Asked Questions 3M Sterilization Assurance Techline by Sandra Velte, BA, CSPDT FAQFrequently Objectives After completion of this self-study activity, the learner will be able to: 1. Develop a policy and procedure for monitoring implants based on recommended practices from the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of perioperative Registered Nurses (AORN) and guidance from the Centers for Disease Control and Prevention (CDC). 2. Explain the purpose of running a positive biological indicator control. 3. Identify the information related to the steam sterilization process that should be documented and maintained in a record keeping system. 4. Comply with the Environmental Protection Agency s (EPA s) final rule on ethylene oxide (EO) emissions from hospital sterilizers. 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 (1) contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for one (1) contact hour 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 86. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. Test Questions Circle the correct answer. 1. In the event of a positive biological indicator (BI) result, all loads back to the last negative BI must be recalled. 2. Physical monitors are recommended for all steam sterilizers, including table-top sterilizers in clinics. 3. A positive control BI should be incubated with every load that is tested with a BI. 4. AAMI ST79 recommends the use of Class 6 chemical indicators (CIs) for routine release of implants. 5. The Food and Drug Administration (FDA) regulates sterilization monitoring products and the companies that manufacture and sell them, but not the healthcare facilities that use them. 6. It is recommended to place peel pouches flat on the sterilizer rack. 7. AORN recommends placement of two internal CIs in opposite corners of each level of multi-level rigid containers. 8. The reason for flash sterilization should be documented for each flash cycle. 68 MANAGING INFECTION CONTROL
9. Sterilization records are legal documents that should be stored for seven years. 10. The new EPA final rule on EO emissions from hospital sterilizers requires hospitals to adopt a management practice of running full loads. An acceptable alternative to this management practice is the use of an air pollution control device, such as an abator. Introduction As a member of the 3M Sterilization Technical Services Team, my job responsibilities include answering the 3M Sterilization Techline. In my career, I have responded to thousands of telephone and e-mail inquiries from healthcare professionals from across the country. These inquiries are not limited to questions about 3M Sterilization Assurance products, but also include requests for information related to sterilization standards and recommended practices. Therefore, it is important that I am familiar with the most current industry standards, such as the updated AAMI standards that were published at the end of 2008: 1. ANSI/AAMI ST79:2006/A1:2008 Comprehensive guide to steam sterilization and sterility assurance in health care facilities and 2. ANSI/AAMI ST41:2008 Ethylene oxide sterilization in health care facilities: Safety and effectiveness. Staying up-to-date with the most current industry standards, plus being well-informed about new product introductions to the marketplace, can be a challenge for sterile processing professionals and a wide variety of questions are asked by callers to the 3M Sterilization Techline. Although I am continually asked questions I have never heard before, there are several topics that seem to come up over and over again. Answers to the following 10 frequently asked questions are discussed in this self-study lesson. 1. What is the recommended frequency for routine testing with a biological indicator? 2. How should I monitor a table-top steam sterilizer? 3. How often do I need to incubate a positive control biological indicator? 4. Can I use a Class 5 Integrating Indicator or Class 6 Emulating Indicator to release implants? 5. Does the FDA regulate how sterilization monitoring products are used in healthcare facilities? 6. What is the recommended procedure for loading peel pouches in the sterilizer? 7. How many chemical indicators should be placed inside multi-level trays? 8. What information should be documented for each steam sterilization cycle? 9. How long should sterilization records be retained? 10. What do I need to do to comply with the new regulation from the EPA related to EO sterilization? What is the recommended frequency for routine testing with a biological indicator? For steam sterilization, routine sterilizer efficacy testing with a biological indicator process challenge device (BI PCD) should be done weekly, preferably each day the sterilizer is used. If a sterilizer is designed to be used for multiple types of cycles (e.g., 270 F gravity flash, 270 F vacuum-assisted, 250 F gravity, etc.), then each sterilization cycle type used at a facility should be tested. Additionally, all loads containing implants should also be monitored with a BI PCD. In section 10.5.3.2 Using biological indicators, of AAMI ST79 it states: Biological indicators should be used within PCDs (see 10.5.4, 10.7.2.1, 10.7.3.1, 10.7.4.1) for routine sterilizer efficacy monitoring at least weekly, but preferably every day the sterilizer is in use (see 10.7). Additionally, BIs within PCDs should be used to monitor every load containing implants (see 10.6.1). 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. 1 NOTE If a sterilizer will run the same type of cycle (e.g., dynamic-air-removal at 132 C to 135 C [270 F to 275 F] for different exposure times (e.g., 4 minutes and 10 minutes), then only the shortest cycle time needs to be tested. 1 Additionally, each type of tray configuration used for flash sterilization should be routinely tested with a BI PCD or BI challenge test tray. In section 10.7.4 1 Composition of the PCD (BI challenge test tray) under 10.7.4 Routine biological monitoring of flash sterilization cycles, of AAMI ST79 it states: A representative of the same type of tray to be routinely processed through the flash sterilizer should be selected to serve as the PCD (BI challenge test tray). Each type of tray configuration in routine use for flash sterilization should be tested separately. 1 70 MANAGING INFECTION CONTROL
The recommended frequency for routine testing with BI PCDs for all sterilization methods are summarized in the table below. Note that the recommendation to monitor implant loads with a BI PCD and quarantine until the BI result is known is universal for all methods of sterilization used to process implantable devices. Table 1. Frequency of Routine Testing with Biological Indicators Sterilization Method Steam Frequency Weekly, preferably daily, and with each load containing implantable devices which should be quarantined until the BI results are available. 1,2 of weekly, preferably daily, for BI monitoring of steam sterilizers and monitor every load with a BI PCD. Reasons why facilities adopt an every load monitoring program include the following, to: provide the same standard of care for all patients; improve patient safety; ensure all implants are monitored with a BI; ensure all cycle types used are tested with a BI; ensure all types of packaging used in flash sterilization are tested with a BI; reduce the risk and cost of a recall; reduce the risk and cost of healthcare-associated infections (HAIs); and reduce variability and the chance for errors. Ethylene oxide Every load, including each load containing implantable devices which should be quarantined until the BI results are available. 2,3 To achieve the highest level of sterility assurance, monitor every load with a BI PCD. Low temperature hydrogen peroxide gas plasma Ozone Liquid peracetic acid Dry-heat Daily, preferably each load, and with each load containing implantable devices which should be quarantined until the BI results are available. 2,4 Daily, preferably each load, and with each load containing implantable devices which should be quarantined until the BI results are available. 2,4 Daily 2 Weekly, preferably daily, and with each load containing implantable devices which should be quarantined until the BI results are available. 2 In the event of a positive BI result, all items processed in that sterilizer since the last negative BI result should be recalled and reprocessed. In section 10.7.5.1 General procedure, of AAMI ST79 it states: The following actions should be taken if a BI tests positive: b) If it is determined that the sterilization failure was not the result of operator error (e.g., selection of the incorrect cycle), items processed in that sterilizer since the last negative BI result should be considered unsterile. They should be retrieved, if possible, and reprocessed (see 10.11). The sterilizer in question should be taken out of service. 1 To ensure the highest level of sterility assurance, many facilities go above and beyond the recommended frequency How should I monitor a table-top steam sterilizer? Many healthcare professionals in office-based settings believe that they are not subject to the same standards and guidelines as hospitals and surgery centers. This is not true. AAMI ST79 guidelines pertain to all healthcare facilities that perform steam sterilization including clinics and dental offices that use a table-top sterilizer. ST79 is a consolidation of five previous standards including ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities. Physical monitors such as recorders, displays, digital printouts and gauges that provide real-time measurements of time, temperature and pressure are a critical component of a steam sterilization monitoring program. After each cycle, a trained and knowledgeable operator should read and initial the physical monitor to verify that all cycle parameters were met. Some older model table-top sterilizers do not have physical monitors. According to section 10.5.1 of AAMI ST79, Sterilizers that do not have recording devices should not be used. 1 Like other types of steam sterilizers, table-top sterilizers should be monitored routinely with a BI PCD weekly, preferably every day the sterilizer is used. The BI testing of a table-top sterilizer is conducted in a fully loaded chamber. The BI PCD should be representative of the load contents and placed in the cold point or area least favorable to steam sterilization. This area is typically the center of the load toward the front of the chamber but varies with sterilizer design; therefore, the manufacturer of the sterilizer should 72 MANAGING INFECTION CONTROL
be consulted about placement of the BI PCD. All different cycle types used should be tested. For example, if a table-top sterilizer is used to run cycles at both 250 F and 270 F, then both of these cycles should be routinely tested with a BI PCD. There are no commercially available BI PCDs designed for table-top sterilizers so the user must make his or her own BI PCD that represents the most challenging package configuration in the load. The BI PCD should also contain one or more CIs and items normally present during routine sterilization. For example, if routine loads contain single instruments in peel pouches then the appropriate BI PCD is a BI and a CI along with a representative instrument in a peel pouch. If wrapped sets are also routinely processed, then a dummy wrapped set that contains a BI and one or more CIs and representative instruments should be used as the BI PCD. An internal CI should be placed inside each package and an external CI should be placed on the outside of each item, unless the internal CI is visible. External CIs are used to distinguish items that have been processed through the sterilizer from items that have not been processed yet. Internal chemical indicators provide information about whether or not the steam penetrated inside the package to the location of the instruments. The results of internal chemical indicators should be interpreted by trained and knowledgeable healthcare professionals at the point of use before the items are used for patient care. As with all other types of steam sterilizers, qualification testing of table-top sterilizers should be conducted after sterilizer installation, relocation, major repairs and malfunctions, and after sterilization process failures. For qualification testing of a table-top sterilizer, a representative BI PCD should be run in three consecutive full loads and the load items should be quarantined until the BI results are negative. A table-top sterilizer should be routinely tested with a representative BI PCD run in a full load in all types of cycles used. How often do I need to incubate a positive control biological indicator? First let s discuss why it is important to run a positive control biological indicator (BI). It is recommended by AAMI and AORN as well as BI manufacturers. Incubating a positive control BI for a visual color-change result ensures that: the temperature of the incubator or Auto-reader is correct; the viability of the spores has not been altered due to improper storage; temperature, humidity, or proximity to chemicals; and the culture media is capable of supporting growth. A positive control is a BI that is not sterilized; therefore, the spores should be viable. When the control yields a positive result, you are assured that you are challenging your sterilizer with viable spores and that your system is able to detect them. This is important because you want to be sure that you are able to detect any spores that survive the sterilization process. Running a positive control BI is good science it is the quality assurance step that ensures the test BI results throughout the day are accurate. AAMI ST79 recommends that you incubate a positive control every day a test BI is run. If several test BIs from the same lot are run on the same day, only one control BI from that lot needs be incubated so incubating a control for every load that is tested with a BI is not necessary. The lot number of the control must match the lot number of the test BIs. It is important that the control and test BIs have experienced the same shipping and storage conditions. If a new lot of BIs is opened during the day, a new positive control should be incubated. Keep in mind that if you run two types of BIs and have several incubators or Auto-readers you need to run a positive control for each BI type in each incubator or Auto-reader used that day. Each day a sterilizer is tested with a BI, a positive control BI from the same lot number should be incubated. Can I use a Class 5 Integrating Indicator or Class 6 Emulating Indicator to release implants? Facility polices and procedures should be based on standards and recommended practices from organizations such as AORN and AAMI and guidance from the CDC. Let s review what these recommended practices say about monitoring implants. AORN recommends that implantable devices be monitored with a biological indicator and quarantined until the BI result is negative. each load containing an implantable device should be monitored with a BI and quarantined until the results of the BI testing are available 2 AAMI ST79 recommends that implant loads be monitored with a BI PCD that also contains a Class 5 integrating indicator, 74 MANAGING INFECTION CONTROL
and that the load should be quarantined until the BI results are known. In section 10.6.1 Process monitoring devices, of AAMI ST79 it states: 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. 1 In section 10.6.3 Release criteria for implants, of AAMI ST79 it states: The load should be quarantined until the results of the BI testing are available (CDC, 2003a). 1 In the 2008 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, it states: Use biologic indicators for every load containing implantable items and quarantine items, whenever possible, until the biologic indicator is negative. 5 The reason that only biological indicators can be used to release implants is because BIs provide the only direct measure of lethality of a sterilization cycle. Biological indicators are the monitoring tool that provides the greatest challenge to the sterilization process because they contain a large population of spores that are highly resistant to steam sterilization. If the cycle is able to kill all the spores in the biological indicator, then you have the highest assurance that the bioburden on the items in the load was also killed. In section 10.5.3.1 General considerations, of AAMI ST79 it states: 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. 1 If it is not possible to quarantine the implant until the biological indicator is negative, because of a documented medical emergency, then the implant can be prematurely released on the result of the Class 5 CI in the BI PCD provided that all the other monitoring results were acceptable. In Annex L of ST79 two forms are provided an implantable devices load record to document all implant loads and an exception form to document premature release of implants before the BI results are known. The exception form documents: the name of the patient, the name of the implant, the name of the surgeon, the reason the implant was released early, and what could have prevented the premature release. ST79 clearly states that premature release of implants is unacceptable and should be the exception, not the rule. In the event of an emergency requiring flash sterilization of an implant, AORN recommends the use of a rapid-action BI and quarantining of the implant until the BI result is known. In an emergency, when flash sterilization of an implant is unavoidable, a rapid-action BI and a Class 5 chemical integrating indicator (or enzyme-only indicator) should be run with the load. The implant should be quarantined on the back table and should not be released until the rapid-action BI provides a negative result. 2 (Note: The enzyme-only indicator product has been discontinued and is no longer available.) Class 6 emulating indicators are not recommended to be used as a substitute for biological indicators for routine sterilizer testing, qualification testing, or load release of implants. AAMI ST79 was updated at the end of 2008 and the updated document contains no information about Class 6 emulating indicators. Each healthcare facility develops policies and procedures based on laws and regulations, current scientific knowledge, and accepted practice guidelines, and these policies and procedures should be consistent throughout the healthcare facility. It is necessary for facilities to follow written policies and procedures so they can obtain Joint Commission accreditation. An easy-to-use sterilization process monitoring program should follow the most stringent recommended practices, standards and guidelines set forth by organizations such as AAMI, AORN, and the CDC. Implant loads should be monitored with a BI PCD that contains a Class 5 integrating indicator and quarantined until the BI result is known. Does the FDA regulate how sterilization monitoring products are used in healthcare facilities? Sterilization monitoring products, defined by the FDA as Class II medical devices, are cleared for sale. The FDA s role is to assure that products sold in the United States are safe and effective when the manufacturer s instructions are followed. The FDA regulates sterilization monitoring products and the companies who make and sell them, but not the healthcare professionals who use them. Therefore, the FDA clearance process is limited to assuring safety and efficacy, and does not offer guidance on how sterilization monitoring products should be used. The specific use and frequency-of-use of sterilization monitoring products, such as biological and chemical indicators, are determined by healthcare professionals, such as sterile processing and operating room personnel, at each healthcare facility. 76 MANAGING INFECTION CONTROL
Healthcare professionals establish policies and procedures that describe the use and frequency-of-use for the sterilization monitoring products used at their facility. Written policies and procedures should be based on industry standards, guidelines, and recommended practices, such as those published by AAMI, AORN and the CDC. Electing to develop policies and procedures that deviate from standards or recommended practices should be approached with caution and should include evaluation of relevant scientific data, consideration of potential legal issues, and involvement of all stakeholders throughout the facility (e.g., infection control, risk management, surgeons). Healthcare facilities establish policies and procedures based on industry standards, guidelines, and recommended practices from AAMI, AORN and the CDC. What is the recommended procedure for loading peel pouches in the sterilizer? Paper-plastic pouches should be placed on edge in the sterilizer and oriented so that the paper side of one pouch faces the plastic side of the pouch next to it (see Figure 1). This ensures adequate steam penetration and air removal from each pouch. Only small, lightweight items should be packaged in peel pouches because heavy metal instruments can cause problems with drying and sterility maintenance (i.e., heavy objects can cause the package to tear). In section 8.5.2 Paper-plastic pouches, of AAMI ST79 it states: Paper-plastic pouches should stand on edge in relation to the cart or shelf, with the paper side of one pouch next to the plastic side of the next pouch; holding racks or baskets specifically designed for pouches can be used. 1 Additionally, AORN recommends that: Paper-plastic pouches should not be used within wrapped sets or containment devices because the pouches cannot be positioned to ensure adequate air removal, sterilant contact, and drying. 5 Due to the risk of inadequate air removal and steam penetration, it is not acceptable to use paper-plastic pouches inside wrapped trays or containers even if the pouch is not sealed. For the purpose of confining small items within wrapped or containerized sets, a packaging material that allows adequate air removal and steam penetration, such as a paper-paper pouch or wire mesh basket, should be used. It is always important to confirm that packaging materials are being used in accordance with the manufacturer s instructions and are FDA cleared for that usage. Double packaging with paper-plastic pouches is acceptable as long as the outside pouch is big enough to accommodate the inside pouch without folding and the packaging manufacture has FDA clearance for double packaging using their product. Folding of the inside pouch can cause sterilization process failures due to inadequate air removal and steam penetration. Both pouches should be sealed and oriented in the same direction (i.e., plastic facing plastic) (see Figure 2). Figure 1. Loading of paper-plastic pouches in sterilizer (placed on edge). Figure 2. Example of single- and double-packaging with paper-plastic pouches. Figure 9 (continued) Loading the sterilizer Reprinted from ANSI/AAMI ST79:2006 and A1:2008 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2008 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited. Figure 8 Example of single-and double-packaging with paperplastic pouches Reprinted from ANSI/AAMI ST79:2006 and A1:2008 with permission of Association for the Advancement of Medical Instrumentation, Inc. (C) 2008 AAMI www.aami.org. All rights reserved. Further reproduction or distribution prohibited. 78 MANAGING INFECTION CONTROL
In section 8.3.4 Paper-plastic pouches, of AAMI ST79 it states: If the item is to be double-packaged, two sequentially sized pouches should be used (i.e., the sealed inner pouch should fit inside the other pouch without folding). The pouches should be positioned so that plastic faces plastic and paper faces paper. 1 Figure 3. Example of multi-level rigid container with two chemical indicators in opposite corners of each level. Peel pouches should be placed in a rack or basket to allow them to be standing on edge and oriented so that paper faces paper and plastic faces plastic. How many chemical indicators should be placed inside multi-level trays? AAMI ST79 recommends an internal chemical indicator in each package, tray or rigid container system placed in the area least accessible to steam penetration. In section 10.5.2.2.2 Internal chemical indicators, of AAMI ST79 it states: The CI should be placed in that area of the package, tray, or containment device (rigid sterilization container system, instrument case, cassette, or organizing tray) considered to be least accessible to steam penetration; for a container system, the manufacturer s instructions for placement of the CI should be consulted. This location might or might not be the center of the package, tray, or containment device. 1 The packaging systems recommended practice of AORN offers the most detailed guidance on the placement of internal chemical indicators. The AORN guidelines for placement of internal chemical indicators are summarized below: The internal chemical indicator/integrator should be placed in the geometric center of the wrapped package, not on top. Two chemical indicators/integrators should be placed inside rigid containers, one in each of two opposite corners of the inside basket on each level (see Figure 3). A chemical indicator/integrator should be placed in the geometric center on each level of multi-level wrapped sets (see Figure 4). 6 Figure 4. Example of multi-level wrapped sets with chemical indicator in geometric center of each level. Two internal chemical indicators should be placed in opposite corners on each level of multi-level rigid containers. A chemical indicator should be placed in the geometric center of each level of multi-level wrapped sets. What information should be documented for each steam sterilization cycle? Each package must be traceable to the load in which it was sterilized. This is usually accomplished by labeling each package in 80 MANAGING INFECTION CONTROL
If the sterility of a load is later called into question, it is important that all of the packages from that load can be identified and pulled from use. each load with the sterilization date, the sterilizer number, and the load number. If the sterility of a load is later called into question, it is important that all of the packages from that load can be identified and pulled from use. In section 10.3.1 Lot control number, of AAMI ST79 it states: Each item or package intended for use as a sterile product should be labeled with a lot control identifier. The lot control identifier should designate the sterilizer identification number or code, the date of sterilization, and the cycle number (cycle run of the sterilizer). 1 Lot identification enables personnel to retrieve items in the event of a recall and to trace problems (e.g., wet packs) to their source. 1 AAMI recommends that the following information should be recorded and maintained for each sterilization cycle: the lot number; the specific contents of the lot or load, including quantity, department, and a specific description of the items (e.g., towels, type/name of instrument sets); the exposure time and temperature, if not provided on the sterilizer recording chart; the name or initials of the operator; the results of biological testing, if applicable; the results of Bowie-Dick testing, if applicable; the response of the CI placed in the PCD (BI challenge test pack, BI challenge test tray, or CI challenge test pack), if applicable; and any reports of inconclusive or nonresponsive CIs found later in the load. 1 The physical monitors (e.g., digital printout) for each cycle should be dated and signed by the operator and saved in the sterilizer records. Additionally, a log of repairs and preventive maintenance should be maintained for each sterilizer. Sterilizer and load information may be maintained in a paper or electronic record keeping system. In section 9.7 Record-keeping, of AAMI ST79 it states: A maintenance record, in either paper or electronic format, should be kept for each sterilizer The maintenance record should include sufficient information to identify the equipment and to establish a continuous history of all scheduled and unscheduled service. At least the following information should be recorded: the date on which service was requested; the model and serial number of the sterilizer; the location of the equipment (hospital identification, if applicable); the name of the individual from the health care facility who requested and authorized the service; the reason for the service request; a description of the service performed (e.g., calibration, repair); the types and quantities of parts replaced; the name of the person who performed the service; the date the work was completed; the handwritten or electronic signature and title of the person who acknowledged completion of the work; and the results of any post-maintenance testing performed, if needed, before the sterilizer was returned to service. 1 Even though labels are typically not used on flash sterilized items, a lot number should be assigned to each flash sterilization load and a load record should be documented for each flash cycle. According to AORN, sterilization records for each flash load should include the following information: the item(s) processed; the patient receiving the item(s); the cycle parameters used (e.g., temperature, duration of cycle); the date and time the cycle is run; the operator information; and the reason for flash sterilization. 2 AAMI ST79 emphasizes that implantable devices should not be flash sterilized. However, if flash sterilization of implantable devices is unavoidable due to an emergency situation, full traceability to the patient should be maintained. 1 Label each package with the date of sterilization, the sterilizer number, and the cycle number. How long should sterilization records be retained? In section 10.3.2 Sterilizer records, of AAMI ST79 it states: 82 MANAGING INFECTION CONTROL
The length of time that records must be retained varies throughout the country. Each health care facility is responsible for determining its recordretention policy based on state and local regulations, legal considerations (e.g., statutes of limitation for lawsuits), and its individual situation. Sterilization records should be retained according to the policy and procedure established by the individual health care facility. 1 Check with your risk management department to find out what the record-retention policy is at your facility. Each facility determines their own record-retention policy based on local laws and regulations. Legal considerations pertaining to any special circumstances are also taken into account. For example, a children s hospital may decide to keep their records longer than what is required by law. Each healthcare facility needs to determine its own record-retention policy based on local laws and regulations, legal considerations, and any special circumstances. What do I need to do to comply with the new regulation from the EPA related to EO sterilization? At the end of 2007, the U.S. EPA issued a final rule regulating emissions from hospital EO sterilizers. Under the new final rule, hospitals running EO cycles without an air pollution control device must sterilize full loads of items having common aeration time, except when running a partial load is medically necessary. The EPA recognizes that the practice of running full loads is being done at most facilities already. The use of an air pollution control device (e.g., 3M EO Abator) is an acceptable alternative to running full loads. If your hospital has an EO sterilizer without an air pollution control device, you must: Submit an Initial Notification of Compliance Status letter including: the name and address of your facility, the physical location of the EO sterilizer, a description of the EO sterilization done at your facility (such as typical number of sterilization cycles/year, etc.), and a statement that your facility will adhere to running full loads. Record the date and time of each EO sterilization cycle. Note any EO sterilization cycles that were not full loads, including an acknowledgement from a hospital CS staff member, administrator, or physician that it was medically necessary. If your hospital has an air pollution control device and is subject to state or local regulations, you must: Submit an Initial Notification of Compliance Status letter stating that you are operating the sterilizer in accordance with your state or local regulations and following the control device manufacturer s recommended procedures. If your hospital has an air pollution control device, but is not subject to state or local regulations, you must: Submit an Initial Notification of Compliance Status letter stating that you are venting the EO emissions from each sterilizer to an add-on air pollution control device and that this device is operating during all sterilization processes and in accordance with the manufacturer s recommended procedures. The compliance date for existing sterilizers was December 29, 2008 and upon start-up for new sterilizers. The Initial Notification Compliance Status letter is due 180 days after the compliance date. Use the following link to view the complete standard on the EPA s Web site. http://www.epa.gov/fedrgstr/epa-air/ 2007/December/Day-28/a25233.pdf To be compliant with the EPA final rule on EO emissions, a healthcare facility that uses EO sterilization must use a pollution control device or document that each load was full or medically necessary. Summary Healthcare professionals have many questions related to sterilization ranging from how to conduct a recall after a positive BI result to what is the recommended procedure for monitoring implant loads. Consulting industry standards, recommended practices, and guidelines from AAMI, AORN and the CDC will help you make the best choices for your facility and patients. Use the information in this selfstudy lesson to update your facility s polices and procedures to ensure you are following accepted practice guidelines, laws, and regulations as well as improving patient care. 84 MANAGING INFECTION CONTROL
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 (1) contact hour 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, Inc. 148 Main St., Lebanon, NJ 08833 or call 908-236-0530 or visit the Web site at www. sterileprocessing.org. IAHCSMM has awarded one (1) Contact Point 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 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 85255-9998 7. 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 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. Association of perioperative Registered Nurses (AORN). Recommended Practices for Sterilization in Perioperative Practice Setting, 2009. 3. Association for the Advancement of Medical Instrumentation. Ethylene oxide sterilization in health care facilities: Safety and effectiveness. ANSI/AAMI ST41: 2008. 4. Association for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58:2005. 5. Centers for Disease Control. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. 6. Association of perioperative Registered Nurses (AORN). Recommended Practices for Selection and Use of Packaging Systems for Sterilization, 2009. Sandra Velte, BA in Microbiology, is one of the voices at the 3M Sterilization Techline (800.441.1922 option 2). In this role, she answers technical questions about 3M products, troubleshoots sterilization process failures, and provides information related to sterilization best practices. Ms. Velte is a member of the Minnesota Healthcare Central Service Members Association (MHCSMA) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and is a certified Central Sterile Processing and Distribution Technician. Date application submitted Signature Offer expires June 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 ANSWERS 1. A 2. A 3. B 4. B 5. A 6. B 7. A 8. A 9. B 10. A Copyright 2009/Workhorse Publishing L.L.C./All Rights Reseved. <06/09> 70-2010-7275-1 Reprint with permission from Workhorse Publishing L.L.C. 86 MANAGING INFECTION CONTROL