{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,12]],"date-time":"2026-04-12T16:29:41Z","timestamp":1776011381469,"version":"3.50.1"},"reference-count":25,"publisher":"Oxford University Press (OUP)","issue":"2","license":[{"start":{"date-parts":[[2017,5,3]],"date-time":"2017-05-03T00:00:00Z","timestamp":1493769600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2018,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objective<\/jats:title>\n                  <jats:p>The US Food and Drug Administration (FDA) has recognized the need to improve the tracking of medical device safety and performance, with implementation of Unique Device Identifiers (UDIs) in electronic health information as a key strategy. The FDA funded a demonstration by Mercy Health wherein prototype UDIs were incorporated into its electronic information systems. This report describes the demonstration\u2019s informatics architecture.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>Prototype UDIs for coronary stents were created and implemented across a series of information systems, resulting in UDI-associated data flow from manufacture through point of use to long-term follow-up, with barcode scanning linking clinical data with UDI-associated device attributes. A reference database containing device attributes and the UDI Research and Surveillance Database (UDIR) containing the linked clinical and device information were created, enabling longitudinal assessment of device performance. The demonstration included many stakeholders: multiple Mercy departments, manufacturers, health system partners, the FDA, professional societies, the National Cardiovascular Data Registry, and information system vendors.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The resulting system of systems is described in detail, including entities, functions, linkage between the UDIR and proprietary systems using UDIs as the index key, data flow, roles and responsibilities of actors, and the UDIR data model.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>The demonstration provided proof of concept that UDIs can be incorporated into provider and enterprise electronic information systems and used as the index key to combine device and clinical data in a database useful for device evaluation. Keys to success and challenges to achieving this goal were identified. Fundamental informatics principles were central to accomplishing the system of systems model.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jamia\/ocx041","type":"journal-article","created":{"date-parts":[[2017,3,31]],"date-time":"2017-03-31T20:20:34Z","timestamp":1490991634000},"page":"111-120","source":"Crossref","is-referenced-by-count":19,"title":["Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration"],"prefix":"10.1093","volume":"25","author":[{"suffix":"Jr","given":"Joseph P","family":"Drozda","sequence":"first","affiliation":[{"name":"Mercy Research, Mercy, South Outer Forty, Chesterfield, MO, USA"}]},{"given":"James","family":"Roach","sequence":"additional","affiliation":[{"name":"Mercy Technology Services, Mercy, Chesterfield, MO, USA"}]},{"given":"Thomas","family":"Forsyth","sequence":"additional","affiliation":[{"name":"Data Analytics and Engineering, Mercy, Chesterfield, MO, USA"}]},{"given":"Paul","family":"Helmering","sequence":"additional","affiliation":[{"name":"Technology and Business Solutions, Resource Optimization and Innovation, Chesterfield, MO, USA"}]},{"given":"Benjamin","family":"Dummitt","sequence":"additional","affiliation":[{"name":"Virtual Care Center, Mercy, Chesterfield, MO, USA"}]},{"given":"James E","family":"Tcheng","sequence":"additional","affiliation":[{"name":"Division of Cardiology, Duke University Medical Center, Durham, NC, USA"}]}],"member":"286","published-online":{"date-parts":[[2017,5,3]]},"reference":[{"key":"2020110612445885500_ocx041-B1","unstructured":"Strengthening Our National System for Medical Device Postmarket Surveillance. 2012; http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDRH\/CDRHReports\/UCM301924.pdf. Accessed April 20, 2017."},{"key":"2020110612445885500_ocx041-B2","unstructured":"Strengthening Our National System for Medical Device Postmarket Surveillance: Update and Next Steps. 2013. http:\/\/www.fda.gov\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDRH\/CDRHReports\/UCM301912. Accessed July 27, 2015."},{"key":"2020110612445885500_ocx041-B3","doi-asserted-by":"crossref","first-page":"e6848","DOI":"10.1136\/bmj.e6848","article-title":"Postmarket surveillance for medical devices: America\u2019s new strategy","volume":"345","author":"Normand","year":"2012","journal-title":"BMJ."},{"issue":"17","key":"2020110612445885500_ocx041-B4","doi-asserted-by":"crossref","first-page":"1583","DOI":"10.1056\/NEJMp1113608","article-title":"Unique device identification in the service of public health","volume":"367","author":"Gross","year":"2012","journal-title":"N Engl J Med."},{"key":"2020110612445885500_ocx041-B5","unstructured":"US Food and Drug Administration. Global UDI Database (GUDID). http:\/\/www.fda.gov\/medicaldevices\/deviceregulationandguidance\/uniquedeviceidentification\/globaludidatabasegudid\/default.htm. Accessed March 29, 2016."},{"key":"2020110612445885500_ocx041-B6","unstructured":"US Department of Health and Human Services. Centers for Medicare and Medicaid Services. 45 CFR Part 170. Medicare and Medicaid Programs; Electronic Health Record Incentive Program\u2014Stage 3; 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications; Proposed Rules. http:\/\/www.cms.gov\/Regulations-and-Guidance\/Legislation\/EHRIncentivePrograms\/Downloads\/Stage3_Rule.pdf. Accessed July 28, 2015."},{"key":"2020110612445885500_ocx041-B7","unstructured":"US Food and Drug Administration. 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Contract DHHS\/FDA-22320172C from the Center for Devices and Radiological Health, US Food and Drug Administration. http:\/\/www.fda.gov\/downloads\/MedicalDevices\/DeviceRegulationandGuidance\/UniqueDeviceIdentification\/BenefitsofaUDIsystem\/UCM416128.pdf. Accessed October 2, 2014."},{"key":"2020110612445885500_ocx041-B14","unstructured":"Global Medical Device Nomenclature Agency. https:\/\/www.gmdnagency.org\/. Accessed October 9, 2015."},{"key":"2020110612445885500_ocx041-B15","unstructured":"GS1. Global Data Synchronisation Network. http:\/\/www.gs1.org\/gdsn. Accessed March 29, 2016."},{"key":"2020110612445885500_ocx041-B16","unstructured":"GS1. Global Location Number (GLN). http:\/\/www.gs1.org\/gln. Accessed October 9, 2015."},{"key":"2020110612445885500_ocx041-B17","unstructured":"Dun & Bradstreet. The D-U-N-S\u00ae Number. http:\/\/www.dnb.com\/get-a-duns-number.html. Accessed October 9, 2015."},{"key":"2020110612445885500_ocx041-B18","unstructured":"US National Library of Medicine. Access GUDID. https:\/\/accessgudid.nlm.nih.gov\/. Accessed March 29, 2016."},{"key":"2020110612445885500_ocx041-B19","unstructured":"Krucoff\n              MW\n            , NormandS-L, EdwardsF, et al\n          Recommendations for a national medical device evaluation system: strategically coordinated registry networks to bridge clinical care and research. http:\/\/www.fda.gov\/downloads\/aboutfda\/centersoffices\/officeofmedicalproductsandtobacco\/cdrh\/cdrhreports\/ucm459368.pdf. Accessed October 12, 2015."},{"key":"2020110612445885500_ocx041-B20","unstructured":"Building UDI Into Longitudinal Data for Medical Device Evaluation: The BUILD Initiative. http:\/\/mdepinet.org\/build\/. Accessed September 22, 2016."},{"key":"2020110612445885500_ocx041-B21","unstructured":"Medical Device Epidemiology Network. SMART. http:\/\/www.mdepinet.org\/smart\/. Accessed October 9, 2015."},{"issue":"11","key":"2020110612445885500_ocx041-B22","doi-asserted-by":"crossref","first-page":"1153","DOI":"10.1001\/jama.2016.8708","article-title":"Need for a national evaluation system for health technology","volume":"316","author":"Shuren","year":"2016","journal-title":"JAMA."},{"key":"2020110612445885500_ocx041-B23","unstructured":"Daniel\n              GW\n            , McClellanMB, ColvinH, AuroraP, KhaterzaiS. Strengthening patient care: building an effective medical device surveillance system. February 23, 2015. http:\/\/www.fda.gov\/downloads\/AboutFDA\/CentersOffices\/OfficeofMedicalProductsandTobacco\/CDRH\/CDRHReports\/UCM435112.pdf. Accessed May 14, 2015."},{"key":"2020110612445885500_ocx041-B24","unstructured":"Daniel\n              GW\n            , ColvinHM, SilcoxCE, McClellanMB, BryanJM. Better evidence on medical devices: a coordinating center for a 21st century national medical device evaluation system. National Medical Device Evaluation System Planning Board Report. April 2016. https:\/\/healthpolicy.duke.edu\/sites\/default\/files\/atoms\/files\/med-device-report-web.pdf. Accessed September 19, 2016."},{"key":"2020110612445885500_ocx041-B25","unstructured":"Daniel\n              GW\n            , ColvinHM, SilcoxCE, McClellanMB, BryanJM. The National Evaluation System for Health Technology (NEST): priorities for effective early implementation. A NEST Planning Board report. September 20, 2016. https:\/\/healthpolicy.duke.edu\/sites\/default\/files\/atoms\/files\/NEST%20Priorities%20for%20Effective%20Early%20Implementation%20September%202016_0.pdf. 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