Medical Device Servicing: Why it Matters to You
We often hear from our patient leaders about their “scanxiety.” Whether you are receiving a medical imaging scan to look for potential cancer or as a routine checkup to ensure your cancer is still in remission, the weeks leading up to that appointment and the wait for the results can be nerve-wracking. With the many concerns that may arise, there is one worry that no patient should ever have to have: Is this machine safe?
Much like any other device or piece of machinery, 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 correctly. But unlike a simple device like your phone, medical imaging devices are highly complicated, some using strong magnetic fields, ionizing radiation, or acoustic energy. If these machines are not properly serviced, it could result in a missed or incorrect diagnosis, and possibly injuries such as inadvertent overexposure to radiation or burns.
Consequently, the individuals servicing these devices must be highly trained and their employers regulated to make sure you and all patients are receiving safe and accurate scans. Servicing technicians who work for original equipment manufacturers (OEMs) 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 and Drug Administration (FDA).
Unfortunately, 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. By comparison, dietary supplement makers face more federal oversight than these third-party servicers. This means that some highly complicated machines used to identify deadly diseases are serviced by firms that are not required to meet any proper quality and safety standards, so their work is done with little to no oversight.
Our country’s leaders should fight to ensure our diagnostic medical devices are properly maintained to maximize efficacy and patient safety. As a first step, lawmakers and federal regulators should require third-party servicers to meet the same quality and safety standards expected of OEMs.
Americans seeking care deserve the best our healthcare system has to offer. Imposing accountability on unregulated third-party servicers would be a modest but essential step towards this shared goal.
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