CSA Group A guide for developing and implementing a medical device performance assurance program - Essential process information for Clinical Engineering PERFORMANCE ASSURANCE GUIDE

A Performance Assurance (PA) program is a medical device risk management system - critical to the clinical engineering function - that clearly defines performance verification, preventive maintenance and operational safety testing. A variety of professionals are involved in managing a clinical engineering department including: Medical equipment management; biomedical equipment management; biomedical engineering; clinical engineering; clinical equipment management; healthcare technology management; and maintenance & operations personnel. An effective PA program provides several benefits such as improved patient safety, reduced corporate risk, and increased organizational efficiency and effectiveness. This Guide provides a framework for the development and implementation of a comprehensive and effective regional PA program. This publication is not a standard and any reference to published standards is presented merely as reference for additional information sources to consult where necessary. Highlights Helps improve patient safety by providing clear guidance on how to direct scarce resources to the highest risk devices, and thus achieving the greatest improvement possible for patient care within available resources Provides guidance and information for clinical engineering staff in the process of consolidating their performance assurance system into a regional program Adaptable – can also be applied to developing new single-site performance assurance programs since the described program structure and examples of standard operating procedures can be scaled down to a single site