MoreQuestionsAsked Understanding and following recommended practices in the sterilization process by Cynthia Hubbard, RN, BS, and Martha Young, BS, MS, CSPDT Objectives After completion of this self-study activity the learner will be able to: 1. Order documents from the Association for the Advancement of Medical Instrumentation (AAMI). 2. Discuss how to perform sterilizer qualification testing for flash or immediate use steam sterilization cycles. 3. Discuss how to perform routine sterilizer efficacy testing of table-top sterilizers. 4. Describe what actions to take when an internal chemical indicator has not reached its endpoint. Test Questions 1. Becoming certified is important to document your competency and verify your qualifications and workplace training which is required by regulatory and accrediting agencies. 2. Qualification testing in flash or immediate steam sterilization cycles requires that all types of cycles used be tested (gravitydisplacement at 132ºC to 135ºC [270ºF to 275ºF], gravitydisplacement 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], and flash with a single wrapper or other packaging). 72 healthvie.com
3. The BI PCD used in flash sterilization cycles is userassembled and made by placing a biological indicators (BIs) and chemical indicators (CIs) in the type of tray configuration normally used such as a perforated, meshbottom, open surgical tray or a rigid-sterilization container. 4. Steam sterilization processes should be routinely monitored with a biological indicator process challenge device (BI PCD) weekly, preferably daily (each day the sterilizer is used). 5. The more often you monitor steam sterilizers with a BI PCD the greater chance of detecting a sterilization process failure before a patient becomes involved. 6. Do not use a package if the internal chemical indicator (CI) suggests inadequate steam sterilization processing. 7. If the internal CI suggests inadequate steam sterilization processing. and the BI PCD results are not yet available, quarantine the remaining packages from the same load until the BI results are obtained. 8. Implants can be released based on the one and three hour FDA-cleared readout time for the 3M Attest Rapid Readout Biological Indicators. 9. Quaternary ammonium germicidal detergents can be used to clean surgical instruments. 10. Instrument trays with dirty instruments should not be used in the OR but returned to sterile processing to be re-cleaned and sterilized. Introduction This inservice will provide answers to more questions recently asked at seminars and webinars and to questions posed on the discussion forums of the International Association of Healthcare Central Service Materiel Management (IAHCSMM) and Association of perioperative Registered Nurses (AORN) Web sites (http://www.iahcsmm. org and AORN s online resource center http://www. ornurselink.org/ Pages/home.aspx). The information presented in the answers below is based on recommended practices from the Association for the Advancement of Medical Instrumentation (AAMI), AORN, and the Centers for Disease Control and Prevention (CDC). These recommended practices are the guidelines for the use, care, and/or processing of a medical device no matter where it is processed: the goal is always to ensure patient safety. Therefore, it is important that everyone involved in this process understands these recommended practices, is following policies and procedures, and is competent when performing all steps of the process. The patient is depending on you to provide a safe medical device for their use. Ordering AAMI Documents Many thanks to the team at 3M Health Care for working with healthvie.com to provide the following accredited course. IAHCSMM has awarded 1 contact point for completion of this continuing education lesson toward IAHCSMM recertification. The CBSPD has preapproved this inservice for 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 1 contact hour. This form is valid up to five (5) years from the date of publication. Instructions for submitting results are on page 90. healthvie.com and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of healthvie.com. QHow do I order the AAMI ST79 document? AOrdering information for ANSI/AAMI ST79: 2010 Comprehensive guide to steam sterilization and sterility assurance in health care facilities is below. This document will replace the ANSI/AAMI ST79: 2006, A1:2008, A2:2009 document. This document includes the previous amendments and additional information added after the A2:2009 amendments. This is the most complete recommended practice available on the market and should be in the library of anyone who is involved with processing medical devices for healthcare facilities. Abstract: This recommended practice covers steam sterilization in healthcare facilities. The recommendations are intended to promote assurance of sterility and to guide healthcare personnel in the proper use of processing equipment. Included within the scope of the recommended practice are functional and physical design criteria for sterilization processing areas (decontamination, preparation, 74 healthvie.com
sterilization, and sterile storage areas): staff qualifications, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizer; quality control; and quality process improvement. The member/list price is $120/$240. You may be able to purchase this document for less than the list price through the Association of perioperative Registered Nurses (AORN.org) or the International Association of Healthcare Central Service Materiel Management (IAHCSMM.org). Ordering Information ANSI/AAMI ST79:2010, Comprehensive guide to steam sterilization and sterility assurance in health care facilities Order code: ST79 or ST79-PDF Available in print or electronic format. AAMI documents can be purchased through AAMI by credit card using the following four options: 1. Internet: http://www.aami.org 2. Call: 1-877-249-8226 3. Fax: 1-301-206-9786 4. Mail: AAMI publications, PO Box 2011, Annapolis Junction, MD 20701-0211 A free PDF of future amendment(s) may be downloaded by visiting http://www.aami.org/publications/standards/st79.html. The A1:2010 amendment which is already part of the ST79: 2010 document provides the AAMI recommendations for the use of Class 6 emulating indicators. Order the ANSI/AAMI ST79:2010 version to ensure you have the most up-to-date information on the steam sterilization process. Certification QWhy should I become certified if I work in a sterile processing area? AYou should become certified to document your competency and verify your qualifications and workplace training as this is required by regulatory and accrediting agencies. (ANSI/AAMI ST79 Section 10.2.2) 1 Section 10.2.2 also states: It is recommended that all personnel performing sterile processing activities be certified as a condition of employment. At a minimum, all such personnel should successfully complete a central service certification examination within two years of employment and should maintain that certification throughout their employment. 1 As a sterile processing person you need to demonstrate competency in all aspects of sterile processing: Decontamination; Preparation; Sterilization; Sterile storage, and; Distribution of sterile medical devices. (ANSI/AAMI ST79 Section 4.2.2) 1 All preparation and sterilization activities should be supervised by a competent, qualified employee. If a Joint Commission or Centers for Medicare or Medicaid surveyor asks you if you are competent to perform processing tasks and if required to also determine the competence of other staff members how will you prove that? You will prove your competency by completing a sterile processing certification exam and maintain that certification throughout your employment. (ANSI/AAMI ST79 Section 4.2.2) 1 As a sterile processing supervisor you also need to demonstrate competency in: Cleaning methods and products; Containment of contaminated items; Sterilization and disinfection methods; Infection prevention, and; Standard/transmission-based (enhanced) precautions. (ANSI/ AAMI ST79 Section 4.2.2) 1 A supervisor also needs to demonstrate comprehensive knowledge of pertinent state and federal regulations such as those provided by the Occupational Safety and Health Agency (OSHA) and the department of Health (DOH). Information concerning certification of sterile processing supervisors, managers and technicians can be obtained from the following organizations: Certification Board for Sterile Processing and Distribution (CSSPD) 148 Main Street, Suite B-1, Lebanon, NJ, 08833 1-800-555-9765 http://wwwsterileprocessing International Association of Healthcare Central Service Materiel Management 213 Institute Place, Suite 307, Chicago, Ill. 60610 312-440-0078 http://iahcsmm.org Presently mandatory certification is only required if you work in the state of New Jersey but at least 12 more states are working toward mandatory certification. The information about 76 healthvie.com
states working on mandatory certification can be accessed on the IAHCSMM Web site (http://iahcsmm.org/mandatorycertification.html). Completion of a certification exam and continuing education helps maintain your competency and improve patient safety, which is necessary due to the importance of your role in providing products that are safe for the patient. Become certified to document your competency and verify your qualifications and workplace training as required by regulatory and accrediting agencies. Encourage and support your colleagues in becoming certified too. Flash or Immediate Use Steam Sterilization Cycles QWhen should I do sterilizer qualification testing in a flash or immediate use sterilizer? ASterilizer qualification testing using a biological indicator process challenge device (BI PCD) is performed after the same events occur in sterilizers greater than 2 cubic feet, for table-top sterilizers and for flash or immediate use sterilization cycles. This testing is done after: sterilizer installation and relocation to assess the sterilizer performance in the environment in which it will be used; sterilizer malfunctions and sterilization process failures if there is a major repair of the sterilizer or utilities to ensure the sterilizer is performing to specifications; > a major repair is a repair outside the scope of normal maintenance. This includes weld repairs of the pressure vessel, replacement of the chamber door or major piping assembly, or rebuilds or upgrades of controls. Normal preventive maintenance, such as the rebuilding of solenoid valves or the replacement of gaskets, is not considered major repair. Changes to the utilities connected to the sterilizer such as those that result from a water-main break, annual boiler maintenance, additional equipment loads and installation of new boilers should be treated as major repairs. (ANSI/AAMI ST79 Section 10.8.1) 1 ANSI/AAMI ST79 Section 10.8.1 states if a steam sterilizer is designed to be used for multiple types of cycles then: each type of cycle used should be tested to ensure all cycles are working before the sterilizer is placed into routine use; > gravity-displacement at 132ºC to 135ºC [270ºF to 275ºF], > 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. 1 If you are running both 4 and 10 minute cycles in a dynamic-air removal sterilizer at 132 C to 135 C [270 F to 275 F], then only the shortest sterilization time needs to be tested.(ansi/aami ST79 Section 10.8.1) 1 This would also apply if you are running both 4 and 10 minute cycles in a gravity-displacement sterilizer at 132 C to 135 C [270 F to 275 F]. Only the shortest sterilization time also needs to be tested. If for some reason you are running both dynamic-air-removal and gravity-displacement flash or immediate use sterilization cycles, then both of these types of cycles need to be tested at the shortest cycle length used. Each type of cycle needs to be tested because it creates a different challenge to air removal and steam penetration. The BI PCD will be user-assembled and should be representative of the tray configurations routinely used. For sterilizer qualification testing not every tray configuration used routinely needs to be tested as is required in routine sterilizer efficacy monitoring. So choose the tray configuration used most often or that creates the greatest challenge to air removal and steam penetration. These include: Perforated, mesh-bottom, open surgical trays; Rigid sterilization container systems; Protective organizing cases; and, Single-wrapped surgical trays. (ANSI/AAMI ST79 Section 10.7.4.1) 1 For example, if you use both perforated, meshbottom, open surgical trays and rigid sterilization containers during the day for flash or immediate use sterilization then use the rigid sterilization container as the BI PCD for sterilizer qualification testing. AORN suggests in the Recommended Practice for Selection and Use of Packaging, Recommendation IX, that CIs be placed inside the rigid sterilization container in two opposite corners and on each layer of the container. These are the areas where the BIs are also placed. 2 Be sure to read the BI manufacturers instructions for use to determine which BI is appropriate for which cycle you select. Some brands of BIs have different products for the 132 C to 135 C [270 F to 275 F] gravity-displacement and dynamic-air-removal steam sterilization cycle. See Figures 1 and 2 on page 80 for placement of the CIs and BIs. Note in these figures that different BIs are used for gravity-displacement and dynamic-air-removal sterilizers as noted by the difference in the color of the caps of the BIs The BI PCD should be placed on the bottom shelf of the sterilizer, over the drain, in an empty load to create 78 healthvie.com
Figure 1. Biological indicator process challenge device for flash or immediate use sterilization in gravitydisplacement sterilizers. Figure 2. Biological indicator process challenge device for flash or immediate use sterilization in dynamic-air removal sterilizers. the greatest challenge to air removal and steam penetration. The empty load minimizes the heat-up-time which minimizes the lethality of the process and creates a greater challenge to the BI. (ANSI/AAMI Section 10.8.4) 1 Run three consecutive empty test cycles. For dynamic-air-removal sterilizers Bowie-Dick testing is also performed in three consecutive empty cycles. The release of the steam sterilizer for routine use after sterilizer qualification testing should be an active decision based on the evaluation of all available data. An experienced and knowledgeable person should make that decision based on the results of the physical monitors, BI PCDs, and the Bowie-Dick tests, if applicable. Further information about sterilizer qualification testing is available at www.healthvie.com. 3 QIf I am running a perforated, mesh bottom, open surgical tray or rigid sterilization container in a large sterilizer, not in the small sterilizers between the OR suites and immediately transferring the load to the sterile field is this also flash sterilization? AYes, you are doing flash or immediate use sterilization if you are not using a dry time and the devices are going directly to the sterile field. ANSI/AAMI defines flash sterilization as a: Process designed for the steam sterilization of patient care items for immediate use. (ANSI/AAMI ST79 Definition 2.48) 1 A flash sterilization cycle is run at 132 C to 135 C [270 F to 275 F] in either a gravity-displacement or dynamic-air-removal sterilizers with a 0 to 1 minute dry time. (ANSI/AAMI ST79 Section 8.6.2) 1 The packaging used includes: Perforated, mesh-bottom, open surgical trays; Rigid sterilization container systems; Protective organizing cases; and, Single-wrapped surgical trays. (ANSI/ AAMI ST79 Section 10.7.4.1) 1 The size of sterilizer makes no difference. Flash or immediate use sterilization can be done in a sterilizer greater than 2 cubic ft., a table-top sterilizer or in the smaller sterilizers located between the OR or other treatment areas. A BI PCD should be run after a sterilizer is installed, relocated, and after a malfunction or a sterilization process failure that requires a major repair. Test each type of cycle used in flash steam sterilization with a BI PCD that is representative of the tray configuration routinely used and which creates the greatest challenge to air removal and steam penetration. Run the BI PCD in three consecutive empty cycles. If the sterilizer is a dynamic-air-removal sterilizer also run three BD tests. Release the sterilizer for routine use if the physical monitors are correct, the BIs are negative, and the BD tests show a passing result. Routine Sterilizer Efficacy Testing of Tabletop Sterilizers QWe use four table-top sterilizers and perform weekly biological indicator testing. Does it need to be done daily? ARoutine sterilizer efficacy monitoring establishes a regular pattern of testing the efficacy of the sterilization process. ANSI/AAMI ST79 Section 10.4 recommends steam sterilizers should be monitored with a BI PCD weekly, preferably daily (each day the 80 healthvie.com
sterilizer is used). 1 The advantage of running a BI PCD more often is the ability to detect sterilization process failures sooner and preventing more patients from coming into contact with nonsterile medical devices. It is all about the level of risk your healthcare facility is willing to assume. The more often you monitor with a BI PCD the more sterilization process failures you will detect. If you only monitor once a week and have a positive BI, you should recall all items processed in that sterilizer since the last negative BI and follow your facility s recall policy and procedures. How likely is it that you will be able to retrieve these items? Generally, the majority will already be distributed and used and it may be impossible to know which patients contacted many of the items. If you monitor these tabletop sterilizers daily with a BI, fewer items need to be recalled and fewer patients are involved. If you monitor every load with a rapid-readout BI PCD and quarantine the items until the BI is negative, then you will eliminate recalls, save time and frustration, and have no need to contact patients. In addition, if a BI PCD is used in each load this monitoring frequency meets the recommended practice requirements for routine sterilizer efficacy monitoring and takes the guess work out of knowing whether all implants and every type of steam sterilization cycle used is monitored with a BI PCD. Every load monitoring with a BI PCD also ensures consistency and detects operator errors which are the main reason for sterilization process failures. No matter the monitoring frequency schedule you choose for a BI PCD, ANSI/AAMI ST79 Section 10.7.1 states that if a steam sterilizer is designed to be used for multiple types of cycles then each type of cycle should be routinely tested because each cycle creates a different challenge to air removal and steam penetration. 1 Table 1 shows examples of different cycles run that need to be routinely tested and the appropriate BI PCDs to use for the load contents. The BI PCD will be user-assembled and should be representative of the same type of Table 1. BI PCDs for Routine Sterilizer Efficacy Monitoring of Table-Top Steam Sterilizers Program/Load Unwrapped instruments on a perforated instrument tray*** or glassware Wrapped trays of instruments, instruments in peel pouches Packs, wrapped Temperature 270 F-274 F (132 C-135 C) 270 F-274 F (132 C-135 C) 250ºF (121ºC) Time* 3 min 4 min 30 min BI PCD** BI in unwrapped perforated instrument tray or glassware BI in a wrapped tray or peel pouch and include porous items (e.g., towel, foam pad, etc.) if applicable BI in wrapped pack that is representative of the load, include porous items if appropriate *Check with the medical device or sterilizer manufacturer for correct times for the items being processed. **Check with the sterilizer and biological indicator manufacturer to make sure you are using the correct BI for the cycles being tested. ***Perforated or mesh bottom package or tray to be routinely processed and which is the most difficult to sterilize. See Figure 3 for examples of BI PCDs. (ANSI/ AAMI ST79 Section 10.7.3) 1 One BI PCD is placed on edge, if it is a small pack, or flat if it is a tray or large pack. The placement is in a full load in the areas that creates the greatest challenge to air removal and steam penetration (which is normally the front of the table-top sterilizer). The more often you monitor tabletop steam sterilizers with a BI PCD the greater chance of detecting a sterilization process failure before a patient becomes involved. Test each type of cycle used in a table-top steam sterilizer with a BI PCD that is representative of the load. Ensure that your recall policy and procedures are up-to-date. (ANSAMI ST79 Section 10.7.5) 1 Chemical Indicators QIf we find that an internal chemical indicator (CI) has not reached its endpoint in a sterilized package should we recall all packages from that load? AAs you know, the purpose of an internal chemical indicator is to provide a visual clue for the user that the sterilization medium has penetrated through the packaging, exposing the package contents to the sterilant, and achieving two or more critical parameters required for sterilization. As such, if interpretation of this internal process monitor suggests inadequate processing, the items should not be used. (ANSI/AAMI ST79 Section 10.5.2.2.2) 1 But, finding one non-responsive CI does not initially mean that all packages in the load must be recalled. Further investigation is needed to make a responsible decision. It is very important to call the sterile processing personnel when you find a non-responsive CI to tell them the lot control number of the affected cycle. Also, 82 healthvie.com
Figure 3. Examples of Biological Indicator Process Challenge Devices for table-top sterilizers. save all of the CIs, packaging materials and contents of the package for immediate review by sterile processing. It could be that this package had some special considerations that do not apply to other packages in the load, or it may be that there were inadequacies in the sterilization process that did affect the entire load contents. It could also be that the end user did not correctly interpret the results of the internal CI. The user should be trained and knowledgeable about the performance characteristics of the monitoring system and should demonstrate competency. (ANSI/AAMI ST79 Section 10.5.2.2.2) 1 Sterile processing will start their investigation by reviewing the cycle printout and contents list from the affected load. They will review the distribution of the load. Some of the factors that influence the effectiveness of the sterilizing process are the cycle settings (time, temperature, etc.); the presence and quality of the sterilant; packaging; the density, weight and configuration of the tray/package; placement of items in the sterilizer and function of the sterilizer itself (leaking door gasket, pump or valve malfunction, etc.). Additional factors to consider when analyzing the cause of a non-responding CI are the correct storage, the shelf life of the product (do not use a CI if it is not within its shelf life), and placement of CIs. (ANSI/AAMI ST79 Section 10.7.5 Table 8 Checklist for identifying reasons for steam sterilizer process failures) 1 The pass response of a CI does not prove that the item monitored by the indicator is sterile. The use of CIs is part of an effective quality assurance program; they should be used in conjunction with physical monitors and BIs to demonstrate the efficacy of the sterilization process. All CIs should be used in accordance with the CI manufacturer s instructions. (ANSI/ AAMI ST79 Section 10.5.2.1) 1 As sterile processing reviews these factors and investigates how they apply to the particular load, it will become clearer how the rest of the load should be handled. This decision should be based on the results of physical monitoring (time and temperature recordings), the results of internal CIs elsewhere in the load, and, if applicable, the results of any PCDs in the load (a PCD containing a BI, a PCD containing a BI and a Class 5 integrating indicator, or a PCD containing a Class 5 integrating indicator or a Class 6 emulating indicator). If the results of a PCD containing a BI are not yet available, the remaining packages from the same load should be quarantined and not used until the BI results are obtained. (ANSI/AAMI ST79 Section 10.5.2.2.2) 1 In summary, the investigation will focus on identifying any operator errors in packaging, loading or cycle selection and malfunctions in the sterilizer and utilities. A few other packages like the one in question can be opened to check the internal process monitoring CIs. If these packages demonstrate CIs that do not reach the endpoint this information is also weighed in the ultimate decision regarding the safety of the load and advisability of recall. Do not use a package if the internal CI suggests inadequate steam processing. Ensure that education about how to correctly interpret process monitors is part of the general orientation and annual competency testing for all personnel in sterile processing and clinical environments in which sterile packages are used. If process monitoring products are changed, appropriate education must be disseminated and competency documented for the new products. If the results of a PCD containing a BI are not yet available, the remaining packages from the same load should be quarantined and not used until the BI results are obtained. 1 Investigate the reasons for the CI failure using Table 8 in ANSI/AAMI ST79. Retrain sterile processing personnel in the factors which cause operator errors, such as the packaging of devices, loading of the sterilizer and cycle selection. If there are multiple incidents of the same tray or set showing CIs that do not reach their end point, further investigation is definitely needed for this product. The packaging may be incorrect, the contents too dense or heavy, or the cycle length ineffective for sterilization. 84 healthvie.com
If you monitor every load with a rapid-readout BI PCD and quarantine the items until the BI is negative, then you will eliminate recalls, save time and frustration, and have no need to contact patients. Monitoring Implants QOur Attest biological indicator process challenge pack gives a readout at three hours but the true readout is 48 hours. So is the three hour time frame appropriate or do we need to wait to release the implant load at 48 hours? AYou do not need to wait 48 hours to release the implant because the final FDA-cleared readout time for this product is three hours. This readout time is addressed in the 3M Attest 41382/41382F Rapid 5 Steam-Pack Test Pack package insert in the Processed Biological Indicators section: In the Attest 290 Auto-reader periodic readings are automatically taken and positive results are provided as soon as they are obtained. A positive fluorescent result (red light or +) will be detected within 3 hours and indicates a sterilization process failure. The load should not be used and a recall should be initiated back to the last negative biological indicator. The final negative reading (green light or -) is made in 3 hours and indicates an acceptable sterilization process. Record the fluorescent results and discard the processed biological indicator. 4 The package insert also has an Optional Visual Color Change Result section which states: The processed Attest biological indicator may also be further incubated at 60ºC for a visual ph color change, when special studies are desired. 4 Finally, the Product Description area of the same package insert says: Due to the accuracy of the fluorescent results, however, there is no advantage to incubating the Attest 1292 Rapid Readout Biological Indicator beyond 3 hours. 4 For all of the following 3M Attest Rapid Readout Biological Indicator products the final readout is 3 hours: 3M Attest 41382/41382F Rapid 5 Steam-Plus Test Pack; 3M Attest 1296/1296F Rapid Readout Biological Indicator Steam Pack; 3M Attest 1292 Readout Biological Indicator. The final readout time for the 3M Attest 1291 Rapid Readout Biological Indicator is one hour. With the one and three hour readout time it is possible to meet the recommendations from AAMI and AORN to quarantine implants until the biological indicator results are available. (ANSI/AAMI ST79 Section 10.6.3 and AORN Recommendation XVI,h.2.) 1,5 The final readout time for the 3M Attest 1291 Rapid Readout Biological Indicator is one hour and the final readout time for the 3M Attest 1291 Rapid Readout Biological Indicator is three hours. Implants can be released based on the one and three hour FDA-cleared readout time for the Attest rapid readout BIs. Cleaning QIs it appropriate to use a quat to clean instruments? ANo, it is not appropriate to use a quat to clean instruments. The Centers for Disease Control and Prevention (CDC) states in the Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 in Table 1 on p. 104 that quaternary ammonium germicidal detergents are low-level disinfectants used to process noncritical items that will come in contact with intact skin. 6 This includes mechanical equipment surfaces and patientcare surfaces such as bedrails and over-the-bed tables. Surgical instruments are critical items that will enter tissue or vascular system or blood will flow through them. (CDC Table 1, p. 104) 6 They require sterilization but must be cleaned with water and a detergent or water and enzymatic cleaners before the sterilization procedures. (CDC C. Recommendations 2.b., p 83) 6 The manufacturer of the devices being cleaned should provide you with instructions on how to clean those instruments before they are sterilized. Section 7 in ANSI/ AAMI ST79 provides information on the cleaning process that can be used to develop or update policies and procedures. The information addressed in this section includes: Policies, procedures and manufacturers instructions; Presoaking; Disassembly; Cleaning; Microbicidal processes; and, Terminal sterilization processes to prepare devices for the next patient use. 1 86 healthvie.com
If process monitoring products are changed, appropriate education must be disseminated and competency documented for the new products. QIf a tray is opened in the OR and you see bone chips on the reamer can you use the rest of the instruments in the tray? A2No you cannot use the rest of the instruments in the tray. According to Ramona L. Conner, MSN, RN, CNOR, manager, Standards and Recommended Practices of AORN: The presence of bone chips or any other debris on sterilized instruments creates doubt as to whether the device is actually sterile. The first critical step in sterilization is known to be cleaning and decontamination. Bone chips clearly demonstrate that this critical step in the sterilization process was not effective. If the reamer was not cleaned properly, you cannot have confidence that the other instruments in the set were cleaned properly either, even though it may not be as visibly evident as bone chips on a reamer. The old adage when in doubt, throw it out should apply in this instance. 7 Instruments should be cleaned according to the instrument manufacturers instructions for use with water and a detergent or water and enzymatic cleaners before the sterilization procedures. Instrument trays with dirty instruments should not be used in the OR but returned to sterile processing to be re-cleaned and sterilized. Instrument inspection (under lighted magnification) of hard-to-clean instruments, such as those used in orthopaedic and cardiac surgery, should be done prior to assembly and packaging. Any dirty instruments should be returned to decontamination for further cleaning. Instrument cleaning starts in the OR with proper handling during the surgical procedures to remove gross soils. Products such as foam enzymatic pre-cleaning products applied in the OR are also very helpful to keep instruments moist until they can be cleaned in the decontamination area. Summary The recommended practices from AAMI, AORN and CDC provide excellent guidelines for the use, care, and/or processing of medical devices. No matter where they are processed, the goal of ensuring patient safety should be foremost in our minds. It is very important that everyone involved in reprocessing understands these recommended practices, is following policies and procedures and competently performing all steps of the sterilization process. The patient is depending on you to provide a safe medical device and thus prevent infections. You are invited to submit additional questions to marthalyoung1@aol.com. References 1. Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2010. 2. Association of perioperative registered Nurses. Recommended Practices for Selection and Use of Packaging Systems for Sterilization. Perioperative Standards and Recommended Practices. 2010. 3. Young, Martha. Sterilizer Qualification Testing Using Process Challenge Devices. healthvie.com. July 2010. 4. 3M Attest 41382/41382F Rapid 5 Steam-Plus Test Pack package insert. @3M 2009. 5. Association of perioperative Registered Nurses. Recommended Practices for Sterilization in the Perioperative Practice Setting. Perioperative Standards and Recommended Practices. 2010. 6. Centers for Disease Control and Prevention. Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008. 7. Personal communications by email on 8/18/2010 from Ramona L Conner MSN, RN, CNOR, Manager, Standards and Recommended Practices of AORN. Cynthia Hubbard RN, BS, is an author and independent nurse consultant. She has worked in the healthcare industry for more than 30 years, including positions in ER nursing, occupational health nursing, materials management, and central service management at Saint Mary Hospital-Mayo Clinic in Rochester, Minn. Ms. Hubbard was a design consultant on national and international construction projects related to sterile processing, materials and waste management for 14 years with the Lerch Bates Hospital Group of Littleton, Colo. After moving to Washington State in 2003 Ms. Hubbard served as the sterile processing manager at Sacred Heart Medical Center in Spokane during their most recent surgical building addition. She is a recipient of the ASHCSP Educator of the Year Award. 88 healthvie.com
Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code Martha Young, BS, MS, CSPDT, is president of Martha L. Young LLC, providing SAVVY sterilization solutions to healthcare manufacturers and facilities and a consultant for 3M. She recently retired from the 3M Infection Prevention Division, St. Paul, Minn. after 31 years and has more than 28 years of experience in the specialty area of sterilization and disinfection. Ms. Young has lectured around the world, has numerous publications on infection prevention with an emphasis on how to improve the performance of the sterilization process, and is a technical advisor for healthvie.com and writes a quarterly column for OR Manager. She is a member of IAHCSMM, AORN (past professional/ practice issues chair for AORN Speciality Assembly for Sterilization Processing and Materials Management from 2006-2010), APIC and a certified central sterile processing and distribution technician. Additionally, Ms. Young is a member of several AAMI working groups developing recommended practices. In 2007 HPN acknowledged her as one of the 30 Pros Worth Knowing who are the most influential in healthcare sterile processing. Ms. Young can be reached at marthalyoung1@aol.com. The CBSPD (Certification Board for Sterile Processing and Distribution) has pre-approved this inservice for 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, 148 Main St., Lebanon, NJ, 08833 or call 908-236-0530 or 800-555-9765 or visit the Web site at www.sterileprocessing.org. IAHCSMM has awarded 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 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: TKMK 3M Sterilization Media, LLC Assurance, Attn HC4160 healthvie.com RR Donnelly Fulfillment Services PO 585 Box Hale 25310, Ave N, Scottsdale, Oakdale, MN AZ 55128-9935 85255-9998 7. For questions, contact craig@firstaccessmedia.com. 8. Participants who score at least 70% will receive a certificate of completion within 30 days of healthvie.com 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. A 2. A 3. A 4. A 5. A 6. A 7. A 8. A 9. B 10. A Signature Offer expires Nov. 2015 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 <11/2010> Copyright 2010-2011/TKMK Media L.L.C./All Rights Reseved. Reprint with permission from TKMK Media L.L.C. 90 healthvie.com