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

Area of Science:

• Healthcare Quality Improvement
• Medical Device Reprocessing
• Sterile Processing Technology

Background:

• National standards mandate quality management systems for medical device reprocessing.
• Effective mechanical cleaning of surgical instruments is critical for patient safety.
• Ultrasonic cleaners require validation to ensure proper function (cavitation, soil removal, lumen perfusion).

Purpose of the Study:

• To assess current practices in ultrasonic cleaner usage and performance qualification (PQ) in healthcare facilities.
• To provide guidance on installation, operational, and PQ for ultrasonic cleaning equipment.
• To highlight the benefits of PQ testing in improving the quality of surgical instrument reprocessing.

Main Methods:

• A survey was conducted among sterile processing personnel regarding their use of ultrasonic cleaning units.
• Analysis of survey responses to audit current practices.
• Development of guidance for assessing ultrasonic cleaner installation, operation, and PQ.

Main Results:

• Survey data provided insights into the current state of ultrasonic cleaner use and PQ implementation.
• Identified variations in practices related to the testing of ultrasonic cleaning units.
• Highlighted the need for standardized PQ testing protocols.

Conclusions:

• Performance qualification testing of ultrasonic cleaners is essential for effective reprocessing of lumened surgical instruments.
• Implementing PQ testing decreases the risk of contaminated surgical instruments reaching the Operating Room (OR).
• Reduced risk of soiled instrumentation directly correlates with a lower incidence of patient infections and adverse events.