FDA Issues Final Rule on Identifier Codes

The U.S. Food and Drug Administration (FDA) has announced a final rule that requires medical device manufacturers to assign amedical device unique item code to each medical device and enter that information into a database so that healthcare officials could later find the devices’ history and use.

The two-part, unique device identification system (UDI) has the potential to “improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety,” the agency says in a press release. Patient information will not be included in the UDI, according to Medical Daily.

“UDI represents a landmark step in improving patient safety,” says Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used.”

The system will be phased in over several years. The agency will focus first on medical devices that have the greatest risk to patients, such as pacemakers, defibrillators, heart pumps, and artificial joints, reports Reuters. Low-risk devices may be exempt from some or all of the new requirements.

The new rule will improve the public’s safety, says Josh Rising, director of the Pew Charitable Trusts’ medical devices initiative, but added that more can be done. “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 says.

The FDA did not go through with some of the requirements that it had proposed in an initial rule in July 2012. Reuters explains further:

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.

In addition to the first system in which a unique tracking number is assigned to each medical device, the FDA is also establishing an accessible database called the Global Unique Device Identification Database. Companies will be required to test barcode printing software, train their employees, and redesign device labels to incorporate a barcode.

Source: “FDA finalizes new system to identify medical devices,” FDA, 9/20/13
Source: “FDA Finalizes New System to Identify Medical Devices: Unique Item Codes And Searchable Database To Come,” Medical Daily, 9/20/13
Source: “U.S. FDA issues final rule on medical device identifier codes,” Reuters, 9/20/13
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