Tracking Medical Devices to Improve Safety

U.S. Senators Chuck Grassley (R-Iowa), Richard Blumenthal (D-Conn.) and Herb Kohl (D-Wis.) introduced legislation in the Senate on December 15, 2011, to help protect patients from unsafe medical devices.  Problems with artificial hips and other medical implants, along with growing public disatisfaction, led to the bipartisan bill that would force manufacturers to track the performance of medical devices after they were approved for sale.

Under “The Medical Device Patient Safety Act” (S. 1995), the Food and Drug Administration (FDA) would have new tools to discover problems with faulty medical devices sooner and to better manage recalls when problems do occur, without slowing down the approval process for new devices.  The FDA would be allowed to track implants, such as replacement hips, that do not currently require human testing for approval.

The proposal would address longstanding complaints by patient advocates and others like the Institute of Medicine about the 510(k) process that the FDA uses to clear the sale of certain implants like artificial joints.  Currently under the 510(k) application, device manufacturers only need to  show that a device is “substantially similar” to a product already on the market.  While the FDA can request clinical study data, the 510(k) process is still considered a “fast-track” approval compared to the more lengthy premarket approval, or PMA, process. The 510(k) clearance process is intended for moderate risk devices, while the PMA process is intended for high risk devices.

Some all-metal hips, however, are now failing prematurely in patients.  These devices were approved through the 510(k) system.  The proposed legislation would not require added premarket testing of such implants, but would broaden the FDA’s post-approval oversight by giving it the authority to mandate that companies collect data on device performance.  The bill, if adopted, would also tighten federal scrutiny of product recalls.  The bill also would implement Government Accountability Office (GAO) recommendations and give the FDA new authority to require conditional clearance pending safety studies for devices reviewed under the fast-track 510(k) approval process.

Whether the legislation has enough support in both chambers to pass is unknown.  The legislation will face an uphill battle from device manufacturers, especially after numerous bills were introduced this year to streamline the medical devices approval process.  Ultimately, the bill may be used as leverage in the debate over FDA device regulation.