Recent changes to approval guidelines for medical devices through the United States Food and Drug Administration (FDA) have many patient safety advocates concerned. Despite testimony in 2011 on FDA regulations regarding the large number of allegedly defective medical devices released under the current guidelines, the FDA recently announced that they were working toward faster approvals of new devices.
Patient Safety Concerns
Patient safety advocates have warned Congress that allowing even more devices to be processed through the 510(k) program could increase the number of defective medical devices released on the market. More than 90 percent of all medical devices are processed through the less stringent program with only high-risk devices processed through the more rigorous pre-market approval program.
Doctors’ Concerns With Updated Guidelines
Doctors also struggle with medical device approvals and FDA changes for the use of those devices. A Kentucky surgeon was sued after using a pain pump that injured a patient. The doctor used the device for an off-label purpose, as he was unaware that the FDA had not approved the device for such use nor was he told of a new warning to avoid using the product under certain types of anesthesia. Although the pain pump was not necessarily a defective medical device, doctors argue that it is already difficult to keep up with changing FDA regulations and that the new, relaxed guidelines could lead to even more errors.
Large Number of Recalls
As many as 112 million medical devices were recalled between 2007 and 2012. Because pre-market review can cost tens of millions of dollars and take years, medical device manufacturers often work to avoid the more rigorous requirements. Patient safety advocates say that 70 percent of recalls between 2005 and 2009 were those cleared through the 510(k) program. Nevertheless, the FDA updated guidelines so that more devices are eligible for processing under the program, concerning patient safety experts in Kentucky and other states.
Injured by a Defective Medical Device?
Medical device manufacturers reportedly put strong pressure on Congress to help speed up the approval of new medical devices, and it is feared that this may be done at the expense of patient safety. If you or a loved one has been injured by a defective medical device, or if a loved one has died after using a medical device, contact Attorney Group for Kentucky for a free, no-obligation consultation to determine whether you are eligible to file a defective medical device lawsuit.