by John R. Fischer
, Senior Reporter | December 05, 2018
The Summit on Safety, Quality and
Effectiveness of Servicing Medical Devices
As the RSNA annual meeting wound down last Thursday in Chicago, medical equipment OEMs, third-party servicers, clinical engineers and industry associations came together at the Swissotel Chicago hotel to discuss the FDA report on equipment service and seek consensus on the road ahead.
Dubbed the Summit on Safety, Quality and Effectiveness of Servicing Medical Devices
, the event was held in response to the FDA's call for Collaborative Communities to work together addressing challenges and ambiguities in the service arena. Hosted by the Alliance for Quality Medical Device Servicing, a group of independent third-party service providers, the meeting also looked ahead to the December 10-11 FDA Workshop
to address the distinctions between servicing and remanufacturing.
The all-day event focused on four key points of interest identified in the report:
Service versus remanufacturing
- Clarify the Difference Between Servicing and Remanufacturing
- Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices
- Promote the Adoption of Quality Management Principles
- Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing
Although attending OEMs, providers and third-parties all described feeling confused as to which term a specific action falls under, "servicing" or "remanufacturing", most agreed that the distinction must lie in the extent of the changes made.
“If the change is made so that it goes back to the way it was originally labeled and marketed, that doesn’t constitute a change significantly. Otherwise, that would warrant a title change,” said David Francoeur, senior director of brand and quality for Sodexo Clinical Technology Management. “If a change has been done that alters the original intent, then I think we should label it as something that needs to be looked at differently.”
A white paper entitled “Evaluating Whether Activities are Servicing or Remanufacturing”
was issued by the FDA in conjunction with the workshop announcement in October and provides additional insight into how they are approaching the discussion surrounding these two terms.
Comments concerning the white paper are being accepted at https://www.regulations.gov
in Docket No. FDA-2018-N-3741 until January 25, 2019.