Principal Investigator: Joseph P. Drozda, Jr., M.D.
The U.S. Food and Drug Administration (FDA) envisions strengthening the system of medical device postmarket surveillance through the use of electronic health information gathered in the course of care and sees unique device identifiers (UDIs) as keys enabling linking of disparate systems. To this end, the FDA supported a demonstration performed by Mercy Health (a 4-state regional health system headquartered in St. Louis, Missouri) that had 3 aims:
- to implement a coronary stent surveillance system in its electronic health record (EHR),
- to identify the obstacles for creating such a system along with potential solutions, and
- to assess the usefulness of the EHR data in device safety surveillance.
Mercy designed and implemented a system for capturing prototype coronary stent UDIs by means of barcode scanning in its cardiac catheterization laboratories (cath labs) and incorporating them in its supply chain management, inventory management, billing, and cath lab clinical systems. The UDI was used to link the specific coronary stent with the patient in whom it was implanted. This resulted in creation of a database that included pertinent UDI-related device information and clinical data obtained from the EHR thus enabling assessment of coronary stent safety and effectiveness over time.
This “proof of concept” pilot demonstrated that EHR data can be useful in evaluating implanted medical devices in the postmarket setting. The next step would be to work with a national device registry to obtain this same information in de-identified format from multiple health systems in order to assess large numbers of devices nationally and create a clearer picture of device performance and safety in the real world.
Read the report (ppt): MDEpi UDI Demo FDA Epi Conf Final
Mercy is a member of the Healthcare Transformation Group (HTG)—an alliance of 5 large health systems that includes Geisinger, Intermountain Healthcare, Kaiser Permanente, and Mayo Clinic. HTG is advocating for supply chain standardization aimed at reducing costs while improving healthcare quality and safety and actively supported the Mercy UDI demonstration. In conjunction with its HTG partners, Mercy assembled an expert panel of interventional cardiologists to help in refining the project design and to select meaningful coronary stent attributes for inclusion in the surveillance database. The expert panel accomplished this task by working with a broader group of stakeholders that included representatives of HTG health systems, professional societies (American College of Cardiology and Society for Cardiovascular Angiography and Interventions), and industry (Abbott, Boston Scientific, and Medtronic) as well as FDA.
The Mercy team was multidisciplinary; it was led by a senior health services researcher, and was a combined effort of a number of departments: Cath Lab, research, information technology, supply chain, and operational optimization.
Sources of Funding
The UDI implementation pilot was a part of the MDEpiNet Methodology Center of Harvard Medical School. This work was supported by contract DHHS/FDA-22320172C from the Center for Devices and Radiological Health, USA Food and Drug Administration.
The major product of this initiative was a dynamic database (the UDI Research database or UDIR) that is a dataset generated from Mercy’s data warehouse, that contains UDI-associated coronary stent attribute data and clinical data, and that receives clinical data extracted from the EHR on a weekly basis to enable long term patient follow up. The UDIR, then, provides information that can be used in assessment of device safety and effectiveness.
Open Source Information
Detailed information on the project including UDIR data structure is available at Advancement of Innovative Methodologies and Medical Device Specific Infrastructure for Evidence-Based Regulatory Science and Public Health Surveillance.
Tcheng JE, Crowley J, Tomes M, Reed TL, Dudas JM, Thompson KP, Garratt KN, Drozda Jr. JP. Unique device identifiers (udis) for coronary stent post-market surveillance and research: A report from the FDA’s Medical Device Epidemiology Network (MDEpiNet) udi demonstration, American Heart Journal, 2014;168(4);405-13,e2., doi: 10.1016/j.ahj.2014.07.001.
Drozda JP, Smith TR. Medical device research at a regional health system: the Mercy experience. Asian Hospital & Healthcare Management, 2014:30, http://www.asianhhm.com/equipment_devices/medical-device-research.html. Accessed November 20, 2014.
Drozda JP, Dudley C, Helmering P, Roach J, Hutchison J. The Mercy unique device identifier demonstration project: Implementing point of use product identification in the cardiac catheterization laboratories of a regional health system, Healthcare (2015), http://dx.doi.org/10.1016/j.hjdsi.2015.07.002i.
Slayton R, Roach J, Smith P, Helmering P, Reed T, Resnic F, Normand S-L, Drozda JP Jr. Leveraging health information technology in a large health system: barriers to designing and implementing a unique device identifier research database. Academy Health Health Information Technology Interest Group Meeting, June 7, 2014.
Unique Device Identifiers in Electronic Health Records. U.S. Food and Drug Administration Unique Device Identification (UDI) for Postmarket Surveillance and Compliance Public Workshop, Bethesda, MD, September 12, 2011.
Results of the FDA Unique Device Identifier Demonstration. GS1 Connect 2013 Conference, San Antonio, TX, June 13, 2013.
Food and Drug Administration UDI Demonstration. Global GS1 Healthcare Conference, San Francisco, CA, October 3, 2013.
Implementation of Unique Device Identification Demonstration Project – A Report from MDEpiNet. Food and Drug Administration Center for Device and Radiologic Health Epidemiology Grand Rounds, Silver Spring, MD, February 20, 2014.
Food and Drug Administration UDI Demonstration. HIMSS 2014, Intelligent Hospital Pavilion, Orlando FL, February 25, 2014
Update on Mercy’s UDI Demonstration: What’s Next? GS1 Connect Conference, San Diego, CA, June 11, 2014.
Device Specific Surveillance: The UDI Demonstration and Beyond. MDEpiNet Annual Meeting. Bethesda, MD, October 14, 2014.
FDA UDI Demonstration. HIMSS webinar: UDI at the Heart of the Triple Aim. November 19, 2014.
Evaluate how UDI capture in patients’ medical records and other data systems used by providers and clinicians can improve care and affect workflow, and identify standards revisions that are needed to obtain benefits. Part of a panel. Realizing the Benefits of the Unique Device Identifier in Health Care. An event co-hosted by the U.S. Food and Drug Administration, the Office of the National Coordinator for Health Information Technology, and The Pew Charitable Trusts, Washington, DC, December 9, 2014.
Mercy’s UDI Journey. GS1 Canada Carenet Healthcare Sector Board Meeting Conference Call and Webinar. March 4, 2015.
Mercy’s Unique Device Identification Journey. GS1 Canada Healthcare Advisory Council Meeting, Conference Call, and Webinar, April 9, 2015.
Medical Devices and the Triple Aim. GHX Supply Chain Summit, Scottsdale, AZ, May 6, 2015.