would allow more comprehensive collection of information on shunt complications using standard definitions, but makes no specific recommendations (64).
It is clear that the approved CSF shunt devices continue to have important problems with both function and infection. The existing system for monitoring these devices for problems should be examined for effectiveness both in identifying problems and in prompting corrective action.
The 1976 Medical Device Amendments granted FDA authority to issue regulations requiring adverse event reporting for marketed medical devices. FDA issued these medical device reporting regulations in 1984. A medical device reportable event as defined by the statute means:
(1) An event about which user facilities become aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury; or (2) An event about which manufacturers or importers have received or become aware of information that reasonably suggests that one of their marketed devices:
(i) May have caused or contributed to a death or serious injury; or
(ii) Has malfunctioned and that the device or a similar device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. (21 CFR 803.3)
Subsequent adverse event reports were collected in the Medical Device Reports (MDR) database. To strengthen the reporting system, Congress enacted the Safe Medical Devices Act of 1990 (SMDA), which established requirements for reporting by device manufacturers, distributors, and user facilities. The FDA established a new database, Manufacturer and User Facility Device Experience (MAUDE), and began the transition from the MDR database in 1992. Since August 1996, MAUDE has been the exclusive adverse event report database.
In 1990, Congress also enacted separate regulatory authority for postmarket surveillance. The FDA website provides the following statement regarding the purpose of postmarket surveillance (68).
The primary objective of postmarket surveillance is to study the performance of the device after marketing as it is to be used in the general population for which it is intended. Generally, the primary variables to be studied are morbidity or mortality. The major interest lies in device failure and its attendant impact on the patient.
Postmarket surveillance is considered a warning system for the early detection of potential problems within a reasonable time of their first marketing. The intent of the regulation is to:
Provide safety warnings