On March 15th Senators Jeff Merkley (D-OR), Charles Grassley (R-IA), Michael Bennet (D-CO), and Herb Kohl (D-WI) introduced the bipartisan “Ensuring Safe Medical Devices for Patients Act.” The bill would give the FDA the tools it needs to improve oversight of medical devices. Defective medical devices have been associated with thousands of deaths in recent years.
Safety problems and recalls of certain medical devices including metal-on-metal hips, surgical mesh, and implantable programmable infusion pumps have called into question whether the FDA and its Center for Devices and Radiologic Health (CDRH) have the tools needed to protect patients and keep harmful devices off the market.
According to Grassley, the post-market surveillance work of the FDA needs to be empowered to use the important and valuable information about drugs and devices as the information becomes available when millions of people start using the drugs as compared to what is known before a drug or device goes on the market.
The legislation would require FDA to issue a final Unique Device Identifier (UDI) rule by the end of 2012 requiring implantable devices to carry a unique numerical identifier so products can be tracked through the distribution chain and also once they are being used with patients. The UDI program was created nearly five years ago but FDA has not implemented it.
Also, the legislation would add medical devices to the Sentinel post-marketing surveillance initiative launched in 2008. Sentinel is a national integrated, electronic system that currently monitors prescription drug safety after FDA approval once the drugs are being marketed to patients.