Letter

Pew Letter Encouraging New Meaningful Use Objective to Capture Identifiers for Implanted Devices

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The Pew Charitable Trusts sent a letter to the Office of the National Coordinator for Health Information Technology strongly urge the Meaningful Use Workgroup to recommend a new core meaningful use objective to encourage eligible providers and hospitals to capture Unique Device Identifiers for implanted devices in patient’s health records.

By providing incentives to hospitals to incorporate these UDIs in EHRs, there is added insurance that device identifiers are utilized, thus improving patient safety, facilitating product recalls, and enabling quality assurance practices.

Download the Letter (PDF)


May 24, 2013

HIT Policy Committee, Meaningful Use Workgroup
Office of the National Coordinator for Health Information Technology
Patriots Plaza III
355 E Street, SW
Washington, DC 20201

RE: A new meaningful use objective to capture identifiers for implanted devices.

Dear Workgroup Members,
We appreciate your recent interest in the unique device identifier (UDI) system under development by the U.S. Food and Drug Administration (FDA). While we support new electronic health record (EHR) certification criteria to facilitate the documentation of device identifiers, we strongly urge the Meaningful Use Workgroup to also recommend a new core meaningful use objective to encourage eligible providers and hospitals to capture UDIs for implanted devices in patient’s health records.

The Pew Charitable Trusts is an independent, non-profit research and public policy organization. Pew seeks to enhance medical device safety and foster device innovation that benefits patients.

By providing incentives to hospitals to incorporate these UDIs in EHRs, the Meaningful Use Workgroup and Health Information Technology (HIT) Policy Committee can ensure that device identifiers are utilized, thus improving patient safety, facilitating product recalls, and enabling quality assurance practices.

UDI capture in EHRs is integral to postmarket surveillance, assessing quality

Medical device implantations are among the most frequent procedures performed in U.S. hospitals, according to statistics from the Agency for Healthcare Research and Quality.1 In 2009, there were 644,240 hospital stays involving cardiac stent procedures alone2 and more than 285,000 estimated total hip replacements.3 In recent years, medical devices have been associated with numerous high-profile recalls and safety problems.

Unfortunately, it can be difficult in the current healthcare system to find the specific make and model of implanted devices in patient records. As a result, clinicians, health systems, and even patients may not know essential details about the product. A UDI system will provide that critical information and serve as the cornerstone for significant improvements in medical device safety once it is widely adopted. The UDI system will benefit patients, clinicians, hospitals, and public health officials by:

  • providing for more rapid identification of medical devices associated with adverse events;
  • assisting with prompt and efficient resolution of device recalls;
  • delivering an easily accessible source of definitive device identification; and
  • increasing health savings through a more accurate accounting of the devices used.
Sporadic and intermittent UDI capture in EHRs puts these benefits at risk. Robust UDI capture in EHRs—through a new core meaningful use objective—will enable health systems, hospitals, clinicians, and patients to realize these important capabilities.

The Meaningful Use Workgroup should propose a new core meaningful use objective

A core meaningful use objective to support the capture of UDIs for implanted devices meets the three high-level benefits laid out by the Office of the National Coordinator for Health Information Technology:

  • Complete and accurate information: UDIs will correlate with critical information on products often not captured in patient records.
  • Better access to information: The UDI capture in EHRs will enable clinicians to identify device problems early and facilitate care coordination, especially for patients who see multiple providers.
  • Patient empowerment: UDI documentation in EHRs will provide an accessible data source for patients to take an active role submitting more precise adverse event reports and tracking product performance.
Therefore, we encourage the Meaningful Use Workgroup to recommend the capture of UDIs in EHRs for implanted devices as a Stage 3 core meaningful use objective for eligible hospitals. The core objective we propose, which would be satisfied through attestation, is: “the incorporation of the UDI into EHRs for patients whose care involves an implanted medical device.”

We propose this objective for hospitals where the medical device implantation occurs at the time of the procedure. The focus on implanted medical devices is appropriate since it is a clearly defined set of products, they are not visible to the human eye once implanted, and they have been associated with significant adverse events and costs.

Conclusion

Realizing the full benefits of a UDI system requires that these identifiers are regularly included in electronic health information. Infrequent and inconsistent UDI capture would decrease the ability of the healthcare system to ensure safety and quality. Therefore, we strongly urge the Meaningful Use Workgroup to seize this opportunity to develop a new core meaningful use objective that would ensure sufficient capture of UDIs for implanted devices.

Should you have any questions or if we can be of assistance, please contact Josh Rising, director of medical devices at The Pew Charitable Trusts, at 202-540-6761 or jrising@pewtrusts.org.

Sincerely,

Josh Rising, MD
The Pew Charitable Trusts


1 Pfuntner, Anne, Lauren M. Wier, and Carol Stocks. Statistical Brief #149: Most Frequent Procedures Performed in
U.S. Hospitals, 2010. U.S. Agency for Healthcare Research and Quality. February 2013.
2 Auerbach, David, Jared Lane Maeda, and Claudia Steiner. Statistical Brief #128: Hospital Stays with Cardiac Stents, 2009. Agency for Healthcare Research and Quality. April 2012.
3 American Academy of Orthopaedic Surgeons. Fact Sheet: The Role of Orthopaedics. 2012. http://anationinmotion.org/wp-content/uploads/2012/04/Ortho-Consumer.pdf. Accessed: May 20, 2013.


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