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Postmarket Surveillance[index]

Postmarket surveillance is the core of the FDA's new regulatory approach. While device manufacturers and device user facilities have had reporting duties for several years, these are limited in scope and not universally followed. The critical limitation was that the user facility's duty to report was not triggered until there was a serious injury. I believe that this is a holdover from drug regulation, in that drugs have simpler failure modes than devices: drugs have few human factors considerations, they do not wear out, they are not reused, there are no maintenance issues beyond storage conditions, physicians are expected to be expert in their use, and defects are seldom detected by inspection. In contrast, while many device problems can be detected before there is a patient injury, they will not come to the FDA's attention until there is an injury. This problem was addressed in the Medical Device Amendments of 1992, which requires manufacturers to report when their product:

"(A) may have caused or contributed to a death or serious injury, or

(B) has malfunctioned and that such 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;..."

This change makes it clear that all potentially dangerous failures must be reported, but, in itself, is not a great change from the existing rules for manufacturers. (This change does not apply to device user facilities, whose reporting duties are still tied to the occurrence of a severe patient injury.) The key change is that the FDA has targeted physicians and other health care professionals as the first line in their device reporting system.

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