FDA and its collaborators should move quickly in the next year or two to start an incubator project with fact-finding activities and pilot programs to help launch a national postmarket surveillance system that builds on unique device identifiers (UDIs), registries and innovative data capture and analysis strategies, a multi-stakeholder planning board recommends.

The goal of the incubator project should be to formulate a five-year implementation plan, according to a Feb. 23 report issued by the planning board, which was formed out of FDA's effort launched in 2012 to remake U.S. postmarket surveillance. (See Also see "FDA Post-Market Plan Gains Support, But Many Details Still Lacking" - Medtech Insight, 17 September, 2012.). While the project would be led by FDA, the board says it should be guided by multiple stakeholder groups who can bring their expertise and experiences to the table.

In the second phase of the project the report recommends the findings from the incubator project be followed through over a span of four to five years. The leadership built through a public-private partnership should set and oversee the system’s strategic development priorities, begin to build and sustain broader stakeholder participation, oversee implementation of the organizational plan, and establish system performance measures.

Some of the challenges that need to be addressed at this stage include making widespread adoption of UDIs, minimizing data capture and sharing costs, ensuring patient privacy, and making sure a wide gamut of stakeholders find the system valuable. (See Table)

A key element of the plan is using UDIs to combine postmarket device data from multiple sources including electronic health records, registries and insurance claims. But the planning report argues that more funding will be needed to make this a reality. For instance, while Congress enacted legislation in 2012 to expand FDA’s Sentinel system to capture medical device data from claims and other databases, the report notes legislators did not provide the necessary funds to support that activity.

“The Planning Board believes that improved medical device surveillance is a public health and national priority and that the most effective way to address this priority is through the broad public-private partnership described in the report,” said the board. “However, without some initial seed funding and active FDA engagement, it will be difficult to assure the purpose and sustain the momentum necessary for other stakeholders to fully engage in the development of MDS.”

FDA launched the national surveillance system effort as a public-private partnership in 2012 based on recommendations from the Institute of Medicine. The agency emphasized four pillars in formulating the plan: establishing a unique device identification system and incorporating it in electronic health information; promoting the development of national and international device registries; modernizing adverse event reporting and analysis; and developing new methods for evidence generation, synthesis and appraisal. (See Also see "CDRH Details Path Forward For National Post-Market Surveillance System" - Medtech Insight, 29 April, 2013.).

The latest report was unveiled at an event at The Brookings Institution, which facilitated the formation and deliberations of the planning board.

The event was kicked off by CDRH Director Jeffrey Shuren, who pointed to three major developments over the past decade that make the current reform possible: the increasing adoption of electronic health information, including health records and registry databases, the development of advanced tools to analyze data the vast electronic data and what he called a fundamental change in thinking at CDRH to reemphasize its mission to "promote" public health in addition to protecting it. Strengthening the postmarket surveillance infrastructure makes it possible to shift more of the data burden from the premarket to postmarket stage, when possible, Shuren explained.

“We have a brave new world that faces us and of course we have an opportunity now to take advantage of it,” he said.

Medical Device Surveillance Challenges and Proposed Pilots

Goal

Current Challenges

Potential Pilots

Building Blocks

Adoption of UDI in health IT infrastructure

- Investment cost of automated capture technology

- Investment cost in adapting current data sources

- Data transfer and system interoperability

- Establishing UDI adoption as a priority initiative

- Evaluate the effectiveness of UDIs in identifying devices within the health care system

- Leverage hospital systems and early adopters of UDI in provider settings

- Major health care systems’ UDI integration

- Bipartisan Congressional support for including UDI into claims forms

- Certification of electronic health technology for UDI and meaningful use objectives

Sophisticated safety surveillance and evidence development for select, high priority devices

- Data entry burden

- Developing methods and analytical tools

- Data security

- Utilize registries created for clinical research and/or CED to conduct active safety surveillance on targeted medical devices

- "Data Extraction and Longitudinal Time Analysis" (DELTA) active surveillance program for cardiovascular devices. (See Also see "Harvard Device Safety Surveillance Project Could Inform FDA Efforts" - Medtech Insight, 17 May, 2010..)

- Other major surveillance registries, e.g., TVT, INTERMACS.

Basic population-level safety surveillance, utilization monitoring, and evidence development for broader range of devices

- Lack of important clinical information in claims (e.g., UDI, revision rates)

- Developing methods and analytic tools

- Data source fragmentation (like EHRs)

- Leverage existing population-based surveillance systems like Sentinel to conduct device-specific safety surveillance and evidence development

- Device-specific registries

- Mini-Sentinel and collaborating institutions

- Innovation in Medical Evidence Development and Surveillance program

- MDEpiNet public-private partnership

Patient-reported evidence on device performance and safety issues

- Lack of easily accessible and user-friendly means for patients to contribute patient reported outcomes

- Lack of validated methods and analytical tools

Leverage patient networks

- Medical Device Innovation Consortium patient-centered project

- PCORnet and Patient-Powered Research Networks

- Patients Like Me

- Disease-based registries (e.g., CF Foundation, MyMeds and Me103)

- NIH PROMIS

Source: "Strengthening Patient Care: Building a National Medical Device Surveillance Program," The Brookings Institution, February 2015

Focus Beyond Safety

Although a core FDA use of postmarket surveillance data is to ensure device safety, a major focus among stakeholders at the Brookings meeting was on the potential value and pitfalls of the proposal to support the evolution towards a value-based health care landscape.

Some at the meeting noted that similar systems are already in use in countries such as the United Kingdom where the National Institute for Health and Care Excellence (NICE) uses a surveillance system to justify reimbursement rates. However experts, such as Medtronic PLC CEO Omar Ishrak, say the U.S. system needs to focus on capturing data within its own borders.

"Obviously there are governments and health care systems around the world where similar efforts are taking place...and we're learning from those,” he said. “But at this stage I think you'd better do this country-by-country because it's complex enough even within one country, you start bringing in global stakeholders into the same program, it's just going to get more difficult.”

While most agreed the surveillance system is a welcome development, some raised concern it could hurt innovation in the medical device industry. Ross Jaffe, managing director at Versant Ventures, says that despite all the technological advances in medical device innovation, the industry is in the worst funding slump of the past two decades. He says reimbursement timeframes a decade ago meant companies would be able to pay off their investors in five to seven years but now that can be stretched as long as 15 years which has led to a 70 percent decline in medical device startup funding since 2008.

“The postmarket surveillance can be a great boon [for investment] or create additional problems. It really depends on how it is particularly used by the payment community,” said Jaffe. He says if it is used as a safety net to allow new products on to the market it could help spur innovation but if it is used by payment companies and CMS to wait and see whether the device is worth the reimbursement then it could prevent new devices from coming to market.

Planning Board Proposes Postmarket Device Surveillance Timeline

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