By Robert Kerwin

In some cases, hospitals and healthcare providers receive medical device obsolescence notices simply because the software for the reporting printer is outdated.

One provider was recently advised by a manufacturer “[a]s that technology [device] has aged, components have become harder to maintain or obsolete; including the Window XP operating system, which is no longer supported by Microsoft.” Though the manufacturer acknowledged a willingness to continue to provide servicing and parts support (based on availability) for a limited time, they also indicated that new or renewed service agreements would be “accepted at the discretion” of the manufacturer.

This ‘discretion’ can be a hospital budget buster, as new equipment costs, depending upon the modality, may run from $260,000 to $1,800,000 or more.

According to a recent Navigant study, nearly one in five rural hospitals in the U.S. are at high risk of closing. These hospitals are crucial to the health and economic success of communities, and 'end of support' equipment issues can be a contributing factor to the continued viability of rural hospitals. System downtime, software upgrade costs. and loss of technical support can have a dramatic impact on rural hospitals. Yet some of the imaging equipment for which a notice has been received regarding 'end of support' may still be able to meet ACR standards for image quality.

Nancy Godby, director of radiology at Cabell Huntington Hospital, notes that while Cabell Huntington is fortunate to be in a position to purchase new imaging equipment, some rural hospitals are not so fortunate. “Some of the smaller hospitals in rural communities may have facilities that are crumbling," she said. "If these smaller hospitals close, it will be difficult, particularly in the winter months, for some patients to make the trip to another hospital.”

Fortunately, some manufacturers have attempted to assist their customers by offering permanent service keys and training their customers. Mike Powers of Christiana Healthcare has had experiences concerning "end of support" equipment issues with OEMs that were collaborative and helpful.

"We have systems that have aged gracefully, and continue to serve in an accredited diagnostic manner. The relationship we have always had with those OEMs meant that as the systems aged, access to service keys and schematics was not an issue, due to our ability to purchase factory training when the systems were new," said Powers, who credits that cooperation, in part, to the resources available to his facility, and stresses that cooperation across all manufacturers is not consistent.

"When those units reached end-of-life we received the same letters everyone else has gotten. However, we have been able to purchase service from the OEM or a third party organization with specialized skills and certified quality parts, and there are small companies that meet both requirements," said Powers. "While my organization may have the resources and capacity to make sure things are always done right, there could be other organizations under different circumstances."

When the base technology does not change, the device can be supported in an ethical, safe manner, according to Powers. "When the root technology changes, for example: CMOS digital detectors, unique targeted radioisotopes, or higher tesla field magnets, the return of better patient outcomes drives adoption, and mandated obsolescence is irrelevant," he added.
 
Although cybersecurity concerns with older equipment abound, there are sometimes ways to ensure that the operation of the equipment does not unduly expose the hospital to a cyber risk. Godby noted that Cabell Huntington’s IT department has been willing to step in, particularly with regard to expensive equipment and ensure that the equipment is largely isolated from a cyber threat.

Steve Grimes, principal consultant from Strategic Healthcare Technology Associates, recommends an organization consider compensating controls when faced with equipment that is no longer supported by the manufacturer. He said compensating controls are alternative protections that can be put in place when faced with a new vulnerability (e.g., security patches for operating systems no longer available from equipment manufacturer). With appropriate compensating controls, equipment may conceivably continue to be used for some time after the manufacturer declares it has reached "end of support". Compensating controls means restricting the environment in which a device operates so that it isolates the older equipment operations from another computer environment.

Even when the medical device is cyber secure and the hospital has cooperation from the manufacturer for access to permanent service keys and parts, the hospital may learn, given the age and quality of the equipment, that CMS is reducing or eliminating reimbursement. Even if the equipment is recertified, this does not always resolve the situation.

A rural hospital may be forced to close, in part, because its budget will not permit the purchase of replacement equipment and "end of support" cooperation may be limited with respect to key equipment. While the impact of a rural hospital's closure is most directly felt on patients in the region, it can also have unintended consequences for the greater local economy, since businesses can’t always attract new hires without quality healthcare close to home.

The solution is multifaceted and may indeed require a collaboration of sorts, in which manufacturers cooperate more consistently when faced with an "end of support" situation, including sharing cyber security best practices. Meanwhile, CMS should ensure that reimbursements for the rural hospital are not reduced to the point where they cannot make ends meet.

About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.