Remaining MDSCC Members Disappointed About Departures
By John Wallace
Manufacturer trade groups AdvaMed and MITA sent emails a week apart informing members of the FDA-recommended Medical Device Servicing Collaborative Community (MDSCC) that they will no longer participate. Remaining members David Francoeur, senior vice president of marketing and sales for TKA, and IAMERS President Diana Upton each expressed disappointment in the decision.
The creation of the MDSCC was prompted by a 2018 FDA report. The report was issued after a probed found that there was not enough evidence to warrant increased regulation of third-party, or non-original equipment manufacturer (OEM), for maintaining and providing service of medical equipment.
“The Medical Device Servicing Collaborative Community (MDSCC) has been actively working through continuous opportunities since its inception in January of 2019. The group consists of 25 individuals made up of a comprehensive representation across the industry consisting of; Healthcare Delivery Organizations (HDOs), Independent Service Organizations (ISOs), regulatory/industry agencies and Original Equipment Manufacturers (OEMs),” Francoeur explained.
The MDSCC was intended to bring all entities representing the industry together to discuss issues in an effort to find opportunities/solutions related to establishing a baseline, verify tools/key performance indicators (KPIs) that demonstrate, and where possible raise the level of quality, safe maintenance of medical equipment. As of today, the MDSCC has not made the progress they hoped/envisioned, however, progress has been made, and the membership is encouraged and engaged.
“While it is always helpful to have all stakeholders participate and in particular the manufacturers’ trade associations, they departed MDSCC before substantive work in the work groups on Training, QMS, Data/Benchmarking and Education could complete their work,” Upton wrote in an email to TechNation.
One issue that created an obstacle in the MDSCC’s work was a consensus regarding how voting would be conducted within the group.
“A majority of the collaborative group had agreed to a compromise to determining what percentage of the 25 industry representatives would be appropriate to vote on and ratify a position. AdvaMed, supported by MITA, would only accept 100% unanimity. We are at a stalemate. So, why I actually agree with the spokesperson for AdvaMed’s comment that ‘ultimately we did not feel the group made sufficient progress in basic organizational or other areas’ I and many other MDSCC members see AdvaMed supported by MITA as being the cause,” Francoeur explained.
He said anti-trust language was another challenge.
The AdvaMed comment Francoeur is referring to is the following statement from an AdvaMed spokesperson:
“While we appreciated and supported FDA’s aim of bringing together third-party servicers and manufacturers to address issues surrounding the safety of third-party servicing of medical devices, ultimately we did not feel the group made sufficient progress in basic organizational or other areas to justify AdvaMed’s continued participation.”
A MITA spokesperson also shared a statement with TechNation that reads:
“We commend the FDA’s efforts to launch the Collaborative Community and trust that there will be future opportunities to work with FDA and others to promote safety and quality in medical device servicing. But despite over a year of regular meetings and numerous attempts to find consensus, it has become clear that progress is unlikely any time soon given the divergence of opinions held by participants as well as the time constraints imposed on industry by the COVID-19 pandemic. For this reason, MITA will no longer participate in the Collaborative Community.”
Francoeur said that there had been a few instances where smaller work groups had been commissioned to work on specific projects. In each case the smaller groups meet with success measured by, short time frames, and successful outcomes. The MDSCC seeing how this method appeared to work, it was decided to formulate four more such groups. The four groups and the challenges they are tasked with and the chairperson for each are:
- Training tools/manuals – What should be available to ensure high quality and safe maintenance of medical equipment? Chairperson Robert Kerwin
- Definitions – What are the terms and their definitions so the industry can have a common set of accepted nomenclature? Chairperson Samantha Jacques
- Quality Management System – What would be the important aspects of a quality management system that the industry could use to demonstrate they are working to an acceptable level and providing high-quality, safe maintenance of medical equipment? Chairperson TBD since the MITA representative will no longer be participating
- Key Performance Indicators – What are the set of metrics that the industry would accept and see as evidence that the service entity was providing high-quality and safe maintenance of medical equipment? Chairperson Dave Francoeur
Individuals with an interested in participating in one of these group should reach out to the chairperson, Francoeur said.
Going forward, Francoeur and Upton said they will continue to work with the other stakeholders to complete the work of the MDSCC.
“In speaking with a few of my colleges of MDSCC and through these four groups, with or without AdvaMed and MITA participation, we will continue to provide the MDSCC as well as the FDA recommendations that will advance the HTM profession in an enhanced manor regarding quality and safe maintaining of medical equipment,” Francoeur said.
“IAMERS is committed to continuing to work with the remaining stakeholders including the HDOs, regulators, accreditation organizations, Veterans Administration and others to attempt to work for patient safety and for best practices,” Upton said.
However, they each said that they understand that the organizations supporting the unique interests of OEMs will continue to use other avenues to achieve goals that benefit their members.
“IAMERS favors collaboration and is disappointed that AdvaMed and MITA have elected to depart. We are aware that they continue to report lobbying expenses pertaining to lobbying before the U.S. Congress and other legislative and regulatory bodies on issues including third-party servicing. We think a better use of their time would be to confer with the other parties in the health care ecosystem, but they are, of course, free to undertake what they consider to be best for the industry and for their members,” Upton said.
