It may not be comforting news that an Institute of Medicine (IOM) panel issued Friday, July 29, in saying that the approval process for thousands of medical devices each year is “fatally flawed” and needs to be replaced. The U.S. Food and Drug Administration (FDA) had asked the IOM to look at the 510(k) approval process, which allows manufacturers to bypass any scientific scrutiny of a new medical device as long as it is “substantially similar” to one already on the market, reports Reuters.
Manufacturers love this option and about 4,000 applications are filed every year with about 3,000 being approved. That means that a medical device, such as a hip implant placed in your body, likely has not undergone any premarket review for safety. That is the shocking revelation to thousands of patients every year who find their device, whether a defibrillator, an artificial hip, or a piece of surgical mesh, has failed and it never received a premarket approval for safety.
The IOM report says “What we are recommending is that the 510 (k) is fatally flawed in terms of not evaluating safety and effectiveness of a device.” The FDA quickly defended itself saying in a statement that the fast-track process should not be eliminated, “but we are open to additional proposals and approaches for continued improvement of our device review programs,” according to Dr. Jeffrey Shuren who directs the Center for Devices and Radiological Health which oversees medical devices.
For its part, the major medical device manufacturers argue that 510(k) is needed because it brings much needed technologies to patients. A group representing industry, Advanced Medical Technology Association or AdvaMed, said Congress should not consider the report’s conclusions. That is no wonder considering that the 510(k) delivers billions in profits to the major manufacturers such as Johnson & Johnson, Boston Scientific, Medtronic Inc, and Abbott Laboratories.
Unfortunately, we often find after a device is placed in a patient that it needed to undergo premarket clinical trials because problems that would have shown up premarket surface instead by injuring the implanted patient. Sometimes the product must be recalled, but the patient is still injured, some permanently or fatally. Consider J&J’s DePuy artificial hips which were recalled last year after some 93,000 patients received the implant. External defibrillators found in public places such as airports have also been recalled recently after thousands of reports of malfunctions of the defective product.
If you have been injured by a medical device, or believe the device you received is the source of your pain and further injury, the Florida medical equipment error attorneys at Farah & Farah can help you understand the process and your options under product liability law.
Sources: http://health.usnews.com/health-news/managing-your-healthcare/policy/articles/2011/07/29/report-urges-new-review-system-for-medical-devices and http://www.reuters.com/article/2011/07/29/us-medical-device-regime-idUSTRE76S4D720110729
