Abstract
BACKGROUND: For implanted devices, an effective postmarket surveillance system does not exist. For medications, the Food and Drug Administration's Sentinel Initiative plays that role, relying mainly on drug codes in insurance claims. Unique device identifiers (UDIs) could play an analogous role for implants, but there is no mandate for providers to include UDIs in claims or for payers to record them. Objections have been raised to incorporating UDIs into claims based on a potential burden on providers. METHODS: To assess this purported barrier, we modified information systems at 2 provider-payer dyads to allow for the transmission of UDI data from provider to payer. In addition, to illustrate the potential benefit of including device data in claims, we used our data to compare rates of 90-day adverse events after implantation using the electronic health record (EHR) alone with the EHR plus claims. RESULTS: The software system modifications were modest and performed as designed. Moreover, the level of difficulty of their development and implementation was comparable to that associated with a typical new release of an existing system. In addition, our data demonstrated the ability of claims-based data plus EHR data to reveal a larger percentage of postprocedure adverse events than data from EHRs alone. CONCLUSIONS: Modifying information systems to allow for the transmission of UDI data from providers to payers should not impose a substantial burden on either. Implementation of a postmarket surveillance system based on such data in claims will require, however, the development of a system analogous to Sentinel.