Ch 6 Managing Medical Devices within a Regulatory Framework

What is it about?

General advances in medicine have helped to increase the life span across the globe and particularly in the United States. Improvement in overall health together with the US capacity to continuously advance implant technology and other medical devices expected to survive permanently in vivo, biocompatibility becomes a critical component for long-term survival and success. In order to insure the safety of medical devices and implants, regulatory agencies are faced with challenges associated with in vivo performance measured by clinical indications and several ethical challenges. This chapter aims to address some of these ethical challenges from the perspective of legislation, hybrid medical devices and their biocompatibility. We suggest recommendations focused on increased utilization of interprofessional collaboration and input from clinical organizations as the most pragmatic approach to the formation of biocompatibility testing requirements.

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Why is it important?

Biocompatibility is a growing topic of interest as new materials and procedures are developed to be utilized in the human body.