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New Medical Device Surveillance System Proposed

X-ray of heart pacemaker

(National Library of Medicine, NIH)

23 February 2015. A report today by a Washington, D.C. think tank proposes a new system for tracking medical devices after going on the market, to better serve patients and encourage innovation in the field. A conference at Brookings Institution that published the report highlighted many of the benefits, but also difficulties the proposed system would face.

Brookings Institution’s Engelberg Center for Health Care Reform, at the request and with funding from U.S. Food and Drug Administration, convened in 2014 a planning board from medical devices developers, industry and professional associations, academia, insurance companies, patient advocates, National Institutes of Health, and FDA. The board was given a mission to create a long-term vision for improving the agency’s surveillance of medical devices following initial approval for safety and effectiveness, but also to provide data to device manufacturers to encourage innovation and help the health system overall improve delivery of care to patients. Gregory Daniel, the Engelberg Center’s managing director for evidence development and innovation, led the Brookings team that prepared the report from the board’s recommendations.

The system envisions capturing information at the point of care, which would feed data into electronic health records, but also make the data available to medical device developers as part of the feedback needed for improving safety, reliability, and usability of their devices, while protecting patients’ privacy and security. The system would kick in after devices are approved by FDA, or postmarket as called by the agency, thus its formal name: National Medical Device Postmarket Surveillance System.

A key feature, underscored in the report and repeated at today’s conference, is the surveillance system needs to fit into the larger emerging platform of standard electronic health records, and not become a stand-alone system. In addition, the data captured by the surveillance system needs to be compatible with other data-driven regulatory initiatives, such as the FDA’s Sentinel system now tracking drugs and biologics, and the Patient-Centered Outcomes Research Institute, or PCORI, a publicly-funded but independent research center supporting comparative effectiveness studies.

Jeffrey Shuren, director of the Center for Devices and Radiological Health at FDA, the office asking Brookings to prepare the report, told the conference that FDA began discussing a surveillance system for medical devices in 2012, when concerns were raised about the ability of FDA to track safety and effectiveness of new devices, as well as encourage the industry to continue to innovate. Adding the need to innovate, said Shuren, represents an expanded responsibility for FDA beyond its traditional focus on device safety and effectiveness.

Shuren added that the surveillance system would provide real-world data to device makers, making the data particularly valuable in calculating benefit/risk ratios. And while he did not promise explicitly that the system would result in faster pre-approval reviews by FDA, he noted that the system would “relieve pressure on premarket data collection.”

Covering all stakeholders, starting with patients

Kathleen Blake, vice president for performance improvement at American Medical Association and a member of the planning board, told the conference the board operated under three assumptions about the direction of data collection and management for health care in the U.S. First, said Blake, health care in the U.S. would be based increasingly on documented evidence, with payments to providers based on results. There would also be a unique identifier assigned to each device that makes it possible to track the performance of that device to the health of individual patients. In addition, a platform of interoperable health records would be available to support the surveillance system.

Blake said the surveillance system would provide data in real time, centering on patients and physicians, yet integrated into the larger electronic health records environment as well as respectful of patient privacy. She added no single stakeholder could build and maintain the system, but would likely need public funding to get started.

Mark Overhage, chief medical informatics officer at health information technology company Cerner Health Services and also a planning board member, said the board envisioned a 2-stage process for rolling out the surveillance system. Years 1 and 2 would be devoted to incubation of the system, particularly in conducting pilot studies and developing a detailed implementation plan. Years 3 to 8 would carry out that plan and integrate the surveillance system into the larger electronic health records network.

A panel of executives from medical device and insurance companies, federal agencies,  and a patient advocate pointed out several obstacles and challenges the surveillance system will need to overcome. Omar Ishrak, CEO of device maker Medtronic pointed out that manufacturers needed the data collected by devices as soon as possible to get value from surveillance system. In addition, both the data collected and their analytics needed to be standardized to prevent misinterpretations of data by patients, physicians, or regulators.

Lewis Sandy, vice president for clinical advancement at insurance provider UnitedHealth Group, highlighted the importance of the unique device identifier in the overall data infrastructure. The unique device identifier proposed by FDA, said Sandy, would connect a device’s performance directly to a patient’s health record, and provide the real-world evidence needed by insurance companies and device makers. Governance of the surveillance system is another key element where more details are needed, to answer questions of financing, data collection, and response to safety alerts.

A later panel, however, went further in describing the problems device makers are facing in the current regulatory environment. Ross Jaffe, managing director of life sciences venture capital company Versant Ventures, said the industry is now facing the worst financing environment in 20 years, due largely to the long times required for device approvals. What used to be a 5 to 7 year process is now extending for as long as 15 years, said Jaffe.

He noted, however, that while regulatory time frames are improving, reimbursements are taking longer. Implementation of the surveillance system, said Jaffe, should help make insurance companies more comfortable with device performance, and not provide another excuse to delay reimbursements.

Michael Mussallem, CEO of Edwards Lifesciences, a provider of replacement heart valves, said the system needs to support a learning environment, where data from the device can help developers improve the device as it is built, tested, and deployed. The current system of surveillance is looking for safety issues and isn’t set up to support innovation.

Mussallem described a registry that tracks performance of transcatheter heart valves made by Edwards Lifesciences, which he said the company uses to get feedback on its devices. The registry, however, collects data manually. Integrating data collection with electronic health records would make the system more feasible.

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