In the works, if certain challenges can be overcome: a “collaborative community” of medical device servicers.
By Chris Hayhurst
Among the many things that HTM professionals seem to agree on is that collaboration is key to quality and safety in medical equipment servicing. So last April, when a broad range of representatives from across the medical device world came together to discuss forming a “collaborative community,” the biomeds in the room had reason to be optimistic.
The idea for the gathering, explains Mike Powers, MBA, CHTM, CDP, CBA, clinical engineering supervisor at Christiana Care Health System in Newark, Del., came out of a report on medical device servicing published a year earlier by the FDA. “Stakeholders,” that document noted, “have differing views about the quality, safety, and effectiveness of servicing performed by OEMs and third-party entities, and the need for imposing additional regulation.”
Based on its own review of the industry, the agency said it had determined that OEM and third-party entities alike can service medical equipment safely and effectively, and that the work provided by third-party service organizations “is critical to the functioning of the U.S. healthcare system.”
The report included a list of actions the FDA intended to pursue to improve medical device servicing, and in closing it offered this as a suggestion: “We believe there may be value in the creation of a public-private forum, such as a Collaborative Community, to address the challenges associated with delivering high-quality, safe, and effective servicing of medical devices. If there is sufficient interest and broad willingness to participate by all stakeholder groups, we would facilitate the creation of such a community.”
The meeting in the spring of 2019, Powers recalls, “was effectively our kickoff for building that collaborative community of medical device servicers.” Held in Arlington, Virginia, at AAMI’s headquarters, it included not only people from AAMI and the leaders of hospital HTM departments, but also representatives from The Joint Commission, the FDA and its Centers for Devices and Radiological Health (CDRH), the International Association of Medical Equipment Remarketers and Servicers (IAMERS), the Advanced Medical Technology Association (AdvaMed), the Medical Imaging & Technology Alliance (MITA), and other organizations as well as individuals from a number of major manufacturers.
“We realized we had four main groups,” Powers explains: “OEMs, independent service organizations, healthcare delivery organizations, and regulatory agencies.”
First up, after the introductions, came discussion about the need for a charter that clearly stated their mission. They would also need written rules to prevent them from violating antitrust laws and to dictate their eventual work together. “When you take organizations that are natural competitors and ask them to collaborate, there are challenges inherent to that process,” Powers notes.
The participants didn’t talk about money, “but at the end of the day, money is a factor, and it kind of becomes the 500-pound gorilla in the room.” He remembers feeling hopeful that they’d eventually make progress, but he also got the sense that things were a bit tenuous: “You could see that buy-in wasn’t going to be easy.”
Driving Improvements for All
In January 2018, in its 2018-2020 Strategic Priorities, the CDRH noted that it intended to establish at least 10 collaborative communities (CCs) by the end of 2020. Defining a collaborative community as a “continuing forum” where members of the public and private sectors work together to solve problems in an open and trusting environment, the agency explained that participants in such efforts “share a collective responsibility to help each other obtain what they need to be successful.” It went on to describe several programs in the early stages of development (its Case for Quality initiative, for instance) as examples of what could evolve into CCs over time.
A little less than two years after the publication of that report, in September 2019, CDRH announced its involvement in the first two CCs “working to develop solutions to medical device innovation challenges” that met its standards for participation. The National Evaluation System for health Technology Coordinating Center (NESTcc) Collaborative Community, the agency explained, would work to make device data collection and analysis more efficient and “increase the value and use of real-world evidence to meet the needs of the medical device industry, healthcare professionals and regulatory bodies.”
And the Ophthalmic Imaging Collaborative Community would attempt to advance innovation in that field while also working to develop best practices and stronger standards. The agency clarified that it doesn’t “establish, lead, or operate” CCs, but simply chooses to take part in such an initiative when “doing so is in the best interest of the public health and is consistent with the law.” It also announced it had created a collaborative communities “toolkit” that groups could use for ideas and direction as they pursued creating CCs of their own.
“What we’re trying to drive is strong representation, to have all key stakeholder groups included,” says CDRH director Jeffrey Shuren, MD, JD. A collaborative community made up of groups that may not typically work together, he explains, can help create “more trusting relationships, and I think that ultimately leads to better solutions that benefit everybody involved.”
Patients, in particular, stand to gain when groups with conflicting interests put aside their differences and come together to tackle challenges, Shuren says. “They’re the real beneficiaries here, so it’s about taking it to the next level in serving the public health.”
Shuren says that he understands how some organizations might balk at collaboration even if the intent is to improve the community overall. “But what we’re seeing is that once they sit down together, they actually start having conversations with one another and realize they can help each other.” In a successful collaborative community, he adds, participants make an effort to reach across the aisle, “to understand each other’s perspectives so they can better serve the needs of the community writ large.”
Trouble at the Table
An TM leader who agrees with that statement is Dave Francoeur, senior vice president of marketing and sales with the independent service organization Tech Knowledge Associates (TKA). As one of those invited to take part in the initial talks about a possible medical device servicing CC, Francoeur was in Arlington last spring with Powers and has participated in every follow-up meeting since. “In theory, everybody involved is interested in ensuring safety and quality in medical equipment servicing,” he says. “But now it seems like interest and biases are preventing us from making progress.”
Representatives from OEMs, Francoeur explains, “seem concerned about how what we do might impact their environment, their market share, or other concerns.” (A spokesperson for the trade association AdvaMed, when asked if someone from that organization might offer their perspective on the value of CCs, did not provide a statement in time for this article’s publication.)
Commenting on behalf of IAMERS, president Diana Upton wrote this: “IAMERS will continue to support” a medical device servicing CC “as it has done so since the stakeholder meetings began in early 2019. We are pleased to see the commitment of the HTM community. We would, however, welcome more manufacturer participation in both the monthly meetings and the various workgroups.”)
Francoeur describes the impasse as “really frustrating,” especially since, from his point of view, the independent HTM community had no choice but to come to the table. “I mean, this opportunity was presented to us by the FDA following the accusation that safe and quality service couldn’t be guaranteed unless it was performed by a trained professional from an OEM.”
HTM professionals agreed to form a collaborative community with all stakeholders because we believe that working together is an effective way to develop a better understanding of one another, he says. “We didn’t want to get involved in this in the first place, but the fact of the matter is, we’re here now. We want to make a difference, and this collaborative community is an opportunity to do that—but everyone has to be willing to actually collaborate.”
Hope for the Future
As of presstime, the group—which some have dubbed a “pre-collaborative” community—has been meeting for 10 months. According to Mike Powers, the group has developed a rough charter and a draft antitrust statement, although the former has not yet been finalized, and the latter is being debated due to disagreement about a single word. “We almost have our rules and governance, but we’re not quite there,” he notes. “The question is whether we can get past this and move on to work that will make a difference.”
Still, Powers says, even as the group has struggled to make significant progress, it has notched a few victories. It tries to convene once per month, usually via conference call, and members recently agreed to form four subgroups “to try and create some output and maybe light a fire to help this thing build momentum and catch.”
Those subgroups, he explains, include one focused on quality management system (QMS) best practices (“What should a QMS look like for a medical device servicer? Is it a copy-paste of ISO 13485, or does a thorough alignment with 21 CFR get us there?”); one on training and the qualifications that should be expected of a “great engineer”; one devoted to sharing perspectives on the biggest pain points for each market segment involved in the CC, including HDOs, OEMs, ISOs, and regulatory bodies; and finally, a subgroup focused on quality and safety benchmarking (“How can we hope to improve if we do not know where we are now?”).
When it comes to the barriers preventing their “pre-CC” from becoming a group that can collaborate effectively, Powers says he’s hopeful they can get past them eventually. “Everyone taking part in this initiative has a unique set of challenges in their day to day, and maybe the problem that’s preventing collaboration is not understanding” each other’s challenges, he says.
For example, OEMs may not know that HDOs have to follow Joint Commission standards around preventive maintenance periodicity in order to remain accredited. Or an HDO may not understand how the European Union’s Medical Device Regulation (MDR) might impact the business practices of certain manufacturers. “Every group is dealing with its own headaches, so let’s talk about them and figure out what to do about them.”
At his organization, Powers notes, they rely on both ISOs and OEMs for a portion of their medical equipment servicing workload, “and it’s the same thing for nearly everyone now—most of us are depending on each other in some way.” (By his estimate, Christiana Care Health System keeps 80% of service activities in-house and outsources the remaining 20%.)
Powers’ message to manufacturers is that the purpose of a collaborative community “is not for access to intellectual property outside of our business agreements, but to drive even higher levels of quality and safety in the work we all do.” Will they eventually agree on a charter, create an antitrust statement, and all put their heads together to come up with solutions that lead to improvements in their work? “I guess we’re going to have to wait and see how this plays out,” he says.
Chris Hayhurst is a contributing writer for 24×7 Magazine. Questions and comments can be directed to chief editor Keri Forsythe-Stephens at [email protected].
Assessing a Collaborative Community
In its “Collaborative Community Toolkit,” the FDA suggests CCs evaluate themselves and their members by assessing:
- Whether the group of diverse stakeholders that make up a community are working effectively in a collaborative manner;
- The impact that the collaborative community is having on the larger ecosystem through solving identified challenges and proactively building for the future; and
- The value that participating in the collaborative community generates for each contributing member.
Source: Collaborative Communities Toolkit, September 2019
Many OEMs believe that “their” service manuals are only needed by “other” competing servicers intending to “fix their stuff”. This is a misconception and there is so much more to the story…
Service manuals are needed at many key points in the device life cycle:
by CEs during the product evaluation and selection process, AEM evaluation, IT security, risk assessment, alarm management, device integration/interoperability and facility planning.
by Value Analysis Teams who are making the purchase decision that best fits the needs of their organizations. (Think about understanding costs of implementation and ownership.)
by BMETs and CBETs as equipment is brought into the facility to guide our Demo device inspections in support of caregivers needs to keep their patients safe.
by BMETs and CBETs as purchased equipment arrives at the facility and we do incoming inspections , acceptance tests, inventory, installations, deployment and training.
by BMETs and CBETs as we plan our PM workload and write our PM checklists and AEM or OEM procedures and do our repairs and PM tasks
by BMETs and CBETs as we support, repair and maintain equipment at the point of care in support of caregivers and the needs of our hospitals to insure equipment safety and uptime.
by CEs and CBETs as we do forensic device investigations in support of QA and risk management and in support of the FDA MEDSUN and SMDA and ECRI reporting systems.
by veteran BMETs to help teach new BMETs about equipment and to carry on the mission of service to our nation’s healthcare providers and healthcare institutions.
When retired equipment is donated to charitable organizations and their BMETs must work to begin a new chapter in the device lifecycle.
There are CMS requirements that PM activities are guided by procedures in service manuals and TJC EC.01.01.01, EP 3. requires us to have a library of service information to refer to.
Service manuals are an essential component of safe, effective high quality service by all parties.
I am reminded of my work in interoperability in general and on the 80001 standards committee particularly, especially when I helped draft a Responsibility Agreement (RA) guidance document.
Money is indeed the elephant in the room everyone would prefer to ignore. Manufacturers can afford to send representatives to every meeting on any topic that has the potential to impact them. others not so much. One of the reasons I was able to serve on the 80001 standards committees was that AAMI funded my participation. Very few providers were represented let alone involved in standards development throughout my career. Manufacturers also bring lobbying resources to bear apart from forums like meetings. That’s not a complaint, just a reality that should be factored into strategy development.
Getting back to the development of the 80001 RA draft, manufacturers dug in their collective heels in opposition to providers defining what risk management information providers would need to manage their networks. They were adamant that they would choose what information they would share. I was not surprised. In a recent column for 24×7, I shared a story about how a number of years ago a manufacturer refused to share information from its risk management file for a failure of consequence impacting networked medical devices.
Simon and Garfunkel’s “The Boxer” includes the following relevant lyrics:
“All lies in jest, till a man hears what he wants to hear
And disregards the rest”
The concept of collaborative communities is a great one; it has tremendous positive potential. But it’s really not far removed (If at all) from the concepts underlying committees that create voluntary standards. Participants should engage with eyes wide open and aware of the interests of all at the table, including their own.