Regulate Medical Devices? Demand Safety and Utility? The Best Congress Money Can Buy

It’s difficult to believe anyone would want to deregulate control of drugs or for that matter medical devices. Without a neutral third party review of efficacy and safety, it’s anyone’s guess what would be foisted onto an unsuspecting public.

Consider that over the years defects have been very commonly found in such implantable devices. In fact thousands of recall notices/year are the norm.

Meanwhile, the number of items implanted in people’s bodies is soaring, as is the number of recalls. Nearly 2,500 medical devices were recalled for potential safety problems in fiscal 2008, according to the Food and Drug Administration. That was nearly double the number reported the previous year and a 164 percent increase since 2000.

With all this, we now have legislators who have accepted campaign contributions from venture capitalists working to undermine the oversight process:

Over the following month, Mr. Paulsen’s campaign committee took in $74,000 from people with a stake in device regulation, much of it from executives affiliated with venture capital funds and their spouses. Now Mr. Paulsen, a two-term Republican, is a sponsor of a bill that would make it easier to bring new medical products to market.

“They have this unwritten assumption that every new device is innovative,” Dr. Rita Redberg, who is the editor of the Archives of Internal Medicine, said, referring to the venture capital funds. But some devices, she said, “are killing people or causing significant harm.”

Further complicating the medical device business is the established fact that the gate keepers, medical providers, often take payment from device manufacturers to encourage use of their “innovations.” Without some brake in the system we have a recipe for development of faulty devices and their overuse and/or misuse.

Furthermore, these same forces want tort reform so as to protect these same manufacturers from being sued for bad outcomes from faults in the device and the selfsame overuse and misuse.

Note: Bringing devices to market without careful continuing oversight, when there is a money driven motivation, is a recipe for disaster.


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