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

doi:10.1016/j.ahj.2014.07.001

American Heart Journal

Volume 168, Issue 4, October 2014, Pages 405-413.e2

https://doi.org/10.1016/j.ahj.2014.07.001 Get rights and content

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.

Section snippets

The demonstration project and Mercy Health

The MDEpiNet includes 2 major “work streams”: a methodology work stream contracted to the Methodology Center at Harvard University and an infrastructure work stream assigned to Cornell University. The methodology work stream houses the UDI demonstration project. The UDI demonstration project has 3 principal aims:

•
To implement a prototype UDI solution for coronary stents in the information systems of a multihospital system,
•
To identify obstacles to implementation of the prototype UDI solution and

Participants

Critical to the demonstration project and to the larger UDI strategy was the establishment of a partnership of key stakeholders of coronary stent UDI-associated data. For this reason, we identified pertinent stakeholders and invited representatives to participate in an expert workgroup in-person meeting and follow-up teleconferences. These included stent manufacturers, health system supply chain divisions, cardiology professional societies, and the NCDR. Specifically, the 3 companies

Future development of a UDI-based device surveillance system

The expert workgroup took advantage of the face-to-face meeting to initiate discussions about the creation of a robust system of postmarket device surveillance and research using UDI-associated attributes and clinical data from EHRs and national registries. Expanding the current demonstration project with coronary stents to include interchange of UDI data with the NCDR CathPCI Registry among all of the participating health systems was proposed by Mercy as a way of testing the strategy of a

Additional discussion topics

The expert workgroup engaged in discussions of several other important issues related to the establishment of a robust system of medical device surveillance that are summarized in the online Appendix. The topics discussed included the following:

•
Technological and operational framework of SUDID
•
Data ownership and governance of SUDID services
•
Financial support of SUDID services
•
Conceptual model of a distributed network.

Summary

We have described the specifics of a demonstration project for the implementation of coronary stent UDI-associated data in the information systems of a multihospital health system. We anticipate that the systematic redesign of enterprise information systems will improve operational and supply chain efficiencies, facilitate the care of patients, provide interoperable data that can be linked via registries such as the NCDR CathPCI Registry, and enable postmarket device surveillance and research.

Disclosures

Dr Thompson is an employee of Medtronic, Inc. Mr Crowley is an employee of USDM Life Sciences. Ms Tomes is an employee of Avalere. Dr Garratt is a consultant for Boston Scientific Corporation and The Medicines Company and has equity holdings with Infarct Reduction Technologies (IRT). Dr Drozda’s son is a sales representative for Boston Scientific Corporation. All other authors have no relevant relationships with industry to declare.

Acknowledgements

The authors acknowledge the editorial assistance of Renata Slayton in preparation of this manuscript.

The authors are solely responsible for the drafting and editing of the manuscript and its final contents.

Glossary

CathPCI Registry: An National Cardiovascular Data Registry of diagnostic cardiac catheterization and percutaneous coronary intervention procedures.
Controlled vocabulary: A carefully selected and vetted list of words (or terms) that describe units of information. The purpose of controlled vocabularies is to enable and facilitate information communication and knowledge retrieval. Examples of controlled vocabularies include subject indexing schemas, subject headings, thesauri, taxonomies, and other

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The MDEpiNet is a public-private partnership between the US Food and Drug Administration's Center for Devices and Radiological Health and participating partners. The PASSION program is an MDEpiNet-sponsored program that aims to demonstrate the goals of MDEpiNet by using cardiovascular medical device registries to bridge evidence gaps across the medical device total product life cycle. To this end, a PASSION Think Tank meeting took place in October 2014 in Silver Spring, MD, to facilitate discussion between stakeholders about the successes, challenges, and future novel applications of medical device registries, with particular emphasis on identifying pilot projects. Participants spanned a broad range of groups including patients, device manufacturers, regulators, physicians/academicians, professional societies, providers, and payers. The meeting focus included 4 areas of cardiovascular medicine intended to cultivate interest in 4 MDEpiNet disease-specific/device-specific working groups: coronary intervention, electrophysiology, valvular disease, and peripheral vascular disease. In addition, more general issues applying to registry-based infrastructure and analytical methodologies for assessing device benefit/risk were considered to provide context for the working groups as PASSION programs going forward. This article summarizes the discussions at the meeting and the future directions of the PASSION program.
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We developed national projections for time, cost and failure in implant identification prior to revision total hip and knee arthroplasty (THA/TKA) using American Association of Hip and Knee Surgeons 2012 membership survey data, Nationwide Inpatient Sample 2011 data and THA/TKA demand projection data.
Our projections suggest that cumulative surgeon time spent identifying failed implants could reach 133,000 h in 2030, representing opportunity to perform over 500,000 15 min established patient office visits. Staff time could reach 220,000 h with a cost of $3.3 m. Failed implants that cannot be identified may be greater than 50,000 preoperatively and 25,000 intraoperatively in 2030.
Study projections indicate significant time, cost and inability to identify failed implants, supporting need for improvement of implant documentation. FDA’s UDI Rule sets the foundation for UDI scanning and documentation in the electronic health record, a process poised to serve as the standard system for device documentation.
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: Eric R. Bates, MD, served as guest editor for this article.

: Financial Support: This work is supported by contract DHHS/FDA-22320172C from the Center for Devices and Radiological Health, US Food and Drug Administration.

ⁱ: Formerly Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD.

View full text

Results of Expert MeetingsUnique 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

Background

Methods

Results

Conclusions

Section snippets

The demonstration project and Mercy Health

Participants

Future development of a UDI-based device surveillance system

Additional discussion topics

Summary

Disclosures

Acknowledgements

Glossary

Postmarket surveillance for medical devices: America's new strategy

BMJ

Unique device identification in the service of public health

N Engl J Med

Strengthening our National System for Medical Device Postmarket Surveillance

Roadmap for Implementation of UDI System

Commission recommendation of 5 April 2013 on a common framework for a unique device identification system for medical devices in the Union

Unique Device Identification System. A rule of the Food and Drug Administration

Global Unique Device Identification Database (GUDID), draft guidance for industry

45 CFR Part 170. Voluntary 2015 Edition Electronic Health Record (EHR) Certification Criteria; Interoperability Updates and Regulatory Improvements

Results of Expert Meetings
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