Fulfilling the Promise of Unique Device Identifiers
Authors: Sanket S. Dhruva, Joseph S. Ross, Wade L. Schulz, Harlan M. Krumholz
Journal: Annals of Internal Medicine (2018)

Ideas and Opinions7 August 2018Fulfilling the Promise of Unique Device IdentifiersSanket S. Dhruva, MD, MHS, Joseph S. Ross, MD, MHS, Wade L. Schulz, MD, PhD, and Harlan M. Krumholz, MD, SMSanket S. Dhruva, MD, MHSNational Clinician Scholars Program at Yale School of Medicine, New Haven, Connecticut, and Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut (S.S.D.), Joseph S. Ross, MD, MHSNational Clinician Scholars Program at Yale School of Medicine, Yale School of Public Health, and Center for Outcomes Research and Evaluation at Yale New Haven Hospital, New Haven, Connecticut (J.S.R.), Wade L. Schulz, MD, PhDCenter for Outcomes Research and Evaluation at Yale New Haven Hospital and Yale School of Medicine, New Haven, Connecticut (W.L.S.), and Harlan M. Krumholz, MD, SMYale School of Public Health, Center for Outcomes Research and Evaluation at Yale New Haven Hospital, and Yale School of Medicine, New Haven, Connecticut (H.M.K.)Author, Article, and Disclosure Informationhttps://doi.org/10.7326/M18-0526 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail In 2013, our capacity to understand the real-world safety and effectiveness of medical devices for surveillance and clinical purposes took a major step forward when the U.S. Food and Drug Administration issued the unique device identifier (UDI) final rule (1). This rule states that any medical device (defined as "an instrument, apparatus…implant, in vitro reagent, or other similar or related article…intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action…" [2]) must contain a distinct code on its label and packaging. The ...References1. Department of Health and Human Services, ed. Unique Device Identification System. Silver Spring: U.S. Food and Drug Administration; 2013. Google Scholar2. U.S. Food and Drug Administration. Is the product a medical device? Updated 22 March 2018. Accessed at www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm051512.htm on 17 April 2018. Google Scholar3. Department of Health and Human Services Office of the Inspector General. Shortcomings of device claims data complicate and potentially increase Medicare costs for recalled and prematurely failed devices. 2017. Accessed at https://oig.hhs.gov/oas/reports/region1/11500504.asp on 17 April 2018. Google Scholar4. 21st Century Cures Act, Pub. L. No. 114-255 (2016). Google Scholar5. Moscovitch B, Rising JP. Medical device identification in claims data [Letter]. JAMA. 2017;318:1936-7. [PMID: 29164249] doi:10.1001/jama.2017.15146 CrossrefMedlineGoogle Scholar6. Medicare Payment Advisory Commission. An overview of the medical device industry. In: Medicare and the Health Care Delivery System. Washington, DC: Medicare Payment Advisory Commission; June 2017:207-44. Accessed at www.medpac.gov/docs/default-source/reports/jun17_reporttocongress_sec.pdf on 17 April 2018. Google Scholar7. Drozda JP, Dudley C, Helmering P, Roach J, Hutchison L. The Mercy unique device identifier demonstration project: implementing point of use product identification in the cardiac catheterization laboratories of a regional health system. Healthc (Amst). 2016;4:116-9. [PMID: 27343161] doi:10.1016/j.hjdsi.2015.07.002 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAffiliations: National Clinician Scholars Program at Yale School of Medicine, New Haven, Connecticut, and Veterans Affairs Connecticut Healthcare System, West Haven, Connecticut (S.S.D.)National Clinician Scholars Program at Yale School of Medicine, Yale School of Public Health, and Center for Outcomes Research and Evaluation at Yale New Haven Hospital, New Haven, Connecticut (J.S.R.)Center for Outcomes Research and Evaluation at Yale New Haven Hospital and Yale School of Medicine, New Haven, Connecticut (W.L.S.)Yale School of Public Health, Center for Outcomes Research and Evaluation at Yale New Haven Hospital, and Yale School of Medicine, New Haven, Connecticut (H.M.K.)Financial Support: Dr. Dhruva is supported by the Department of Veterans Affairs. Dr. Ross has received research support, through Yale, from the Food and Drug Administration to establish the Yale University–Mayo Clinic Center of Excellence in Regulatory Science and Innovation (U01FD005938); from the Agency for Healthcare Research and Quality (R01HS022882); and from the National Heart, Lung, and Blood Institute of the National Institutes of Health (R01HS025164).Disclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M18-0526.Corresponding Author: Harlan M. Krumholz, MD, SM, 1 Church Street, Suite 200, New Haven, CT 06510; e-mail, harlan.[email protected]edu.Current Author Addresses: Dr. Dhruva: 333 Cedar Street, SHM I-456, Box 208088, New Haven, CT 06520.Dr. Ross: Yale Section of General Medicine, Box 208093, New Haven, CT 06520.Dr. Schulz: 55 Park Street, PS345D, New Haven, CT 06511.Dr. Krumholz: 1 Church Street, Suite 200, New Haven, CT 06510.Author Contributions: Conception and design: S.S. Dhruva, J.S. Ross, H.M. Krumholz.Analysis and interpretation of the data: S.S. Dhruva, H.M. Krumholz.Drafting of the article: S.S. Dhruva, W.L. Schulz.Critical revision of the article for important intellectual content: J.S. Ross, W.L. Schulz, H.M. Krumholz.Final approval of the article: S.S. Dhruva, J.S. Ross, W.L. Schulz, H.M. Krumholz.Administrative, technical, or logistic support: H.M. Krumholz.Collection and assembly of data: S.S. Dhruva.This article was published at Annals.org on 5 June 2018. 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