| (i) All items to be sterilized shall be prepared to reduce the bioburden. All items shall be thoroughly cleaned, decontaminated and prepared in a clean, controlled environment. Cleaning is the removal of all adherent visible soil from the surfaces, crevices, joints, and lumens of instruments. Decontamination is the physical/chemical process that renders an inanimate object safe for further handling. (ii) One of the following methods of cleaning and decontamination shall be used as appropriate. (I) Manual cleaning. Manual cleaning of instruments at the sink is permitted. (II) Ultrasonic cleaning. Ultrasonic cleaning of instruments cleans by cavitation and reduces the need for hand scrubbing. When grossly soiled items are placed in the ultrasonic cleaner the water shall be changed more than once a shift. If using this method for cleaning, chambers shall be covered to prevent potential hazards to personnel from aerosolization of the contents. (III) Washer-sterilizers. Washer-sterilizers clean by using rotating spray arms to create water jets that clean by impingement and appropriate soap and disinfectant. These machines shall reach a temperature of 140 degrees Celsius (285 degrees Fahrenheit). (IV) Washer-decontaminator machines. Washer-decontaminator machines clean by numerous water jets and a high pH of detergent even if instruments are grossly soiled. The thorough cleaning is followed by a neutralizing rinse to quickly restore the pH to neutral. (iii) All articles to be sterilized shall be arranged so all surfaces shall be directly exposed to the sterilizing agent for the prescribed time and temperature. (D) Packaging. (i) All wrapped articles to be sterilized shall be packaged in materials recommended for the specific type of sterilizer and material to be sterilized, and to provide an effective barrier to microorganisms. Acceptable packaging includes peel pouches, perforated metal trays, or rigid trays. Muslin packs shall be limited in size to 12 inches by 12 inches by 20 inches with a maximum weight of 12 pounds. Wrapped instrument trays shall not exceed 17 pounds. (ii) All items shall be labeled for each sterilizer load as to the date and time of sterilization, the sterilizing load number, and the autoclave. (E) External chemical indicators. (i) External chemical indicators, also known as sterilization process indicators, shall be used on each package to be sterilized, including items being flash sterilized to indicate that items have been exposed to the sterilization process. (ii) The indicator results shall be interpreted according to the manufacturer's written instructions and indicator reaction specifications. (F) Biological indicators. (i) The efficacy of the sterilizing process shall be monitored with reliable biological indicators appropriate for the type of sterilizer used (e.g., Bacillus stearothermophilus for steam sterilizers). (ii) Biological indicators shall be included in at least one run each day of use for steam sterilizers. (iii) A log shall be maintained with the load identification, biological indicator results, and identification of the contents of the load. (iv) If a test is positive, the sterilizer shall immediately be taken out of service. A malfunctioning sterilizer shall not be put back into use until it has been serviced and successfully tested according to the manufacturer's recommendations. (v) All available items shall be recalled and reprocessed if a sterilizer malfunction is found. A list of all items which were used after the last negative biological indicator test shall be submitted to the administrator. (G) Sterilizers. (i) Steam sterilizers (saturated steam under pressure) shall be utilized for sterilization of heat and moisture stable items. Steam sterilizers shall be used according to manufacturer's written instructions. (ii) Other sterilizers shall be used in accordance with the manufacturer's instructions. (H) Maintenance of sterility. (i) Items that are properly packaged and sterilized shall remain sterile indefinitely unless the package becomes wet or torn, has a broken seal, is damaged in some way, or is suspected of being compromised. (ii) Medication or materials within a package that deteriorate with the passage of time shall be dated according to the manufacturer's recommendations. (iii) All packages shall be inspected before use. If a package is torn, wet, discolored, has a broken seal, or is damaged, the item may not be used. The item shall be returned to sterile processing for reprocessing. (I) Commercially packaged items. Commercially packaged items are considered sterile according to the manufacturer's instructions. (J) Storage of sterilized items. The loss of sterility is event related, not time related. The facility shall ensure proper storage and handling of items in a manner that does not compromise the packaging of the product. (i) Sterilized items shall be transported so as to maintain cleanliness and sterility and to prevent physical damage. (ii) Sterilized items shall be stored in well-ventilated, limited access areas with controlled temperature and humidity. (iii) Sterilized items shall be positioned so that the packaging is not crushed, bent, compressed, or punctured so that their sterility is not compromised. (iv) Storage of supplies shall be in areas that are designated for storage. (K) Disinfection. (i) The manufacturer's written instructions for the use of disinfectants shall be followed. (ii) An expiration date, determined according to manufacturer's written recommendations, shall be marked on the container of disinfection solution currently in use. (iii) Disinfectant solutions shall be kept covered and used in well-ventilated areas. (L) Performance records. (i) Performance records for all sterilizers shall be maintained for each cycle. These records shall be retained and available for review for a minimum of two years. (ii) Each sterilizer shall be monitored during operation for pressure, temperature, and time at desired temperature and pressure. A record shall be maintained either manually or machine generated and shall include: (I) the sterilizer identification; (II) sterilization date and time; (III) load number; (IV) duration and temperature of exposure phase (if not provided on sterilizer recording charts); (V) identification of operator(s); (VI) results of biological tests and dates performed; and (VII) time-temperature recording charts from each sterilizer (if not provided on sterilizer recording charts). (M) Preventive maintenance. Preventive maintenance of all sterilizers shall be performed according to individual policy on a scheduled basis by qualified personnel, using the sterilizer manufacturer's service manual as a reference. A preventive maintenance record shall be maintained for each sterilizer. These records shall be retained at least two years and shall be available for review to the facility within two hours of request by the department. |
