Health Groups Make the Case for Unique Device Identifiers in EHRs

January 23, 2015 in News

On Tuesday, several organizations sent a letter to HHS Secretary Sylvia Mathews Burwell urging unique device identifier fields to be included in upcoming electronic health record certification criteria, Healthcare IT News reports (Miliard, Healthcare IT News, 1/23).

Under the 2009 economic stimulus package, providers who demonstrate meaningful use of certified EHRs can qualify for Medicaid and Medicare incentive payments.


In 2013, FDA issued a final rule establishing a unique device identification system for tracking medical devices. Under the UDI system, manufacturers must assign a unique identifier to track devices. Manufacturers began labeling high-risk medical devices with UDIs in 2014. All devices will be expected to have a UDI by 2018 (iHealthBeat, 9/20/13).

Letter Details

The letter was signed by 10 health care organizations, including:

  • American Association of Orthopaedic Surgeons;
  • American Joint Replacement Registry;
  • Geisinger Health System;
  • Intermountain Healthcare;
  • The Leapfrog Group;
  • Mercy;
  • Pacific Business Group on Health;
  • The Pew Charitable Trusts;
  • The Society of Thoracic Surgeons; and
  • Trust for America‚Äôs Health (Letter, 1/20).

In the letter, the groups argued that using EHRs to track medical devices implanted in patients is essential to “improve patient safety and care quality for the millions of patients.”

Specifically, the groups said that incorporating UDIs in EHRs would:

  • Bolster analyses on device performance;
  • Boost patient engagement;
  • Enhance clinical decision support and care coordination;
  • Facilitate recall resolution; and
  • Improve adverse event reporting (Healthcare IT News, 1/23).

Further, they wrote that upcoming EHR certification criteria should include a mandatory field for implanted medical devices’ UDIs.

In addition, they said the certification criteria should ensure EHRs can:

  • Automatically alert physicians to known risks;
  • Automatically retrieve additional UDI data from external databases; and
  • Generate a list of patients with a particular device (Letter, 1/20).

The groups also said that the Office of the National Coordinator for Health IT and CMS should include UDI documentation as a requirement for providers attesting to meaningful use (Gold, “Morning eHealth,” Politico, 1/21).

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