However, if this servicing is done improperly, it 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).
When unregulated remanufacturing occurs, it can put technicians and patients at risk for serious injury or result in poor image quality, leading to a delayed or missed diagnosis or repeated imaging procedures, and increased healthcare costs.
Fortunately, Congress is considering action to protect the health and safety of patients and healthcare providers by addressing this issue.
New legislation, The Clarifying Remanufacturing to Protect Patient Safety Act (H.R. 7253), would spell out the meaning of remanufacturing as it relates to medical devices to better protect patients by helping educate those who service these complex medical devices about remanufacturing activities and ensure they fall under proper FDA oversight.
But Congress needs to hear from patient leaders like you in order to pass this commonsense, patient-protecting legislation.
Please use this tool to send a simple email now asking lawmakers to support the Clarifying Remanufacturing to Protect Patient Safety Act!