A new system that provides
unique labels to identify medical devices is being instituted by the US Food
and Drug Administration.
Called the unique device
identification system (UDI), it will potentially improve the ability to
identify devices that malfunction or cause harm to patients, enable faster
targeted recalls and improve patient safety, agency officials said on Friday.
"UDI may be an acronym
for a unique device identification system, but what it really stands for is
better information, better access to safe and effective medical devices, and,
ultimately, better patient health," Dr Jeffrey Shuren, director of the
FDA's Center for Devices and Radiological Health, said during a late-morning
This is a new way to
identify medical devices throughout their distribution and use, he said.
"Many medical devices will be required to have a code on their label,
packaging or the product itself in plain text and machine-readable format –
like a barcode," Shuren said.
The system includes two
parts. First, each device will be assigned a unique identification code number.
"The code identifies the model and version of the device and provides
production information such as lot number and expiration date," Shuren
Catalogue of every device
Second, the FDA will
establish the Global Unique Device Identification Database, which will be a catalogue
of every device with an identifier. This database will be accessible by the
public, but no patient-identifying information will be stored in the system,
the agency said.
The unique device
identification system will be phased in over time with so-called high-risk
devices (Class III) the first to be listed. These devices include implanted
pacemakers, defibrillators, artificial joints, heart valves and heart pumps.
Many devices considered
low-risk will not have to be listed at all, according to the FDA.
When complete, the system
is expected to benefit patients, the health care system and the device
industry, the agency said in a news release.
The system will make it
easier and faster to identify devices being recalled, improve the accuracy of
reports of problems with devices, and provide a way to spot counterfeit
devices, according to the FDA.
Making things easier
In addition, the system
will make it easy to trace the use of devices in electronic health records and
"We did this so that
it would be easy to eventually link the use of a device with the patient's
experience with that device," Shuren said.
This could be a valuable
clinical resource, for assessing the benefits of medical devices in real-world
use, "which will support not only safety, but innovation," he said.
High-risk medical devices
will be required to have unique device identifiers within one year, and the
number and device information must be included in the new database.
For most Class II devices,
such as powered wheelchairs, joint prostheses and infusion pumps, manufacturers
will have three years to comply. For Class I devices not exempt from the rule,
manufacturers will have five years, the agency said. Class I devices include
items such as bandages, exam gloves and tongue depressors.
For more about
medical-device safety, visit the US
National Library of Medicine.