Groups Call on FDA To Boost Medical Device Registries
September 3, 2014 in News
The recommendations were submitted by:
- The Blue Cross and Blue Shield Association;
- The Pew Charitable Trusts; and
- The Science Infrastructure Center, which is run by Weill Cornell Medical College’s Medical Device Epidemiology Network (Lee, Modern Healthcare, 9/3).
In July 2012, FDA released a proposed rule to create a unique device identification 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.
FDA in September 2012 issued a report that outlined the agency’s approach to improving its post-market surveillance system for medical devices, including the creation of a UDI system.
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.
The report also solicited input and participation from device manufacturers, health care providers, patients, insurers, government agencies and other stakeholders (iHealthBeat, 9/10/12).
Details of Recommendations
In the report released Wednesday, the three organizations cite several objectives for implementing a national system of registries, noting that the UDI system would be the main source of data for a national registry.
According to the report, “The UDI could be used by FDA with its Sentinel surveillance system to proactively query databases — in particular, administrative and insurance claims databases — to locate potential safety issues” (Hall, FierceHealthIT, 9/3).
The groups urge the Office of the National Coordinator for Health IT to require electronic health record systems to collect UDI information under the next round of meaningful use rules (Modern Healthcare, 9/3). Under the 2009 economic stimulus package, providers who demonstrate meaningful use of certified EHRs can qualify for Medicaid and Medicare incentive payments.
Further, to improve the way registries can benefit FDA’s surveillance system, the report recommends:
- Clarifying legal interpretations of provisions regulating registry-related quality improvement initiatives;
- Implementing practices that improve the registry data collection process and reduce the time and cost of reporting;
- Making registry data publicly available;
- Setting criteria to determine whether a registry is the best tool for post-market surveillance; and
- Using registry data to speed up the innovation of medical devices and help meet regulatory responsibilities (Pew release, 9/3).