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.
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.
Another point made in the editorial is that there is substantial underreporting of adverse events. On this we, the FDA and most experts agree. But for those who understand the industry, they know underreporting is due to device user facilities being reluctant to report any problems, and their staff being inadequately educated about the process. Better reporting and analysis of data will help all those in the industry to ensure that technology is manufactured, acquired, used and supported safely. But the way to better reporting is not to add registrations or more reporting, but to educate the staff of device user facilities about what and when to report under the current reporting system and to ensure they see reporting as a no-blame process. Creating regulations that require third-party servicers to report adverse events which those servicers are highly unlikely to be aware of benefits no one and serves only to unnecessarily burden the industry and increase costs with more regulation.
The editorial goes on to claim that "others who service medical devices" are "treated differently [from manufacturers] and held to a lower standard" and asks the question "are not patients the primary focus here?" While we agree that manufacturers are treated differently than servicers, those differences are related to the manufacturing processes and NOT to servicing. It is grossly misleading to suggest servicers are held to a lower standard when clearly it makes no sense to hold servicers to manufacturing-specific regulations. The editorial also ignores the fact that the Centers for Medicare and Medicaid Services (CMS) and state departments of health regulate how device user facilities service their medical devices and the accrediting organizations (e.g., the Joint Commission, DNV-GL) regularly validate compliance. Regardless of who device user facilities choose to service their medical devices (i.e., in-house staff, third-party servicers or manufacturers) those facilities are required to monitor the competency of servicers and to ensure the quality of service those servicers provide.
The editorial is critical of the FDA's May 2018 report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices because the report states that "currently available objective evidence is not sufficient to conclude whether or not there is a widespread health concern related to servicing ... of medical devices that would justify imposing additional/different burdensome regulatory requirements at this time." The editorial claims the FDA's failure to find evidence that "third-party servicing poses a widespread public health concern," but that's because no evidence is collected. With no sense of its irony, the editorial seems to be suggesting that the absence of evidence of a problem is evidence of the problem.
Against the FDA report's recommendations, the editorial calls on Congress to pass the very controversial Medical Device Servicing Safety and Accountability Act (H.R. 2118). This act would create regulations that would, by design, burden third-party servicers with paperwork and costs without producing any commensurate safety benefit, not to mention duplicating an adverse reporting system already in place. The only real beneficiaries of the act are MITA's members, who stand to gain an additional share of the medical device service market when burdensome regulations force third-party servicers to raise costs.
ACCE supports the FDA report's findings and recommendations because they are based on evidence and not innuendo. We do recognize the growing, critical role that increasingly sophisticated medical technologies play in healthcare. We agree with the FDA report that all elements of the industry involved in the use and technical support of medical devices should look to adopt quality management systems. We also support the FDA's recommendation for the formation of collaborative communities made up of representatives from device manufacturers, users, patients, healthcare professionals, and regulators that would work together to identify challenges and develop solutions. We believe solutions to the healthcare technology challenges of today and tomorrow are more likely to be successfully addressed through the efforts of a collaborative community than through lobbying for burdensome regulation that benefits one segment of industry without improving public safety.
ACCE invites MITA to join us, the FDA and other key industry stakeholders in a collaborative community that will work together to address real challenges.
About the author: Arif Subhan is the president of the American College of Clinical Engineering.