Health Care Costs (Large Savings Await for a Gov’t that Wants to Save)/NYT

Recall that FDA’s Device Center was recently shown to make political decisions re medical device approvals, and to grandfather in devices on the basis of earlier approvals of very different devices.  GAO wrote several damning reports including this one from June 2009: Shortcomings in FDA’s Premarket Review, Postmarket Surveillance, and Inspections of Device Manufacturing Establishments.  GAO pointed out in January 2009 that only cursory reviews were taking place for most devices.  Thus the Center’s Director was let go.

Yesterday’s NYT reports on devices that fail, and how the health care system has to eat the very expensive results of such failures.  But in the US, medical devices come with no warranty:

When a car breaks, a computer fails or a toaster flames out, the manufacturer is often liable under the product warranty. But that is not how the multibillion-dollar orthopedics industry tends to work, according to doctors, industry experts and three of the biggest device makers.

The article points out that the new healthcare bill should have addressed this issue, but did not.

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Anonymous
Anonymous
12 years ago

Every day, the public and the medical profession rely on marketed medical devices to be safe. Innocently or sometimes in their own justification medical personnel recommend the use of various medical devices. Easy for them, they are not the ones to usually suffer the consequences if something "goes wrong". Being a victim of a malfunctioning and highly questionable medical device, it was absolutely shocking…disturbing to find out how slack the FDA is concerning medical devices. Had I known back then what I know now then my decision would have been different. Now I worry about the long term effects that may show up, or may already be showing up, as I contemplate other medical procedures that I must most likely go through and the dangers of the devices used. Tomorrow I must make a decision, and that decision could be fatal. What a hard choice, that really isn't much of a choice. Is the medical facility really being "on the level" with me ? Are the medical professionals deceived by marketing ? Only time will tell. I may be another future statistic for "bad medicine".

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