Need for a National Evaluation System for Health Technology

Journal JAMA
Authors Jeffrey Shuren, MD, JD; Robert M. Califf, MD
Year Published 2016
Link to article

Abstract

Conclusion 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.

Population-Based Estimates of the Prevalence of Uterine Sarcoma Among Patients With Leiomyomata Undergoing Surgical Treatment

Journal JAMA Surgery
Authors Mao, Jialin ; Pfeifer,Samantha; Zheng, Xi Emily; Schlegel, Peter; Sedrakyan, Art
Year Published 2015
Link to publication

Abstract

Uterine leiomyomata are one of the most common gynecologic problems among women in the United States, with an annual diagnosis range from 2.0 to 12.8 per 1000 reproductive-age women.1 Intervention is a standard management for symptomatic patients, and various procedures include open and laparoscopic hysterectomy, myolysis, uterine artery embolization, and magnetic resonance–guided focused ultrasonographic surgery.

The practice of electric morcellation has been used by gynecologic surgeons during laparoscopic and robotic-assisted hysterectomies and myomectomies as a less invasive alternative to open surgery. In April 2014, the US Food and Drug Administration (FDA) stated that they discouraged the use of this technique over concern that morcellation may spread unsuspected sarcoma tissue. Based on the literature, the FDA reported that 1 in 352 women have unsuspected uterine sarcoma while undergoing surgery for presumed benign leiomyoma. A recent study using an all-payer database found that 1 in 368 women who underwent morcellation had uterine cancer. However, the estimates in this study were limited by the selective participation of hospitals and by the lack of pathologic confirmation. The literature estimates used by the FDA are prone to referral and reporting bias. We sought to determine the population-based estimates of the prevalence of uterine sarcoma, as well as the risks of major complications following open surgery.

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.

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

Journal Medical Care
Authors Campion Jr, Thomas R., Stephen B. Johnson, Elizabeth W. Paxton, Alvin I. Mushlin, and Art Sedrakyan.
Year Published 2014
Link to Publication

Abstract

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.

The international registry infrastructure for cardiovascular device evaluation and surveillance

Journal JAMA
Authors Sedrakyan, Art; Marinac-Dabic, Danica; Holmes, David
Year Published 2013
Link to publication

Since the creation of the US Food and Drug Administration (FDA) Medical Device Epidemiology Network (MDEpiNet), there has been an increasing FDA commitment to support the development of a global medical device research and surveillance infrastructure. The FDA’s new postmarket surveillance plan strengthens this commitment and highlights the importance of national and international registries, and multi-stakeholder involvement for ensuring this commitment is fulfilled.This Viewpoint summarizes the potential for development of an International Consortium of Cardiovascular Registries, modeled on a consortium established for orthopedic devices, as an initial project in the realm of cardiovascular devices with the focus on transcatheter aortic valve replacement (TAVR).