Earlier this year, the Food and Drug Administration (FDA) proposed a new system to increase patient safety by tracking medical device malfunctions and streamlining the product recall process. Pursuant to the plan, which was revealed on July 3, 2012, the FDA will label high-risk medical devices with tracking numbers, known as Unique Device Identifiers (UDIs). A UDI is a unique numeric or alphanumeric code, which operates ‘‘as a key to certain basic identifying information about a device, such as the name of the manufacturer, type of device, expiration date and batch or lot number.’’ This information will be available to the public on the FDA database.
According to this Wall Street Journal article, more than 17,700 deaths reported to the FDA were tied to medical devices over a five-year period, but some doctors fear that the new plan doesn’t do enough to adequately protect patients.
Currently, the FDA has no comprehensive way to keep track of the frequency of medical device malfunctions. Under the new plan, the FDA hopes to connect with additional databases maintained by government agencies, insurers, and hospital systems in order to quickly determine when a specific medical device has a high failure rate.
According to the FDA’s press release, the UDI system is expected to provide a number of benefits, including:
- More accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduction in medical errors by enabling health care professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- A consistent way to enter information about devices in electronic health records and clinical information systems.
- A standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- A foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
The FDA will begin attaching UDI tracking codes in 2014, with the system fully implemented for all high-risk medical devices by 2021. Medical devices that are not required to meet good manufacturing practices, such as bedpans, and devices with UPCs that are sold without a prescription by retailers would be exempt from the proposed UDI system. Comments on the FDA’s proposed UDI system can be submitted until November 7, 2012.