By: Jeffrey Shuren, M.D., J.D.
Medical devices are an important part of everyday life for many people. Some are used to diagnose, others to treat patients. Some are implanted in the body. Some are used by doctors in hospitals, while others are used by patients in their home or at work.
Nevertheless, it may surprise you that unlike consumer products and medications, many medical devices do not have a unique identifier that unambiguously distinguishes one product from another.
This is about to change. FDA is implementing a new system that will provide a consistent and standard way to identify medical devices throughout their distribution and use.
It is called the Unique Device Identification (UDI) system. Most devices may be required to have a code on their label and packaging, and for certain devices, on the product itself, in plain text and a machine-readable format, like a bar code. This code will correspond to the specific model or version of a device and will include production information, such as the lot number and expiration date.
It will also provide a link to a publicly available database – called the Global Unique Device Identification Database – where you can find information about some of the devices’ key characteristics, such as model and brand – but no identifying patient information will be stored there.
FDA worked with the health care community and the device industry to develop a system that will provide a clear way of documenting device use in electronic health records and clinical information systems.
Companies, health care professionals and patients will be able to report medical device adverse events more accurately. And recalls will be faster and more effective. When there are critical issues with a medical device, the UDI could be specified in safety alerts and recall notices. Health care professionals would be able to rapidly identify patients who have or are using the recalled device. At the same time, similar devices not implicated would not be taken out of use in a broad attempt to remove potential hazards.
Implementation of the UDI system will take place over several years, beginning with devices that pose higher risks to patients – such as heart valves and hip prostheses (also known as artificial hips). Other devices, such as powered wheelchairs and blood glucose meters, will follow.
This is a landmark step for FDA. UDI may be an acronym for Unique Device Identification, but what it really stands for is better patient health.
Jeffrey Shuren, M.D., J.D., is the Director of FDA’s Center for Devices and Radiological Health
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