Featured Product
This Week in Quality Digest Live
Health Care Features
Grant Ramaley
FDA seeks to align Part 820 with ISO 13485:2016; why that may not be enough.
Claudine Mangen
If you have the energy to try and address organizational overwork, start small
Gregory Way
Drug designers are rethinking their response to medications that affect multiple targets
Adam Zewe
Research on machine-learning models that can help doctors consult patient records more easily
Karina Montoya
Analysis of social and economic impact bolsters the fight against hepatitis C

More Features

Health Care News
Making the new material freely available to testing laboratories and manufacturers worldwide
Google Docs collaboration, more efficient management of quality deviations
MIT course focuses on the impact of increased longevity on systems and markets
Delivers time, cost, and efficiency savings while streamlining compliance activity
First responders may benefit from NIST contest to reward high-quality incident command dashboards
Enhances clinical data management for medtech companies
Winter 2022 release of Reliance QMS focuses on usability, mobility, and actionable insights
The tabletop diagnostic yields results in an hour and can be programmed to detect variants of the SARS-CoV-2 virus
First Responder UAS Triple Challenge focuses on using optical sensors and data analysis to improve image detection and location

More News

Duke University

Health Care

Nation Should Implement a Medical Device Evaluation System

Report by expert panel describes method for safer, innovative medical devices

Published: Thursday, April 14, 2016 - 10:33

Evidence on the safety and effectiveness of medical devices is difficult to coordinate and assess, despite the critical role medical devices play in diagnosing and treating patients.

A new report from the planning board for a national medical device evaluation system (NMDES) describes how the nation can implement a coordinated network of partners to improve evidence on the safety and effectiveness of medical devices. The system will work to improve patient outcomes by being smarter and more efficient when generating and evaluating real-world electronic health data on medical devices.

The planning board consists of a diverse set of experts representing patients, clinicians, academic researchers, the medical device industry, and others, and is supported in its work by the Duke-Margolis Center for Health Policy.

In its previous work, the planning board described how major gaps in the nation’s ability to reliably track medical device safety and effectiveness significantly affect public health. This shortcoming makes it more difficult for patients and clinicians to make informed decisions, adds to long delays and gaps in managing defective device recalls, and harms biomedical innovation by hindering the timely development of new treatment options. Altogether, the inability to collect robust and timely evidence on devices increases the costs and inefficiency of our healthcare system.

The new report, “Enabling Better Evidence on Medical Devices: A Coordinating Center for a 21st Century National Medical Device Evaluation System,” describes how the nation can establish a national system by coordinating and building on the work of a nationwide network of partners, including the U.S. Food and Drug Administration (FDA) and other public agencies, patient communities, provider systems, medical device manufacturers, academic institutions, health payers, and others. The report emphasizes the importance of developing more efficient approaches, such as using routine reporting of standard electronic data as well as patient-reported data, to develop this evidence at significantly lower cost than is possible in existing systems.

The planning board’s report outlines recommendations on the objectives, tasks, and capabilities that a coordinating center would be charged to undertake. The panel hopes to encourage a public discussion on this pressing need for better information about medical devices.

“As the vision of the NMDES becomes a reality, more complete and accurate information regarding the safety and performance on medical devices will be readily available to clinicians and patients,” says Dr. Michael Mack, a planning board member and chair of the cardiovascular service line at Baylor Scott & White Health. “This allows them to make better, more informed decisions.”

The NMDES should give device manufacturers a faster, more predictable path to approval and health care coverage decisions, the report notes. Then, once products are on the market, the NMDES will provide more cost-effective approaches to developing real-world evidence, which would give clinicians and insurers greater confidence in the products they use. Health insurance payers would also benefit from better evidence to improve their coverage decisions and to understand the state of care.

The planning board envisions NMDES as a coordinated network of voluntary partners, including device manufacturers, institutional data partners, methods partners, and patient communities. All would be working toward generating higher-quality data at lower costs. The system would develop resources that improve medical device safety updates, recall management, and effectiveness data.

According to the report, a recommended public-private coordinated partnership would ensure that all stakeholders can participate in the formation and use of the NMDES. This coordinating center would continually assess the needs of stakeholders and ensure that the NMDES’s tools and methods stay up-to-date, flexible, and adaptable. The coordinating center would be responsible for demonstration projects to show the value of NMDES in its early stages.

The first demonstration projects might include improving and expanding an existing medical device registry by linking with other data sources and data types, or by creating a new virtual registry using electronic health records and claims data on a higher-risk device with potentially serious but rare adverse events.

The concept of a national evaluation system for medical devices grew out of a 2012 action plan by the FDA’s Center for Devices and Radiologic Health (CDRH). Under the guidance of the Brookings Institution, the planning board released its first report “Strengthening Patient Care: Building an Effective National Medical Device Surveillance System,” in Feb. 2015. The FDA then asked the Duke-Margolis Center for Health Policy to reconvene the planning board in late 2015 to help lead the next phase of planning for the system’s coordinating center and governing body.

In Jan. 2016, CDRH released its strategic priorities for 2016–2017, which included the establishment of a national system for evaluating medical devices with real-world evidence to support regulatory decision-making and technological innovation.

“The planning board believes that to improve high-quality, safe, effective, and timely care for patients, better information about medical devices must be a priority for the nation,” says Mark McClellan, director of the Duke-Margolis Center for Health Policy.

Discuss

About The Author

Duke University’s picture

Duke University

Duke University has about 13,000 undergraduate and graduate students and a world-class faculty helping to expand the frontiers of knowledge. The university has a strong commitment to applying knowledge in service to society, both near its North Carolina campus and around the world.