Affiliations: Emeritus Professor, University of Tennessee Medical Center, Memphis, TN, USA
Note: [] Address for correspondence: Professor J. Autian, 6997 Fords Station Road, Germantown, TN 38138, USA. Tel.: +1901 755 9465; E‐mail: [email protected].
Abstract: The manufacture of medical devices made in whole or part of a man‐made material (biomaterial) has expanded experientially in the last several decades. This expansion has led to an increasing number of adverse effects of medical devices, with estimates being that the number may be as high as 100,000 each year, from minor injuries to those very serious causing deaths. Since the 1976 Medical Device Amendment to the US Food, Drug and Cosmetic Act. This act requires that a new medical device to enter the American market place must be safe and effective for its intended use. The first step in designing a medical device is the selection of a suitable material that has the mechanical and the physical‐chemical properties appropriate for the device. After the selection of the material, consideration must be given to the biocompatibility of the material, which in turn will require that appropriate toxicity tests be conducted on the material to ensure safety. Under the section on “Adverse effects from medical devices”, a summary of the laws governing medical devices and various definitions used in regard to biomaterials and devices is given. This is followed by discussing, some in greater details than others, examples of selected adverse effects of medical devices. Finally, attention is given to reporting and monitoring of medical devices to help reduce the number of adverse effects, which in turn may lead to the removal of the device from the market place or to have the device redesigned to prevent the adverse effect.
Keywords: Medical devices, adverse effects, biomaterials, biocompatibility, toxicity tests, cancer studies, monitoring and reporting, rules regulations, Food and Drug Administration
