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Comforting or disturbing? FDA's report on medical device recalls

Patient harm in the medical industry is a serious and understandable concern in Ohio and across the rest of the country. Myriad studies from a number of sources have chronicled in recent years the frightening extent to which medical industry negligence has resulted in medication error, misdiagnosis, egregious surgical mistakes, hospital-acquired infections and other patient-adverse outcomes.

One source of patient harm that is widespread across the United States, yet perhaps not as widely publicized as other medical errors, is the deficient design or manufacture of medical devices. Defective medical devices -- which span a wide universe of products ranging from defibrillators and transvaginal mesh to hip/knee implant replacements and infused bone grafts -- harm or kill high numbers of patients each year.

And regulatory safety recalls regarding product defects are increasing, as noted by a recent FDA report.

Notably, and notwithstanding news that safety recalls for medical devices have almost doubled over a recent decade, the FDA implies that consumers and would-be patients should be heartened by the recall spike.

The reason is this, states the agency: The increased recalls underscore the agency’s resolve and greater ability in recent years to identify and more quickly respond to device concerns.

Of course, there is a flip side to such logic, and it is sharply expressed by one device industry commentator, Dr. Robert Hauser. As noted by a media article discussing the recent FDA report, Hauser “questions the report’s conclusion that increased recalls signals improved safety.”

In fact, states Hauser, precisely the opposite conclusion should logically be reached from the data.

A truly exacting and safety-enhancing regulatory process, he says, “would have prevented most recalled devices from being approved” in the first place.

Medical device recalls of any magnitude are always big news across the country, for obvious and compelling reasons. Our blog consistently strives to keep readers fully and timely apprised of material updates, which we shall continue to do in future posts.

Source: Minneapolis Star Tribune, "FDA report shows medical device recalls climbing," James Walsh, March 21, 2014

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