The Advanced Medical Technology Association (AdvaMed) is at odds with a government task force over how unique device identifiers (UDI) could be used in a proposal for a coordinated registry network for medical devices.
In 2012, the US Food and Drug Administration (FDA) issued a report, Strengthening Our National System for Medical Device Postmarket Surveillance, which detailed the agency's vision for improving device surveillance. One of the report's objectives is to "promote the development of national and international device registries" for specific devices. An update to the report discussing the agency's next steps was released the following year.
Then in 2014, FDA launched a Medical Device Registries Task Force (MDRTF) to "consider both the objectives and logistics of leveraging existing and evolving electronic registries, records, and even mobile technologies in the structure of such a national system."
The data generated by these registries, FDA says, could eventually be used to "support premarket approval and clearance" of new medical devices.
Task Force Recommendations
In August, the MDRTF released a report, Recommendations for a National Medical Device Evaluation System, which laid out its vision for a revamped system for evaluating medical devices.
The new system envisioned in the report relies on medical device registries, called "coordinated registry networks" (CRNs) that integrate unique device identification (UDI) and unique patient identification with existing device registries, electronic health records (EHRs) and claims data.
Doing so, the task force says, "should promote ongoing promote ongoing device evaluation, increase patient and device data and outcome information quality … and so reduce cost and enhance overall efficiencies and timelines associated with regulatory milestones."
While both Pew and AdvaMed have voiced their support for using CRNs to support the evaluation of medical devices, the two groups are at odds over incorporating UDIs into claims data, such as insurance or hospital claims forms.
According to Pew, "UDI incorporation in health data sources will enable researchers to know which products are associated with safety problems or other patient outcomes … to achieve the task force's vision … this data must be included in EHRs, registries and health insurance claims."
However, AdvaMed took issue with including UDIs in claims forms, and said that doing so would be "costly [and] pose significant operational challenges." Instead, AdvaMed said that including UDIs in EHRs is more practical and should take priority.
AdvaMed's Wish List
In its comments, AdvaMed requests that the task force provide further information and examples for how the proposed evaluation system could speed access to new medical devices. Specifically, AdvaMed asks for "examples that show the successful use of postmarket data to extend a product line, update a product, or expand an indication of use."
AdvaMed also says it would like to see the task force provide an "overarching roadmap that outlines all of the currently active and identified initiatives and stakeholders, as well as the planned and pilot components, in order to understand how they fit into the total picture of a future National System."
The group also expresses concerns over the presence of bias in postmarket data, and asks that a pilot be included that "addresses biases in surveillance data and the potential impact such biases may have on study results."
Recommendations for a National Medical Device Evaluation System