Electronic Health Records

How EHRs can promote safety of medical devices using UDIs

Responding to a request from the Senate Finance Committee seeking input on how to increase the usefulness and availability of health data, the Pew Charitable Trusts are calling for improvements in the way that information about medical devices is captured and shared by healthcare providers and payers.

The comments addressed to Senators Ron Wyden (D-OR) and Chuck Grassley (R-IA) highlight in particular the important role EHRs could play in assessing the performance of medical devices so long as certain “necessary conditions” are met.

One such condition involves enabling the interoperability of EHR systems, which would support both the collection and sharing of information in large databases (i.e., registries).

“There are also a number of other challenges that must be overcome to enhance the use of registries in the United States today,” writes Josh Rising, MD, Director of Medical Devices. “First, despite the dramatic uptake of electronic health information sources, these systems cannot easily transmit data among one another.”

The lack of interoperability has led to the development of one-off solutions for extracting health data from EHR systems on a facility-by-facility basis or the manual parsing of data, says Rising. To remove this obstacle between EHR systems, the Pew Charitable Trusts is urging the Senate Committee to evaluate the work of Office of the National Coordinator for Health Information Technology (ONC) on EHR interoperability.

Another condition to be met is the integration of unique device identifiers (UDIs) into the electronic record and insurance claims, which is on the horizon.

According to Rising, incorporating UDIs into the patient health records will provide a number of tangible benefits — from being able to track potentially malfunctioning devices to supporting more informed clinical decisions regarding implantable devices. “This information is especially critical when patients switch providers or see multiple physicians, all of whom may need information on the specific device,” he adds.

The Pew Charitable Trusts have called attention to the efforts of the ONC and the HIT Policy Committee in proposing the creation of a standardized field in EHRs for listing UDIs and incentives for eligible providers in meaningful use including this information in the electronic record.

The last condition necessary for enhancing the safety and innovation of medical devices deals with sharing information widely.

“The utility of these new tools relies on the dissemination of findings to patients, providers, regulators, payers, manufacturers and researchers,” Rising maintains. “These data will provide patients and physicians with information on the safety and effectiveness of medical products, enable payers to assess the quality of product used by beneficiaries, and give manufacturers information to improve the next generation of products.”

Releasing information regularly and publically should allow patients, providers, manufacturers, and payers to identify potential problems related to medical devices and hopefully prevent threats to patient safety.

Read the full letter here.