From the August 2018 issue of HealthCare Business News magazine
An editorial by Patrick Hope
The U.S. Food and Drug Administration’s (FDA) conclusion last month that unregistered and unknown third-parties who service medical imaging and other devices require no additional regulation was not the news that manufacturers expected to hear.
While we agree with many FDA findings, we reach a far different conclusion on this one. When the original equipment manufacturer (OEM) services an imaging device, there are regulations imposed in the interest of patient safety: Why should others who service medical devices be treated differently and held to a lower standard? Are not patients the primary focus here?
We already know that third-parties are not required to report adverse events observed in the course of servicing medical imaging and other devices. The FDA report found, in part, that there is not enough evidence to conclude that third-party servicing poses a widespread public health concern, but that’s because there is no evidence collected. It is reasonable to surmise that the evidence that is available is the information provided by the OEMs that they are required by law to report. Clearly, the available evidence is incomplete.
How incomplete? The FDA report informed us how little they actually know about medical imaging and other device servicing in the U.S. In fact, we learned from the FDA report that the number of firms performing medical device service in the U.S. is between 16,520 and 20,830. Most of these are non-OEMs and therefore, unregulated, unregistered, and with no requirement to report adverse events. So how much do we really know when only a minority are reporting?
With patient safety driving all aspects of healthcare these days, it seems beyond odd that regulators are not interested in straightforward provisions that would enhance quality and safety for all Americans who need diagnostic imaging.
Each year, millions in this country depend on imaging devices to identify and guide treatment of serious medical issues. Physicians count on imaging technology to aid in precise identification of problems. But these devices – like CT scanners and MR machines – also have the potential to cause physical harm if they are improperly maintained or operated. Beyond that, subpar image quality resulting from poor maintenance could lead to a missed or mistaken diagnosis.
Government policy regarding the standards that govern the servicing and maintenance of medical imaging equipment does not put all parties on an equal playing field. Unlike OEMs, which have to follow strict registration and quality reporting guidelines when servicing their own devices, the 20,000 or so third-party servicing firms in the U.S. are operating in a regulatory void.