Take Action to Protect Patient Safety!
Medical imaging devices can catch disease early and save lives, but they’re also complex machines that require extensive training and skill to safely maintain. Regular servicing ensures patients and healthcare providers remain safe and that these machines provide accurate information needed for doctors to accurately diagnose and treat patients.
Unfortunately, if servicing is done improperly, it may cross the line into remanufacturing. Remanufacturing is an activity in which a medical device is altered in such a way that there is a significant risk that the device will no longer function as intended. Remanufacturing is, rightfully, regulated by the U.S. Food & Drug Administration (FDA) and includes a range of activities like changes to a device’s sterilization methods, reprocessing instructions, control mechanisms, operating principles, energy input or output, and design.
Without proper oversight, remanufacturing can put patients, healthcare providers, and servicing technicians at risk for serious injury. It can also lead to poor image quality which can cause a delayed or missed diagnosis or repeated imaging procedures, increasing healthcare costs.
The FDA has acknowledged more clarity is needed around the difference between servicing and remanufacturing, and Congress is taking action to ensure safety for anyone using a medical device. The recently introduced Clarifying Remanufacturing to Protect Patient Safety Act (H.R. 7253) is new legislation that would better protect patients by:
- Defining remanufacturing in statute and clarifying the activities that require registration, reporting, and FDA oversight.
- Provide for educating those who service these complex medical devices about remanufacturing activities and ensuring they meet FDA regulations.
We need you to take action to protect patients and technicians! CLICK HERE to send an email asking lawmakers to support this important legislation. With your voice, we’ll be one step closer to passing this commonsense policy to help protect patients.