Sterilization Overview from the CDC

Transcription

1 Sterilization Overview from the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 New evidence-based topics and recommendations by Cynthia Hubbard RN, BS Objectives Identify new topics that are included in the Centers for Disease Control (CDC) Guideline for Disinfection and Sterilization in Healthcare Facilities, Identify critical factors affecting the efficacy of sterilization. 2. Identify the four CDC category rankings that apply to sterilization processes. 3. List the CDC Guideline recommendations for sterilization. Test Questions True or False. Circle the correct answer. 1. This document supersedes relevant sections contained in the 1985 Centers for Disease Control Guideline for Handwashing and Environmental Control. 2. Failure to adequately clean instruments results in higher bioburden, protein load, and salt concentration. 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 89. Managing Infection Control and 3M Health Care will be working collaboratively to provide continuing education courses in monthly editions of Managing Infection Control. 3. Spore forming organisms are the most resistant to sterilization and are the test organisms required for FDA clearance. 4. Sterilants must come into contact with microorganisms to be effective. Device designs that prevent or inhibit this contact (e.g., sharp bends, blind lumens) will decrease sterilization efficacy. 5. Antibiotic-resistant bacteria are less sensitive than antibiotic-sensitive bacteria to the liquid chemical germicides at currently used germicide contact conditions and concentrations. 6. The new CDC Guideline strongly recommends that Sterile Processing is included in an annual infection control rounds to ensure that reprocessing instructions are current and accurate and are being implemented correctly. 7. Liquid peracetic acid is a high-temperature sterilization method introduced in 1988 to chemically reprocess endoscopes. 8. The new CDC Guideline strongly recommends the use of biologic indicators for every load containing implantable items and to quarantine items, whenever possible, until the biologic indicator is negative. 9. The new CDC Guideline does not include visual inspection of packaging materials and traceability of load contents in a quality control program for sterilized items. 10. The new CDC Guideline strongly recommends an annual review of the written reprocessing instructions to ensure they comply with the scientific literature and the manufacturers instructions. 72 MANAGING INFECTION CONTROL

2 Introduction The long-awaited Centers for Disease Control (CDC) document, Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 has recently become available. It supersedes relevant sections contained in the 1985 CDC Guideline for Handwashing and Environmental Control. This new Guideline includes more than 1,000 literature references and presents evidence-based recommendations on the preferred methods for cleaning, disinfection and sterilization of patientcare medical devices and for cleaning and disinfecting the healthcare environment. 1 The sterilization recommendations and a short introduction to the new topics included in the Guideline are summarized in this article. New Topics Included The 2008 CDC Guideline for Disinfection and Sterilization in Healthcare Facilities includes a discussion about topics not previously addressed in 1985, including: inactivation of antibiotic-resistant bacteria, bioterrorist agents, emerging pathogens and bloodborne pathogens; toxicologic, environmental and occupational concerns associated with disinfection and sterilization practices; new sterilization processes, such as hydrogen peroxide gas plasma and liquid peracetic acid; disinfection of patient-care equipment used in ambulatory settings and home care; and disinfection of complex medical instruments (e.g., endoscopes). 1 The new topics relevant to this article s focus on sterilizationrelated issues and recommendations include: Antibiotic-Resistant Bacteria: When changes take place in bacterial susceptibility that renders a previously effective antibiotic ineffective in treating the infection the bacteria are termed resistant. There is no data available that shows that antibiotic-resistant bacteria are less sensitive than antibiotic-sensitive bacteria to the liquid chemical germicides at the currently used germicide contact conditions and concentrations. 1 Inactivation of Bioterrorist Agents: CDC has categorized several biological agents as high priority for biological terrorism as they can be easily transmitted between humans, cause high mortality and are likely to cause public panic and social disruption. These agents include: Bacillus anthracis (anthrax); Yersinia pestis (plague); Variola major (smallpox); Clostridium botulinum toxin (botulism); Francisella tularensis (tularemia); Filoviruses (Ebola hemorrhagic fever and Marburg hemorrhagic fever); and Arenaviruses (Lassa [Lassa fever], Junin [Argentine hemorrhagic fever]) and related viruses. The susceptibility of these agents to germicides in vitro is similar to that of other related pathogens. The data suggest that our current methods/procedures and disinfecting and sterilizing agents will manage to inactivate these potential bioterrorist agents on patient care equipment and surfaces when potentially contaminated patients are evaluated and/or admitted in a healthcare facility. 1 Emerging Pathogens: Several emerging pathogens have been identified as presenting increased concern to the public heath, including: Cryptosporidium parvum; Helicobacter pylori; E. coli O157:H7, HIV, HCV; Rotavirus; Norovirus; Severe acute respiratory syndrome (SARS) coronavirus; Multidrug-resistant M. tuberculosis; and Nontuberculous mycobacteria (e.g., M. chelonae). Studies on the susceptibility of these pathogens to chemical disinfectants and sterilants have been conducted. To inactivate them it is important that reprocessing guidelines be followed completely and only approved methods of decontamination and sterilization be used. 1 Bloodborne Pathogens: The new CDC Guideline reinforces compliance with Occupational Safety and Health Administration (OSHA) policies for use of Environmental Protection Agency (EPA) registered disinfectants that are effective against HIV and HBV for cleaning and disinfecting equipment and environmental surfaces contaminated with blood. Studies demonstrate that a 1:10 final dilution of EPAregistered hypochlorite solution should be used to inactivate the bloodborne viruses in a large blood spill to minimize the risk for infection to healthcare personnel from percutaneous injury during cleanup. 1 Toxicologic, Environmental and Occupational Concerns: There are concerns and health hazards associated with the use of germicides (agents that destroy microorganisms, especially pathogenic ones). It is important that workers in healthcare settings understand how to properly and carefully handle them. When a chemical exposure 74 MANAGING INFECTION CONTROL

3 occurs certain factors must be assessed to determine the health risk, including the amount of chemical, the route (e.g., skin, mucous membranes and inhalation) and the length of exposure time. Toxicity can be acute or chronic and employers must inform workers about workplace chemical hazards and how to safely handle all products. Information on workplace exposures and methods to reduce them through work practices, engineering controls, and personnel protective equipment (PPE) are available from OSHA and National Institute for Occupational Safety and Health (NIOSH). 1 In the United States some states also have excluded or limited the concentrations of certain chemical germicides that can be disposed of through the sewer system. These rules are intended to minimize environmental harm; consequently the healthcare community must practice safe disposal of regulated chemicals. 1 Steam sterilization is the CDC preferred method of sterilization for such materials as it has the largest margin of safety due to its reliability, consistency and lethality. Newer Sterilization Processes (hydrogen peroxide gas plasma and liquid peracetic acid) The hydrogen peroxide gas plasma process inactivates microorganisms by the combined use of the hydrogen peroxide gas and the generation of free radicals during the plasma phase of the cycle. The process has the ability to inactive a broad range of microorganisms, including resistant bacterial spores on heat and/or moisture-sensitive materials. Like other sterilization processes the effectiveness can be altered by lumen length and diameter and the presence of inorganic salts and organic materials. Initially introduced in the United States in 1993 the process operates in the range of C with a processing time of minutes. 1 Liquid peracetic acid is a low-temperature (50-55 C) sterilization method introduced in 1988 to chemically reprocess endoscopes. Paracetic acid is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soils to inactivate gram-positive and gramnegative bacteria, fungi and yeasts. The correct use of channel connectors to flush the solution through the endoscope lumens is very important to a successful sterilization outcome. The cycle time is minutes and is used for immersible instruments only. 1 Sterilization Sterilization destroys all microorganisms on the surface of an article or in a fluid to prevent disease transmission associated with the use of that item. Medical devices that have contact with sterile body tissues or fluids are considered critical items (see Spalding Classification System in the Glossary of Terms) and should be sterile when used. Most items used in the treatment of patients are made of heat stable materials and can be steam sterilized. Steam sterilization is the CDC preferred method of sterilization for such materials as it has the largest margin of safety due to its reliability, consistency and lethality. Items that are heat- and moisture-sensitive require a low-temperature sterilization process such as ethylene oxide, hydrogen peroxide gas plasma or peracetic acid. 1 Also, when you are determining the best sterilization method for devices, it is important to ensure that the process used is compatible with the recommendations from the medical device manufacturer, is Food and Drug Administration (FDA) cleared and that occupational safety concerns are addressed. Consult Table 5 in the Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 for a complete summary of the advantages and disadvantages of the chemical agents currently used as chemical sterilants or high-level disinfectants. You will find the advantages and disadvantages listed for these agents: steam; peracetic acid/hydrogen peroxide; Glutaraldehyde; hydrogen peroxide; Ortho-phthalaldehyde; peracetic acid; hydrogen peroxide gas plasma; 100 percent ethylene oxide (ETO) and ETO mixtures. 1 Table 6 in the Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 has a complete summary of the advantages and disadvantages of commonly used sterilization technologies. Consistency in Sterilization Practice Ensuring consistent application of the best sterilization practices within any organization requires a comprehensive program of training, supervision and ongoing monitoring of procedures and outcomes. Every employee involved with sterilizing medical devices must understand these factors: the importance of cleaning; packaging; correct sterilizer loading and use of the cycles for the method selected; and how to effectively monitor the entire process. From an infection control perspective it is also important to have consistent cleaning and sterilizing procedures throughout your facility. 76 MANAGING INFECTION CONTROL

4 Infection control rounds help reinforce consistency and call attention to the importance of the work accomplished by sterile processing technicians in high-risk areas such as the GI lab and sterile processing. It is vital to resolve any conflicting instructions or reprocessing recommendations that exist between the numerous medical device manufacturers and your sterilizer manufacturer. It is also strongly recommended that all written reprocessing instructions are reviewed regularly to ensure compliance with the scientific literature and the manufacturers instructions. Establishing a fully functional quality control program is strongly recommended and would at a minimum include these components: a sterilizer maintenance contract with records of service; a system of process monitoring (mechanical, chemical and biological monitors); air-removal testing for prevacuum steam sterilizers; visual inspection of packaging materials; and traceability of the load contents. 1 CDC s Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 reinforces the high value of biological monitors for use in sterilization process monitoring in healthcare facilities. Verification of Sterilization Cycles and Records Retention The new CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 stresses the importance of verifying sterilization processes. The importance of documenting successful results of chemical and biological monitoring for sterilizer installation prior to use in a healthcare facility is emphasized. Installation testing is accomplished by running three (3) consecutive empty steam cycles with biological and chemical indicators in appropriate test packages or trays, and three (3) consecutive empty cycles run with a Bowie-dick test (for prevacuum sterilizers). These same cycle validations are also repeated when a sterilizer is relocated, redesigned, after major repairs and after sterilization failures. The sterilizer is not put back into service until all the biological and chemical monitoring test results are satisfactory. 1 The new CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 also emphases the importance of product testing and ongoing quality assurance testing of representative samples of actual products being sterilized. When major changes are made in packaging, wraps or load configurations, biological and chemical monitors are also to be used to document successful sterilization. The biological and chemical monitors should be placed inside the products. The products should be processed in a full load and quarantined until the test results are negative. When three (3) consecutive cycles show negative biological indicators and chemical indicators with a correct end point response, you can put the change made into routine use. 1 Sterilization records (mechanical, chemical and biological) should be retained for the period of time required by state and federal agencies. The Joint Commission for the Accreditation of Healthcare Facilities requests three years of sterilizer records retention. 1 Monitoring the Sterilization Process Close monitoring of the sterilization process is required and is accomplished by use of mechanical, biological and chemical monitors. Monitor every load with mechanical monitors to verify temperature, time and pressure. Monitor every package with a chemical indicator that will be visible to the user before the package is opened. CDC also notes it is preferable to place a chemical indicator on the inside of each pack to verify sterilant penetration. Chemical indicators are grouped into five classes based on their ability to monitor one or more parameters of sterilization; remember they do not prove sterilization has been achieved. But, if the internal and/or external chemical indicator suggests inadequate processing the item should not be used. Chemical indicators should be used in conjunction with biological indicators, but based on current studies should not replace them because they have been shown to falsely indicate sterilization at marginal time/temperatures. Only a biological indicator consisting of resistant spores can measure the microbial killing power of the sterilization process. 1, 2, 3 Biological Indicators Remain the Gold Standard CDC s Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 reinforces the high value of biological monitors for use in sterilization process monitoring in healthcare facilities. Because they measure the sterilization process directly by using the most resistant microorganisms (Bacillus spores) biological monitors are recognized as being closest to an ideal monitor of the sterilization process. All sterilizers should be monitored at least weekly with an appropriate biological indicator. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of equipment malfunction or procedural errors and thus minimizes the extent of patient surveillance and product recall needed in the event of a positive 78 MANAGING INFECTION CONTROL

5 Table 10: Factors affecting the efficacy of sterilization 1 FACTORS Cleaning 1 Bioburden 1 Pathogen type Protein 1 Salt 1 Biofilm accumulation 1 Lumen length Lumen diameter Restricted flow Device design and construction EFFECT Failure to adequately clean instrument results in higher bioburden, protein load, and salt concentration. These will decrease efficacy. The natural bioburden of used surgical devices is 10 0 to 10 3 organisms (primarily vegetative bacteria), which is substantially below the 10 5 to 10 6 spores used with biological indicators. Spore forming organisms are most resistant to sterilization and are the test organisms required for FDA clearance. However, the contaminating microflora on used surgical instruments consists mainly of vegetative bacteria. Residual protein decreases efficacy of sterilization. However, cleaning appears to rapidly remove protein load. Residual salt decreases efficacy of sterilization more than does protein load. However, cleaning appears to rapidly remove salt load. Biofilm accumulation reduces efficacy of sterilization by impairing exposure of the sterilant to the microbial cell. Increasing lumen length impairs sterilant penetration. May require forced flow through lumen to achieve sterilization. Decreasing lumen diameter impairs sterilant penetration. May require forced flow through lumen to achieve sterilization. Sterilant must come into contact with microorganisms. Device designs that prevent or inhibit this contact (e.g., sharp bends, blind lumens) will decrease sterilization efficacy. Materials used in construction may affect compatibility with different sterilization processes and affect sterilization efficacy. Design issues (e.g., screws, hinges) will also affect sterilization efficacy. Modified from Alfa and Rutala. 4,5 1Factor only relevant for reused surgical/medical devices biological indicator. The new CDC Guideline strongly recommends the use of biological indicators for every load containing implantable items and to quarantine items, whenever possible, until the biological indicator is negative. 1 Factors Affecting Sterilizing Efficacy The new CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 lists factors affecting the efficacy of any type of sterilization process. These include the cleaning, bioburden, types of pathogens, protein and salt residuals, biofilm accumulation, lumen length and diameter, restricted sterilant flow and the design/construction of the medical device. See Table 10 of the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 for a summary of these factors CDC Guideline: s for Sterilization Rationale: Reducing the rates of healthcareassociated infections is the ultimate goal of the new CDC recommendations. To ensure that we are using informed judgment in our decision-making about disinfection and sterilization practices, each recommendation is categorized according to the available scientific evidence, theoretical rationale, applicability and federal regulations supporting it. A rankings system is used to categorize this information. There are five rankings in the CDC system; the four rankings that apply to sterilization processes are: Category 1A: Strongly recommended for implementation and strongly supported by welldesigned experimental, clinical or epidemiologic studies. Category 1B: Strongly recommended for implementation and supported by some experimental, clinical or epidemiologic studies and by a strong theoretical rationale. Category II: Suggested for implementation and supported by suggestive clinical or epidemiologic studies or by a theoretical rationale. Category IC: Required by state or federal regulations. 1 Summary of Sterilization s The following tables organize the CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 recommendations related to sterilization issues. Included are: 80 MANAGING INFECTION CONTROL

6 methods of sterilization; flash sterilization; monitoring of sterilizers; packaging; load configuration; storage of sterile items (displayed together); and quality control. 14.j. Because narrow-lumen devices provide a challenge for all low-temperature sterilization technologies and direct contact is necessary for the sterilant to be effective, ensure that the sterilant has direct contact with contaminated surfaces (e.g., scopes processed in peracetic acid must be connected to channel irrigators). I. METHODS OF STERILIZATION Category 1A: Strongly Recommended and Strongly Supported 1 Category II: Suggested for Implementation and Supported by Suggestive Clinical or Epidemiologic Studies or by a Theoretical Rationale 1 14.a. 14.d. Steam is the preferred method for sterilizing critical medical and surgical instruments that are not damaged by heat, steam or moisture. Use low-temperature sterilization technologies for reprocessing critical patient-care equipment that is heat or moisture sensitive. 14.g. Critical items that have been sterilized by the peracetic acid immersion process must be used immediately (i.e., items are not completely protected from contamination, making long-term storage unacceptable). Category 1B: Strongly Recommended and Supported by Some Studies and a Strong Theoretical Rationale 1 II. FLASH STERILIZATION Category 1B: Strongly Recommended and Supported by Some Studies and a Strong Theoretical Rational 1 14.b. Cool steam- or heat-sterilized items before they are handled or used in the operative setting. 13.a. Do not flash sterilize implanted surgical devices unless doing so is unavoidable. 14.c. 14.e. 14.f. 14.h. Follow the sterilization times, temperatures, and other operating parameters (e.g., gas concentration, humidity) recommended by the manufacturers of the instruments, the sterilizer, and the container or wrap used, and that are consistent with the guidelines published by government agencies and professional organization. Completely aerate surgical and medical items that have been sterilized in the EtO sterilizer before using these items in patient care. Sterilization using the peracetic acid immersion system can be used to sterilize heat-sensitive and immersible medical and surgical items. Dry-heat sterilization (e.g., 340 F for 60 minutes) can be used to sterilize items (e.g., powders, oils) that can sustain high temperatures. 13.c. 13.d. 13.e. When using flash sterilization, make sure that the following parameters are met: 1) clean the item before placing it in the sterilizing container (use FDA cleared containers for use with flash sterilization) or tray; 2) prevent exogenous contamination of the item during transport from the sterilizer to the patient; and 3) monitor sterilizer function with mechanical, chemical, and biological monitors. Do not use packaging materials and containers in flash sterilization cycles unless the sterilizer and the packaging material/container are designed for this use. When necessary, use flash sterilization for patient-care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument). 14.i. Comply with the sterilizer manufacturer s instructions regarding the sterilizer cycle parameters (e.g., time, temperature, concentration). 13.f. When necessary, use flash sterilization for processing patient-care items that cannot be packaged, sterilized, and stored before use. 82 MANAGING INFECTION CONTROL

7 Category II: Suggested for Implementation and Supported by Suggestive Clinical or Epidemiologic Studies or by a Theoretical Rationale 1 13.b. Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time. 16.f. After a positive biologic indicator with steam sterilization, objects other than implantable objects do not need to be recalled because of a single positive sport test unless the sterilizer or the sterilization procedure is defective as determined by maintenance personnel or inappropriate cycle settings. If additional spore tests remain positive, consider the items nonsterile and recall and reprocess the items from the implicated load(s). III. MONITORING OF STERILIZERS Category 1B: Strongly Recommended and Supported by Some Studies and a Strong Theoretical Rationale 1 16.a. Use mechanical, chemical and biologic monitors to ensure the effectiveness of the sterilization process. IV. PACKAGING, LOAD CONFIGURATION AND STORAGE OF STERILE ITEMS Category 1B: Strongly Recommended and Supported by Some Studies and a Strong Theoretical Rationale 1 16.c. 16.d. Do not use processed items if the mechanical (e.g., time temperature, pressure) or chemical (internal and/or external) indicators suggest inadequate processing. Use biologic indicators to monitor the effectiveness of sterilizers at least weekly with an FDAcleared commercial preparation of spores (e.g., Geobacillus stearothermophilus for steam) intended specifically for the type and cycle parameters of the sterilizer. 15.a. 15.b. 17.a. Ensure that packaging materials are compatible with the sterilization process and have received FDA 510[k] clearance. Ensure that packaging is sufficiently strong to resist punctures and tears to provide a barrier to microorganisms and moisture. Place items correctly and loosely into the basket, shelf, or cart of the sterilizer so as not to impede the penetration of the sterilant. 16.g. Use biologic indicators for every load containing implantable items and quarantine items, whenever possible, until the biologic indicator is negative. 18.c. Label sterilized items with a load number that indicates the sterilizer used, the cycle or load number, the date of sterilization, and, if applicable, the expiration date. Category II: Suggested for Implementation and Supported by Suggestive Clinical or Epidemiologic Studies or by a Theoretical Rationale 1 16.b. 16.e. Monitor every load with mechanical (e.g., time, temperature, pressure) and chemical (internal and external) indicators. If the internal chemical indicator is visible, an external indicator is not needed. After a single positive biologic indicator used with a method other than steam sterilization, treat as nonsterile all items that have been processed in that sterilizer, dating from the sterilization cycle having the last negative biologic indicator to the next cycle showing satisfactory biologic indicator results. These nonsterile items should be retrieved if possible and reprocessed. 18.d. The shelf life of a packaged sterile item depends on the quality of the wrapper, the storage conditions, the conditions during transport, the amount of handling, and other events (moisture) that compromise the integrity of the package. If event-related storage of sterile items is used, then packaged sterile items can be used indefinitely unless the packaging is compromised. Category II: Suggested for Implementation and Supported by Suggestive Clinical or Epidemiologic Studies or by a Theoretical Rationale 1 18.a. Ensure the sterile storage area is a well-ventilated area that provides protection against dust, moisture, insects, and temperature and humidity extremes. 84 MANAGING INFECTION CONTROL

8 18.b. Store sterile items so the packaging is not compromised (e.g., punctured, bent). Category II: Suggested for Implementation and Supported by Suggestive Clinical or Epidemiologic Studies or by a Theoretical Rationale 1 18.e. 18.f. 18.g. Evaluate packages before use for loss of integrity (e.g., torn, wet, punctured). The pack can be used unless the integrity of the packaging is compromised. If the integrity of the packaging is compromised (e.g., torn, wet, or punctured), repack and reprocess the pack before use. If time-related storage of sterile items is used, label the pack at the time of sterilization with an expiration date. Once this date expires, reprocess the pack. V. QUALITY CONTROL (FOR STERILIZATION) Category 1B: Strongly Recommended and Supported by Some Studies and a Strong Theoretical Rationale 1 19.d. 19.e. Include the following in a quality control program for sterilized items: a sterilizer maintenance contract with records of service; a system of process monitoring; air-removal testing for prevacuum steam sterilizers; visual inspection of packaging materials; and traceability of load contents. For each sterilization cycle, record the type of sterilizer and cycle used; the load identification number; the load contents; the exposure parameters (e.g., time and temperature); the operator s name or initials; and the results of mechanical, chemical and biological monitoring. 19.a. 19.b. 19.c. Provide comprehensive and intensive training for all staff assigned to reprocess semicritical and critical medical/surgical instruments to ensure they understand the importance of reprocessing these instruments. To achieve and maintain competency, train each member of the staff that reprocesses semicritical and/or critical instruments as follows. 1) provide hands-on training according to the institutional policy for reprocessing critical and semicritical devices; 2) supervise all work until competency is documented for each reprocessing task; 3) conduct competency testing at the beginning of employment and regularly thereafter (e.g., annually); and 4) review the written reprocessing instructions regularly to ensure they comply with the scientific literature and the manufacturers instructions. Compare the reprocessing instructions (e.g., for the appropriate use of endoscope connectors, the capping/noncapping of specific lumens) provided by the instrument manufacturer and the sterilizer manufacturer and resolve any conflicting recommendations by communicating with both manufacturers. Conduct infection control rounds periodically (e.g., annually) in high-risk processing areas (e.g., the Gastroenterology Clinic, Central Processing); ensure reprocessing instructions are current and accurate and are correctly implemented. Document all deviations from policy. All stakeholders should identify what corrective actions will be implemented. 19.f. 19.g. 19.h. 19.i. Retain sterilization records (mechanical, chemical and biological) for a time period that complies with standards (e.g., 3 years), statutes of limitations, and state and federal regulations. Also Category IC - Required by state or federal regulations. Prepare and package items to be sterilized so that sterility can be achieved and maintained to the point of use. Consult the Association for the Advancement of Medical Instrumentation or manufacturers of surgical instruments, sterilizers, and container systems for guidelines for the density of wrapped packages. Periodically review policies and procedures for sterilization. Perform preventive maintenance on sterilizers by qualified personnel who are guided by the manufacturer s instruction. Summary The CDC Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 has updated content and recommendations based upon an evidence-based review of relevant literature largely published between 1980-August This article summarized key sterilization-related issues and recommendations. A free copy of the Guideline can be obtained by accessing this Web site: Disinfection_Nov_2008.pdf. 86 MANAGING INFECTION CONTROL

9 Glossary of Terms Biofilm: the accumulated mass of biological and extracellular material that is tightly adhered to a surface and cannot be easily removed. 1 Biological Indicator (BI): Microbiological test system providing a defined resistance to a specified sterilization process. 1 Bowie-Dick test: Diagnostic test of a dynamic-airremoval steam sterilizer s ability to remove air from the chamber and prevent air re-entrainment. 1 Chemical Indicator: device for monitoring a sterilization process. The device is designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. 1 Flash sterilization: process designed for the steam sterilization of unwrapped patient-care items for immediate use (or placed into a specially designed, covered, rigid container to allow for rapid steam penetration. 1 Spalding Classification: strategy for reprocessing contaminated medical devices. The system classifies a medical device as critical, semicritical, or noncritical on the basis of risk to patient safety from contamination on a device. Semicritical items: objects which contact mucous membranes or nonintact skin. These devices should be free from all microorganisms; however, small numbers of bacterial spores are permissible. Critical items: objects which enter sterile tissue or the vascular system and thus confer a high risk for infection if they are contaminated with any microorganism. Non-critical items: objects that come in contact with intact skin, but not mucous membranes. 1 Sterilization: Validated process used to render a product free of all forms of viable microorganisms. 1 References 1. Centers for Disease Control. Guideline for Disinfection and Sterilization in Healthcare Facilities, MANAGING INFECTION CONTROL

10 2. Rutala WA, Gergen MF, Weber DJ. Evaluation of a rapid readout biological indicator for flash sterilization with three biological indicators and three chemical indicators. Infection Control Hospital Epidemiology. 1993:14: Schneider PM, Reich RR, Kirckof SS, Foltz WG. Performance of various steam sterilization indicators under optimum and suboptimum exposure conditions. In: Rutala WA, ed. Disinfection, sterilization and antisepsis: Principles, practices, challenges, and new research. Washington DC: Association for Professionals in Infection Control and Epidemiology, 2004: Alfa MJ. Flexible endoscope reprocessing. Infection Control Sterilization Technology. 1997:3: Rutala WA, Weber DJ. Clinical effectiveness of low-temperature sterilization technologies. Infection Control Hospital Epidemiology. 1998;19: Cynthia Hubbard, RN, BS, is a published 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 sterile processing 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 she served as the sterile processing manager at Sacred Heart Medical Center in Spokane during their surgical building addition. She is a fellow member and served on the ASHCSP Board of Directors and received their Educator of the Year Award. 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, 121 State Hwy 31N, Suite 500, Flemington, NJ or call or visit the Web site at 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 (5) years from the date of publication. 1. Make a photocopy of this form. 2. Print your name, address and daytime phone number and position/title. 3. Add the last 4 digits of your social security number or your nursing license number. 4. Date the application and sign. 5. Answer the true/false CE questions. KEEP A COPY FOR YOUR RECORDS. 6. Submit this form and the answer sheet to: Workhorse Publishing Managing Infection Control PO Box 25310, Scottsdale, AZ For questions or follow-up, contact craig@manageinfection.com. 8. Participants who score at least 70% will receive a certificate of completion within 30 days of Managing Infection Control s receipt of the application. Application Please print or type. Name Mailing Address City, State, Country, Zip Daytime phone ( ) Position/Title Social Security or Nursing License Date application submitted ANSWERS 1. A 2. A 3. A 4. A 5. B 6. A 7. A 8. A 9. B 10. A Signature Offer expires April 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 Copyright 2009/Workhorse Publishing L.L.C./All Rights Reseved. <04/09> Reprint with permission from Workhorse Publishing L.L.C. MANAGING INFECTION CONTROL 89