Stricter Guidelines for Devices?

A story in today’s The New York Times examines the issue of product-safety monitoring at medical device companies. The scope of the piece is limited in that it focuses almost exclusively on C.R. Bard subsidiary Davol, and its 2005 recall of the Kugel patch, a hernia repair device (it also briefly mentions Boston Scientific and Guidant). But it raises the interesting issue of how FDA approaches product-safety complaints about devices.

“Under F.D.A. rules, producers are required to have systems in place to collect and analyze any complaints they receive from doctors and hospitals about their devices. They are also required to send to the agency any report indicating that a device’s failure may have contributed to a patient’s death or injury. But the agency gives device makers significant leeway about how to set up such systems, including what guidelines to use to help them determine when to issue product alerts to doctors or to issue a recall. In addition, a company can decide not to forward a complaint to the agency if it decides after an internal review that its product was not at fault.”

Optimists within med device firms may consider this an isolated instance of negative press coverage about one of their fellow companies. But consumer interpretation is another matter — and one not to be taken lightly. Look where consumer-friendly stories in The New York Times have gotten the pharmaceutical industry. Medical device firms best stay on top of this one.

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