization you need to test all of the cycles discussed in AAMI ST79 section Using biological indicators as discussed above. In addition you also need to test each tray configuration used. AAMI ST79, section Composition of the PCD (BI challenge test tray): Each type of tray configuration in routine use for flash should be tested separately. One or more BIs and one or more CIs should be placed in the tray configuration to be tested: a perforated, mesh-bottomed, open surgical tray; a rigid sterilization container system; a protective or organizing case; or a single wrapped surgical tray. 1 AORN says when flash sterilizing a Class 5 chemical integrating indicator should be used within each sterilizer container or tray. 5 What does this mean to you? It means that each type of cycle and tray configuration routinely used at your facility needs to be tested. Table 2 shows examples of the cycle/tray configurations that need to be tested if used. For example, if you routinely run an open perforated tray in a F () gravity cycle for 3 minutes and a rigid container in a 10 minute, F Table 2. Examples of Cycles to Monitor with a BI PCD for Routine Sterilizer Efficacy Testing for the Flash Sterilization Process* Cycle Gravity, 270 F, 3 min., open perforated tray Gravity, 270 F, 10 min., rigid container system Dynamic-air-removal, 270 F, 4 min., open perforated tray Dynamic-air-removal, 270 F, 4 min., rigid container system Express cycle, 270 F, 4 min., single wrapped, perforated tray, no lumens or absorbent material Monitor with BI PCD *There are no commercially available BI PCDs for flash sterilization. Make a representative BI PCD by placing a BI and CI in the type of packaging used. () gravity cycle then both of those cycle/tray configurations need to be tested routinely (i.e., weekly, preferably daily) with a BI PCD. This is because the BI results from the 3-minute cycle tested with a BI in an unwrapped tray does not provide information about the effectiveness of achieving sterilization inside a container system in a 10-minute cycle. Remember that the BI PCD should be representative of the load and create the greatest challenge to the load. Examples of BI PCDs for routine sterilizer efficacy testing for flash sterilization are shown in Table 3. In flash sterilization the BI PCD is placed on the rack near the drain in an empty cycle. Check with the sterilizer manufacturer to ensure this area represents the greatest challenge to the BI. Minimizing the types of tray configurations used and running a BI PCD in every load will ensure that each type of sterilization cycle and tray configuration is routinely tested. Test each type of sterilization cycle and tray configuration used with a BI PCD when performing routine sterilizer efficacy testing for flash sterilization cycles or test every load to ensure all required routine sterilizer efficacy testing is performed. 98 MANAGING INFECTION CONTROL

8 Table 3. BI PCDs for Different Cycle/Tray Configurations for Flash Sterilization Time (minutes) Temperature Type of Cycle Type of Tray Configuration BI PCD Includes a Class 5 Integrating Indicators 5 3 Gravity Unwrapped tray BI in center of unwrapped tray 4 10 Gravity Wrapped tray, with or without porous item (towel, foam pad, etc.) BI in center of wrapped tray (include porous items if in patient care tray) 4 10 Gravity Container system BI in container system in area that creates the greatest challenge to sterilant penetration and air removal (two opposite corners) Dynamic-airremoval Unwrapped tray, with or without porous item (towel, foam pad, etc.) BI in center of unwrapped tray (include porous items if in patient care tray) Dynamic-airremoval Wrapped tray, with or without porous item (towel, foam pad, etc.) BI in center of wrapped tray (include porous items if in patient care tray) Dynamic-airremoval Container system BI in container system in area that creates the greatest challenge to sterilant penetration and air removal (two opposite corners) 4 DID YOU KNOW THAT IN FLASH STERILIZATION FOR STERILIZER QUALIFICATION TESTING YOU SHOULD RUN A BIOLOGICAL INDICATOR PCD (BI PCD) IN EACH TYPE OF STEAM STERILIZATION CYCLE USED BUT YOU NEED TO TEST ONLY ONE TYPE OF TRAY CONFIGURATION? For qualification testing select one type of tray configuration to test all the types of cycles run. 1 Place the BI and Class 5 integrating indicator inside the tray configuration in the area considered the most difficult to sterilize. 1,4 Place the tray configuration on the rack over the drain in an empty sterilizer. Test each type of sterilization cycle and one type of tray configuration with a BI PCD when performing sterilizer qualification testing in flash sterilization cycles. Implant Monitoring DID YOU KNOW THAT IMPLANTS SHOULD BE MONITORED WITH A BI AND QUARANTINED UNTIL THE BI IS NEGATIVE? AAMI ST79 section Process monitoring devices Every sterilization load containing implants should be monitored with a PCD containing a BI (a BI challenge test pack). A Class 5 integrating CI or an enzyme-only indicator should be included in this PCD. 1 AAMI ST79 section Release criteria for implants The load should be quarantined until the results of the BI testing are available (CDC, 2003a). 1 Note: enzyme-only indicators are no longer on the market. AAMI ST79 section Using 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. In addition Garner and Favero (1985) and CDC (2003a) recommend routine biological monitoring of sterilizer efficacy. While the performance of Class 5 integrating CIs and enzyme- MANAGING INFECTION CONTROL 99

9 only indicators has been correlated to the performance of BIs, these sterilization monitoring devices do not contain spores and thus do not directly measure the lethality of a sterilization cycle; however, they provide additional information about the attainment of the critical parameters of the sterilization process. 1 For monitoring implants in sterilizers greater than 2 cubic ft., use an AAMI 16 towel pack or a disposable PCD of equivalent performance containing a BI and a Class 5 integrating indicator. Place the BI PCD on the bottom shelf, over the drain in a full load. The AORN sterilization recommended practices state: Flash sterilization should not be used for implantable devices. Implants are foreign bodies, and they increase the risk of surgical site infections. Careful planning, appropriate packaging, and inventory management in cooperation with suppliers can minimize the need to flash sterilize implantable medical devices. When an implantable device is sterilized at a health care facility, a biological indicator should be run with the load and the implant should be quarantined until the results of the biological indicator are known. If an emergency situation makes flash sterilization unavoidable, a rapid-action biological monitoring device should be used along with a class 5 chemical integrator. The implant should not be released until the rapid-action indicator provides a negative result. After the rapid-action negative result is obtained, the implant can be released for use in the immediate situation. If the implant is not used, it cannot be saved as sterile for future use. Resterilization of the device is required. If the biological indicator is later determined to have a positive result, the surgeon should be notified as soon as the results are known. 5 If flash sterilization is done in an emergency situation, place the BI and Class 5 integrating indicator inside the tray configuration containing the implant and aseptically remove as soon as possible for incubation. 5 Place the tray on a separate back table until the BI is negative. 5 Run a BI and Class 5 integrating PCD in each load containing implants and quarantine until the BI is negative. Product Testing DO YOU KNOW THAT AS PART OF A QUALITY ASSURANCE TESTING PROGRAM YOU SHOULD PERIODICALLY TEST REPRESENTATIVE SAMPLES OF ACTUAL ITEMS BEING STERILIZED WITH CHEMICAL AND BIOLOGICAL INDICATORS TO VERIFY THEY ARE BEING EFFECTIVELY STERIL- IZED? AAMI ST79, section10.9 Periodic product quality assurance testing of routinely processed items Quality assurance testing of routinely processed items should be performed on an ongoing basis. Rationale: The standardized BI test pack of presents a known challenge to the sterilization process. However, the pack does not reflect the items routinely processed in a health care facility. Therefore, product testing is recommended as part of a complete quality assurance program to ensure the effectiveness of the sterilization process and avoid wet packs. 1 Routinely sterilized items should be tested periodically and when major changes are made in packaging, wraps, or load configuration, such as dimensional changes, weight changes, or changes in the type or material of packaging or wrapper. 1 The test program should include both BI and CI testing and an evaluation of post-sterilization moisture content (i.e., the occurrence of wet packs ). 1 Multiple BIs and CIs (Class 3, Class 4 or Class 5) should be placed within the package configuration to be tested. The number of samples will depend on the size and configuration of the pack being tested. BIs and CIs are placed inside each layer in multiple locations. For example, place the BIs and CIs on all levels, in the corners and middle, by the largest heat sink and next to the smallest lumen. The product testing packages should be labeled test and placed among other products in a full load. After the sterilization process, the test BIs should be retrieved, incubated along with a positive control BI and the results recorded along with the CI results. A photo of the placement of the BIs and CIs for your records would assist in recording the results according to location of the BIs and CIs. 1 The packages should also be inspected for evidence of moisture. If moisture is observed, steps should be taken to remedy the problem. 1 These include changing the packaging, adjusting the loading or decreasing the amount of metal in the load, selecting a longer sterilization and/or drying time, or adjusting the unloading and cooling procedure. If any test results indicate a problem, an investigation should determine the cause. When the problem is corrected the items should be retested. It might be necessary to change the configuration of the load and/or items within the package or to service the sterilizer. Document in the sterilization records the 100 MANAGING INFECTION CONTROL

10 test protocol, the initial test results, corrective actions taken, and the final test results. Include product testing as part of a quality assurance testing program to ensure that routinely processed and new items are being effectively sterilized. Summary Did you learn something? Can you make changes that will improve the outcome of your sterilization process and patient safety? The AAMI and AORN Standards and Recommended Practices set a standard of practice for sterilization and sterility assurance in healthcare facilities. Use critical thinking skills, optimize processes without sacrificing quality, meet the most stringent recommended practices, and improve patient safety. References 1. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79: 2006 and A1:2008 (Consolidated text). 2. Hancock, Charles, O. What to do when you have a Bowie-Dick Test Problem. Managing Infection Control, January Association for the Advancement of Medical Instrumentation. Sterilization of health care products-chemical indicators-part 1: General requirements, ANSI/AAMI/ ISO : The Association of perioperative Registered Nurses (AORN) Recommended Practices for Selection and Use of Packaging Systems for Sterilization, Association of perioperative Registered Nurses. Recommended Practices for Sterilization in the Perioperative Practice Setting, Martha Young, BS, MS, CSPDT is a senior technical service specialist in the Sterilization Assurance group of 3M s Infection Prevention Division in St. Paul, Minn. She has more than 25 years of experience in the area of sterilization and disinfection. Ms. Young lectures around the world and has numerous publications on infection prevention with an emphasis on improving the performance of the sterilization process. She is a member of IAHCSMM, AORN (Professional/ Practice Issues Chair for AORN speciality assembly for Sterile Processing Materials Management) and APIC and a certified Central Sterile Processing and Distribution Technician. She is a member of several AAMI working group committees that are developing recommended practices and the special technical editor for the 3M sponsored inservice in Managing Infection Control. Ms. Young was named in 2007 by HPN as one of the 30 Pros to Know who are the most influential in healthcare sterile processing. Reprint with permission from Workhorse Publishing L.L.C. Copyright 2009/Workhorse Publishing L.L.C./All Rights Reseved MANAGING INFECTION CONTROL 101

11 Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for one and one-half (1.5) contact hours for a period of five (5) years from the date of publication. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until recertification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification contact: CBSPD, 121 State Hwy 31N, Suite 500, Flemington, NJ or call or visit the Web site at IAHCSMM has awarded one and one-half (1.5) Contact Points for completion of this continuing education lesson toward IAHCSMM recertification. Nursing CE Application Form This inservice is approved by the California Board of Registered Nurses, CEP 5770 for one (1) contact hour. This form is valid up to five (5) years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add the last 4 digits of your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ For questions or follow-up, contact craig@manageinfection.com. 8. Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) Position/Title Social Security or Nursing License Number Date application submitted ANSWERS 1. B 2. A 3. A 4. A 5. B 6. A 7. A 8. A 9. A 10. A Signature Offer expires January 2014 On a scale of 1-5, 5 being Excellent and 1 being Poor, please rate this program for the following: 1) Overall content 2) Met written objectives 3) Usability of content <01/09> MANAGING INFECTION CONTROL 105