The United States Institute of Medicine (IOM) — an organization that is charged with reviewing issues related to public health — recently shocked the medical community by releasing a report recommending a complete overhaul of the process used by the government to approve medical devices. According to Florida defective medical devices attorneys, this could be an important step forward in the fight to get defective products off the market.
Currently, the U.S. Food and Drug Administration (FDA) relies on a 35-year-old system, known as the 510(k) process, to evaluate the fitness of medical devices from bandages to pacemakers. During this evaluation process, the FDA checks to ensure that a device is “substantially equivalent” to similar devices on the market.
This criterion is woefully inadequate, says the IOM, which was asked to study whether or not the 510(k) process is promoting the safety and effectiveness of medical devices. The organization found that neither is the case, and that the current system is too broken to fix because it does not ensure that products sold to patients are safe.
“Rather than continuing to modify the 35-year-old 510(k) process, the committee concludes that the FDA’s finite resources would be better invested in developing an integrated premarket and postmarket regulatory framework that provides a reasonable assurance of safety and effectiveness throughout the device life cycle,” the IOM committee wrote in the report.
IOM Recommendations for Medical Device Approvals
In order to create a more effective medical device approval process, the Institute of Medicine recommended that the FDA create a clear and straightforward framework that relies on sound science. In addition, a new system should make devices available for sale in a timely manner, while ensuring that these products are effective — and not defective — throughout their life cycles.
The FDA says that the agency is open to suggestions that will improve the process, but has no plans to completely replace it.
Injuries Caused by Defective Medical Devices
The IOM report comes on the heels of significant medical device recalls, including prosthetic hip recalls.
According to a study by the Archives of Internal Medicine, the FDA had approved the majority of medical devices that were recalled between 2005 and 2009. The medical devices in the study posed a risk of serious injury or death. Had there been a more effective medical device approval process, these defective devices might not have been approved and serious injuries could have been prevented.

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