Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use

Transcription

1 Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use by Donald P. Satchell, Ph.D. Objectives After completion of this self-study activity, the learner will be able to: 1. Understand the importance of reading and understanding the manufacturer s label on the high-level disinfectants and chemical sterilants (liquid and gas) being used in their facility. 2. Wear the appropriate personal protective equipment (PPE) for routine protection. 3. Write a policy and procedure for routine monitoring of highlevel disinfectants (HLD), liquid chemical sterilants (LCS) and gaseous chemical sterilants (GS). 4. Understand the purpose of manual verification tools used for liquid and gaseous chemical sterilants and high-level disinfectants discussed in the new Association for the Advancement of Medical Instrumentation standard, Chemical Sterilization and High-level Disinfection in Health Care Facilities ST58:2005. 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 re c e rt i f i c a t i o n. The CBSPD has pre a p p roved 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 f rom the date of publication. Instructions for submitting results are on page 97. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. 82 MANAGING INFECTION CONTROL

2 Test Questions True or False 1. Pre-cleaning of medical devices is recommended for some high-level disinfectants (HLDs) and liquid chemical sterilants (LCSs). 2. Safe use and handling requirements of chemicals are the same for all HLDs and LCSs. 3. Some HLDs and LCSs require activation prior to being used. 4. All chemical disinfectants can be classified as sterilants. 5. Personal protective equipment (PPE) is the only required safety feature recommended for use of HLDs, LCSs and GSs. 6. Once the medical device is disinfected or sterilized, PPE is no longer necessary. 7. Room ventilation at a rate of 10 air exchanges per hour is the most common facility requirement to minimize indirect HLD or LCS exposure. 8. An appropriate test strip or chemical monitoring device should be used to test the minimum recommended concentration (MRC) or minimum effective concentration (MEC) of an HLD or LCS before each use. 9. Gaseous chemical sterilants should be tested with a biological indicator in a process challenge device (PCD or test pack) at least daily and preferable in each load. 10. Reusable HLDs and LCSs can be used repeatedly as long as the expiration date has not been reached. High-Level Disinfectants (HLD), Liquid Chemical Sterilants (LCS) and Gaseous Chemical Sterilants (GS) Application Scope The objectives of this article are to introduce the new ANSI/AAMI ST58:2005 standard Chemical Sterilization and High-level Disinfection in Health Care Facilities; provide a summary of the topics covered by this new standard; and highlight the recommended practices for high-level disinfectants (HLD), liquid chemical sterilants (LCS), and gaseous chemical sterilants (GS). Training questions are provided that cover specific topics reviewed in this article. These questions are included to emphasize the key points about the topics being covered and to allow readers to reflect on their understanding of these topics relative to their specific work settings. Reuse of medical devices is a necessity in all healthcare facilities. As technology drives the invention of more sophisticated medical devices, cost control measures increasingly add pressure for the repeated use of these medical tools. Fortunately, technical innovations are also creating new products to facilitate the cleaning and decontamination of these tools. Prior to reuse, medical devices contaminated by potentially pathogenic organisms such as bacteria or viruses must first be disinfected or sterilized. The level of decontamination required depends on the intended use of the medical device. This intended use is divided into three categories: noncritical, semicritical and critical medical devices. The Food and Drug Administration (FDA) has regulations governing medical device high-level disinfection and sterilization. All HLDs, LCSs and GSs, as well as equipment that may use HLD and LCS products, exist in the regulatory domain of the FDA. In order for HLDs, LCSs and GSs to be used on medical devices, they must meet strict requirements for approval by the FDA. Such requirements are necessary to determine that these products meet basic criteria against which all such medical devices are compared. 1 Meeting standard test conditions assures that, with proper use and handling, the HLD, LCS and GS will provide the indicated performance required for cleaning and disinfecting of equipment being treated. Equally important as the approval of these products by the FDA is that the recommended practices for their use be consistently followed to ensure that expected disinfection performance is achieved and that the safety of the healthcare professionals is assured. Since HLDs, LCSs and GSs vary widely in their safe and recommended use patterns, the Association for the Advancement of Medical Instrumentation (AAMI) has developed a new unified standard for recommended practices and safe use of chemical HLDs, LCSs and GSs to reenforce this imperative. 2 Close attention to the specific product being used is important since the nature of the chemistry, the associated equipment being used for a given type of chemical product, and safe handling methods for each of the devices can vary considerably. Factors such as available personal protective equipment (PPE), environmental limitations of a medical facility, types of monitoring devices, work practices, annual training and recommended disposal procedures are all highly specific for any particular HLD, LCS or GS. The new A N S I / A A M I ST58:2005 Chemical Sterilization and High-level Disinfection in Health Care Facilities standard is written to address these issues. It details the appropriate requirements and procedures to provide the healthcare professional with a solid foundation for in-service use of these products and a concise resource to address concerns or questions regarding these issues. The FDA provides the regulatory parameters and device intended use definitions to guide manufacturers and healthcare professionals in determining the level of decontamination required for a particular medical device and the criteria for the defined levels of disinfection and sterilization. 3 A liquid chemical sterilant or high-level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semicritical medical devices prior to patient use. Critical devices make contact with normally sterile tissue or body spaces during use. Semicritical devices make contact during use with mucous membranes or nonintact skin. 84 MANAGING INFECTION CONTROL

3 High Level Disinfectant: A germicide that inactivates all microbial pathogens, except larg e numbers of bacterial endospores, when used a c c o rd i n g to labeling (Rutala, 1990; Spaulding, 1970). The FDA further defines a high level disin - fectant as a sterilant used under the same contact conditions except for a shorter contact time. Sterilant: An agent that destroys all viable forms of microbial life. AAMI provides a clearer definition of the criteria and conditions necessary for disinfection or sterilization, and helps in our understanding of these criteria by defining the type of organisms used in the certification testing and evaluation of HLDs, or chemical sterilants (LCS or GS). The conditions given on the product label for high-level disinfection or sterilization are determined by the manufacture r. The labeled conditions for high-level disinfection are the time and temperature re q u i red to achieve a six-log reduction of an appropriate Mycobacterium species, such as M. bovis BCG or M. terrae, that has resistance characteristics similar to those of the human strain of M. tuberculosis under the conditions specified in the recommended test protocol. For most FDA-cleared sterilants or HLDs, the labeled contact conditions for sterilization are the contact conditions re q u i red to pass the A O A C Sporicidal Activity Test as a sterilant (i.e., to pass the test with no failures). 2 These two definitions emphasize that sterilants and HLDs are products tested to assure complete and safe removal of microbial contamination in a manner that is matched to the intended use of a given medical device (semicritical or critical). In addition, for FDA approval, these devices need to pass a series of evaluations under certified laboratory conditions to demonstrate their safety and eff e c t i v e n e s s. 1 Once done, it becomes the healthcare professional s responsibility to assure compliance with the manufacturer s recommended use instructions. These instructions can be obtained for any HLD, LCS or GS from the manufacturer and are also included on the labels of products intended for this use. Additional in-service details of the products and their safe and effective use may not be provided by the manufacturer, which is why AAMI has established its own in-service document to address these issues. AAMI has created a uniform list of recommendations covering the safety, necessary competence and specific use consideration that are necessary for all HLDs or LCSs and GSs. AAMI has previously standardized the recommended practices for these devices in two separate documents. 4, 5 In ANSI/AAMI ST58:2005 Chemical Sterilization and High-level Disinfection in Health Care Facilities, these standards present comprehensive coverage of all the approved HLD or LCS chemistries and gaseous chemical sterilants used in a sterilizing device, including revised recommendations for safe use, quality control technology, training assessments, in-service training qualifications, regulatory recommendations, and chemical material and compatibility recommendations. Additional guidelines are provided for the safe handling and stewardship of these chemicals, an essential element of the in-service document because it emphasizes both the safety of the healthcare professionals working with these devices and the safety of the patient services being provided by these devices. Examples of FDA-Cleared HLDs, LCSs and GSs There are currently eight general HLD, LCS or GS chemical categories that have clearance for use as a HLD, LCS or GS (Table 1). The basis for this categorization is linked to the specific chemical type for these products. It is important to understand that the use requirements of individual products within the same chemical category may vary. It may be helpful to remember that manufacturers of each product within e a c h chemical category strive to differentiate their products from the others. Ease of use, treatment conditions, cycling time, s t a b i l i t y, safety and costs are all considerations that manufacturers are trying to optimize. These product differences need to be recognized and understood to ensure that the selected HLD, LCS or GS product is used both on the appropriate medical device and in the appropriate manner. Examples of these product differences include product activation requirements, storage conditions, reusable lifetimes and neutralization requirements prior to disposal. Chemical d i fferences between the different HLDs, LCSs and GSs can have very different and sometimes deleterious effects on the materials (stainless steel, glass, etc.) of medical devices being treated. In addition, the required treatment conditions or device preparation (wrapped or unwrapped, heat sensitivity, etc.) can vary significantly for different HLD or LCS with specific medical devices. The details of the product categories covered in Table 1 on page 87 are listed in ANSI/AAMI ST58:2005 C h e m i c a l Sterilization and High-level Disinfection in Health Care F a c i l i t i e s, but specific details for a given product s use and limitations must be determined from the manufacturer s product label. Also, as identified in Table 1, some of the chemical products may be listed as an HLD (for treatment of semicritical devices), as a sterilant (for treatment of semicritical or critical medical devices), or both. Products listed as both an HLD and a sterilant will require different treatment conditions for the MANAGING INFECTION CONTROL 85

4 Table 1. Device Type Glutaraldehyde Hydrogen Peroxide 1 Ortho-phthaladehyde Peracetic Acid and or Hydrogen Peroxide 2 Sodium Hypochlorite Chemical Vapor with Formaldehyde Hydrogen Peroxide Gas Plasma Ozone Gas Current FDA-Cleared High-Level Disinfectants and Sterilants Number of Registered Products* Sterilization High-level Disinfection respective level of decontamination to be achieved. The manufacturer s label is the best source for the most current information. Also listed in Table 1 are the relative numbers of products currently registered for each device type along with their intended use profile as a sterilant and/or HLD. A range of products are readily available for use in small and large facilities, and the number of such registered devices provides a perspective on the number of chemical variants being employed for high-level disinfection and sterilization use. This table does not define the numerous application types associated with the different chemical categories. In general, many of the products listed can be used in a manual solution bath or in appropriate automated equipment, but prior to this use it must be determined that the intended product is approved for a selected application. 86 MANAGING INFECTION CONTROL

5 An advantage for many solution chemistries is the relative low cost for implementation due to the low hardware requirements and, for some of the solutions, their general medical device component compatibility. There are several solution chemistries that are commonly used for highlevel disinfection and/or sterilization. Glutaraldehyde-based solutions are the most prevalent and have a long history of use as HLD and LCS products. Peracetic acid and hydrogen peroxide solutions (or mixtures thereof) and aldehyde (glutaraldehyde or ortho-phthaladehyde) based products can be used as in-bath solutions or in automated reprocessing equipment. A key benefit of either peracetic acid or hydrogen peroxide is that disposal concerns are relatively minimal. For all of these product formulations, the range of compatible materials must be closely monitored because the proportions of the active ingredients in a chemical formulation can vary s i g n i f i c a n t l y. Some formulations require activation prior to their use and once activated can be reused for only a predetermined period of time. Other formulations may not require activation, such as ortho-phthaladehyde and some glutaraldehyde formulations, but the open bottle reuse duration as defined by the manufacturer must be followed. Sodium hypochlorite is an active disinfectant that has the longest history as a general disinfectant. Technology is now being applied to allow for the use of common salt solutions to create the active ingredient hypochlorous acid, bridging new technology development with older chemistries for liquid chemical sterilization of solid, heat-sensitive materials and equipment. Other related technologies include hydrogen peroxide ionization and gaseous sterilants (GS) by ozone gas generation. Each of these devices generates the active chemical sterilant within the automated device from other materials (H 2 O 2 or O 2 respectively) as the processing cycle initiates. Irrespective of the chemical selected or the sophistication of the equipment, successful processing relies on the healthcare provider to manage appropriate use of the HLD, LCS and GS by ensuring the compatibility of the medical equipment and to employ the proper precleaning and process verification. 88 MANAGING INFECTION CONTROL

6 Minimizing Exposure, Maximizing Safety In an attempt to address the growing challenge of improving safety recommendations, while recognizing and balancing in-service realities, ANSI/AAMI ST58:2005 document provides a clear plan for minimizing exposure to HLDs, LCSs and GSs through recommended practices and the use of appropriate personal protective equipment (PPE). All manufacturers of HLDs, LCSs and GSs recommend the use of PPE and, as may be expected, different types of chemical products and disinfecting equipment may require diff e r e n t types of PPE (Table 2 on page 92) or PPE made of specific types of material. In addition to direct exposure concerns, vapor or fumes can be released from these products such that proper ventilation of the assigned rooms used for performing disinfection or sterilization processes or tasks is recommended. PPE is intended to be the primary barrier that protects individuals through the handling and processing of the contaminated medical equipment, including the decontamination steps performed by manual application of an HLD or LCS. The PPE represents a barrier between potentially harmful chemical exposure (from splashes or droplets), and physical hazards (burns) for face, eyes and skin. Standard protective equipment includes chemical goggles, face shields and gloves. PPE is also designed to protect the healthcare professional from potentially biohazardous material derived from contaminated medical devices. Safe use of HLDs, LCSs and GSs requires an evaluation of the exposure and duration conditions prior to use. Recommended PPE is listed in Table 2 on page 92 for Standard protective equipment includes chemical goggles, face shields and gloves. 90 MANAGING INFECTION CONTROL

7 r o u t i n e exposure conditions. It must be noted that if nonroutine exposure conditions occur (such as for handling spills, new types of equipment, or sharps), additional precautions are w a r r a n t e d. 6 I m p o r t a n t l y, PPE is also intended to protect the healthcare provider from any residual material or hazards present on or in a processed medical device. Prior to thorough rinsing or neutralization, the presence of residual HLD/LCS chemistry is very likely, both on the outside of the device and also potentially residing within the luminal spaces of the medical equipment, such as found in endoscope equipment. Proper PPE must be worn during all phases of the medical device cleaning. Identification of the proper PPE is only part of the challenge for the healthcare providers using HLD, LCS or GS products and equipment. The ANSI/AAMI ST58:2005 standard addresses these challenges by recommending procedures for when and how to effectively use this equipment. It identifies the specific issues associated with a particular hazard, the appropriate PPE types, and situational issues such as nonroutine spill containment, safe disposal, HLD or LCS neutralization, and emergency treatment in case of accidental exposure. Equally important topics include the types and appropriate application of different PPE materials such as glove construction (recommending nitrile and butyl rubber as opposed to latex), and the safe use conditions for a given type of PPE. Recommended use conditions for several of the HLDs and LCSs utilize open tray or other types of open containers. Although properly used PPE will protect the healthcare professional from direct contact from these chemicals, indirect exposure and the hazards of indirect exposure must be minimized in a safe work environment. All manufacturers of HLDs and LCSs used either in an open tray system or in enclosed automated equipment recommend operation of these devices in a well-ventilated environment. ANSI/ AAMI ST58:2005 Chemical Sterilization and High-level Disinfection in Health Care Facilities recommends a minimum ventilation of 10 air volume changes per hour, but additional optimizations are also recommended (such as overhead fume hoods) pertaining to each of the specific HLD or LCS devices. In addition, exposure limits such as the threshold limit value MANAGING INFECTION CONTROL 91

8 Table 2. Recommended Personal Protective Equipment (PPE)* Device Type Minimum PPE Recommended [1] Ventilation Recommended [2] Vapor Monitoring Recommended PPE Recommended Operations [3] Note Glutaraldehyde G, E, F A, P, I, T, S, R, H Minimize splashing Rinse thoroughly Hydrogen Peroxide G, E, F P, I, T, S, R, H Minimize splashing Rinse thoroughly Hydrogen Peroxide - Peracetic Acid G, E, or F P, I, T, S, R, H Minimize splashing Rinse thoroughly Ortho-phthaladehyde G, E, or F P, I, T, S, R, H Minimize splashing Rinse thoroughly Peracetic Acid G, E, or F P, I, T, S, R, H Minimize splashing Rinse thoroughly Sodium Hypochlorite G, L, E, or F P, I, T, S, R, H Minimize splashing Rinse thoroughly Chemical Vapor with Formaldehyde G, E, or F P, H Read applicable sterilizer cautions Hydrogen Peroxide Gas Plasma G, E P, H Read applicable sterilizer cautions Ozone Gas Read applicable sterilizer cautions * Recommended when following manufacturer s label guidelines for routine use. 1. Legend 7 : Gloves (G), Splash proof eye protection (E), Face shield (F), Laboratory coat or other protective clothing (L) 2. Automated devices have regulated exhaust and or exhaust through filter apparatus 3. Legend: Activation of disinfection solutions (A), Pouring solutions or addition to equipment (P), Immersing devices to be disinfected (I), Rinsing disinfected items (R), Transporting solutions (T), Storing opened solutions (S), Handling sterilized devices from automated equipment (H) 92 MANAGING INFECTION CONTROL

9 ( T LV ) [both the short term exposure limits (STEL) and time-weighted average (TWA) values, if applicable] are defined for some of HLDs and LCSs. These safety considerations are critical components of the recommended procedures for all stages of the medical device HLD/LCS/GS process cycle. The beginning of the cycle includes handling of the contaminated medical equipment and using cleaning aids and/or scrubbing of the equipment to remove soil residue. Intermediate steps in the cycle include p u rging small lumens in the equipment or wrapping of the equipment in appropriate materials. The disinfection stage of the cycle is when the medical devices are submersed into a chemical reservoir, attachment to the automated equipment or placed within an open chamber sterilizer. T h e final stage involves removing the treated equipment from the HLD/LCS/GS environment and final rinsing and/or drying. The recommended practices covered by the ANSI/AAMI ST58:2005 document are in place to protect the healthcare professional from exposure to these important but potentially hazardous materials and to ensure safe and effective processing of the medical devices. Process Verification As the technology for HLDs, LCSs and GSs improves, it would be expected to have subsequent improvements in the quality assurance for the different medical device sterilizing equipment. These improvements include recent invention of sophisticated automated reprocessing equipment. However, the reality of new medical device sterilizers executing a complete cycle with automated verification has yet to be fully realized. Currently, the most automated devices will only measure the chemical and system variables of a process cycle. Indeed, the majority of HLD or LCS users are required to manually handle the contaminated equipment and the HLD or LCS solutions at some or all stages of the medical device decontamination. In addition, external variables that could affect successful processing, such as the bio-burden present on the medical equipment or device packing, must be evaluated by visual inspection (Table 3 on page 94). 2 A second important issue relevant to both automated and manual processing of HLD or LCS systems is the reuse of the HLD or LCS chemical. Manufacturers supply shelf-life expiration dates, reuse-life (open bottle) expiration dates, and minimum recommended concentration (MRC) or minimum effective concentration (MEC) information with each of their products. Understanding these values and their implication for the use of a product is critical to safe and effective product use. Manufacturer shelf-life recommendations should be clearly marked on each product package. The shelf-life value is established for a given product to verify that material stored appropriately will meet or exceed the MRC/MEC for use as a HLD or LCS. If the shelf life is exceeded, this solution must be discarded whether or not the solution meets the MRC/MEC. Once the container is opened, reuse-life or the open-bottle expiration date must be followed. This value represents the reuse period for a product under defined use conditions. These conditions include the temperature of the system being used as well as any storage variables. Typical ranges for reusable products are 14 to 28 days. Within this reuse period, the user of this material must continually verify that the MRC/MEC for the product is met prior to each HLD or LCS process. As the solution is being used and the volume MANAGING INFECTION CONTROL 93

10 decreases over time, it is recommended that no replenishment take place. If a minimum volume for use is reached, it is recommended that the entire contents of the bottle be discarded and replaced with a fresh bottle. So-called topping-off of reusable HLD or LSC solutions is not recommended. 8 Finally, the MRC/MEC value itself can be informative to distinguish if a solution can be safely used. If a new or nonexpired solution fails to meet the MRC/MEC, this solution should not be used, and additional verification measures should be taken to determine that subsequent HLD or LCS solutions meet the necessary specifications. Appropriate test strips or chemical monitoring devices (CIs) that indicate the MRC/MEC are the recommended method for verification that a chemical product has the required level of the active ingredients recommended. 9 Table 3. High-Level Disinfection and Sterilization Process Verification Device Type Recommended Routine Verification CI [1] BI [2] PCD [3] Measurement Glutaraldehyde CI should be used before each use Hydrogen Peroxide CI should be used before each use Ortho-phthaladehyde CI should be used before each use Hydrogen Peroxide CI should be used before each use Peracetic Acid CI should be used before each use Peracetic Acid Automated CI and BI as recommended by manufacturer Sodium Hypochlorite CI should be used before each use Chemical Vapor with Formaldehyde CI as recommended by manufacturer BI- should use at least daily and preferable each load in a PCD -BI automated cycle verification Hydrogen Peroxide Gas Plasma CI as recommended by manufacturer BI should use at least daily and preferable each load in a PCD. -BI automated cycle verification Ozone Gas CI-as recommended by manufacturer BI-Should use at least daily and preferable each load in a PCD -BI automated cycle validation 1. Chemical Indicator (CI) An FDA-approved test strip or reagent chemical monitoring device that evaluates the active concentration of a HLD, LCS or GS product. 2. Biological Indicator (BI) An FDA-approved device containing viable microorg a n i s m s used to determine the effectiveness of the HLD, or LCS or GS process. 3. Process Challenge Device (PCD) An FDA-approved device used to mimic standard devices sterilized by this process that contains a BI. Their use is recommended as part of a routine quality verification program, in conjunction with a CI. 94 MANAGING INFECTION CONTROL

11 Manufacturer recommendations for specific test strips or CIs should be followed. The CIs should be used prior to every HLD, LCS or GS process as part of the routine verification for both manual and automated procedures. Products from different manufacturers that contain the same chemical active ingredient, such as glutaraldehyde, may have different MRC/MEC values because of different concentrations or other components in the product formulation and therefore may require a different series of test strips or CIs to perform the verification. Manufacturer recommendations for specific test strips or CIs should be followed. Additional verification procedures applying to the automated LCS and GS devices include the use of biological indicators (BI). These indicators contain test organisms that are used to determine the effectiveness of the sterilization process. They are typically spore-contaminating carriers that are placed in simulated devices known as process challenge devices (PCD), within packages or open trays in the processing equipment. 1 0 Once the sterilization process is completed these indicators are incubated in a growth medium selective for that organism type. Verification of the sterilization process requires that no growth occurs from any of the BIs placed in the equipment (e.g. indicating that the spores were killed). It is clear that continual improvement in the automation of HLD and LCS cycle verification is being made. The range of HLD and LCS cycle verification includes manual test indicators and some automated measurements made internally by the equipment. Regardless of the sophistication of the equipment, other factors such as material types, packaging and packing density can affect the quality of the process cycle. Therefore, the current recommended practices for HLD and LCS cycle verification are that chemical and biological indicators be utilized as routine practice to ensure quality and safety. Tracking logs should be maintained to record processing dates, times, solution temperatures, cycle parameters, and CI and BI indicator results (positive, negative or inconclusive). The ANSI/AAMI ST58:2005 Chemical Sterilization and High-level Disinfection in Health Care Facilities recommends very specific actions to be taken in the event of a positive BI r e s u l t. 11 These and additional recommendations made in the A N S I / A A M I ST58:2005 standard are part of a process for continual improvement. Quality process improvement strives to ensure both the safety of the healthcare professionals working with the equipment and the patients receiving the medical care. The object of any process improvement program is to provide assurance that recommended procedures are being followed, that expected results are being met and, most importantly, that deficiencies are quickly identified and corrected. MANAGING INFECTION CONTROL MANAGING INFECTION CONTROL 95

12 Regular training and process verification is essential. Summary As the number and types of medical devices and their requisite cleaning and disinfecting material increase, so do the competencies for adequate training and experience. Each topic in this in-service document is designed to highlight and simplify the relative complexity of these issues. The essence of this document is to provide a solid overview of the recommended practices for use of all chemical HLD and LCS products and gaseous sterilization devices. It must be said that the ANSI/AAMI ST58:2005 recommended practice on C h e m i c a l Sterilization and High-level Disinfection in Health Care Facilities is a series of v o l u n t a ry recommended practices. The in-service recommendations cover a broad range of topics, including not only the subject of HLDs or LCS and GS products, but also operation and use of these products within a healthcare facility. Providing these guidelines to healthcare professionals should emphasize the need for regular training and process verification. It is incumbent on the user of these devices to have read the manufacturing label on the device, to be familiar with the safe working requirements of the products, and to be aware of the resources that are available to them for further education on the safe and effective use of these devices. Medical device HLDs or LCSs and GSs require a high degree of attention and understanding to ensure they are being used safely and e ff e c t i v e l y. Their use potentially affects all semicritical and critical medical devices being used in a healthcare setting. While many of these materials are hazardous, adopting a standardized decontamination process and understanding the appropriate device applications will facilitate their safe use and allow the verification of their effectiveness. The new standard has successfully combined into a single document recommended safe and effective use procedures and implementation plans for all chemical and gaseous sterilization and high-level disinfection devices and represents a key source for acquiring this information. AAMI documents can be purchased through AAMI by credit card using the following four options: 1. Internet: Index.cfm 2. Call: , ext 217 or , ext Fax: Mail: AAMI, Customer Service Center, 1100 N. Glebe Road, Suite 220, Arlington, VA References 1. Content and Format of Pre-market Notification [510(k)] Submissions for Liquid Chemical Sterilants or High Level Disinfectants. FDA, January 3, Association for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58: Code of Federal Regulations. 21 CFR Association for the Advancement of Medical Instrumentation. Safe use and handling of glutaraldehyde-based products in health care facilities. ANSI/AAMI ST58: Association for the Advancement of Medical Instrumentation. Chemical sterilants and high-level disinfectants: A guide to selection and use. A A M I TIR7: Respiratory selection requires training prior to use. Refer to section in Association for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities; ANSI/AAMI ST58: MANAGING INFECTION CONTROL

13 7. Determine material recommendations for personal protective equipment (PPE) devices for each respective products listed in Association for the A d v a n c e m e n t of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. A N S I / A A M I ST58: Guideline for the Use of High-Level Disinfectants and Sterilants for Reprocessing of Flexible Gastrointestinal Endoscopes. Society of Gastroenterology Nurses and Associates, Inc., Association for the Advancement of Medical Instrumentation. Sterilization of health care products-chemical indicators-part 1: General requirements. ANSI/AAMI ST60: Association for the Advancement of Medical Instrumentation. Process challenge devices/test packs for use in health care facilities. A A M I TIR31: Sections 9.3, 9.4, 9.5 listed in A s s o c i a t i o n for the Advancement of Medical Instrumentation. Chemical sterilization and high-level disinfection in health care facilities. ANSI/AAMI ST58:2005 Donald P. Satchell, Ph.D., is a Dow Chemical Company Senior R e s e a rch Biochemist and is the Global Technical Specialist for disinfection and HLD products. As a re s e a rcher with Dow Biocides he developed Ta u N o v a t e technology for testing antimicro b i a l disinfectant and preservative efficacy, a high-throughput technology that is used for new biocide discovery and for performance evaluation of biocide formulations. With more than eight years of experience studying antimicro b i a l agents, he has published several papers on the discovery and characterization of novel antimicrobial agents and their applications. Reprint with permission from Workhorse Publishing L.L.C. Copyright 2006/Workhorse Publishing L.L.C./All Rights Reseved. Sterile Process and Distribution CEU Information CEU Applicant Name Address City State Zip Code The CBSPD (Certification Board for Sterile Processing and Distribution) has preapproved this inservice for one (1) contact hour for a period of five years from the date of publication and to be used once in a recertification period. Successful completion of the lesson and post test must be documented by facility management and those records maintained by the individuals until re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD. For additional information regarding Certification, contact: CBSPD, 2 Industrial Park Road, Suite 3, Alpha, NJ or call or visit IAHCSMM has awarded one and one-half (1.5) contact point for completion of this continuing education lesson toward IAHCSMM recertification. Nursing CEU Application Form 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 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 your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the CE questions. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ 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 ANSWERS 1. F 2. F 3. T 4. F 5. F 6. F 7. T 8. T 9. T 10. F City, State, Country, Zip Daytime phone ( ) P o s i t i o n / Ti t l e Social Security or Nursing License Number Date application submitted Signature Offer expires June MANAGING INFECTION CONTROL 97