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.

HTM Homepage