Device Remanufacturing and Why It Matters to You
Medical imaging has revolutionized healthcare, especially over the past 30 years, offering doctors the opportunity to find diseases earlier and improve patient outcomes. But as these imaging devices become more innovative and complex, they require regular maintenance services from highly trained and regulated individuals to ensure they are functioning correctly.
In some instances, if this servicing is done improperly, servicers’ work may constitute remanufacturing. Remanufacturing is an activity in which a medical device is altered in such a way that there is significant risk that the device will no longer function as intended and thus is rightfully regulated by the Food & Drug Administration (FDA). Unregulated remanufacturing could result in a missed or incorrect diagnosis and injuries, including overexposure to radiation or burns, for both patients and device technicians.
According to a 2018 report, the majority of adverse medical device events reported to the FDA were the result of unregulated remanufacturing. Because there is a lack of clarity distinguishing the difference between servicing and remanufacturing of a device, patient safety, device performance, and cybersecurity are all at risk.
Fortunately, Congress recently introduced new legislation, the Clarifying Remanufacturing to Protect Patient Safety Act (H.R. 7253), to address this issue.
If passed, this legislation would provide a more precise definition of remanufacturing and help to educate servicers about remanufacturing activities to ensure they fall under proper FDA oversight.
You can help protect patient safety by urging your Member of Congress to support this legislation. Click here to get started!