The Medical Device Amendments to the Food, Drug, and Cosmetic Act, Part 803, contain a requirement that manufacturers report to the FDA whenever they become aware of information suggesting that one of their marketed medical devices: a) may have caused or contributed to a death or serious injury or b) have malfunctioned in such a manner that it or a similar manufactured device could result in a death or serious injury. The purpose of this requirement was to provide a mechanism to help FDA insure that devices were safe and effective.
In this presentation we discuss three aspects of this reporting system. First, the most recent data on laser associated injuries are reviewed. Because of the nature of the reporting requirement, this system will not include injuries that might have occurred prior to final approval of the medical device or any injury that might have occurred from basic research uses. Secondly, we show how the information contained within the reporting system can be used to initiate and support some type of FDA safety initiative. Finally we discuss, using some of the same information that was presented in item two, some of the difficulties FDA has in coding and extracting information from the reporting system.
Although the Medical Device Report (MDR) system does have some problems, it has proven overall to be successful as a source of information on safety concerns for a number of other medical devices. Data in the MDR system has been the basis of decision on educational needs aimed at improving safe use of medical devices such as hemodialyzers, apnea monitors, and defibrillators.