An equipment qualification framework for healthcare

Abstract

Manufacturing, in regulated industries, has developed systematic practices, protocols and tools for equipment acceptance testing, described by the term Equipment Qualification. This paper, in drawing parallels between requirements of manufacturing equipment and medical equipment, hypothesizes that the protocols, practices and tools of Equipment Qualification can be adapted for application in healthcare. In manufacturing, where the quality of output is of critical concern, the scope of Equipment Qualification is building confidence that the equipment can produce product to specification. In healthcare, where patient safety is the critical concern, the identification and control of potential causes of adverse events is of central importance in establishing confidence that the equipment is “ready for its intended use.” This paper details the development of an Equipment Qualification framework for healthcare to guide healthcare practitioners in best practice tools, techniques and considerations for the identification and control of potential causes of adverse events. The Equipment Qualification framework presented in this paper synthesizes existing knowledge in the domains of risk management, quality, safety, reliability, maintenance, calibration, human factors engineering and lean methods with empirical findings of benchmarking case studies in manufacturing companies and requirements analysis case studies and questionnaire in healthcare. The framework is written in the systems engineering modeling language IDEFØ.