Performance Qualification Testing Improves Processing of Lumened Surgical Instruments in Ultrasonic Cleaners

Author:

Anderson Kevin,Drosnock Mary Ann,Kovach Stephen M.,Zitek Thea

Abstract

ABSTRACTThe use of performance qualification (PQ) tests for ultrasonic cleaners leads to improvements in the quality of processing lumened surgical instruments. Evidence and national standards assert the need for health care facilities to implement a quality management system related to device reprocessing and testing the adequacy of mechanical cleaning processes. Testing includes showing that ultrasonic cleaners have properly functioning cavitation, soil removal, and lumen perfusion capabilities. This article summarizes survey responses from an audit of sterile processing personnel regarding ultrasonic cleaning units in health care facilities. The article also provides guidance to facilities regarding assessing installation, operational, and PQ related to ultrasonic cleaning equipment. Implementing PQ testing of ultrasonic cleaners in sterile processing units leads to a decreased risk of soiled instrumentation in the OR, which can reduce the risk of patient infection and adverse events.

Publisher

Wiley

Subject

Medical–Surgical Nursing

Reference12 articles.

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2. Association for the Advancement of Medical Instrumentation.ANSI/AAMI ST79:2017 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities.Arlington VA:AAMI;2017.

3. Product classification. US Food and Drug Administration. Updated March 20 2023. Accessed April 3 2023.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=FLG

4. 21 CFR §880.6150. Ultrasonic cleaner for medical instruments. Updated January 17 2023. Accessed April 3 2023.https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=880.6150

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