Congressman Edward J. Markey (D-MA) released a comprehensive new report titled, “Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices.” Markey’s report highlights the federal loophole that requires FDA to clear medical devices that demonstrate their similarity to an earlier model, even if that previous model was recalled for a major safety defect. This loophole in the 510(k) device approval process has enabled a number of defective products to enter the market and cause serious harm, and in some cases even death. Markey was joined in the release of the report by a victim of a serious injury caused by such a device and a consumer advocate who both understand the devastation caused when defective medical devices are implanted in unsuspecting patients. Markey introduced H.R. 3847, the Safety Of Untested and New Devices Act (SOUND) of 2012, to close this regulatory loophole and ensure that new medical devices are not cleared by FDA if they are based on an product that was recalled because it caused serious harm to patients.
“The 510(k) process should really be called ‘510 pray’ since patients should hope and pray that the medical device implanted in them won’t cause serious harm,” said Markey, a senior member of the Energy and Commerce Committee, which has jurisdiction over FDA. “The SOUND Devices Act closes a major loophole in the current 510(k) device approval process. I will fight to include this bill in FDA legislation that Congress will consider this summer as part of the Medical Device User Fee Act to ensure that medical devices are not repeating known defects.”
A copy of Rep. Markey’s report, “Defective Devices, Destroyed Lives,” can be found at his website.