Medical Hardware

Welcome to
Medical Hardware

Medical Hardware - Featured Article

August 01, 2011

Medical Device Approval Process Debated by Scientists and Industry

The National Academy of Sciences said this week in an FDA-commissioned report that thousands of medical devices are allowed to go on the market without proper safety testing.

And the Institute of Medicine has just published a report being furiously denounced by the medical device industry, recommending that certain types of medical devices now be regulated, according to a story by Christine Mai-Duc at According to a story at by Barry Meier, the medical device industry is fighting hard to discredit the report by the Institute of Medicine, that completely agrees with the National Academy of Sciences, with which it is aligned.

Mai-Duc writes at that the National Academy of Sciences told her the Food and Drug Administration (FDA) needs to “stop permitting thousands of medical devices to be marketed and used in patients without proof of safety or effectiveness.”

The academy's report, coming after a wagonload of recalls and problems with such devices, referred to a “little-known quirk” in the law, Mai-Duc writes. The FDA supposedly has broad responsibility to ensure that drugs and medical devices are safe and effective. But thousands of devices do what amounts to an end run around the agency, “going through an expedited review because they are considered similar to older devices that are already on the market,” Mai-Duc writes.The Institute of Medicine and the National Academy of Sciences, recommended that the system be abolished and new procedures established, according to Mai-Duc’s story."It's not clear that the … process is serving the needs of either industry or patients, and simply modifying it again will not help," David Challoner, chairman of the committee that wrote the report, said in a statement, as reported by Mai-Duc.In a surprise twist, the FDA disputed the institute's conclusions, even though it had asked for the analysis, according to Mai-Duc.Medical devices range from stents to pacemakers to hip and knee replacements to heart defibrillators, and earn their companies hundreds of millions of dollars a year, according to Meier. He writes that  some devices, like the “so-called metal-on-metal artificial hips” appeared to work well when tested only on mechanical simulators but then were a disaster when implanted in patients.

He notes in his story that these implants are currently the subject of scrutiny and lawsuits. Mai-Duc adds that almost 100,000 of these artificial hips were recalled last summer after studies showed that about 1 in every 8 recipients needed to have them replaced because they released small metallic particles into patients' bloodstreams over time.

Even though all devices are supposed to be tested by the FDA, according to Mai-Duc, the vast majority of medical devices are approved without medical or clinical analysis.

Makers of medical devices are having a hard time, overall.   According to a story at, they’ve now been slapped with a 2.3 percent excise tax, starting in 2013. 

Deborah DiSesa Hirsch is an award-winning health and technology writer who has worked for newspapers, magazines and IBM in her 20-year career. To read more of her articles, please visit her columnist page.

Edited by Rich Steeves
Get stories like this delivered straight to your inbox. [Free eNews Subscription]

Medical Hardware Related Articles