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VA Moves to Launch Implant Registry with FDA, CMS, DoD Input

Posted 05 June 2018 | By Ana Mulero 

VA Moves to Launch Implant Registry with FDA, CMS, DoD Input

The US Department of Veterans Affairs (VA) intends to implement the nation’s largest registry for tracking medical implants in collaboration with three federal agencies.
 
Collaborating with the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) and the Department of Defense (DoD) “will enable VA to monitor the safety of devices in Veterans and their families, track quality metrics and ensure the best possible care for patients,” the agency said in an announcement of a summit that took place on Monday.
 
Officials from the federal agencies—joined by experts from scientific research and healthcare organizations—offered perspectives during the VA’s summit on some of the current challenges and untapped opportunities in the current device registry landscape.
 
There was consensus during the sessions and panel discussions around several factors deemed crucial to ensure short- and long-term success with the VA’s registry program, including the harmonization of efforts on device registries and the need for registry data to be linked with other data sources, such as insurance claims and electronic health records (EHRs).
 
Registries have continued to proliferate in recent years over the perceived benefits in early device intervention, as well as a potential reduction in device recalls, and the associated costs due to the real-world evidence (RWE) of patients’ and care providers’ experiences that can be collected, analyzed and acted upon. 
 
“A medical device registry will allow VA to notify patients about safety recalls, identify devices when patients show up for medical emergencies with complications and track and compare outcomes of implants,” the agency said, adding that the most commonly used devices in the US veteran population include cardiac implants, orthopedic implants and neurosurgical implants.
 
Still, achieving global harmonization of device registries and supporting the access of data across multiple sources is easier said than done, and collaboration is and will continue to be key.
 
From the Medical Device Epidemiology Network Initiative (MDEpiNet) to the Transcatheter Valve Therapy Registry, officials from FDA’s Center for Devices and Radiological Health (CDRH) pointed to some of the partnerships it has leveraged for greater use of RWE in regulatory decision-making and achieve an improved balance between pre- and post-market data.
 
Gregory Pappas, associate director for National Device Surveillance at CDRH, previously told Focus the center is also assessing the potential of a national registry for implantable cardiac defibrillators via the National Evaluation System for Health Technology Coordinating Center—funded by FDA in efforts to create a medical device safety net.
 
At the VA’s summit, Pappas stressed that RWE quality can be facilitated by a nationwide unique device identifier system (UDI). But implementation of the UDI system is still a work in progress and while the deadlines for most devices to comply with FDA’s UDI requirements have already passed, many of the anticipated benefits have yet to come.
 
FDA has continued to call on Congress for UDI inclusion in claims data, but it has faced pushback from CMS. Yet some progress has been made with UDI implementation.
 
CDRH is close to reaching nearly 2 million records in its Global Unique Device Identification Database (GUDID) and about 98 EHR vendors in the US have integrated UDI data capabilities into their systems, said Danica Marinac-Dabic, director of CDRH’s Division of Epidemiology.
 
In addition to harmonization and data linking, other challenges facing the VA relate to how data ownership is defined across different stakeholders and ensuring data quality. CDRH officials suggested the creation of a three-year roadmap that takes into account these challenges as the VA continues to refine the vision for its implant device registry program.

Categories: Regulatory News

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