Medical Device Incident Reporting under

Medical Device Incident Reporting under the Safe Medical Devices Act (SMDA)... 

The Competent Authority to which the incident was originally reported usually takes on the role of monitoring and evaluating how the incident is dealt with. When all actions are complete, including any necessary Field Safety Correction Actions, the manufacturer must submit a final report to the Competent Authority. Under a safeguard clause. Competent Authorities may take unilateral action to remove a device from their market, if they believe that it poses an unacceptable health risk, but the Commission must be informed of such actions. In less-urgent situations, concerns may be referred to the Committee for Medical Devices for consideration. 

Adverse Events. The Safe Medical Devices Act of 1990 included a provision by which both users and manufacturers (and distributors) of medical devices are required to report adverse patient events that may be related to a medical device. Manufacturers must report to the FDA if a device (a) may have caused or contributed to a death or serious injury, or (b) malfunctioned in such a way as would be likely to cause or contribute to a death or serious injury if the malfunction were to reoccur. Device users are required to notify the device manufacturer of reportable incidents, and must also notify the FDA in case of a device-related death. In addition, the FDA established a voluntary program for reporting device problems that may not have caused an untoward patient event, but which may have the potential for such an occurrence under altered circumstances. 

Incidents in which a device may have caused or contributed to a death or serious injury must be reported to the FDA under the Medical Device Reporting Program. In additions, certain malfunctions must also be reported (16). 

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