As part of the new system, manufacturers will be required to assign some medical devices with a “unique device identifier,” which will include a product lot number, expiration date and manufacturing date. The FDA will operate a publicly searchable database that will house UDI data. In addition, UDI data could be used in electronic health records, registries and insurance claims.
The FDA says the system will reduce medical errors, lead to more accurate reporting of adverse events, and provide better understand underlying problems in devices.
While manufacturers are required to comply with the system, the participation of healthcare providers is voluntary. Without participation from hospitals, some experts say that hospitals and patients won't achieve all of the possible benefits the system could provide.
“Unique device identifiers will enable faster identification of product failures and more comprehensive recalls,” Josh Rising, director of Pew's medical devices initiative, said in a statement. “But the FDA's rule is just the first step. To fully realize the new system's benefits, hospitals, health plans and physicians must integrate these codes into patients' health records and insurance billing transactions.”
In a separate statement, the Association for Healthcare Resource & Materials Management noted that providers are “instrumental to a UDI system's success; if providers don't use the unique identifiers, much of the intended value of UDI will be lost.”
Discussions are underway to incorporate the use of the UDI in HHS' Stage 3 meaningful-use criteria for the incentive program for electronic health records. An FDA official said during a call with reporters that she was going to the Office of the National Coordinator for Health Information Technology on a six-month detail to represent the agency in meaningful-use discussions.
The FDA will use a risk-based, seven-year process to roll out the marking requirements, starting with the packaging of high-risk devices in Sept. 2014.
The Healthcare Supply Chain Association, a trade group representing group purchasing organizations, and the Premier healthcare alliance expressed disappointment with what they said was an unnecessarily long timeline, a position both organizations took last year in their comment letters.
“The stakes for patients are simply too high to have to wait until 2020 for a fully operational UDI system,” HSCA President Curtis Rooney said in a statement.
The final regulation (PDF) includes some changes that the medical device industry pushed for, including removing a requirement that manufacturers directly mark implantable devices and allowing companies to apply for extensions. The rule also exempts single-use devices and does not require components of kits to be individually marked.
The Advanced Medical Technology Association, a trade group for devicemakers, says those exceptions and the phased implementation are necessary.
“Implementation of a UDI system will be a costly and challenging endeavor, affecting all medical technology manufacturers,” Janet Trunzo, senior executive vice president of technology and regulatory affairs for AdvaMed, said in a statement. “It is imperative that it is implemented correctly the first time.”
Trunzo last year said the proposed rule was one of the most complex and extensive regulations that the FDA had issued in recent years. Legislation mandating the formation of the UDI system was passed in 2007. Last year's user-fee legislation required the FDA issue the proposed rule in 2012.
The final rule is expected to be published Sept. 24 in the Federal Register.
Follow Jaimy Lee on Twitter: @MHjlee