When Congress authorized creation of the Sentinel Initiative in 2007, it was concrete acknowledgment that the failure to follow up on the performance of medical devices recently approved by the FDA was compromising patient safety.

Five years later, medical device followup is still a work in progress, and there’s no reason it can’t be moving along at a friskier pace. In a commentary published in the New England Journal of Medicine, Dr. Robert G. Hauser submits that “patients in the United States continue to be exposed to underperforming and potentially hazardous medical devices after they have been approved by the Food and Drug Administration … despite multiple recalls and some tragic adverse events.”

He cites one particular case involving an implantable cardioverter-debrillator (ICD) that has been implanted in 79,000 heart patients in the U.S. alone. ICDs are used to treat sudden cardiac arrest with a shock, or electrical impulse, via a small device implanted near the heart. But it’s hardly the only “livesaving” device that can put life at risk.

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