Members of the MD Expo keynote panel included (from left to right) Rob Kerwin, general counsel, IAMERS; Kelly Proctor, physical environment Sector Lead, DNV-GL Healthcare; Dave Francoeur, senior director, brand and quality, Sodexo CTM; G. Wayne Moore, CEO, Acertara Laboratories; and Peter Weems, senior director, strategic operations and policy, Medical Imaging and Technology Alliance (MITA).
The ongoing discussion of the FDA report “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (FDA Report on Device Servicing) created in accordance with section 710 of the FDA Reauthorization Act of 2017 (FDARA) continues to be a hot topic in the Healthcare Technology Management community.
Therefore, it is no surprise that the MD Expo keynote address “Updates to Regulatory Affairs and Opportunities” included some debate with what some attendees described as “heated exchanges” among panelists. The session, sponsored by Medigate, provided HTM professionals with valuable information.
The panel discussion included stakeholders from a variety of backgrounds, including G. Wayne Moore, CEO, Acertara Laboratories; Dave Francoeur, senior director, brand and quality, Sodexo CTM; Rob Kerwin, general counsel, IAMERS; Kelly Proctor, physical environment Sector Lead, DNV-GL Healthcare; and Peter Weems, senior director, strategic operations and policy, Medical Imaging and Technology Alliance (MITA). The panel discussion was moderated by Christopher G. Nowak, CBET, CHP, CSCS, senior director, HTM, UHS of Delaware Inc.
The FDA Report on Device Servicing discussed the continued quality, safety and effectiveness of servicing of medical devices by original equipment manufacturers and third-party entities. The report was informed by feedback and comments from an open docket and a public workshop held in 2016, among other information. Based on the available information, the FDA stated the current available evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing of medical devices that would justify imposing burdensome regulatory requirements. The FDA Report on Device Servicing also included several actions the FDA intends on pursuing.
Among those actions are continued discussion, defining whether activities are servicing or remanufacturing and the creation of “Collaborative Communities.”
In response to a December 2018 workshop, MITA was among several individuals and organizations to answer the FDA’s call for comments.
“In both the May 2018 ‘Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ as well as the December 2018 workshop, the Agency made clear that it would like to encourage the development of and participation in ‘Collaborative Communities’ as vehicles for public and private stakeholders to ‘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.’ In this instance, the Agency believes ‘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.’ The Agency also states its willingness to facilitate the creation of such a community, pending sufficient interest from stakeholders,” MITA states in its comments to the FDA.
During the MD Expo keynote address, Weems said he does not expect the “Collaborative Community” to form quickly.
“We are still trying to figure out what is going to happen with this Collaborative Community,” Weems said. “It is probably going to take a long time. Not months, but years.”
Kerwin shared the next FDA meeting will likely address a “largely shared understanding of QMS (Quality Management System).” He also said he still sees issues regarding service keys, access to manuals and technical drawings.
Kerwin added that a July 2019 FDA meeting on the right to repair is a “chance to address the elephant in the room.”
Moore said he hopes to see progress as the FDA also looks to define servicing and remanufacturing in an effort to move the discussion forward.
The process will shine a light on service and remanufacturing and a look at the differences between the two, Moore explained.
“I am hoping for, and looking for, more cooperation at looking at what is servicing and what is remanufacturing,” Moore said. “This does not apply to biomeds in hospitals, but to third-parties.”
Francoeur replied that the FDA has not yet decided and that the definitions could be applied to in-house biomedical teams as well as third-party service providers.
“Until it gets clearly defined it could cause us all angst and anxiety,” Francoeur said.
“The FDA has left a lot of gray area in any definition. We need a clear definition,” Moore said.
Proctor said better definitions will empower his accrediting organization to better serve health care delivery organizations and promote patient safety.
“We enforce rules, but when the rules are gray it’s difficult,” Proctor said.
Panel members seemed to agree that progress is being thwarted by a lack of confidence in what are seen as competing interests.
Kerwin and Weems both said a lack of trust continues to be a roadblock, especially between device manufacturers and third-party service organizations.
“There is a lot of trust that needs to be built,” Weems said. “There is a lack of trust because of competitors. We (MITA) published a white paper on remanufacturing and one thing that became clear is that nothing is clear.”
When asked to predict the future, panelists echoed a desire to continue to focus on patient safety.
“Particularly through this Collaborative Community, we will come to see how much we agree. We are all here because we care about patient safety,” Weems said. “I’d love to see a standard that is multi-stakeholder and defines quality.”
In regards to access to service keys and product manuals, Weems said “our member companies make available what is required by contract or regulation.” He added that MITA has thousands of member companies and that they each think about that differently.
Francoeur inserted that competition should not get in the way of what is important. And, he added that it should not be about the “financial impact.”
“It’s not really OEM versus non-OEM. It really shouldn’t matter,” Francoeur said. “Whatever is best for patient safety is what is important. Whatever is required, get the job done.”
The panel wrapped up the discussion by fielding questions and comments from the meeting room packed with more than 200 attendees.
In closing, Francoeur added that it is time to plow forward with the FDA on this issue and create a solution. He insisted that this is not something that can be kicked down the road and left for future generations to encounter.
“We need to break down walls. We need to guide and direct instead of getting run over,” he said about working with the FDA and a Collaborative Community of stakeholders. “Let’s change the language and perspective and get to the other side.”
“It’s more than getting it done, but getting it done right,” Francoeur said.
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