Last month, the U.S. Food and Drug Administration (FDA) finalized a new
system for tracking medical devices. It is designed to better target product
recalls and improve patient safety.
As we have reported on this San Diego Injury Blog, surgical vaginal mesh
and metal-on-metal hip implants have also caused problems for thousands
of patients across the country over the past several years. The new tracking
system would use unique bar codes to detect malfunctions with specific
devices and alert the public more quickly.
As detailed by the
FDA, the unique device identification system (UDI) has two distinct facets.
The first is a unique number assigned by the device manufacturer to the
version or model of a device, called a unique device identifier. It includes
production-specific information such as the product’s lot or batch
number, expiration date, and manufacturing date. The second component
is a publicly searchable database administered by the FDA, called the
Global Unique Device Identification Database (GUDID). It will function
as a reference catalogue for every device in the new UDI system.
“UDI represents a landmark step in improving patient safety, modernizing
our postmarket surveillance system for medical devices, and facilitating
medical device innovation,” said Jeffrey Shuren, M.D., J.D., director
of the FDA’s Center for Devices and Radiological Health.
The FDA plans to implement the new system in phases, starting with the
most high-risk devices. Class III devices will be required to carry unique
device identifiers on their label and packaging within one year. Manufacturers
will have three years to act for most Class II (moderate risk) devices,
while Class I devices not exempt from UDI requirements will have five
years to enter the system.