The Thin HTM Line
The Corner Office
Wayne Moore
11/11/2024
I was honored in October to give a presentation at the Clinical Engineering Association of Illinois (CEAI). The presentation was focused on how to read an FDA Guidance document in order to use the information gleaned from reading it as a template for vetting potential third-party service providers. The title of the presentation must have resonated with attending HTMs, as the attendance was standing room only.
As I looked out upon the audience, I saw professionals who have dedicated their lives to ensuring that medical devices in their care are and remain safe, functional, and effective. To use a metaphor, I saw them as the “thin blue line” between technology coming into the hospital and the patients these devices would ultimately be used on/with. As I discussed the role of HTMs as the primary vetting agent for selecting third-party servicers to repair or replace defective devices, the outline in the FDA documents became clear to them — specifically, third-party servicers must understand what they are responsible for in terms of quantitative testing and documentation of the parts and/or components they will be using during a repair activity; objectively demonstrating that the repair activity has returned the device to substantial equivalence to the OEM specifications.
Following the Standards for testing that the FDA recognizes, such as the ultrasound device Table listed above, which is found in the FDA’s Ultrasound Guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-clearance-diagnostic-ultrasound-systems-and-transducers. In the recently released FDA Guidance for Remanufacturing versus Servicing, the Agency clearly stated that “Self-identifying as a servicer has no meaning, the activity you are performing defines whether you are servicing or remanufacturing.” The takeaway from the presentation was: Don’t take the word of a third party that they are servicing — demand they show you the testing and OEM comparisons they are doing to ensure they are returning the device to substantial equivalence.
As the metaphorical “blue line” for patients, the HTMs are the gatekeepers for repaired medical devices being returned for use on/with patients. HTMs are amazing.
Until next month,
Wayne