Ch 15 Managing Medical Devices within a Regulatory Framework

What is it about?

Approximately one out of every three medical device user facilities report that they are experiencing challenging problems with device failure tracking and response to manufacturing recalls. The healthcare environment—already a complex environment due to regulatory change, persistent systemic healthcare variables contributing to device failure, the wide span of stakeholders along the total product life cycle (TPLC), and the continuous integration of electronic health records, requires straightforward information to help alleviate this problem. Consequently, this section is devoted to unravelling some of the high-level problems in regulatory interpretation and accountability across the TPLC relating to medical device recalls.

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Why is it important?

An overview of the United States regulatory medical device recall process, definitions, required stakeholder interaction, and specific tasks present an opportunity to alleviate some of the problems related to these processes between and among original equipment manufacturers, regulatory bodies, and device user facilities through education.