Opinion

Consistent Standards Needed to Ensure Imaging Equipment Is Properly Serviced

Interested parties convened in Washington this week for a Federal Trade Commission workshop to explore ways to protect consumers from practices by certain manufacturers that restrict repair options for consumer goods like cellphones, laptops or even coffee machines. The “right to repair” movement aims to empower consumers to repair and modify their own devices without having to go through the manufacturer. For many types of consumer products, this may make sense.

However, right-to-repair advocates should understand that not all requirements, regulations or standards controlling repair are arbitrary or unreasonable. Some devices, such as medical imaging equipment, require specialized training to own, operate and safely repair. These devices are not like everyday consumer products but are used by health professionals to detect, diagnose and treat life-threatening illnesses.

Medical imaging devices are highly complex and use strong magnetic fields, ionizing radiation or acoustic energy. These devices have direct contact with patients and in some cases are inserted into the patient’s body. Improper service could result in a missed or incorrect diagnosis, injuries such as electrical shock, possible overexposure to radiation, infection and burns.

Considering how important it is for this type of equipment to be serviced properly, one would think there would be strong regulations in place to ensure the technicians repairing and servicing these devices are properly trained and are following a defined set of best practices.  Unfortunately, that is not always the case. Manufacturers of these devices, which include MRI machines, CT scanners, X-rays and ultrasound machines, regularly receive reports of devices serviced with improper or unauthorized parts by technicians who fail to follow established guidelines.

In fact, federal oversight of independent, third-party servicing companies is all but absent. Unlike the original equipment manufacturers, which have to register with the Food and Drug Administration and report adverse events to the agency, third-party servicers are largely unregulated, creating a two-tiered system of accountability that leaves medical professionals, and the patients they treat, vulnerable to injury or misdiagnosis. And while many third-party servicers provide quality service, the fact remains: The FDA is unaware of their existence and lacks the information that could be important to patient safety.

Patients should be able to expect that all imaging servicers are following the same high-quality rules. To address the gap in FDA oversight, a diverse coalition of medical imaging industry entities came together earlier this year to develop a set of clear standards for servicing medical imaging equipment that every servicing organization should follow. The NEMA/MITA 2-2019 Requirements for Servicing of Medical Imaging Equipment lays out the minimum requirements servicers must follow to ensure their activities protect patient safety and device integrity.

Though voluntary, this standard will enable servicers who follow these practices to benefit from a clear set of guidelines to ensure their activities are performed in a safe and effective manner. It will also signal to end users — the medical professionals who use these imaging devices and patients who count on them — that their equipment has been properly serviced and maintained.

When it comes to specialized medical equipment, too much is at stake to risk leaving the job up to servicers not held to the highest of qualifications and procedures. Robust servicing standards are needed to ensure that whoever is doing the work — be it an OEM, third party or otherwise — puts patient safety and quality device performance first.

 

Dennis Durmis is the senior vice president of Bayer Radiology, Americas Region, and the chair of the Medical Imaging and Technology Alliance board of directors.

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