June 13, 2019
by John R. Fischer , Staff Reporter
A panel of representatives from across the medical equipment service industry gathered at AAMI to discuss perspectives and activities surrounding the FDA white paper for distinguishing servicing from remanufacturing.
Designed to be a guide on the differences between the two activities, the aim of the paper is to establish a collaborative community among OEMs, ISOs, in-house HTM and other stakeholders to ensure such activities do not compromise patient safety. Katelyn Bittleman, CSO for the FDA, emphasized the need for this type of community for the communication of evidence regarding this risk.
“There is not very robust evidence to show there’s an issue, and there is not very robust evidence to show there is not an issue,” she said. “We really want to challenge the industry to create that baseline, create that evidence. We know that everyone has it, in silos. But we want to promote that collaboration to move forward and get to the key issue. We really believe this is a multi-stakeholder effort, and if you are working in those silos, it’s really not going to go anywhere.”
Robert Philips, vice president of quality operations and compliance at Siemens Healthineers, pointed to patient safety as the number one priority, and that ensuring the high-quality and effective servicing requires a robust and transparent process.
“The robustness in our process has to define and develop the right parts for our devices that go through extensive validation and verification on our systems and within our manufacturing departments to prove those parts can work on the systems once they’re actually deployed and installed,” he said. “We need to ask who, what, where, when and how servicing was performed. We at Siemens try to take this approach to see how this servicing is being done and make sure there is transparency around that servicing, so that anyone that comes in after us can troubleshoot or fix the device.”
Binseng Wang, chair of the International Committee for the American College of Clinical Engineering, agrees with establishing greater transparency, and says doing so requires access to documentation such as service manuals and instructions.
“Without that, it’s not possible to answer the questions with the service organization as to whether they did or did not change the specifications because you don’t know how you’re going to check that,” he said. “If there are components or parts that are critical to the safety and performance of the piece of equipment, they have to be outlined in the documentation so we can know whether we are dealing with an insignificant part or a more critical function of the equipment.”
In a ten-point speech, panelist Robert Kerwin, general counsel for the International Association of Medical Equipment Remarketers and Servicers, reiterated these points but also emphasized the need to provide not just efficient and high quality servicing but affordable as well.
“Health organizations and hospitals should have choices. We are particularly concerned as regional and rural hospitals face closure at record number because of commercial obsolescence issues and the availability of parts,” he said. “Not every Microsoft change to Windows XP on your printer should require new equipment.”
The development of the white paper followed the completion of a two-year FDA investigation which concluded in May 2018 that there was no evidence to suggest that the servicing activities of third-party providers leads to adverse events that put patient safety at risk.
Following a workshop in December to assess the value and ease of the white paper, public commentary for thoughts and improvements was open to the public until February. Another for the final draft is also set to take place in the near future.