EHRs must have device ID, Pew tells HHS

Calls for certification changes, new meaningful use objective for UDI capture
By Mike Miliard
10:53 AM
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In a letter sent this week to Health and Human Services Secretary Sylvia Mathews Burwell, Pew Charitable Trusts – along with providers such as Geisinger Health System, Intermountain Healthcare and Mercy; patient safety advocates The Leapfrog Group; the American Association of Orthopaedic Surgeons and others – argue that medical device tracking in EHRs is essential to "improve patient safety and care quality for the millions of patients" with implanted devices.

[See also: UDI rule is here, but is it enough?]

"We are asking that the Office of the National Coordinator for Health Information Technology and the Centers for Medicare & Medicaid Services include provisions to enable and encourage providers to document the specific medical devices implanted in patients as part of forthcoming rules on the electronic health record certification and meaningful use programs," they wrote. 

Under the U.S. Food and Drug Administration's unique device identifier system, established in 2013, each medical device gets a code corresponding to its make and model to definitively identify it. Manufacturers began labeling all high-risk implantable devices with UDIs in 2014; by 2018 all devices will bear a UDI.

[See also: UDI rule: A new milestone, but 2020 deadline draws disapproval]

In their letter to HHS, Pew et al. argue that, once incorporated into patients' EHRs, UDIs would

  • Facilitate recall resolution: Putting UDIs for implanted devices into EHRs will help providers identify patients implanted with recalled products and deliver appropriate follow-up care, regardless of whether that physician inserted the product.
  • Improve adverse event reports: Inclusion of UDIs in EHRs will enable patients and providers to submit more precise adverse event reports that identify the make and model – and in some cases the lot number – of a potentially malfunctioning device.
  • Enhance clinical decision support and care coordination: The inclusion of UDIs in EHRs will allow providers to make more informed decisions on patient care, especially when patients switch providers or see multiple physicians.
  • Support patient engagement: UDIs will provide a clear, accessible source of data on the devices implanted in patients, enabling individuals to take more active roles in their care.
  • Enrich analyses on device performance: Increased data on device utilization can support hospital analyses on product performance in their patients.

As such, new ONC certification criteria "should include a mandatory field to list the UDIs of implanted medical devices," the letter argues.

Also, it should allow providers to "generate a list of patients with a particular device, thus aiding hospitals with recalls and letting facilities perform analyses of device outcomes."

Certification criteria should aim to ensure EHRs can use the UDI to automatically obtain additional information on the device from external databases as well, the groups contend, enabling a clinician to "tell from a quick glance at the EHR what devices are implanted in a patient to inform clinical decisions, such as whether an implanted device could be contributing to a symptom or whether the patient can undergo an MRI scan."

Finally, ONC should ensure that EHRs are enabled to automatically alert clinicians in the event of known device risks. For example, upon ordering an MRI, the provider should receive an automated alert if the patient has an MRI-incompatible device.

Meaningful use has a role to play here, the letter argues. Presuming that a UDI field is mandated in EHRs, providers then must be sure to use it: "The creation of a new meaningful use objective for UDI capture would provide the needed financial incentives."

Such a measure would be in line with several stated priorities for Stage 3 MU, according to Pew's letter, such as improved clinical decision support, better care coordination and patient engagement.

In addition to the groups noted above, the letter was signed by the American Joint Replacement Registry, Pacific Business Group on Health, the Society of Thoracic Surgeons and Trust for America's Health. Read it here.