(Lack of) FDA device monitoring draws new scrutiny

The FDA is facing new criticism over the lack of a dedicated monitoring system to track problems with artificial hips, pacemakers or other devices. The journalism outfit ProPublica reports on the issue in an article that highlights the shortfall. Each prescription drug has a unique code the government can use to track reports of problems, whereas medical devices do not, the story notes. For devices, the FDA depends on voluntary reports from providers, patients and devicemakers, and only after these reports come in can regulators require further action. To the FDA's credit, and as the article notes, the agency posts adverse event reports online once it receives them. Furthermore, work is under way to use electronic health records data and medical claims to track devices as well as drugs and vaccines (The Sentinel Initiative). Congress has mandated the establishment of a post-market surveillance system to track medical device safety once products are used commercially. But that process hasn't been established yet, 5 years after Congress stepped in. Story

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