The FDA is trying to figure out a better way to control and monitor medical devices, after their initial FDA approval. They have spent the better half of 2012 exploring ideas on how to better track and implement a new system. They outlined their ideas in a report released in September 2012.
Among the changes called for by the FDA are:
- Establishing a unique device identification (UDI) system and promoting its incorporation into electronic health information.
- Promoting development of national and international device registries for select products and integrating those registries into electronic health records.
- Modernizing reporting and analysis of adverse events.
- Developing new methods for generating, synthesizing and evaluating evidence.
“It bears emphasizing that modernizing medical device post-market surveillance is a long-term effort,” FDA officials said in the report, “Strengthening our National System for Medical Device Postmarket Surveillance.” “Our proposed strategic changes are intended to complement our existing programs.”
In July, the FDA issued a proposed rule to place unique device identifiers on medical devices, which aids in post-market surveillance by facilitating the reporting of adverse events. The FDA has been testing UDIs since 2009.
Congress also has pushed for UDIs, with the Senate introducing legislation last spring requiring the U.S. Department of Health & Human Services to issue a final rule on UDIs by the end of this year.
A UDI is a unique numeric or alphanumeric code that acts as a key to certain basic identifying information about a device, such as the name of the manufacturer and the type of device, and may represent certain other information about the device, such as its expiration date and batch or lot number. This information will be contained in a publicly available UDI database, and no identifying patient information will be stored in this device information center.
According to a FDA press statement in July, a UDI system has the potential to improve the quality of information in medical device adverse events reports, which will help the FDA identify product problems more quickly, better target recalls, and improve patient safety. The FDA has worked closely with industry, the clinical community and patient and consumer groups and conducted four pilot studies in the development of this proposed rule.
“The safety of medical devices is a top priority for the FDA, Congress, industry, and patients,” said FDA Commissioner Margaret A. Hamburg, M.D. “The unique identification system will enhance the flow of information about medical devices, especially adverse events and, as a result, will advance our ability to improve patient safety.”
With certain exceptions, under the proposed rule, a UDI would include:
- a device identifier, which is a unique numeric or alphanumeric code specific to a device model; and
- a production identifier, which includes the current production information for a device.
The FDA is proposing a risk-based, phased-in approach to implementation, focusing on the highest-risk medical devices first and exempting low-risk devices from some or all of the requirements. The FDA is proposing to exempt over-the-counter devices sold at retail; these devices generally have UPC codes in place.
The proposed rule reflects the considerable input the FDA received from the medical device industry, the clinical community, patients and consumers, and industry experts. To minimize industry costs and expedite implementation, the proposed rule builds upon current standards and systems already in use by some companies.
A UDI system can provide multiple benefits, including:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce 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.
- Provide a consistent way to enter information about devices in electronic health records and clinical information systems.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.