Mich. Admin. Code 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.
Notes
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