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Am Heart J. 2014 Oct;168(4):405-413.e2. doi: 10.1016/j.ahj.2014.07.001. Epub 2014 Jul 7.

Unique device identifiers for coronary stent postmarket surveillance and research: a report from the Food and Drug Administration Medical Device Epidemiology Network Unique Device Identifier demonstration.

Author information

1
Duke University Medical Center, Durham, NC.
2
USDM Life Sciences, Santa Barbara, CA.
3
Avalere Health, Washington, DC.
4
Duke Clinical Research Institute, Durham, NC.
5
Mayo Clinic, Rochester, MN.
6
Medtronic Corporation, Minneapolis, MN.
7
North Shore Long Island Jewish - Lenox Hill Hospital, New York, NY.
8
Mercy Health, Chesterfield, MO. Electronic address: Joseph.Drozda@Mercy.net.

Abstract

BACKGROUND:

Although electronic product identification in the consumer sector is ubiquitous, unique identification of medical devices is just being implemented in 2014. To evaluate unique device identifiers (UDIs) in health care, the US Food and Drug Administration (FDA) funded the Medical Device Epidemiology Network initiative, including a demonstration of the implementation of coronary stent UDI data in the information systems of a multihospital system (Mercy Health). This report describes the first phase of the demonstration.

METHODS:

An expert panel of interventional cardiologists nominated by the American College of Cardiology and the Society for Cardiovascular Angiography and Interventions was convened with representatives of industry, health system members of the Healthcare Transformation Group, the American College of Cardiology National Cardiovascular Data Registry, and FDA to articulate concepts needed to best use UDI-associated data. The expert panel identified 3: (1) use cases for UDI-associated data (eg, research), (2) a supplemental data set of clinically relevant attributes (eg, stent dimensions), and (3) governance and administrative principles for the authoritative management of these data.

RESULTS:

Eighteen use cases were identified, encompassing clinical care, supply chain management, consumer information, research, regulatory, and surveillance domains. In addition to the attributes of the FDA Global Unique Device Identification Database, 9 additional coronary stent-specific attributes were required to address use case requirements. Recommendations regarding governance were elucidated as foundational principles for UDI-associated data management.

CONCLUSIONS:

This process for identifying requisite extensions to support the effective use of UDI-associated data should be generalizable. Implementation of a UDI system for medical devices must anticipate both global and device-specific information.

PMID:
25262248
DOI:
10.1016/j.ahj.2014.07.001
[Indexed for MEDLINE]

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