Citing the growing number and increasing complexity of medical devices, FDA is seeking industry input about the advisability of a unique device identifier (UDI) system. The agency mandated a similar identification system for human drugs and biologics in February 2004. Devices were originally included under the compulsory rule, but their inclusion was subsequently dropped because of objections by medical device companies, which asserted that such a requirement would be difficult to implement across the broad and diverse range of medical devices and equipment.

CDRH's Schultz: A system with broad applications.

According to Daniel Schultz, MD, director of FDA's Center for Devices and Radiological Health, “A unique device identifier system could have broad applications in reducing medical errors, facilitating device recalls, improving medical device adverse event reporting, and encouraging cost-effectiveness by improving delivery and supply-chain efficiency.”

Von Eschenbach: Improving postmarket device data.

Andrew C. von Eschenbach, MD, acting FDA commissioner, said, “It is essential that we monitor the performance of medical products after they are approved and make sure that we quickly discover any potential problems that might arise. To improve our postmarket data collection at FDA, we are using a total product life cycle approach to how we look at medical devices and focusing more attention on the kinds of systems and processes we need to have in place to monitor products after they are approved.”

In announcing its decision reevaluate the possibility of an identification system for medical devices, FDA said that since the issuance of the final rule on the identification system for human drugs and biologics, the agency has been asked to revisit the issue for devices. Such requests have been made by a number of large hospital consortia and group purchasing organizations (GPOs). FDA also referenced two commissioned reports and a number of meetings with industry stakeholders. The commissioned reports both cited potential benefits of a UDI system for medical devices, but also noted challenges in industrywide application and implementation.

An August 2005 report prepared by ECRI (Plymouth Meeting, PA), a nonprofit health services research agency, cited “a number of challenges and complexities associated with implementing bar codes or other automatic identification technologies for medical devices.” Noting that automatic identification is a rapidly advancing field, the report urged FDA to consider some of the newer technologies, including radiofrequency identification. However, ECRI also noted that given the diversity of medical devices on the market, one approach is not likely to be effective for all products and equipment.

A March 2006 report from the Eastern Research Group (ERG; Lexington, MA) made note of medtech manufacturers' skepticism and resistance to a UDI system for medical devices. The report attributed some of these concerns to fears regarding the commoditization of devices. “UDI systems might allow much greater opportunity for price and performance comparability and, in some current medical device markets, the lack of such comparability probably benefits manufacturers,” the report stated.

According to the ERG report, FDA could “generate net social benefits by providing organizing principles for a UDI system.” The report added that, “This is a traditional role for government, i.e., organizing socially beneficial efforts that the private sector will not organize itself.”

Gee: A small detail in the grand scheme.

Tim Gee, principal of Medical Connectivity Consulting (Beaverton, OR), dismissed FDA's often-cited “stakeholders” as “politicians, GPOs—who probably see another way to extract revenue from vendors and maybe providers—and nonprofit associations.”

“Postmarket surveillance could—and probably should—be improved dramatically,” Gee says. “Assuming postmarket surveillance is increased, creating a system of unique identification for medical devices is an implementation detail when compared to what would be required to actually improve patient safety.”

FDA is soliciting comments on the advisability of a UDI system for medical devices. Interested parties have until November 9 to respond, either electronically or in writing.

For complete details, including links to FDA's press release, the notice in the Federal Register, and the ECRI and ERG reports, visit the CDRH Web site at www.fda.gov/cdrh/ocd/uidevices061405.html.

© 2006 Canon Communications LLC



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