By Toni Clarke
(Reuters) - The U.S. Food and Drug Administration issued a long-awaited rule on Friday requiring companies to include codes on medical devices that will allow regulators to track the products, monitor them for safety and expedite recalls.
The codes, known as unique device identifiers, or UDIs, will be entered into a database that the agency will maintain as a publicly searchable reference catalogue.
"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's medical device division, said.
The FDA plans to phase in the UDI system over several years, focusing first on medical devices that carry the greatest risk to patients such as pacemakers, defibrillators, heart pumps and artificial joints. Many low-risk devices will be exempt from some or all of the requirements.
Josh Rising, director of the Pew Charitable Trusts' medical devices initiative, said the new rule will help improve safety, but added it 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," he said.
The FDA relaxed some of the requirements it had initially proposed based on industry concerns. It removed its initial requirement that companies directly mark implants. It also provided a three-year exemption for products currently held in inventory.
The agency also removed a proposal that would have required UDIs on individual items within a pack of single-use products such as bandages. Now only the package will require the code.
Janet Trunzo, a senior executive at the Advanced Medical Technology Association, which represents medical device companies, said in a statement that while the organization is still reviewing the details of the final rule, it "commends FDA for addressing many of the concerns industry raised."
"Implementation of a UDI system will be a costly and challenging endeavor, affecting all medical technology manufacturers," she said. "It is imperative that it is implemented correctly the first time."
Companies will be required to integrate the UDI into existing information systems, test barcode printing software and train employees. They will also have to redesign device labels to incorporate a barcode and install equipment needed to print and verify the UDI on labelers.
(Reporting by Toni Clarke in Washington; Editing by John Wallace, David Gregorio and Sofina Mirza-Reid)
- medical devices