Pew Seeks Changes to Device Registries, UDI

Posted in Medical Labels by Jamie Hartford on September 2, 2014

The nonprofit organization is calling for public release of information from registries and incorporation of UDI into into EHRs, among other reforms.

By Jim Dickinson

The Pew Charitable Trusts says medical device registries and the new unique device identifier (UDI) system are two tools that can help patients, doctors, manufacturers, and payers assess the performance of different medical devices and determine the right product for each patient. But in a letter to Senators Ron Wyden (D-OR) and Chuck Grassley (R-IA), the nonprofit group says that “several reforms are needed . . . to realize the potential of these new tools.”

The letter calls for:

  • The regular, public release of findings from registries, particularly those used to fulfill FDA and CMS requirements.
  • Improved interoperability of electronic health records, allowing the more efficient extraction of data to registries.
  • Incorporation of UDI into electronic health data sources, including electronic health records and health insurance claims such as those submitted to Medicare and Medicaid.
  • Pew says it, along with the Blue Cross and Blue Shield Association and the Weill Cornell Medical College Medical Device Epidemiology Network Infrastructure Center, will soon release the findings of a series of meetings that brought together medical device stakeholders to better define the role of device registries in the healthcare system.

Based on input from medical device manufacturers, FDA, clinical societies, payers, and patient groups, the groups recommend that registry findings and reports should be released regularly and that the governance, operations, and financing should be made publicly available. Government agencies and other stakeholders should encourage use of registries that meet those criteria, Pew says.

Jim Dickinson is MD+DI's contributing editor. 


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