CENTRAL SERVICE (CS) PROFESSIONALS REQUIRE SIGNIFICANT

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2 by Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT President/CEO of Seavey Healthcare Consulting Safety in Handling Chemical Sterilants LEARNING OBJECTIVES 1. Describe how governmental regulating agencies promote safety practices in Central Service departments 2. Identify how following professional organization standards and guidelines can help decrease common hazards associated with the use of chemical sterilants 3. Discuss safety concerns applicable to chemical sterilants CENTRAL SERVICE (CS) PROFESSIONALS REQUIRE SIGNIFICANT knowledge about a wide range of disciplines and priorities, and none is more important than safety. While safety is everyone s responsibility, there are some areas in which nurses and technicians can control the risks, and where safety concerns for employees and patients must be especially emphasized. This lesson will address the role of governmental regulatory and professional associations in managing safety, and basic safety protocols for handling chemical sterilants and the most frequently-used chemical sterilant systems. OBJECTIVE 1: DESCRIBE HOW GOVERNMENTAL REGULATING AGENCIES PROMOTE SAFETY PRACTICES IN CENTRAL SERVICE DEPARTMENTS REGULATORY REQUIREMENTS Several U.S. governmental agencies have a direct regulatory impact on safety in the CS workplace. These include: U.S. Food and Drug Administration (FDA). The FDA regulates the manufacture of all medical devices and requires the pre-market clearance of new medical devices. The 1990 Safe Medical Devices Act requires healthcare facilities to follow user reporting protocols. 1 For example, facilities must report suspected medical device-related deaths to the FDA and manufacturers within 10 work days, and injuries must be reported to the manufacturers within 10 work days. The FDA also administers the MedWatch program, a voluntary system by which healthcare professionals can notify FDA about issues, including medical device malfunctions. MedWatch provides a vehicle by which healthcare professionals can notify the FDA about medical device malfunctions, including ineffective manufacturers instructions for use (IFU). 2 Forms to report either This series of self-study lessons on CS topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM), and can be used toward CRCST re-certification or toward nursing credits. Pfeidler Enterprises and IAHCSMM both offer grading opportunities. Earn Continuing Education Credits Online: Nursing Credit: Pfiedler Enterprises will award nursing credit for this Self-Study Lesson Plan. Pfiedler Enterprises is a provider approved by the California Board of Registered Nursing, Provider Number CEP 14944, for 1 contact hour. Obtaining full credit for this offering depends upon attendance, regardless of circumstances, from beginning to end. Licensees must provide their license numbers for record keeping purposes. The certificate of course completion issued at the conclusion of this course must be retained in the participant s records for at least four (4) years as proof of attendance. In order to receive credit you must go to and complete the test, evaluation and registration forms. Once completed, you will be directed to print your certificate of completion. Scoring: IAHCSMM will award credit for this Self- Study Lesson Plan toward the renewal of a CRCST certification. To receive IAHCSMM credit, please visit for online grading (nominal fees will apply). Each online quiz with a passing score of 70% or higher is worth two points (2 contact hours) toward CRCST re-certification of 12 CEs. For more information: For questions or problems about Nursing Credits available for this lesson plan, please contact tonia@pfiedlerenterprises.com. For questions about IAHCSMM Credit available for this lesson plan, please contact us at or mailbox@iahcsmm.org. SEPTEMBER / OCTOBER 2017 Communiqué 47

3 voluntary or mandatory device issues may be obtained from the FDA website at: The FDA s role in patient safety is comprehensive. It regulates the sterilants and high-level disinfectants used to process medical devices and enforces medical device recalls when a device is defective and/or poses a health risk. Additionally, the FDA is very concerned about the improper processing of medical devices. It has established requirements for manufacturers as they develop reprocessing instructions for reusable medical devices and other products, and it has released requirements applicable to the reuse of single-use devices. The above programs both regulate the use of chemical sterilants and provide a means to report concerns regarding the use of these products. Environmental Protection Agency (EPA). The EPA regulates chemical disinfectants and sterilants used in CS, and the agency has issued directives for handling medical waste. It also administers the 1990 Clean Air Act and amendments that address standards for the use of ethylene oxide (EtO). Some state EPA offices have issued laws regarding drain discharge which regulates what can and cannot be discarded via the sewer system. Glutaraldehyde is one of the chemicals regulated in some states. Occupational Safety and Health Administration (OSHA). The primary purpose of OSHA is to protect workers from job-related illnesses and injuries. The Occupational Safety and Health Act administered by OSHA requires employers, including healthcare facilities, to provide employees with a place of employment that is free from recognized hazards that cause, or are likely to cause, injury or death. OSHA also has issued numerous requirements about healthcare safety concerns in general work areas. Its personnel conduct announced and unannounced facility inspections and can levy significant penalties for applicable safety violations. OSHA regulations of special concern to CS professionals relate to guidelines for the use of EtO, bloodborne pathogens (disease-causing microorganisms), and Safety Data Sheets (SDSs). OSHA has issued rules for exposure levels for many chemicals that may be hazardous to humans. Chemical sterilants have each been assigned specific exposure levels, the most stringent of these is EtO and glutaraldehyde. OSHA also enforces the use of personal protective equipment (PPE) requirements for CS workers. Centers for Disease Control and Prevention (CDC). The CDC promotes health and quality of life by preventing and controlling disease, injury, disability and by responding to health emergencies. CDC guidelines are written as voluntary guidelines; however, some of their guidelines have been written into law by other federal agencies making those guidelines regulatory. Many CDC guidelines are incorporated into instrument processing protocols, including those for medical devices that are or may have been exposed to prions (an infectious protein particle that causes Creutzfeldt-Jakob Disease). The CDC creates and releases educational information that is helpful toward the prevention of diseases including several posters and power point presentations displaying the proper way to don (put on) and doff (remove) PPE. This free information can be downloaded from and hai/pdfs/ppe/ppe-sequence.pdf. The aforementioned agencies create and enforce guidelines and laws that mandate compliance with their guidelines. State and/or local safety requirements are additionally applicable to healthcare facilities. Failure to comply with these regulations may result in fines and negative media attention for the facility. Also, if conditions exist that are out of compliance, accidents with resulting injuries are more likely to occur. OBJECTIVE 2: IDENTIFY HOW FOLLOWING PROFESSIONAL ORGANIZATION STANDARDS AND GUIDELINES CAN HELP TO DECREASE COMMON HAZARDS ASSOCIATED WITH THE USE OF CHEMICAL STERILANTS Guidelines from voluntary standards organizations also impact CS safety procedures. While not required by law, some of these standards have been written into law by federal and state agencies. Facilities should follow these best practice guidelines and recommendations as if they were legally required to do so. These organizations have a significant impact on how things are done, and some of their guidelines directly relate to safety. Examples include: Association for the Advancement of Medical Instrumentation (AAMI). AAMI Working Groups, under the auspices of the AAMI Sterilization Standards Committees, develop recommended practices and standards that consider the use, care and processing of devices and systems. Standards committees also write standards for manufacturers that recommend the labeling, safety and performance requirements for the products they produce. AAMI documents contains a wide range of safety-related recommendations. Examples include those related to patient safety; decontamination; safe storage handling; disposal of 48 Communiqué SEPTEMBER / OCTOBER

4 NURSING LESSON PLAN contaminated and chemical agents; engineering controls; appropriate labeling; and responsibilities of employers and staff. Safety information about product recalls, chemical and thermal disinfection, and exposure to bloodborne pathogens are also addressed in the AAMI publications. 3, 4, 5, 6 Some examples include:» ST79 Comprehensive guide to steam sterilization and sterility assurance in health care facilities» ST58 Chemical sterilization and high-level disinfection in health care facilities» ANSST41 Ethylene oxide sterilization in health care facilities: Safety and effectiveness» ST91 Flexible and semi-rigid endoscope processing in health care facilities Healthcare accrediting organizations. Organizations such as the Centers for Medicare and Medicaid Services (CMS) and The Joint Commission (TJC) develop standards that are evaluated for implementation by teams of surveyors. Surveyors usually arrive at facilities unannounced and spend several days studying almost every aspect of care within that facility. Their focus is on quality, safety and process improvement. CS professionals must understand and cooperate with their facility s procedures to comply with CMS and TJC requirements, including those relating to all safety standards and especially those that are specific to the CS. They must also attend mandatory inservice training sessions, some of which are directed at safety practices. OBJECTIVE 3: DISCUSS SAFETY CONCERNS APPLICABLE TO CHEMICAL STERILANTS Two safety concerns apply to all chemical sterilants. 7, 8 First, to avoid risks to patients, toxic (poisonous) sterilant residuals cannot be left on packaging or devices after sterilization is completed. Second, providing a safe environment to protect employees. Recommendations of sterilizing equipment and chemical sterilant manufacturers should always be followed to minimize safety risks. In addition, special concerns are applicable to commonly used sterilants: EtO, hydrogen peroxide, ozone and glutaraldehyde. ETHYLENE OXIDE EtO sterilizers should be located in well-ventilated areas, with a room air exchange rate of at least 10 exchanges per hour. Ventilation systems and exhaust lines, including floor drains, should be routinely checked by qualified personnel. To prevent potential health hazards to workers, OSHA has established exposure limits for EtO. Facilities are required to implement engineering controls, including ventilation systems, establish procedures for safe work practices, provide PPE and use other methods to ensure that occupational exposure limits are not exceeded. A permissible exposure limit (PEL) is the average concentration of a chemical in the air to which a worker can be exposed over a specific time period (usually eight hours). The PEL for EtO is 1 part per million (ppm) in air as an eighthour time-weighted average (TWA). A short-term exposure limit (STEL) is the maximum concentration of an airborne chemical to which a worker may be exposed over a 15-minute period. OSHA has adopted a STEL for EtO of 5 ppm. A facility may need to implement a medical surveillance program and develop a written plan to reduce employee exposure at or below the PEL, if exposure levels are exceeded. When the STEL is exceeded, a written plan must be developed to define actions to reduce exposure. Employers must determine employee exposure to EtO using breathing zone air samples representative of 15-minute STEL or the 8-hour TWA exposure levels. Personnel monitoring typically involves the use of devices affixed directly to the employee s clothing in the breathing zone (within one foot of a person s nose); however, one limitation is that results are not available until after the actual sampling period. Therefore, OSHA requires that facilities use a process, such as an air monitoring system, to immediately alert employees of an emergency. These devices provide real-time, continuous monitoring of airborne EtO and can quickly detect emergency situations, such as leaks, spills or ventilation system failures. Area monitors may not provide reliable breathing zone measurements, however, and they may not be appropriate for STEL or TWA data. To comply with OSHA regulations, the employer must inform all affected employees about the results of personnel monitoring results. Today s EtO sterilizers, used in healthcare facilities, operate under negative pressure, so the likelihood of an exposure is greatly reduced. Still, in the event of an incident, direct contact with the liquid or inhalation of the vapor can cause burning of one s eyes, a burning sensation in the throat, and skin redness and irritation. To minimize the safety risks associated with the use of EtO, employees should be instructed about: Hazards of EtO; Sterilizer manufacturer and EtO supplier IFU; Storage and handling of EtO gas cartridges; Procedures to reduce employee exposure; Use of PPE; Principles of EtO monitoring and interpretation of results; Handling canceled cycles; Applicable OSHA standards; SEPTEMBER / OCTOBER 2017 Communiqué 49

5 Figure 2: EtO canisters should be stored in a cabinet specifically designed for this purpose. Applicable Safety Data Sheets; and EtO emergency plans. HYDROGEN PEROXIDE Several types of low-temperature systems use hydrogen peroxide (H2O2) as the sterilant. H2O2 sterilization can be in the form of a gas plasma, vaporized or used with ozone. H2O2 can be irritating to the eyes, nose, throat and lungs; however, a number of safeguards built into the sterilizers are designed to minimize the likelihood of personnel contacting hydrogen peroxide in either liquid or vapor phase. To minimize the likelihood of exposure to H2O2 when removing items from a canceled cycle, technicians should always wear latex, vinyl (PVC) or nitrile gloves. As with any chemical used for sterilization, healthcare workers should consult the SDS and follow all manufacture recommendations and departmental procedures. To minimize hydrogen peroxide risks, employees should be instructed about: Hazards of hydrogen peroxide; Storage, handling and disposal of hydrogen peroxide cassettes; Handling canceled cycles; Applicable OSHA standards; The use of PPE; Applicable SDSs; and Recommendations for routine maintenance of sterilization equipment. OZONE Today, in the U.S., ozone (O3)is used in conjunction with one of the H2O2 sterilization systems. O3 sterilizers were previously sold in the U.S. until the H2O2/O3 technology became available. Whichever system is used, O3 is generated within the equipment and the sterilizer design limits the risk of exposure of personnel. O3 passes through a catalyst that converts it back to oxygen before being exhausted into the room. Since the O3 gas is created in an enclosed generator within the unit, there is no handling of the sterilant. The O3 sterilizer has builtin features that protect the user from exposure to high O3 concentrations; however, all chemicals used for lowtemperature sterilization are toxic, so compliance with the manufacturers safety and other recommendations is always necessary. To minimize O3 risks, employees should be instructed about: Hazards of O3; Handling cancelled loads; Applicable SDSs; and Applicable OSHA standards. CONCLUSION Education and written plans for dealing with any potential exposure to sterilization chemicals is required. Experienced nurses and technicians must pay constant attention to the safety risks inherent in their work because doing so is critical for their own safety and that of other employees and patients. REFERENCES 1. U.S. Congress. H.R.3095 Safe medical devices act of gov/bill/ 101st-congress/house-bill/3095. Accessed June 8, U.S. Food and Drug Administration. MedWatch: The FDA safety information and adverse event reporting program. fda.gov/safety/medwatch/default.htm. Accessed June 8, ANSI/AAMI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, 4. ANSI/AAMI ST58:2013, Chemical sterilization and high-level disinfection in health care facilities. 5. ANSI/AAMI ST41:2008/(R)2012, Ethylene oxide sterilization in health care facilites: Safety and effectiveness. 6. ST91 Flexible and semi-rigid endoscope processing in health care facilites. ANSI/AAMI ST91: AAMI TIR67:2014, Promoting safe practices pertaining to the use of sterilant and high-level disinfectant chemicals in healthcare facilities. 8. Association for the Advancement of Medical Instrumentation. Personnel Safety in Sterile Processing Departments Video. Available at: ProductDetail.aspx?ItemNumber=2726. Accessed 12/21/2016. This lesson was adapted from: IAHCSMM Central Service Technical Manual,Eighth Edition (2016), and Managing Safety Hazards in Central Service, Module 6, in EXX CELL 2000 Plus: Strategies for Success (2000). 50 Communiqué SEPTEMBER / OCTOBER