In any given hospital, on any given day, the servicing of medical devices may be carried out by in-house technicians, a third-party ISO or an OEM servicing engineer. It is not uncommon to find some combination of these service providers working in tandem to keep equipment maintained, calibrated and repaired.
A question that has sparked tension in recent years is the contention, in some quarters, that only original equipment manufacturer (OEM) servicers can provide safe and effective servicing of the medical equipment produced by their companies.
The question of who can provide competent and reliable servicing of medical devices gained further traction in 2016 when the FDA opened a “docket” requesting comments from the servicing community, including OEMs.
The docket was later followed up with an FDA public workshop titled; “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016.”
What the FDA took away from the input of the many stakeholders in the medical device ecosystem was that there were opposing views on the safety, quality and effectiveness of the service provided by OEMs and third-party service providers.
Later research by the agency seemed to provide assurance that there was not a compromise of safety when a non-OEM technician provided service and that the service provided by non-OEM service technicians is critical to the functioning of the U.S. health care system. This was published in a report by the FDA in May of 2018 titled: “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.”
Included as a footnote in the report, the FDA stated: “CDRH (Center for Devices and Radiological Health) has committed to establishing ‘Collaborative Communities.’ The hallmark of a Collaborative Community, is a continuing forum where public and private sector members proactively work together to solve both shared problems and problems unique to other members in an environment of trust and openness, where participants feel safe and respected to communicate their concerns.”
As a result, the FDA suggested bringing all stakeholders to the table to discuss this issue, and determine any consensus that was something they were willing to be a part of. After all, if a regulator is going to issue regulations that have a profound impact on many groups, those regulations should be grounded in reliable and accurate information.
It should also be noted that the FDA’s 2018 report recognized that additional layers of regulations would be viewed as “burdensome.” That view may be different today under a new administration and any evidence to reinforce the view that non-OEM service is safe and effective may need to be buttressed through a further demonstration of industrywide standards.
The Medical Device Servicing Community (previously, the Medical Device Servicing Collaborative Community) was created to bring together thought leadership to address the concerns of regulators and develop consensus among disparate factions and viewpoints within the medical device community.
The procedures and standards developed within the MDSC can also provide assurance to regulators that the highest standards in medical device servicing are utilized among all service-providers and that additional regulations are not warranted.
The initial roster of participants in the MDSC included OEMs, healthcare delivery organizations (HDOs), independent service organizations (ISOs) and the regulators. Although all groups represented the most important stakeholders – the patients – the regulators officially took their position.
Outlining its purpose, structure and framework was a primary goal of the Medical Device Servicing Community ahead of determining deliverables.
The group’s LinkedIn page states, “The mission of the MDSC is to bring together the community of stakeholders to advance the safety, effectiveness and quality of medical device servicing. Created as an outcome of the FDA report on Quality, Safety, and Effectiveness of Servicing of Medical Devices in May 2019, the scope of the MDSC is to define and encourage implementation of actions that advance the community’s mission, including, but not limited to:
The community’s subgroups include: the Standardize Benchmarking, Data Collection, and Analytics (BDCA) subgroup, chaired by Dave Francoeur; the Cross-Stakeholder Education subgroup, chaired by Samantha Jacques; the Best Practices for Servicer Training subgroup, chaired by Dave Anbari; the Best Practices for Quality Management Systems sub-group, chaired by Scott Trevino; and the newer Recruiting subgroup, chaired by Katrina Jacobs.
The initial focus of the subgroups was to determine their mission and articulate that into a written mission statement. Because of the disparate sectors that the groups represent, there was the need to have written rules to prevent each from violating antitrust laws and to outline the structure of the work they would perform as a collaborative body.
The hoped-for outcome of these subgroups – that bring together representatives from often competing interests – was to benefit patients in the end.
With the HTM community’s representative before regulators lacking in comparison to the political strength of major medical equipment manufacturers, the sub-groups are developing standards that will strengthen HTM’s case before these bodies.
This is the point that Francoeur made in a 2021 MD Expo presentation, which provided an update on what the MDSC was working on.
The Training subgroup that Anbari chairs, developed an outline describing the goals of the subgroup titled “Draft Guidance for the Collaborative Community – Technician Training Best Practices.”
The subgroup describes its purpose as; “The Technician Training Best Practices Work Group was to identify common best practices for training technicians to perform quality, effective service on reusable medical devices.”
The document goes on to say that: “The Medical Device Servicing Collaborative Community believes that there ought to be common best practices for training technicians across all types of service organizations, including original equipment manufacturers, in-house healthcare technology management organizations, and independent service organizations. Medical device servicing quality and effectiveness can be improved by identifying these best practices and sharing them among stakeholders.”
The draft guidance the subgroup has set forth seeks input or feedback from the HTM community and all other interested parties. The document will be available on the Medical Device Servicing Community’s LinkedIn page for review. Those in the HTM community should consider becoming a member of that LinkedIn group.
The MDSC is in the process of ratifying a charter and developing voting processes and procedures, shoring up industry participation and establishing a steering committee.
The pandemic has not slowed the forward progress of the sub-groups very much, and they have continued to meet virtually. The steering committee meets monthly as does the entire committee. The leaders of the sub-groups dictate how often they meet based on their goals.
Francoeur believes that one of the most significant steps could be achieved through a concerted, cohesive effort of the HTM community. There need to be many voices heard in large enough numbers to challenge the OEM representation.
Francoeur also believes that the OEM involvement in what was the Medical Device Servicing Collaborative Community bailed out because the effort was strengthening the non-OEM perspective.
Those participants included the Medical Imaging and Technology Alliance (MITA), who resigned from the MDSCC in June of 2020, Philips, who left the group in June of 2020 and AdvaMed, who also left at the same time.
Francoeur says that there have been some substantive developments in what the MDSC has achieved despite the restrictions caused by the pandemic.
“We have added a new subgroup being led by Katrina Jacobs that she and her team have labeled as Recruiting. They are doing an awesome job creating criteria, establishing guidelines and finding individual groups that would be willing to fill the vacant seats of the steering committee. To date we need additional participation/representation from organizations, end users and OEMs,” Francoeur says.
He says that the Training subgroup has created a draft guidance tool that they intend to be posted (online) shortly, with the intention of having a comment period in an effort to make sure everyone has an opportunity to weigh in.
“The committee has taken the approach that we are developing guidance that can be used by any medical device servicer (OEM, ISO or in-house). Internally this document has been vetted and now we’re seeking wider input on feedback,” says Samantha Jacques in describing the Training subgroup’s draft guidance.
“Education has created a tool that was initially intended to be used internally to ensure everyone within the MDSC was working from the same perspective as it relates to who we are and what each entity represents. It appears it will have much greater value and further reach as it has been met with great response to the HTM community at large in terms of definitions and explanations as to whom and what we are. It’s still in the air as to if this document would go to public comment as well,” Francoeur says.
That “further reach” was part of Jacque’s subgroup’s focus with their recent work.
“The goal was to develop some education so that each constituent group (OEM, ISO, in-house, government/regulatory and users/customers) can understand each other’s perspectives around medical device servicing,” Jacques says.
“It covers the role of each constituent in servicing, the value each brings to the ecosystem, the regulatory burdens that each team faces as well as pain points from each constituent’s point of view. The theme — and take-home message — is that the ecosystem needs all these players and we need to work together to ensure safety and quality in the medical device servicing ecosystem,” Jacques adds.
Jacques says that the MDSC is also working with AAMI to incorporate more work out of the groups into existing AAMI Standards groups.
“For example, there is a team working on QMS standards that align well with a new initiative AAMI has – ISO 5137 – Good Engineering Maintenance Management of Active Medical Devices,” she explains.
Of the QMS group, Francoeur says the group’s role from establishment was, by working with several different existing QMS, they would define which components are best suited for the industry and attempt to provide a draft working document that the industry could use as a reference in an effort to demonstrate their desire to perform safe/quality maintenance of medical equipment.
“They are doing a great job of working through the details,” he says.
“Lastly, would be the Key Performance Indicator (KPI) sub-group; to date they have established the list of KPIs that they feel would best provide data/information that could be used as evidence of an effective program where you as an individual and/or organization could use these to demonstrate that you are providing safe/quality maintenance of medical equipment,” Francoeur says.
Francoeur says that it is important that the totality of the useful resources coming out of the MDSC effort can be channeled in a way to give the HTM community a unified voice when new laws and regulations are being considered. Francoeur points out that the OEM community has the means and the resources to lobby lawmakers.
“First, in an effort to be as inoffensive as possible, I would probably state that to ensure everyone is made aware of the opportunity, and to ensure all sides are having as much as possible of an equal voice to speak and be heard, I’m attempting to utilize the industry platforms to educate the HTM professional, regardless of their employer, so they can at least be aware, informed and have the ability to participate at the level they feel best suits them and their concerns. At the end of the day, every person that walks into a health care facility deserves the right to have safe/quality medical equipment for their needs,” Francoeur says.
He says that finding the most effective ways to make that happen is what should be the most important topic/issue for all of us.
“My comments, when I speak to this opportunity, are with the intent in some small way to share what’s going on,” Francoeur says.
He says that among the dozen or so presentations he has given on this topic to 100 or so individuals sitting in the room each time, when asked who knows what’s going on, the largest response yet was a handful or so of individuals. He says that most of those individuals had sat in one of his previous presentations.
“This concerns me; based on the fact we are a small community in the first place,” Francoeur says.
Regarding the work of all the MDSC sub-groups, Francoeur says; “Wonderful progress is being made.”
The training tool developed by Enbari’s, sub-group, can standardize an approach to training that will defend against any OEM assertions that there is a mishmash of training approaches. To view this discussion or keep up with the latest developments with the MDSC, follow the group page on LinkedIn at linkedin.com/groups/12529335.
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