ORL Brochure

Adverse Event Reporting – An FDA Requirement: What, When, Who & How

Mar 8, 2009 | General

Most orthopaedic surgeons in the course of their practice will encounter and explant medical devices which have failed. Such failures may simply result from long-term in-vivo device usage, component material breakdown, technique at the time of implantation or patient noncompliance. Changes in the Safe Medical Devices Act of 1990 (SMDA), a Law enacted by the Congress, requires that medical device user facilities inclusive of hospitals, ambulatory surgical facilities and nursing homes report such events to the Food and Drug Administration (FDA) and manufacturers. These events are inclusive of device problems which cause or contribute to the death, serious illness or serious injury of a patient. The orthopaedic surgeon is involved in the identification and interpretation of these problems. In June 1993, the FDA introduced MedWatch, a medical products reporting program, to facilitate the reporting of adverse events and product problems that arise from medical device usage.

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