WATCH: Patient Advocate Explains the Importance of Safety in Medical Imaging
Medical imaging saves lives. Scans allow providers to diagnose diseases earlier, improving patient outcomes, but the complexity of these devices requires regular servicing to ensure they function properly. If this servicing is not done correctly, it may instead alter how the device works, known as remanufacturing. Without proper oversight, this is dangerous and poses a significant risk to the health and safety of patients and providers.
Remanufacturing is rightfully regulated by the U.S. Food & Drug Administration (FDA), but if improper servicing crosses the line into remanufacturing, it goes unregulated and can lead to poor image quality, delayed or missed diagnoses, injury to patients and technicians, or even death.
In a new video, Kay Hoffman, who has undergone two treatments for a brain aneurysm, explains why this issue is so important to patients like her who rely on medical imaging:
“There is no room for error. This is a matter of life and death. If I had not had the best physicians and the best machinery, I would not be sitting here today,” she said. To protect the lives of patients everywhere, it’s important that Congress provide clarity to medical device technicians.
By clarifying the difference between servicing and remanufacturing, the FDA can ensure that all patients remain safe. You can take just a few minutes to send an email to your representative asking them to pass the Clarifying Remanufacturing Patient Safety Act (H.R. 7253).
This legislation would define remanufacturing in statute and clarify activities that require registration, reporting, and FDA oversight as well as provide for educating those who service complex medical devices about remanufacturing activities and ensuring they meet FDA regulations.