Lawmakers Propose UDI Law

Four U.S. senators have introduced legislation that would require unique identifiers for implantable medical devices and ongoing monitoring of the devices for safety issues.

Sens. Jeff Merkley (D-Ore.), Charles Grassley (R-Iowa), Michael Bennett (D-Colo.), and Herb Kohl (D-Wis.), introduced the Ensuring Safe Medical Devices for Patients Act on March 15.

The legislation would require the U.S. Food and Drug Administration (FDA) to issue a final rule by the end of this year, requiring implantable devices to carry a unique device identifier, commonly referred to as a UDI. This UDI is an issue that has been discussed for years by device makers, regulatory officials and lawmakers.

The Ensuring Safe Medical Devices for Patients Act would require FDA to issue a final 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 once they are being used with patients. The UDI program was created nearly five years ago but FDA has not implemented it.

Last July, the FDA submitted a proposal calling for such an identifier to the Office of Management and Budget (OMB), which reviews regulations before they go through the final approval process. But OMB has yet to release the rule. The senators claim that UDIs would make it easier to track down devices that are harmful or defective. They noted that harmful or defective devices were associated with the death of almost 5,000 Americans in 2009.

In its proposal submitted for OMB review, the FDA noted: “A unique device identification system will help reduce medical errors; will allow the FDA, the healthcare community, and the industry to more rapidly review and organize adverse event reports; identify problems relating to a particular device … and thereby allow for more rapid, effective corrective actions…”

The proposed law also would add medical devices to the FDA’s post-market surveillance initiative, an electronic system that now monitors prescription drug safety after FDA approval.

“Strong post-marketing surveillance of medical devices will ensure that those that are defective or cause harm can be quickly identified, patients and their physicians can be notified, and dangerous products can be removed from the market,” said Senator Jeff Merkley, the bill’s chief sponsor, in a statement.

The bill is similar to one released in December by many of the same senators called the Medical Device Patient Safety Act.