A systems management framework for medical device safety and optimal outcomes

Abstract The huge amount of existing literature on medical devices by a variety of writers using different terminologies has become difficult to digest. This paper presents a simple framework linking the core activities of medical device regulators, technology assessors, and clinical operators across the lifespans of a medical device. The framework can help policy making and systems operation management to ensure patient safety and optimal performance of medical devices; the framework can equally inform the layperson in using home-use medical devices. In addition, it can serve as a universal common framework among stakeholders for education, communication, and collaboration. Descriptions on framework elements are available in the worldwide literature; one can search the Internet for details without losing the “big-picture” relevance, and then choose the right tools appropriate to their situations. This systems management framework derives from medical device regulatory and quality management systems principles.