The U.S. FDA has extended the commentary period for feedback regarding its December workshop to differentiate between medical device servicing and remanufacturing by one month. HTM professionals, independent service organizations, and original equipment manufacturers can now comment on the workshop, as well as its associated white paper, Evaluating Whether Activities Are Servicing or Remanufacturing, until February 25.
December’s public workshop—titled “Medical Device Servicing and Remanufacturing Activities” and held in Gaithersburg, Md., over a two-day period—was organized to help the agency gather feedback for a future draft guidance, something discussed in the agency’s May 2018 servicing report. Follow these links for 24×7 Magazine’s inside look at day one and day two of the FDA’s workshop, as well as webcasts of the event.
“The discussions at the workshop and comments received in the docket will be considered when developing draft guidance as noted in the ‘Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices’ (‘FDA Report on Device Servicing’) in accordance with section 710 of the FDA Reauthorization Act of 2017,” FDA officials said in late 2018.
To submit a formal comment regarding medical device servicing and manufacturing, click here.
There is a significant difference in servicing a device and remanufacturing a product. Servicing and restoring a device to it’s operable state and extending it’s operational life through a repair is totally different than remanufacturing a device. In my opinion the remanufacturing of the device is to disassemble and replace all components of wear and tear that may compromise the operable integrity of that device, validate that all electronic capabilities still meet the original equipment manufacturers specifications, all current software revisions are up to date, all field correction orders or modifications are current and that the equipment is as clean as new equipment. Refurbished or re-conditioned equipment takes on a different definition that should be considered as “used” but validated to meet the current specifications of the specific device. There are still companies out there that have the “spray and pray” approach to remanufactured equipment that need to be weeded out.
It is critical for the CE/HTM community to provide its perspective based on several decades of safe and effective servicing of medical equipment. It would be disastrous if the entire field gets dragged down into the mud by a few naive or recalcitrant persons or organizations exceeding the limits of servicing and venturing into remanufacturing. A report of the ACCE task force that attended and participated in the Workshop is available at https://accenet.org/NewsEvents/PressReleases/ACCE%20FDA%20Task%20Force%20Report%20on%20FDA%20workshop.pdf.