Constructing the informatics and information technology foundations of a medical device evaluation system: a report from the FDA unique device identifier demonstration

Journal Journal of the American Medical Informatics Association
Authors Drozda, Joseph P.; Roach, James; Forsyth, Thomas; Helmering, Paul; Dummitt, Benjamin; Tcheng, James E.
Year Published 2017
Link to article


OBJECTIVE: 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’s informatics architecture.

METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank

Journal Healthcare
Authors Terrie L. Reed, Joseph P. Drozda Jr., Kevin M. Baskinc, James Tcheng, Karen Conway, Natalia Wilson, Danica Marinac-Dabic, Theodore Heise, Mitchell W. Krucoff
Year Published 2016
Link to publication


The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.

Why Interoperability Matters

Report Why Interoperability Matters
Author American Hospital Association
Year Published 2015
Link to publication


While health IT tools are essential for building the care system of the future, and hospitals are making significant ongoing investments, too often, the tools are expensive, unwieldy and do not yet support easy information sharing. The current inability for electronic systems to speak the same language to one another and to efficiently and correctly transmit information – to be interoperable – is among the most pressing issues facing health care stakeholders today.

For more information visit the American Hospital Association interoperability webpage.


Implementing unique device identification in electronic health record systems: organizational, workflow, and technological challenges

Journal Medical Care
Authors Campion, Thomas R JR; Johnson, Stephen; Paxton, Elizabeth; Mushlin, Alvin; Sedrakyan, Art
Year Published 2015
Link to article


Provided from the perspective of the MDEpiNet Science and Infrastructure Center at Weill Cornell Medical College, authors discuss the organizational, workflow, and technological challenges associated with UDI implementation. Recommendations to address UDI implementation challenges from regulatory, peer organization and specialty society perspectives are included. The authors propose that in order to achieve the benefits of the UDI system envisioned by the FDA, there must be integration among involved people, processes, and technology.

BACKGROUND: The United States Food and Drug Administration (FDA) has proposed creating a unique device identification (UDI) system for medical devices to facilitate postmarket surveillance, quality improvement, and other applications. Although a small number of health care institutions have implemented initiatives comparable with the proposed UDI system by capturing data in electronic health record (EHR) systems, it is unknown whether institutions with fewer resources will be able to similarly implement UDI.

OBJECTIVE AND METHODS: This paper calls attention to organizational, workflow, and technological challenges in UDI system implementation by drawing from the literature on EHR and clinical research systems implementation.

FINDINGS: Organizational challenges for UDI system implementation include coordinating multiple stakeholders to define UDI attributes and characteristics for use in EHRs, guiding organizational change within individual institutions for integrating UDI with EHRs, and guiding organizational change for reusing UDI data captured in EHRs. Workflow challenges include capturing UDI data in EHRs using keyboard entry and barcode scanning. Technological challenges involve interfacing UDI data between EHRs and surgical information systems, transforming UDI and related patient data from EHRs for research, and applying data standards to UDI within and beyond EHRs.

DISCUSSION AND CONCLUSIONS: We provide recommendations for regulations, organizational sharing, and professional society engagement to raise awareness of and overcome UDI system implementation challenges. Implementation of the UDI system will require integration of people, process, and technology to achieve benefits envisioned by FDA, including improved postmarket device surveillance and quality of care.

Medical Device Research at a Regional Health System

Journal Asian Hospital and Healthcare Management
Authors Joseph P Drozda and Timothy R Smith
Year Published 2014
Link to Publication – (PDF)


In 2009, Mercy made the decision to embark on a research programme involving implanted medical devices by employing Unique Device Identifiers (UDIs). Mercy is a four-state regional health system headquartered in St. Louis, Missouri that serves communities in Arkansas, Kansas, Missouri, and Oklahoma through 40 hospitals ranging from small, critical access facilities to large tertiary medical centres. In addition, Mercy employs over 2,000 physicians specialised in multiple disciplines and generates in excess of US$4 billion annually.

Mercy’s Information Journey

In 2006, Mercy began implementing EpicCare (Epic, Verona, WI) Electronic Health Record (EHR) in all of the system’s hospitals and employed physician practices – a process that took over six years to complete which resulted in a ‘fully connected’ health system generating a significant amount of clinical data across the healthcare spectrum. Despite this success, Mercy continues to face challenges in turning these data into actionable information due in part to free-standing clinical and administrative databases such as those contained in the cardiac catheterisation laboratory (Cath Lab) software and the Enterprise Resource Planning (ERP) solution. These ‘data islands’ make it difficult to establish a comprehensive view of administrative, clinical processes and of patient outcomes necessary for Mercy leaders to manage in the changing healthcare environment created by US Affordable Care Act (ACA).

New Business Environment and Need for Actionable Information

As healthcare reforms proceed, Mercy must learn to deal with US Centers for Medicare and Medicaid Services (CMS) programmes such as value-based purchasing, and public reporting of hospital and physician performance, along with different delivery models, such as patient centered medical homes and Accountable Care Organisations (ACOs). Mercy’s Springfield ( Missouri), network is participating in CMS’s ACO programme building on experience gained from the network’s successes as part of the earlier CMS Physician Group Practice demonstration. Finally, CMS is also working on new reimbursement strategies meant ultimately to replace fee for service. These include shared savings; bundled payments; and, potentially, monthly payments per assigned beneficiary (capitation). All of these changes will require an in-depth understanding of both the clinical and administrative aspects of the business and how the two interrelate.