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You are here: Twin Peaks Group > Unique Device Identifier > What it will take to Create an Effective Post-market Surveillance System for Implanted Devices by 2025?

What it will take to Create an Effective Post-market Surveillance System for Implanted Devices by 2025?

Posted at 1:25 pm on Apr 26, 2021 by

4 logosIn my last blog post – nearly 4 years ago! – I announced that I was co-investigator in a project to assess the feasibility of recording the unique device identifiers (UDI) of implanted medical devices in the operating room and transmitting them to insurance companies as part of the claim. At that time, our project had advanced to the point that we felt confident that we could successfully implement the process we had designed.

Our optimism was justified. Only modest changes to existing information systems at two hospitals and their insurance company partners were needed. And the designers and implementers of the modified systems told us that the effort required was comparable to a routine system upgrade. Based on our experience, we concluded that nationwide implementation of recording UDIs at the point of care and transmitting them to insurance companies would not be a major burden on most providers and insurance companies. In most cases, the modifications to their information systems would be made by their system vendors. You can read the details here.

Sentinel System

But how do you get from our demonstration to a post-market surveillance system for devices? Well, it helps to know there is already a post-market surveillance system for medications. It’s the Sentinel System, and it relies on the national drug codes contained in claims and electronic health records. It turns out that Sentinel’s mandate includes devices. Moreover, Sentinel has the data structure and processes that could be adapted to handle devices. So far, however, the US Food and Drug Administration (FDA), which facilitated the development of Sentinel, has not asked the contractor that runs Sentinel to extend its functionality to devices.

There is no point, however, in extending Sentinel‘s capability to handle UDIs in claims unless those UDIs are being transmitted in claims from providers to insurers. And that would mean that insurance companies – at least a substantial percentage of them – would need to ask providers to start including those UDIs in claims. We came to the conclusion, however, that this was unlikely because insurers might not see any individual benefits from having UDIs of implanted devices in their claims databases.

So, what might induce insurance companies to request that their providers include UDIs in their claims? To answer this question we interviewed a representative group of 20 UDI experts. The majority told us that if the Centers for Medicaid & Medicare Services (CMS) requested that their providers include UDIs in claims, the other insurers would follow its lead.

This led us to make two recommendations: We have called (1) for CMS to require its providers to include UDIs in their claims and (2) for the FDA to ask Sentinel’s contractor to extend Sentinel’s capabilities to include devices.

The title of this blog suggests that the post-market surveillance system for devices based on UDIs in claims could be ready by 2025. How did we arrive at that date? For that, I invite you to read our blog in Health Affairs, published on April 23, 2021.

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