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.