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.

The time has come for Congress to ensure that all imaging and other device servicers meet the same high regulatory and quality standards. The bipartisan Medical Device Servicing Safety and Accountability Act (H.R. 2118) requires third-party servicers to register with the FDA, report information about adverse events, and maintain a complaint handling system. This legislation would be a much-needed step in the right direction. It is essential that repairs or maintenance performed by non-OEM entities be held to the same quality, safety, and regulatory requirements, including FDA oversight.

Fortunately for patients, laudable third-party servicers do indeed perform quality work that meets safety standards – which is all the more reason why they should register with the FDA and participate in existing federal data collection and trend analysis efforts. Doing so would not only help promote high-quality standards that will benefit the entire industry, but is also the right thing to do for patients and the viability of their businesses.

Without FDA oversight of third-party servicers, we likely will not learn about device issues unless or until an adverse event has occurred, or the owner, operator, or a third-party servicer reports it to an OEM. In the absence of regulation, OEMs will continue to have to step up to fix a failed device. This repair is likely slowed as they have to work backward to try to document what work might already have been done by unregistered servicers. OEM servicers need to baseline the status of the device so that they can proceed, confidently empowered with the latest knowledge of the rapid advances in technology for the imaging field.

In the wake of an FDA report that relies on incomplete data, the imaging community is more hopeful than ever that Congress will fix these issues legislatively. We are confident that requiring third-parties to register with the FDA, report serious problems or injuries, and maintain complaint handling systems will only improve the quality of care that American healthcare consumers deserve. It is time to end this waiting game and actively address these very real risks once and for all.

About the author: Patrick Hope is the executive director of the Medical Imaging & Technology Alliance (MITA).