Last week, FDA issued a report outlining its approach to improving its post-market surveillance system for medical devices, which would include the creation of a unique device identification system, Healthcare Finance News reports (Letourneau, Healthcare Finance News, 9/7).
Background
In July, FDA released a proposed rule to create a UDI system to track medical devices. Such a system would allow FDA officials to electronically track medical tools and promptly recall any devices that could jeopardize patient safety.
The proposed rule would require medical device manufacturers to place UDI codes on their products to identify each device's:
- Make;
- Manufacturer; and
- Lot number.
Such codes would be stored in a public database so regulators, physicians and companies could monitor safety issues related to the devices (iHealthBeat, 7/3).
FDA is expected to issue a final rule on the creation of a UDI system in November (Healthcare Finance News, 9/7).
Report Details
In the report, FDA's Center for Devices and Radiological Health recommended four initiatives to strengthen the surveillance of medical devices after they enter the market:
- Establishing a UDI system that can be incorporated into electronic health record systems;
- Promoting the creation of national and international registries for certain devices;
- Updating adverse-event reporting and analysis procedures; and
- Developing new methods for evidence generation, synthesis and appraisal (Bird, FierceHealthIT, 9/10).
CDRH officials wrote, "We are suggesting smart, tailored modifications to the existing post-market surveillance program," adding, "Furthermore, we recognize that our post-market vision cannot be implemented or achieved by the FDA alone."
The report also solicits input and participation from device manufacturers, health care providers, patients, insurers, government agencies and other stakeholders (Lee, Modern Healthcare, 9/7).