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Introduction: History and Where We Are Headed

  • Shayne C. GadEmail author
Chapter
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Abstract

While medical devices have been derived and used since at least ancient Egypt, means of verifying their biologic safety to patients (biocompatibility) and regulations requiring and governing such pre-use evaluation (testing) are much more recent. Less than a century has seen the modern approach, with testing dictated by type, and duration, of patient contact are much more recent. Such requirements first arise in the 1960s due to concerns with materials migrated from a device into the patient body. The science and complexity of testing involved are continuously evolving (accelerated by concerns as to the safety of silicones in the late 1980’s) and have also served to drive the growth of the medical device market (now nearly a third the size of the pharmaceutical market) and the innovations and complexity of devices and device/drug combinations.

Keywords

Adverse effects on patients Biocompatibility Biodegradation of material or device Breast implants Center for Devices and Radiological Health Constituent materials in the device Cooper Committee Cumulative duration of contact Dalkon Shield Dr. John Autian Food, Drug, and Cosmetic Act IDE Leachables Medical Device Amendments Medical device industry Patient contact mode and duration Patient exposure parameters Safe Medical Devices Act Tripartite 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  1. 1.Gad Consulting ServicesRaleighUSA

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