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Meeting third-party stakeholders halfway: Service after the FDA report A talk with Scot Mackeil and Rob Kerwin

The MITA narrative on third-party equipment service lacks merit: ACCE

By Arif Subhan, FACCE, President ACCE (on behalf of the ACCE Board of Directors)

After reviewing Patrick Hope's (MITA's Executive Director) editorial "Let's stop the dangerous waiting game," we, on behalf of the American College of Clinical Engineering (ACCE), believe it is important for the experts to weigh in.

ACCE represents the community of clinical engineering and healthcare technology professionals who have a long tradition of assisting healthcare providers in the acquisition, safe application and technical support of medical equipment. Ensuring patient and staff safety and the safety, quality and effectiveness of medical technology is, and has always been, our "prime directive." Our professionals are employed by hospitals, vendors, third-party service organizations, academia and manufacturers.
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There are some points made by Mr. Hope in his editorial on which ACCE agrees. We agree that "each year, millions in this country depend on imaging devices to identify and guide treatment of serious medical issues." We also agree that "physicians count on imaging technology to aid in precise identification of problems." Finally, we agree that "these devices ... have the potential to cause physical harm if they are improperly maintained or operated" and that "poor maintenance could lead to a missed or mistaken diagnosis" and treatment.

While we can agree on these points, the editorial then follows with many assertions that, when examined by experts who have authentic knowledge about how healthcare providers and medical equipment servicers work, are clearly without merit.

First, the editorial points out that "third parties are not required to report adverse events observed in the course of servicing" to the FDA. This is true for reasons that make perfect sense to those informed about the roles and responsibilities in clinical settings. Device user facilities are required to report serious adverse events to the FDA and/or the manufacturer because those user facilities are logically the one party that possesses firsthand knowledge when such an event occurs. Because manufacturers receive reports of serious adverse events from multiple device user facilities, the manufacturers are required to report these and any appropriate mitigations to the FDA. It makes no sense to require third-party organizations to report serious adverse events because such reports to the FDA would have already been made as required by the device user facility and/or the manufacturer, and those third-party organizations are not generally going to have any reliable way of knowing that a device they've been asked to service was involved in an event.
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