by
Gus Iversen, Editor in Chief | April 20, 2017
From the May 2017 issue of HealthCare Business News magazine
Medical equipment stakeholders ranging from OEMs to ISOs, refurbishers and health technology management (HTM) professionals came together in 2016 to voice a range of opinions with regard to the FDA’s renewed interest in the terms — and the definitions of the terms — which third-party providers attribute to their services.
For the first time in 20 years, the FDA was taking a microscope to third-party involvement with medical equipment and the industry is still waiting to see what kind of changes could result from what it found.
The administration’s interest in the topic was sparked, according to a docket opened on the FDA’s website, in response to safety concerns that had been brought to its attention.
“We hope that this current effort provides additional clarity on how these activities are defined, and what are some key considerations on the benefits and risks associated with these activities,” Deborah Kotz, press officer of media affairs and external affairs for the FDA, told HealthCare Business News.
Headlines in recent years — issues with duodenoscope reprocessing or patients being overexposed to radiation, for example — have stirred the public interest, but most third-party organizations contend that their safety records speak for themselves and are only hampered by a manufacturing industry that does not always communicate effectively with them.
OEMs, meanwhile, are calling for increased oversight of these third-party organizations, citing the high level of scrutiny their own organizations are subjected to and the comparatively limited data supporting the safety of third parties. From their perspective, neglecting to scrutinize these groups is a disservice to patients receiving care on their equipment.
These two (very generalized) views took shape in the 176 comments that organizations and individuals submitted before the docket’s June 3 deadline.
A few months later, the FDA invited stakeholders to attend a workshop at its Silver Spring, Md., headquarters, where individuals took the floor to further articulate their position and the position of their peers.
Some progress took place at the workshop, including a common interest emerging among virtually all stakeholders, who agreed on the importance of establishing a better record of repairs and service history on a given device. Nobody wants to try to service or repair a piece of equipment without a complete record of all the previous work that has been done on it.
