The U.S. Food and Drug Administration said in a new report (PDF) that it plans to improve its post-market surveillance system for medical devices, in part by establishing a unique device identification system.
In a Sept. 6 report, the FDA's Center for Devices and Radiological Health proposed four initiatives to improve its post-market surveillance of devices.
The agency recommends establishing a UDI system that can integrate with electronic medical records; promoting the development of national and international registries for certain devices; modernizing adverse-event reporting and analysis; and developing new methods for evidence generation, synthesis and appraisal.
"We are suggesting smart, tailored modifications to the existing post-market surveillance program," the FDA said in the report. "Furthermore, we recognize that our post-market vision cannot be implemented or achieved by the FDA alone."
A stronger post-market surveillance system requires participation and input from other stakeholders, such as manufacturers, healthcare providers, patients, payers and government agencies, according to the FDA.
Some of the proposed actions are in progress. Earlier this summer, the FDA issued its long-awaited proposed rule on the UDI system, which will require manufacturers to begin marking the label and packing of high-risk devices with unique identifiers within one year of the final rule taking effect.