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.

Journal The American Heart Journal
Authors Tcheng, James; Crowley, Jay; Tomes, Madris; Reed, Terrie; Dudas, Joseph; Thompson, Kweli; Garratt, Kirk; Drozda, Joseph Jr.;  on behalf of the MDEpiNet UDI Demonstration Expert Workgroup
Year Published 2014
Link to publication

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.

Value of Unique Device Identification in the Digital Health Infrastructure

Journal JAMA
Authors Wilson, Natalia A.; Drozda, Joseph Jr.
Year Published 2013
Link to Publication

IN RECENT YEARS, HIGH-PROFILE CASES OF MEDICAL device failure resulting in patient harm—such as implantable cardioverter-defibrillator leads and metal-on metal hip implants—have received substantial attention both in the medical literature and popular press. These examples illustrate the need for a more effective system of monitoring device performance and protecting patient safety. The first action in the Food and Drug Administration’s (FDA’s) report on strengthening postmarket device surveillance, “establish a Unique Device Identification (UDI) System and promote its incorporation into electronic health information,” was addressed with publication of the UDI Proposed Rule.

This viewpoint article by Natalia Wilson and Joseph Drozda, published prior to publication of the Final Rule, highlights the role of UDI in supporting an effective medical device monitoring system and enhanced patient safety. The authors lay out the expected benefits of a UDI system to strengthen post market surveillance of medical devices, ensure ability to track a device across health care settings, support safe and accurate device use, standardize device documentation in health information technology (HIT) systems, enhance recall management, and support health care cost savings.

Postmarket surveillance for medical devices: America’s new strategy

Journal BMJ
Authors Normand, Sharon-Lise T.; Hatfield, Laura; Drozda, Joseph; Resnic, Fred
Year Published 2012
Link to Publication

Abstract

The FDA’s plan is a big ask but will be well worth the effort

In September 2012, the US Food and Drug Administration (FDA) released its vision for a postmarket surveillance system for medical devices, describing four key strategies to protect public health. But why this initiative now? Firstly, several concerns about the safety of specific devices, such as the Medtronic Fidelis defibrillator lead and the DePuy ASR hip implant, have garnered substantial press coverage. Secondly, the Institute of Medicine recently called for a substantial overhaul of processes for the approval and postmarket safety surveillance of medical devices. Thirdly, the FDA has undertaken several premarket initiatives to improve the efficiency of the regulatory review for innovative devices. With the number and complexity of medical devices growing rapidly, it is timely to complement the new premarket initiatives with a strong postmarket surveillance program.

Regulation of the entry into use of medical devices in the United States was introduced after that for drugs table, and it quickly became apparent that the public health assessment of devices would need to be different from that of drugs. Unlike drugs, medical devices are assembled from many components, may affect patients long after the initial exposure, and have rapid product development cycles, which lead to frequent incremental improvements. Medical devices also pose unique challenges to studying …

Automated surveillance to detect post-procedure safety signals of approved cardiovascular devices

Journal JAMA (Journal of the American Medical Association)
Authors Resnic FS; Gross TP; Marinac-Dabic D; Loyo-Berríos N; Donnelly S; Normand SL; Matheny ME
Year Published 2010
Link to Publication – (PDF)

Context

Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.

Objective

To determine whether automated safety surveillance of clinical registries using a computerized tool can provide early warnings regarding the safety of new cardiovascular devices.

PATIENTS:

Prospective propensity-matched cohort analysis of 7 newly introduced cardiovascular devices, using clinical data captured in the Massachusetts implementation of the National Cardiovascular Data Repository CathPCI Registry for all adult patients undergoing percutaneous coronary intervention from April 2003 through September 2007 in Massachusetts.

MAIN OUTCOME MEASURE:

Presence of any safety alert, triggered if the cumulative observed risk for a given device exceeded the upper 95% confidence interval (CI) of comparator control device. Predefined sensitivity analyses assessed robustness of alerts when triggered.

RESULTS:

We evaluated 74,427 consecutive interventional coronary procedures. Three of 21 safety analyses triggered sustained alerts in 2 implantable devices. Patients receiving Taxus Express2 drug-eluting stents experienced a 1.28-fold increased risk of postprocedural myocardial infarction (2.87% vs 2.25%; absolute risk increase, 0.62% [95% CI, 0.25%-0.99%]) and a 1.21-fold increased risk of major adverse cardiac events (4.24% vs 3.50%; absolute increase, 0.74% [95% CI, 0.29%-1.19%]) compared with those receiving alternative drug-eluting stents. Patients receiving Angio-Seal STS vascular closure devices experienced a 1.51-fold increased risk of major vascular complications (1.09% vs 0.72%; absolute increased risk, 0.37% [95% CI, 0.03%-0.71%]) compared with those receiving alternative vascular closure devices. Sensitivity analyses confirmed increased risk following use of the Taxus Express2 stent but not the Angio-Seal STS device.

CONCLUSION:

Automated prospective surveillance of clinical registries is feasible and can identify low-frequency safety signals for new cardiovascular devices.