Applying Risk Management Principles to Medical Devices Performance Assurance Program—Defining the Process

Biomedical Instrumentation & Technology 401 The management of medical devices entails a number of essential components. These include technology assessment, acquisition, inventory control, repair service, in-service education, performance assurance (PA), etc. The PA program, in some cases referred to as preventive maintenance (PM), deals with device operation, performance, and safety. In this paper, PM is regarded as a specific subcomponent or activity of the PA program. The PA program is defined as “a planned and scheduled method of performing inspections for performance verification, preventive maintenance, and safety testing.”1 In this context, performance verification (PV) entails testing according to a written procedure to ensure that equipment is performing within specified performance limits and PM is a planned periodic procedure for cleaning, lubricating, adjusting, and replacing components whose failure may impair equipment function. Safety testing (ST) in this context is performed to verify that equipment is in compliance with electrical safety requirements. Therefore, PA=PV+PM+ST. A similar equation was described by Ridgway2 but with slightly different terminology. In practice, performance assurance includes management of the program and development of test protocols/procedures.