Tell the FDA to Ensure Safe Servicing to Protect Patients
The medical imaging equipment we rely on to monitor and identify cancer must be serviced and maintained over time to ensure that it is working properly.
The individuals servicing these devices should be highly trained and regulated to make sure that you and other patients are receiving safe and accurate scans. Servicing technicians who work for original equipment manufacturers receive months of training, shadow more experienced technicians, and return for continuing education on new or updated devices –all with the oversight of the Food & Drug Administration (FDA).
Unfortunately, under the present regulatory rules, many medical devices are maintained by unregulated third-party servicers. These individuals are not required to undergo the same rigorous training program and do not have to register with the FDA, so their work is done with little to no oversight.
The solution is straight-forward: The FDA should hold all servicers to the same quality, safety, and regulatory requirements, including proper training, adverse event reporting, and registration, to ensure that patients are receiving safe and accurate scans.
The FIND Act (H.R.1199/S.1544) continues to generate buzz among Members of Congress and healthcare organizations. Recently, the FIND…Read More
Wes Bonebright has over two decades of experience in the medical device servicing industry. As an engineer, Bonebright…Read More