Adding unique device identifiers (UDIs) to electronic health records alone will not be enough to effectively track medical devices, according to a fact sheet from the Pew Charitable Trusts, which advocates for use of the markers on insurance claims as well.
Pew has previously backed U.S. Food and Drug Administration plans for a UDI system, and is urging Congress to require the Centers for Medicare & Medicaid Services to create a field for UDI information on claims forms.
However, CMS has previously argued that requiring the UDI on the forms poses big technical hurdles and would cost too much.
While important for improving patient safety and improving care coordination, the use of UDIs in EHRs will not effectively support large-scale population health analyses necessary to quickly identify problems with devices, according to the Pew release.
Insurance claims data, on the other hand, tracks an individual’s every encounter with the healthcare system. When tracked across millions of patients, UDIs in claims data would help researchers understand whether devices are safe and effective.
As it stands now, claims show only the procedure performed, such as hip replacement, but not the device installed, Pew adds. UDIs would provide a new level of specificity that researchers need.
They would allow for data-driven analysis, such as whether a particular implant device fails more often than others; would improve post-market surveillance of particular products and lead to speedier recalls; help healthcare organizations demonstrate cost-effectiveness and quality; and help ensure patients receive appropriate followup care, according to Pew.
To learn more:
- here's the fact sheet