FDA Works on Draft ID System for Medical Devices, Supplies

By Beth Bacheldor

Nov. 5, 2007—The U.S. Food and Drug Administration (FDA) may soon require manufacturers of medical devices and supplies to apply unique device identification (UDI) mechanisms to individual items so they can be automatically tracked and traced in the supply chain. The agency is also urging companies to file reports electronically whenever an item is involved in an adverse event. Currently, such reports are filed in paper format and must then be manually entered into a computerized system.

Although not directly connected, the two efforts are related. Both are intended to improve the collection of critical information regarding medical devices, ranging from infusion pumps to latex gloves, and both could help drive the adoption of radio frequency identification.

More than a year ago, the FDA began investigating how a UDI system might help automate the collection of information about various devices, such as the manufacturer, make and model, unique attributes, serial numbers, identifying lot and manufacturing numbers, and expiration dates (see FDA Seeks ID System for Medical Devices and Supplies). In addition, a UDI system could be used to facilitate product recalls, improve the consistency of medical device reports (MDRs) and identify device incompatibilities or potential allergic reactions. Such a system would rely on automatic-identification technologies, including RFID and serialized bar codes.

In late September, the Food and Drug Administration Amendments Act of 2007 was signed into law, charging the FDA with establishing a UDI system. Once implemented, the system will require that a label bearing a unique identifier be placed directly on a device, unless an alternative location (such as on the device's packaging) is specified by the FDA, or unless an exception is made for a particular device or group of devices. The unique identifier must be able to identify the equipment and supplies throughout their distribution and use.

While the law does not specify a deadline, the FDA's Center for Devices and Radiological Health (CDRH) is "working diligently" to develop draft regulations to implement the new requirements, says Jay Crowley, CDRH's senior advisor for patient safety.

The act also does not specify any technologies. "Congress gave us latitude," Crowley says, adding that flexibility is important because of the broad array of medical devices. "It allows for the UDI to be on the device itself, or on the box or packaging. It also gives us flexibility to exempt devices or device types that we don't think need to be included under this specific regulation. And we will try and remain as technology-agnostic, or technology-neutral, as possible. With RFID, I see that being useful for devices in hospitals, such as infusion pumps, but that technology probably doesn't make much sense for a box of gloves."

CDRH oversees the current MDR requirements of the Federal Food Drug & Cosmetic Act. The MDR system is designed to help the agency more easily identify patterns in adverse events of medical devices, such as device-related deaths. Currently, the reports come primarily from manufacturers and user facilities such as hospitals. For instance, user facilities are required to file a report whenever an adverse event occurs that might be connected to a patient death.