The Pew Charitable Trusts and other stakeholders are urging the U.S. Department of Health and Human Services to include provisions in the next stage of the Meaningful Use program that encourage providers to document in their electronic health records the unique device identifiers (UDIs) that implantable medical devices soon will be sporting.
In a letter to HHS Secretary Sylvia Mathews Burwell, the organizations suggest that Meaningful Use Stage 3 include an objective to capture this information, and for certified EHRs to include a mandatory field to list UDIs of implantable medical devices. The move would have several benefits, including:
- Facilitating recall resolution
- Improving adverse event reports
- Enhancing clinical decision support and coordinated care
- Supporting patient engagement
- Enriching analyses on device performance
The Office of the National Coordinator for Health IT's Policy Committee has also recommended that such an objective be included in the next stage of Meaningful Use.
The U.S. Food and Drug Administration has released new rules that require implantable medical devises to have a UDI, and the agency is in the process of rolling out the UDI system, which will be phased in through 2018.
"The new UDI system will allow physicians and patients to know which devices are implanted and used in care. ... The development of certification criteria and a Meaningful Use objective to support UDI capture are critical next steps to achieve those benefits," Pew's letter concludes.
This is not the first time that stakeholders have recommended that the data in EHRs can be used to help the FDA promote public safety, and that lack of EHR interoperability impedes medical device evaluation.
In addition, HHS has already submitted a proposed rule implementing Stage 3 of the Meaningful Use program to the Office of Management of Budget for review; ONC's proposed new EHR certification rule is also in the hands of OMB. It is not yet known whether the UDI is addressed in those rules.
To learn more:
- read the letter