By Keri Forsythe-Stephens
As the voice of the HTM sector since 1996, 24×7 Magazine always stays up to date on the latest happenings in the industry. And suffice it to say that a lot has happened recently. Following the FDA’s public workshop in December to distinguish between remanufacturing and servicing—a two-day event that we covered extensively here—the FDA announced in late January that it would extend the feedback period by one month.
Now HTM professionals, independent service organizations, and original equipment manufacturers can comment on the workshop, as well as the FDA’s associated white paper, Evaluating Whether Activities Are Servicing or Remanufacturing, until February 25. (Want to lend your voice to the matter? Click here to share your thoughts.)
Commenting, it seems, may strongly influence the FDA’s next moves. In late 2018, the agency revealed that it would weigh the discussions that took place during the workshop, as well as the comments received in the docket, when developing draft guidance as noted in the “Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices” (“FDA Report on Device Servicing”) in accordance with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.
So speak up, implores Binseng Wang, a member of 24×7 Magazine’s editorial board and a panelist who represented the American College of Clinical Engineering at the FDA’s December workshop. Wang encourages his colleagues in HTM to validate the “decades of safe and effective” equipment servicing; otherwise, the “entire field [will get] dragged down in the mud by a few naive or recalcitrant persons or organizations exceeding the limits of servicing and venturing into remanufacturing”—something he deems disastrous.
In addition to possibly affecting the FDA’s draft guidance regarding servicing and remanufacturing, your feedback is also welcomed in 24×7 Magazine. In the February issue, we launch “Heroes of HTM”—a new feature profiling individuals who have made strong contributions to the HTM field—and we need your help.
We need you to tell us about the movers and shakers of HTM and nominate your colleagues for this distinction. Up now is a profile on Ismael Cordero, a professional whose contributions to the HTM field can be felt globally. But the heroes in subsequent issues of 24×7 Magazine? That’s up to you.
If you have a friend or colleague who is a rising star of HTM—or a legend in the field— email me at [email protected] and let me know. Just make sure to include “Heroes of HTM” in the subject line.
Keri Forsythe Stephens is chief editor of 24×7 Magazine.