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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
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| 17 April 2012 | By Alexander Gaffney, RAC
After a string of "headline-grabbing" recalls involving medical devices in recent months, Minneapolis-based medical device manufacturer Medtronic is announcing its intent to increase its postmarketing safety surveillance of its implantable products, reports Reuters.
"The US Food and Drug Administration (FDA) alone does not have the infrastructure," said Medtronic CEO Omar Ishrak in an interview with Reuters, "so companies have to play a leading role in this."
"We need improvements in device surveillance," he conceded.
Ishrak said the company plans to invest "heavily" in new postmarketing analysis measures, saying to Reuters he believes the company has an obligation to "address these issues as early as possible."
Ishrak's remarks come after a study published in the cardiology journal HeartRythym accused cross-town rival medical device manufacturer St. Jude of manufacturing faulty defibrillator leads purportedly associated with hundreds of patient deaths.
St. Jude launched an all-out public relations assault on HeartRythym, calling for the article's withdrawal in light of what it said was a biased and error-prone analysis. St. Jude also pointed the finger at Medtronic, saying its Quattro defibrillator leads were associated with 377 patient deaths, raising the stakes for Medtronic.
Medtronic's 17 April announcement about increasing its own medical device surveillance activities is likely partially in response to St. Jude's accusation and the growing threat of the FDA and consumer groups calling for more stringent regulation of devices.
FDA is reportedly already looking to institute a new unique device identification (UDI) system to track devices and a new postmarket surveillance program aimed at tracking down malfunctioning devices.
Reuters - Medtronic to boost safety monitoring of devices
Tags: Retraction, HeartRythm, Heart Rythym, Quattro, Riata, Medtronic, St. Jude, Journal, Postmarketing, Monitoring, Latest News, safety, regulatory