Registering all manufacturer repair service providers -- including third parties -- with the FDA could go a long way to reducing patient follow-up imaging fears.
Scanxiety (noun): distress or uneasiness of mind leading up to and immediately following a follow-up scan or medical image, usually in cancer patients. Example: she felt scanxiety as her 6-month post-no evidence of disease CT scan neared.
All right, so maybe scanxiety is a made-up word, but as an 18-year colon cancer survivor, I can tell you the feeling is very real. Like so many other cancer survivors, I experience worry leading up to a follow-up scan until I hear results. What will my doctor find? How am I healing? Has my cancer come back?
But regardless of the terminology, it is clear that cancer survivors have enough to worry about going into their prescribed scans, so anxiety about whether a CT, MRI, or colonoscope will function properly should not be one of them. That is why original equipment manufacturer repairmen (and women!) register with the U.S. Food and Drug Administration (FDA), follow strict quality management systems, and are required to report any malfunctioning devices that produce inadequate images or put technicians and patients at risk.
As a patient, I would hope that anyone working on these life-saving machines would meet those standards, but unfortunately this is not the case. Unregulated non-manufacturer medical device servicing businesses are not required to register with the FDA, have no minimum training requirements, and often are not required to meet appropriate quality controls.
That is a problem I urge the new Congress and Biden Administration to fix because medical imaging devices are complex pieces of capital equipment, some of which emit radiation. Patients and providers depend on the safe and effective operation of these devices. If equipment is improperly serviced, it could put technicians and patients at risk for serious injury. Talk about scanxiety!
Furthermore, sub-standard repairs can increase healthcare costs for patients and providers alike. A poorly serviced device may not physically harm a patient, but poor image quality could lead to a missed diagnosis or the need for repeated imaging procedures – and the anxiety that goes with it!
So why are all medical device servicers not required to meet the same standards? It is a good question with no good answer. It may be the FDA does not have a clear idea of how pervasive the problem is because there is no registration or reporting. But it is a problem with a clear cut solution: Congress should require any medical device servicer to make themselves known to the FDA, commit to following a quality management system, and report medical device errors. Patients deserve to know that medical devices servicers do not cut corners and that they take responsibility for quality and safety. Putting regulatory checks on servicers who currently lack any guardrails is a good place to start.
I have learned to help manage my scanxiety by building an awesome support network, Colontown, talking to my doctor and caring for myself with rest, good food, and self-compassion. And I have been fortunate to have “clear” scans and a relatively good outlook going forward, but no matter how many times I go, that feeling of dread and worry never really goes away. The FDA holding third-party servicers accountable would go a long way to alleviating scanxiety for all cancer patients.
Erika Hanson Brown is Founding Mayor of COLONTOWN, an online community of colorectal cancer patients, survivors, and caregivers.
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