Current through Register Vol. 56, No. 6, March 18, 2024
(a) Methods for processing reusable medical devices shall conform with the following or revised or later editions, if in effect, incorporated herein by reference;
1. The Association for the Advancement of Medical Instrumentation (AAMI) , Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities, ST 79;
2. AAMI, "Safe Handling and Biological Decontamination of Medical Devices in Health Care Facilities and in Nonclinical Settings," ST 35;
3. AAMI, "Ethylene Oxide Sterilization in Health Care Facilities: Safety and Effectiveness," 2008, ST 41; and
4. Society of Gastroenterology Nurses and Associates (SGNA), "Standards of Infection Control in Reprocessing Flexible Gastrointestinal Endoscopes," ( 2018 ).
(b) The documents referenced at (a) above are reviewed and/or revised every five years or more frequently as needed; the most current document is to be used. The AAMI requirements can be obtained from: The Association for the Advancement of Medical Instrumentation, 901 N. Glebe Road, Suite 300, Arlington, VA 22203, http://www.aami.org. SGNA's Standards and Guidelines are available from the Society of Gastroenterology Nurses and Associates, Inc., 330 N. Wabash Avenue, Suite 2000, Chicago, IL 60611-2oOo, http://www.sgna.org .
(c) Emphasis shall be placed on cleaning of these devices prior to sterilization or disinfection. The selection and use of disinfection and/or sterilization methods for patient care items or equipment shall be divided into the following three categories:
1. Critical items are objects that enter sterile tissue or the vascular system. These instruments, excluding scopes, must be sterilized by a process that can demonstrate a sterility assurance level of 10[-6].
i. Laparoscopes, arthroscopes, and other scopes that enter normally sterile areas of the body shall be sterilized or given high-level disinfection after each use according to the manufacturers' written recommendations or according to policy established by the facility's infection control committee.
2. Semicritical items are objects which come into contact with mucous membranes or with skin that is not intact. Semicritical items require high level disinfection or intermediate level disinfection. (At a minimum, the disinfectant must be labeled as tuberculocidal.)
3. Noncritical items are objects that come into contact with intact skin but not with mucous membranes. Noncritical items shall at a minimum be exposed to a low level disinfectant.
(d) The efficacy of chemicals used for high-level disinfection shall be verified by the use of a test method specific to the chemical if a valid and reliable test method is available and feasible for use in an ambulatory setting.
(e) At the completion of each sterilization cycle, the following documentation shall be recorded and maintained on site for at least one year:
1. Time, temperature and pressure readings shall be verified and the print out/chart initialed by the operator before items are removed; and
2. A record of each sterilization/disinfection load, including the date, load/cycle number and the specific contents of the load shall be retained for a least one year or per facility policy, whichever is greater.
(f) Each package shall be labeled with sterilization date and load number.
(g) The manufacturer's instructions for cleaning, testing, disassembly, and sterilization of equipment shall be readily available and followed by employees.
1. All hinged instruments shall be processed in an open position.
2. All instruments that can be disassembled shall be disassembled for decontamination and sterilization.
(h) Sterilized materials shall be stored, handled and transported to maintain sterility. Package integrity shall be maintained until used.
(i) Sterile supplies which bear an expiration date shall not exceed the shelf life date as recommended by the manufacturer of the packaging selected or the device contained therein.
1. A policy and procedure to retrieve and reprocess outdates shall be established and enforced.
(j) If the facility is using an event-related sterility program, the process shall include a continuous quality plan with documentation of facility compliance with the following:
1. Proper transportation of sterile product;
2. Proper storage conditions of sterile product;
3. Proper rotation of sterile product; and
4. Maintenance of sterile pack integrity.
(k) All sterilization equipment shall be installed and operated in accordance with the sterilizer manufacturer's written instructions.
(l) Single use patient care items shall be reprocessed under the following conditions:
1. The manufacturer provides written documentation for cleaning and sterilization of the item and the facility has the resources to meet those specifications;
2. Methods for processing single use patient care items conform with the following Food and Drug Administration regulations:
i. Premarket Notification, Registration and Listing shall comply with 21 CFR, Part 807 , incorporated herein by reference, as amended and supplemented; and
ii. Quality system regulations as specified in 21 CFR Part 807 , incorporated herein by reference, as amended and supplemented; and
3. If the facility retains an outside firm to provide its sterile processing, a quality control program shall be established to ensure the delivery of a safe product as specified in the contract with the third party processor.
(m) Shared reprocessing by outside healthcare reprocessing centers shall meet the following standards:
1. Policies and procedures for all processing protocols shall be approved by all facilities in the network in conjunction with infection control managers.
2. Instruments and devices transported off site for processing shall be inventoried and pre-cleaned prior to transportation.
i. Soiled instruments shall be contained in impervious, closed containers which are either locked or sealed in covered carts.
3. All decontamination, assembly and sterilization shall be performed according to the device manufacturer's written recommendations.
i. Manufacturer's written instructions for processing of all specialty devices shall be obtained, followed and kept on file at the processing facility.
4. The following records shall be maintained at the processing facility:
i. Sterilization logs shall be maintained for all items sterilized; and
ii. Biological monitoring as specified in 8:43A-14.5(a).
5. Immediate notification shall be made to the receiving facility upon a positive biological result.
6. Transport of sterile product shall be performed using disinfected, impervious containers that are either locked or sealed in covered carts.
