由 Gus Iversen
, Editor in Chief | August 10, 2018
From the August 2018 issue of HealthCare Business News magazine
The FDA ignited a debate across the medical equipment landscape when it opened a docket in 2016 aimed at better understanding third-party service. That investigation culminated in May with the publication of the FDA’s findings.
Some imaging stakeholders have praised the FDA’s report and see it as a conclusion to a long debate, while others think the report leaves the industry with more questions than answers, and more work needs to be done.
HealthCare Business News spoke to Dennis Durmis, senior vice president, Head of Americas Region, Bayer Radiology, to find out why he believes legislative action is needed in order to pick up where the FDA left off, ensuring safe medical device service for patients in the U.S.
HCB News: What were the key findings in the FDA's recent report on third party service?
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The FDA issued the following summary of their report:
They believe the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third party servicers, of medical devices that would justify imposing additional/different, and in their opinion, burdensome regulatory requirements at this time.
Rather, the objective evidence indicates many OEMs and third-party entities provide high-quality, safe, and effective servicing of medical devices.
A majority of comments, complaints, and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufacturing” and not “servicing.”
The continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.
The report describes four areas where the FDA intends to pursue action:
1. Promote the Adoption of Quality Management Principles;
2. Clarify the Difference between Servicing and Remanufacturing;
3. Strengthen Cybersecurity Practices Associated with Servicing of Medical Devices; and
4. Foster Evidence Development to Assess the Quality, Safety and Effectiveness of Medical Device Servicing.
HCB News: On June 15, there was a meeting on Capitol Hill to discuss the impact of third-party service and the implications for patient care. Can you tell us about that meeting and the viewpoints that were presented?
The Capitol Hill briefing was sponsored by the Advanced Medical Technology Association (AdvaMed) and the Medical Imaging and Technology Alliance (MITA), in conjunction with Rep. Ryan Costello (R-PA) and Rep. Scott Peters (D-CA) and the House MedTech Caucus, and was chaired by Rep. Anna Eshoo (D-CA) and Rep. Erik Paulsen (R-MN). The briefing provided an overview of third party servicing of medical devices, and the implications for patient care. Specific discussion topics included an overview of the issue and a need for congressional action, from the perspective of medical device manufacturers, third-party servicers, and the patient perspective.