FDA Announces Plans to Track Medical Devices

The FDA announced the creation of the final rule for a new system designed to provide a consistent method of identifying medical devices.

Called the unique identification system (UDI), its implementation will likely result in improved patient safety by increasing the quality of information in medical device adverse reports.

The new rule, the FDA reports, represents a collaborative effort between industry officials, the clinical community and both consumer and patient groups.

"UDI represents a landmark step in improving patient safety, modernizing our postmarket surveillance system for medical devices, and facilitating medical device innovation," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in a statement.

Included in the UDI system are two core features, the first of which includes a unique number for every device indicating its model. Called a "unique device identifier," the number will provide production-specific information, such as batch number and expiration date.

The second item included in the new rule is a searchable database overseen by the FDA that will be made available to the public and serve as a reference catalogue for every device with an identifier.

Among other things, the UDI system will allow health officials to quickly identify marketed devices when recalled, improve the accuracy of adverse event reports and allow for a foundation upon which a global distribution chain can be developed.

High-risk medical devices will receive the greatest focus during the early phases of the system's implementation, 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," Shuren said. "In turn, this can promote safe device use by providers and patients as well as faster, more innovative, and less costly device development."