Device Postmarket Surveillance System a Good Idea, But . . .

Feedback on a plan to set up a medical device postmarket surveillance system applauds the overall idea but points out potential hurdles.

Marie Thibault

Industry, medical professionals, and other stakeholders have weighed in on the FDA-backed public-private plan to create the National Medical Device Postmarket Surveillance System. Reaction was mainly positive, with commenters highlighting various challenges or issues to consider carefully as part of the effort. The initiative, led by the Planning Board, is outlined in a report published in February 2015 and is expected to take several years to implement.

In a recent post she authored for Brookings Institution’s Health360 blog, Elisabeth Wynne, a clinician and visiting scholar at the Center for Health Policy, wrote that postmarket data “will allow us to evaluate important questions such as the quality of the device, short and long term outcomes, comparative effectiveness across devices of the same type, and how the devices work in subpopulations such as age, gender, or race.”  

However, Wynne cautioned, in order for the surveillance system to succeed and be impactful, it should not require clinicians to input large amounts of data and should communicate new findings quickly in a simple manner. Wynne wrote, “it will be necessary to identify ways for physicians to help gather without overburdening workflow with administrative data entry . . . new evidence must be presented in real time, in an easy to access format, and in a way [that] is linked to clinicians’ workflow.”

The Pew Charitable Trusts noted in its comment letter to FDA that the plan will require unique device identifiers (UDIs) to be incorporated into patient electronic health records (EHRs) and insurance claims, more widespread use of active medical device registries, and better organization of individual groups’ actions. 

Not everyone thinks linking UDIs with insurance claims is a good idea now. CMS recently pumped the brakes on the plan, pointing out that it would be a time-consuming, expensive, operational challenge. 

Additionally, the comment letter from the American Medical Association (AMA) detailed the potential complications of incorporating UDIs into insurance claims, including the fact that patients frequently switch health plans, the possibility that linking a device UDI to a payer could make it hard for clinicians to access that information, the potential for negative impacts on timely payments, and the significant time and expense burden associated. The AMA instead wants to see efforts directed toward adding UDIs to patient EHRs. 

Industry input came from Bloomington, IN-based Cook Group Inc. The Cook comment letter highlighted the need to avoid wasteful repetition in such a system by acknowledging similar private and public initiatives. Cook urged the Planning Board to consider partnering with the Sentinel Initiative—which is intended to track drugs and biologics—to add devices to the surveillance list. 

Finding the proper balance between premarket and postmarket data collection is one of CDRH’s three strategic priorities for 2014–2015. In keeping with this priority, CDRH this year has already issued final guidance on “Balancing Premarket and Postmarket Data collection for Devices Subject to Premarket Approval” and has published a list of several device types that are candidates for reclassification from Class III to Class II.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie. 

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