The Food and Drug Administration is moving forward with plans to create a unique identification system for medical devices over the next several years.
In a final rule published Sept. 24, the agency outlined a schedule for placing a unique ID number on most medical devices over 7 years and launching a publicly searchable database with all of the product information.
The new Unique Device Identification (UDI) system requires medical device manufacturers to create a unique number for every version or model of a device. The number will include the lot or batch number, device expiration date, and manufacturing date. That information will then be incorporated into the Global Unique Device Identification Database (GUDID), run by the FDA. The new database will not store identifying patient information, according to the agency.
Dr. Jeffrey Shuren
The new system should help to improve adverse event reporting, allow for faster recalls, and reduce counterfeiting and device diversion, according to the FDA.
"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Dr. Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, said in a statement. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."
While there are no requirements for physicians under the new regulations, FDA officials wrote that they anticipate physicians and other providers will include the unique identifiers in patients’ electronic health records and personal health records to help improve postmarket surveillance, adverse event reporting, and recalls.
Manufacturers of high-risk medical devices, those in class III, are required to place the identifiers on the label and packaging by Sept. 24, 2014. They must also submit information to GUDID within 1 year. Manufacturers of implantable, life-supporting, and life-sustaining devices have until Sept. 24, 2015, to comply.
For moderate-risk devices (class II), manufacturers have 3 years to transition their labeling; and for low-risk devices (class I) they have 5 years. For certain class I and unclassified devices, the compliance date is pushed out to 2020.
The FDA noted that many low-risk devices are exempt from some or all of the labeling requirements in the final rule.
The final rule was called an improvement over a July 2012 proposed rule by the medical device industry. The Advanced Medical Technology Association (AdvaMed) said the final rule made some key changes, such as not requiring that the ID number be marked directly on implants and allowing manufacturers an extra 3 years for devices that are already out in circulation. The FDA is also allowing firms that produce class III devices to petition for a 1-year extension if the extra time is necessary to protect public health.
Implementing the UDI system will be "costly and challenging," Janet Trunzo, senior executive vice president for technology and regulatory affairs at AdvaMed, said in a statement. "It is imperative that it is implemented correctly the first time, and that its ongoing use is practical, economical, and of value to patients, health care providers, industry, and FDA."
The Pew Charitable Trusts, a watchdog group, applauded the FDA for getting the UDI system off the ground. But the final rule is only the first step, Josh Rising, director of Pew’s medical devices initiative, said in a statement. Hospitals, health plans, and physicians need to integrate the identifiers into patients’ health records and insurance billing transactions before the benefits can be fully realized, he said.