| (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. |
