FDA Seeks ‘Remanufacturing’ Feedback from Biomeds

A little more than a month ago, the FDA released the draft guidance “Remanufacturing of Medical Devices” and asked healthcare technology management professionals, original equipment manufacturers, third-party repair organizations and more to submit comments.

United Imaging Goes “All-in” for Nashville

United Imaging makes its debut at HealthTrust University and its in-person debut at AHRA in Nashville over the next two weeks. At both events, the company will focus on several unique aspects of how it solves pervasive pain points in procuring and owning medical imaging equipment.

TechNation Asks Biomeds to Share Right to Repair Issues

TechNation is proud to support and be an advocate for the Right to Repair movement in the healthcare technology management and health care community. A new web form specifically allows biomeds everywhere to report incidents when an original equipment manufacturer...

Delivering precision solutions for a changing world

Change has been the one constant in nuclear medicine from the beginning, with the steady arrival of new radiopharmaceuticals, new technologies and an evolving regulatory environment. Today, as nuclear medicine expands rapidly beyond diagnostics and into novel...

Asset Management and Scheduling Downtime

Asset Management and Scheduling Downtime
By Matt Skoufalos

At Banner Imaging and Telehealth of Phoenix, Arizona, Diagnostic Imaging Support Services Director Sherman Abernathy oversees a multi-modality array of medical imaging systems across dozens of sites in six states, as well as a staff of technicians and engineers who maintain them.

In addition to keeping all those moving parts running smoothly, Abernathy also contributes to the long-range planning decisions around replacement of that medical imaging equipment when it’s time – decisions that, in the midst of the novel coronavirus (COVID-19) pandemic of 2020, have been delayed or deferred.

“We’ve had to become a little more creative and hold off on what we would normally do,” Abernathy said. “Our plan is to get that back in place next year.”

Equipment longevity can vary depending upon its setting; at Banner Health medical centers, CT and MR scanners are used “a little bit heavier” than at its freestanding sites, Abernathy said, and can require more frequent replacement.

About 45 percent of the $80-million Banner Imaging centralized operating expenses budget is allocated to medical imaging, said Perry Kirwan, Banner’s vice-president of technology management. In a typical year, overall capital renewal allocations can range from $60 million to $90 million, but in the revenue-depleted conditions established by COVID-19 in 2020, “everything got pulled back down to minimums,” Kirwan said.

But before the pandemic hit, Banner had begun planning an enterprise-wide upgrade of mammography systems across all 24 of its freestanding imaging centers; in all, the purchase included 15 to 20 CT scanners on a two-to-three-year timeline. When it was time to make those wide-scale changes, the company began an intensive, inclusive process that would shape the future of its women’s health service line for the foreseeable future.

To begin, staffers at each of its sites, from high-volume university settings to rural imaging centers, were asked to participate in the process. As heavily as physicians’ preferences contributed to the conversation, so, too, did input from Abernathy’s department, including its ability to support the technologies involved and its experience working with the vendors in question.

“What was really amazing to see was the collaboration that went on across all the parties at the table, and how we drove that process to a preferred vendor status,” said Banner Health Senior Director Todd Lowe.

It didn’t happen overnight: from the moment Abernathy’s team was tasked with evaluating the status of its current mammography inventory to the point of purchasing new devices lasted about 12 months. In some places, the rollout is still ongoing. But it began with circulating “a very detailed questionnaire” among the in-house staff that would interact with the imaging systems, from which a request for proposals was issued to a variety of medical imaging equipment vendors.

From there, a select number of Banner employees traveled to five different sites across the country, in a variety of health care settings, to ask questions and get answers from customers who’d already selected the same equipment Banner was considering. They conferred among clinicians and executive leaders at those sites to evaluate vendor performance, then combed through the insights gleaned from those visits according to a set of internally established criteria. These provided the means by which to evaluate the viability of the technologies along a variety of measurements, from clinician preference to executive satisfaction to workflow and more. Committee members were asked to rank each vendor’s devices along a scale of ranged responses designed to eliminate favoritism, Lowe said.

“Every member that sat on that evaluation panel, everybody’s voice was equal,” he said. “Everybody got one vote. Everyone’s evaluation was statistically relevant.”

Those objective standards also helped to give committee members a consistent set of metrics by which to consider their experiences at the site visits, Kirwan said. By removing variation from the responses, committee members were able to create a relative ranking that compiled the net results of all perspectives considered in the process.

“If you want to get a lot of people to agree on something, you can’t have a lot of subjective measures,” he said. “Almost two-thirds of the time spent in the process is on requirements, definitions and criteria.”

“If you know what you’re looking for ahead of time and you agree on what those definitions are going to be, your site visits have more meaning,” Kirwan said. “If you’re always evaluating against that defined criteria, you’re going to have much better odds at creating a ranked result.”

At the end of the evaluations, one vendor had separated itself from the others in the field, Lowe said; the second and third choices were quite close to one another, and all three had pulled past the remaining candidates. In narrowing down the results along a weighted scale, Banner decision-makers had everything they needed to begin negotiations with their chosen vendor; they were also able to keep the second and third choices close at hand in case those discussions collapsed.

“We do not treat our suppliers as adversaries,” Kirwan said, “but we spend a lot of effort making sure that the value of Sherman and Todd’s team is commensurate to what we’re paying [when we negotiate service contracts]. That’s probably where we spend the most time negotiating, evaluating where we stand so we can use our quarterly performance reports to decide where to adjust.”

When building the support contracts that accompany new equipment purchases, Banner seeks to define a shared-risk relationship, whereupon cost savings can be related directly to the degree of responsibility for equipment maintenance borne by each party. The most expensive devices, like MR machines, often include a service contract that builds in costs for high-end repairs and replacement of expensive parts, such as X-ray tubes and coils.

Additional cost savings can be driven by trading in legacy equipment to the manufacturer, who will refurbish it and handle the labor and headaches associated with its removal as well as the installation of the replacement devices. Most Banner Imaging sites have multiple CT and MR scanners, Abernathy said, which makes it easier to balance the workload when it’s time to take any one of them offline.

To absorb a manageable amount of repair costs in its service agreements, Banner staffers typically take responsibility for the first evaluation of all in-house requests, and leverage remote service options from vendors wherever possible. When a replacement part is needed, “We want it to come in overnight, before the first shift comes in,” Abernathy said.

“I think it’s really important to set up a really good working relationship with the vendors that you choose for your equipment,” he said. “Down the line, it becomes really important to reach out for technical support and parts, and without that relationship in place, it can be costly.”

“We build our [technician] training model directly from our equipment purchases in the expectation that we’re going to be supporting [the devices] internally,” Abernathy said. “We have service keys, documentation and support that allows us to stretch our use of equipment right up to end-of-life service, which can be around 10 years.”

“Even then, we can still go out to the third-party market and gather parts and support for those systems,” he said. “Once we hit the 15- to 20-year range, we start allocating funds for the replacement of equipment.”

Cost management is ever an ongoing concern, but never more so than amid the COVID-19 pandemic. Given the uncertainty most health systems face as the months roll on and the northern hemisphere heads into flu season, budgets have to recalculate expected patient volumes, adjust hospital capacity for handling any delayed or deferred care that might have been pushed back during the earlier part of the year, and manage financial gaps brought on by governmental shutdowns.

“COVID is still with us,” Kirwan said. “Most health systems are not thriving. If you’re making your budget, you’re likely only making your budget because of the CARES Act. For certain things, people come back, mainly because of medical necessity, but how elective is ‘elective’ moving forward?”

“We don’t know, and anything related to capital is based upon it,” he said. “If we bounce back quick, we could move to something approaching a normal season.”

Sam Maxfield, Banner’s senior director of finance, said that its outpatient ambulatory centers “have the benefit of larger parking lots and retail settings” that can support the addition of a short-term mobile imaging option to supplement any equipment that might be replaced or taken offline for service. Those choices can also help avoid extensive capital outlays at a time when revenues are threatened.

“Instead of making a long-term capital investment, we can go the route of putting things up in the parking lot where we can still see patients and when the short-term contract is up, we can re-evaluate,” Maxfield said. “It’s an option that we’re giving a lot of thought to at existing centers where we’re at capacity, or equipment is on its last legs, or areas where we were planning on growing and expanding, and COVID brought that to a screeching halt. This allows us to test those markets without making a large capital investment up front and over-committing ourselves.”

Those settings that might be less well capitalized than an enterprise system like that of Banner Imaging and Health would do well to consider the implications of taking even a single scanner offline, said Mark Watts, the imaging director at Fountain Hills Medical Center in Fountain Hills, Arizona. Watts urged those decision-makers responsible for managing repairs, replacements and preventive maintenance to keep a few things in mind before acting.

“You do have to be concerned with uptime, but it’s also about understanding what current and future requirements look like,” Watts said. “If you have 136 hospitals in your system, and 90 of them have only one scanner, the replacement has to be coordinated so you don’t lose revenue.”

For example, he said, a hospital that must take its only CT unit offline for repair or replacement may end up forfeiting significantly more revenue than its rescheduled caseload. Loss of that imaging modality may mean diverting emergency neurology cases and all the accordant business that could have come in through the ambulance service, which accounts for six to eight admissions per hospital.

“There’s ramifications for taking down the sole CT scanner within the hospital, and it goes beyond whether you’re providing services for imaging,” Watts said; “it goes to the reputation of the hospital.”

“You have to do whatever’s in your power to make sure that you have business continuity and uptime,” he said.

The careful replacement of even a single CT scanner with a mobile unit requires planning out its location, connections for IT equipment, an installation plan and even the degree of familiarity your technicians have with its replacement device.

“It can take a week to replace the CT scanner, but you have to plan out for a week on either side, so you end up renting the mobile [unit] for a month at a time,” Watts said.

A better move might be seeing whether a scanner could be replaced in its existent location versus bringing in a mobile unit. As Watts points out, “there isn’t any room in a mobile unit to bring gurneys in, there’s no additional space, and when you’re doing work in an unusual environment, there’s greater risk for a sentinel event.

“Every time you change out to a mobile unit, the incident rate for a sentinel event goes up 50 percent,” he said. “This goes for all critical access to systems. If your PACS system goes down, if your CT scanner goes down, these unusual circumstances really do have an effect on your normal operations. But you also have to mitigate the risk that’s associated with not having your normal systems operational.

“Outpatients, ER patients, inpatients; it’s a juggling act,” Watts said. “When you don’t have that one asset, then it doesn’t matter. You put the trust of the public at risk by continuously rescheduling them. Perception is a problem if you need a procedure and you can’t have it done.”



Submit a Comment

Your email address will not be published. Required fields are marked *