Registry Assessment of Peripheral Interventional Devices (RAPID): Registry assessment of peripheral interventional devices core data elements

Journal

Journal of Vascular Surgery

Authors W. SchuylerJones MDMitchell W.Krucoff MDPabloMorales MDRebecca W.Wilgus RN MSNAnne H.Heath BAMary F.Williams BS, James E.Tcheng MDJ. Danica Marinac-Dabic MD PhDMisti L.Malone PhDTerrie L.Reed MSRie Fukaya MMedScRobert A. Lookstein MDNobuhiro Handa MDHerbert D. Aronow MD MPHDaniel J. Bertges MDMichael R. Jaff DOThomas T. Tsai MD MScJoshua A. Smale BSMargo J. Zaugg BSNRobert J. Thatcher MBAJack L. Cronenwett MD


Year Published 2018
Link to publication

Abstract

Background

The current state of evaluating patients with peripheral artery disease and more specifically of evaluating medical devices used for peripheral vascular intervention (PVI) remains challenging because of the heterogeneity of the disease process, the multiple physician specialties that perform PVI, the multitude of devices available to treat peripheral artery disease, and the lack of consensus about the best treatment approaches. Because PVI core data elements are not standardized across clinical care, clinical trials, and registries, aggregation of data across different data sources and physician specialties is currently not feasible.

Methods

Under the auspices of the U.S. Food and Drug Administration’s Medical Device Epidemiology Network initiative—and its PASSION (Predictable and Sustainable Implementation of the National Registries) program, in conjunction with other efforts to align clinical data standards—the Registry Assessment of Peripheral Interventional Devices (RAPID) workgroup was convened. RAPID is a collaborative, multidisciplinary effort to develop a consensus lexicon and to promote interoperability across clinical care, clinical trials, and national and international registries of PVI.

Results

The current manuscript presents the initial work from RAPID to standardize clinical data elements and definitions, to establish a framework within electronic health records and health information technology procedural reporting systems, and to implement an informatics-based approach to promote the conduct of pragmatic clinical trials and registry efforts in PVI.

Conclusions

Ultimately, we hope this work will facilitate and improve device evaluation and surveillance for patients, clinicians, health outcomes researchers, industry, policymakers, and regulators.

 

Need for a National Evaluation System for Health Technology

Journal New England Journal of Medicine (NEJM)
Authors Jeffrey Shuren, MD, JD1; Robert M. Califf, MD1
Year Published 2016
Link to publication

Abstract

Background

Federal regulatory frameworks governing medical products are designed to (1) provide evidence that a product benefits patients when used as intended and should be available despite accompanying risks and (2) ensure timely access to needed therapies and diagnostics. Historically, policy makers and product developers have viewed these objectives as being in tension. However, ensuring safety, expediting patient access, and enabling innovation can be complementary goals within a regulatory framework for medical devices.

The US standard for marketing a medical device is “reasonable assurance of safety and effectiveness” (RASE).1Generally, clinical studies must be conducted to demonstrate RASE for both high-risk and innovative lower-risk devices and US patients and clinicians have greater assurances that the benefits of devices outweigh the potential risks. In contrast, other countries apply a standard of safety and performance with limited clinical data. The greater evidentiary burden of RASE may create disincentives for manufacturers to bring important medical devices to the United States or may delay access to devices. For example, the first transcatheter aortic valve replacement device was available for clinical use in Europe several years before it was available in the United States. However, there are examples of unsafe and ineffective devices that never made it to the US market; these can be found in a report2 from the US Food and Drug Administration (FDA).

A key dilemma for device regulation is how to ensure timely access while also providing evidence to guide safe and appropriate use. When a device is approved for the US market, residual uncertainty about benefit and risk is typically addressed through postmarket evaluation. Premarket studies often do not fully reflect how a device will be used in practice, and participants enrolled in such studies may not represent the entire spectrum of patients likely to receive the device. The effects of operator experience, user learning curves, or skill level of the individual who implants the device and the supporting team also cannot be assessed until the device is in wider use. However, current approaches to postmarket evaluation have limitations. Even though the FDA can require device makers to perform postmarket studies, patients have few incentives to enroll in a study once a device is marketed, and many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished. Generally, if the company makes a good-faith effort in performing postmarket studies, there are no penalties.

Furthermore, reporting of adverse events and device malfunctions currently depends on clinicians identifying and reporting a possible association; therefore, underreporting is likely common. Spontaneous reporting also fails to capture numerators and denominators that allow reliable risk estimation. Safety issues are therefore often not identified until many patients have been exposed to risks, leading to greater potential for avoidable harm as well as greater liability and loss of consumer confidence in the manufacturer. Spontaneous reporting is not systematic and can be biased by extraneous factors such as news reports. Other safety issues also depend on companies appropriately assimilating and reporting data.

However, a strategic approach to linking and using clinically based data sources, such as registries, electronic health records (EHRs), and claims data, could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device. By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices.

Conclusions

A national evaluation system that engages all stakeholders could enable the FDA to focus efforts on facilitating the development and interpretation of more informative data essential for policy making and clinical decisions for individuals and populations. When issues with medical technologies arise, they could potentially be quickly detected and understood within the appropriate context. Ultimately, these changes could contribute to a much more efficient system that rewards innovation that leads to better health outcomes, creating powerful incentives for continuous improvement and accelerating access to technologies that patients and physicians can use with the assurance of safety, efficacy, and a well-characterized balance of benefit and risk.

 

Use of endpoint adjudication to improve the quality and validity of endpoint assessment for medical device development and post marketing evaluation: Rationale and best practices. A report from the cardiac safety research consortium

Journal American Heart Journal
Authors Jonathan H Seltzer, MD, MA, MBA; Ted Heise, Phd, RAC; Peter Carson, MD; Daniel Canos, PhD, MPH; Jo Carol Hiatt, MD, MBA; Pascal Vranckx, MD, PhD; Thomas Christen, MD, PhD; Donald E Cutlip, MD
Year Published 2017
Link to article

Summary

This white paper provides a summary of presentations, discussions and conclusions of a Thinktank entitled “The Role of Endpoint Adjudication in Medical Device Clinical Trials”. The think tank was cosponsored by the Cardiac Safety Research Committee, MDEpiNet and the US Food and Drug Administration (FDA) and was convened at the FDA’s White Oak headquarters on March 11, 2016. Attention was focused on tailoring best practices for evaluation of endpoints in medical device clinical trials, practical issues in endpoint adjudication of therapeutic, diagnostic, biomarker and drug-device combinations, and the role of adjudication in regulatory and reimbursement issues throughout the device lifecycle. Attendees included representatives from medical device companies, the FDA, Centers for Medicare and Medicaid Services (CMS), endpoint adjudication specialist groups, clinical research organizations, and active, academically based adjudicators.

The manuscript presents recommendations from the think tank regarding

(1) rationale for when adjudication is appropriate,

(2) best practices establishment and operation of a medical device adjudication committee and

(3) the role of endpoint adjudication for post market evaluation in the emerging era of real world evidence.

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

Abstract

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.