Elements for medical equipment quality assurance

Abstract

Medical equipment quality assurance is part of an overall medical equipment management program for a healthcare facility or system. A complete program includes corrective maintenance or repair, equipment control, asset management, health care technology planning, education, and activities directed toward improving medical device-related patient safety. The purpose of this paper is to provide some guidance lines in establishing and managing a medical equipment quality assurance program and to present some procedures for inspection, maintenance, evaluation and performance testing for some medical devices. The results of this paper take into consideration the advances in device reliability, reduced preventive maintenance requirements and internal device surveillance (self-test) along with changes in standards. Due to the ongoing efforts at global harmonization, international standards are used and referenced where applicable, such as electrical safety testing references. A computerized medical equipment management system is described. The results demonstrate that it is a useful tool in tracking device inventory and maintenance history. Also risk classes have been designed for medical devices based on the time of testing, risk identification in relation to patient and staff member, clinical function, physical risk, problem avoidance probability, incident history, and regulatory manufacturer requirements.