The Department of Veterans Affairs, the largest integrated healthcare delivery system in the United States, plans to launch a national registry for medical implant devices, enabling the agency to monitor device safety, track quality metrics and ensure optimal care for its patients.
The VA, which is one of the largest purchasers of surgical implants, is hosting an all-day summit on Monday in Washington to kick-start the initiative in collaboration with the Centers for Medicare and Medicaid Services, Department of Defense and the Food and Drug Administration.
According to the VA, the database will be the nation’s largest health system medical-implant tracking program, providing a critical platform for the assessment of device performance in a real-world setting through the identification and study of outcomes.
“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,” states the agency’s announcement. “The most common medical devices in the veteran population may include cardiac implants (valves, pacemakers and stents), orthopedic implants (hip and knee) and neurosurgical implants.”
A 2014 audit by the Government Accountability Office found that the VA wasted more than $3 billion over 10 years on medical implant purchases and lacked the ability to track the implants after they were placed into patients, potentially putting veterans’ health at risk.
For its part, the FDA is tasked with ensuring the safety and efficacy of new medical devices. However, there is a lack of a robust system for assessing the safety and effectiveness of devices after they enter the market.
The hope is that the VA device registry will help provide short- and long-term surveillance, as well as comparative safety and effectiveness assessments, by leveraging data on large numbers of patients—including clinical outcomes over time.
The VA’s national summit on Monday discussing the medical implant device registry—in collaboration with CMS, DoD and FDA—will be webcast live in two parts. A registration link for viewing the morning session is available here, and a separate link for the afternoon session is available here.
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