Mich. Admin. Code R. 325.45337

Current through Vol. 24-21, December 1, 2024
Section R. 325.45337 - Surgical equipment, instruments, supplies, and reprocessing

Rule 337.

(1) Surgical equipment, instruments, and supplies must be maintained in sufficient quantities, stored in a sanitary environment, and maintained in accordance with the applicable manufacturer guidelines and nationally recognized infection prevention and control guidelines published by any of the following organizations:
(a) Centers for Disease Control and Prevention (CDC).
(b) Association for Professionals in Infection Control and Epidemiology (APIC).
(c) Society for Healthcare Epidemiology of America (SHEA).
(d) Association of Perioperative Registered Nurses (AORN).
(2) Policies and protocols must be established for onsite or offsite reprocessing of surgical instruments and equipment to include sterilization, high level disinfection, immediate-use steam sterilization, and indicators to capture sterilization or disinfection failures.
(3) Reprocessing must be performed by trained personnel.
(4) Documentation of reprocessing personnel competency evaluations is to be regularly performed. Certification, competency assessment, and training records are to be kept on each employee.
(5) Records of use, processing, and maintenance are to be kept on each piece of equipment to trace utilization and repair.

Mich. Admin. Code R. 325.45337

2020 MR 4, Eff. 2/21/2020