On July 11, the U.S. House of Representatives voted 403-16 to approve the Food and Drug Administration Amendments Act of 2007 (H.R. 2900), which renews the Prescription Drug User Fee Act (PDUFA) and Medical Device User Fee and Modernization Act (MDUFMA), both of which were set to expire at the end of this September. In addition to extending the two user fee programs, the House bill increases the user fees for drug manufacturers and establishes several new requirements aimed at improving the safety of these products.
Of interest to the nonwoven fabrics industry, H.R. 2900 includes a provision instructing FDA to develop a mandatory unique identification system for medical devices similar to the agency's existing bar code rule for pharmaceuticals. Although the Senate version of the same bill (S.1082) does not contain a similar provision, the idea of establishing unique device identification (UDI) requirements has gained significant traction in recent years and has the support of public safety, hospital groups, Capitol Hill lawmakers and more.
Given that certain members of INDA, Association of the Nonwoven Fabrics Industry, make medical devices that would potentially be covered under this legislation—surgical drapes, gowns, masks, feminine hygiene products, for example – this article will review the status of the UDI initiative.
The concept of creating a unique identification system for medical devices has its roots in a similar program put in place for prescription drugs some 35 years ago as part of an effort by Congress to simplify out-of-hospital reimbursement for Medicare. Specifically, the Drug Listing Act of 1972 requires that drug manufacturers list all commercially distributed prescription medicines with the U.S. Food and Drug Administration (FDA) and also requires manufacturers to assign a unique three-segment number to each drug product. These identifying numbers are called the National Drug Code (NDC).
While devices were left out of the 1972 law, industry interest in a UDI for all medical products increased exponentially after a 1996 industry-sponsored study revealed some $11 billion of "avoidable process costs" in the healthcare supply chain every year. The study further found that most of these costs could be eliminated with process improvements, one of which would be the implementation of a UDI.
Then in 2000, the Institute of Medicine released its groundbreaking report "To Err is Human: Building a Safer Health System," which found that 10s of thousands of Americans die each year from preventable medical errors. The FDA responded to the revelation with a number of patient safety initiatives including its 2004 "Barcode Rule," which required manufacturers to encode the NDC in a one-dimensional barcode on the back of drug and biological products. But the agency did not include medical devices in the scope of the 2004 rule because devices do not have a standardized, unique identifying system comparable to the NDC number for drugs, which complicated efforts to put barcodes on medical devices.
After the barcode rule was implemented, Members of Congress, hospital groups, purchasing organizations and others began asking FDA to revisit the UDI issue. After consulting with various stakeholders, the agency announced in August 2006 it would further explore development of an effective UDI and held a hearing to collect input that fall.
Both the agency and other supporters agree there would be many advantages to developing a unique identification system for medical devices. In addition to reducing device-related medical errors, a UDI could identify and address device compatibility and interoperability issues and provide for a more effective way to track and communicate information about device recalls and counterfeited goods.
There could also be ancillary benefits, according to supporters of a UDI system. On the financial and operations side, supporters claim, a UDI would lead to a more efficient supply chain and operating cost reductions. A UDI system would facilitate improved data accuracy and would allow healthcare providers to better track clinical outcomes according to supporters.
But even with these benefits, FDA acknowledges there are many challenges and questions that need to be answered in order to develop an effective UDI. For instance, what sort of standard scheme should be used for uniquely identifying devices? The FDA has already said that it envisions a unique device identifier that contains more information than is found in drug barcodes and includes specifics like the manufacturer; make and model; the device's unique attributes (size, length, quantity, etc) and the serial number, lot number and expiration date.
And, where on the device should the UDI information be displayed? Since there are a wide variety of medical devices on the market, from capital equipment to disposable items, the question arises as to whether the UDI should be located on the device itself? The packaging? What about a device that is removed from its packaging or is reused or reprocessed? And what kind of database should be developed to capture the information? And what kind of industry costs will be associated with implementing a UDI in order to fully realize the aforementioned benefits? Will the costs outweigh the benefits or vice versa?
These are exactly the kinds of concerns that groups representing medical device makers have raised with the agency in the past. But more recently, opponents have scaled back their criticisms, perhaps sensing that Congress is poised to act. On June 22, for instance, Stephen Ubl, president of AdvaMed, a trade association that represents makers of medical devices and other healthcare technologies that had opposed a mandatory UDI system in the past said in a statement, "AdvaMed commends [Congress] for its bipartisan approval of legislation that will enhance patient safety by providing FDA's device center with the necessary financial resources for the timely and effective review of new medical technologies."
Because there are differences between the House- and Senate-passed versions of the drug and device user fee legislation, the two competing measures will have to go to a legislative conference that will be tasked with cobbling together a compromise version that is acceptable to both Chambers. And even though a bipartisan coalition of more than 20 House members recently came out in support of a creating a unique identification system for devices, it is difficult to say whether the UDI provision will survive conference process.
Either way, however, FDA appears to be moving ahead with a UDI initiative of its own, legislative mandate or not. Indeed, speaking during MDMA's annual meeting in May, Dr. Larry Kessler of FDA's Center for Devices and Radiological Health (CDRH) outlined FDA's ongoing process for adopting the system and indicated the agency is presently evaluating input from various stakeholders to further refine their approach. While he did not specify a time frame, FDA officials last fall said they hoped to have a UDI system up and running in three to five years.