Bill Requiring Unique Device Identifier Introduced in Senate April 1, 2012Posted by Kathleen Blake, MD, MPH, FHRS in Cardiac Rhythm Management, Health Policy.
Tags: FDA, medical devices, S.2193, U.S. Food and Drug Administration
On Friday, March 16, bill S. 2193, “Ensuring Safe Medical Devices for Patients,” was introduced in the Senate by Senator Jeff Merkley (D-OR) with Senators Chuck Grassley (R-IA), Michael Bennet (D-CO) and Herb Kohl (D-WI).
S.2193 is a bipartisan initiative that aims to strengthen and improve the oversight of medical devices. The bill requires the U.S. Food and Drug Administration (FDA) to issue a Unique Device Identifier (UDI) final rule by the end of the year. This rule is long overdue. Under the UDI program, the FDA would require coding of all implantable devices with a unique numerical identifier to facilitate tracking through the total life cycle of a device. Although legislation was passed in 2007 instructing the FDA to implement the UDI program, the Agency has yet to issue a proposed rule. FDA officials have indicated that draft regulations are under review at the Office of Management and Budget, but they are uncertain about when the proposed rules will be released for public comment.
Passage of the current bill would also require registration of devices in the Sentinel program, a post-market surveillance system launched by the FDA in 2008. Sentinel is a national, electronic tracking system, which currently monitors prescription drugs. Through the Sentinel initiative, the FDA is able to query multiple distributed databases maintained by government health systems, private payers and pharmacy benefit programs, accessing de-identified claims data and pharmacy records of over 100 million individuals. The new bill recommends that inclusion of Class II and III devices into the Sentinel system be given priority.
Not surprising, a host of patient advocacy groups have offered their support and endorsement of the bill. Physician groups, including HRS, also recognize the potential of unique device identification, particularly for patient safety and quality improvement initiatives. A number of physician organizations have written to the FDA in support of incorporation of the UDI into clinical registries. EPs can anticipate receiving important information about device performance issues more quickly, which is expected to promote patient safety.
Despite obvious benefits, there must be some offsetting or unexpected consequences. How hard will it be to incorporate UDIs into electronic health record systems? What strategies can be implemented to improve the surveillance of existing devices that lack a UDI? I’m curious to hear what my colleagues think about the UDI. Given what you know, should HRS advocate for the UDI provisions of the bill? What other issues should we be considering as HRS policy is formulated?
Kathy Blake, MD, MPH, FHRS
Chair, Health Policy Committee