By Keri Forsythe-Stephens
One of my favorite things about 24×7 Magazine is the diversity of our readership. We serve all members of the HTM field—hospital-based biomeds, independent service organizations, OEMs, and everything in between—and stay neutral on all major issues. It’s our way of fully supporting the HTM sector (and maintaining the highest journalistic integrity.)
But that’s not to say that we don’t allow you—our dear readers—to voice your opinions on the major issues affecting the field. We allow you to share your likes, gripes, and deepest convictions in the appropriately named Soapbox column and regularly run Viewpoint articles. We don’t take a side; we provide a forum for you to share yours.
Keri Forsythe-Stephens, Chief Editor
Nowhere is this more evident than in our coverage of the FDA’s bid to distinguish between remanufacturing and servicing. It’s no doubt the hottest—and most contentious—topic currently affecting HTM and we haven’t shied away from covering it. August’s cover story takes our analysis one step further by spelling out the various perspectives on the issue.
Written by Technical Prospects’ CEO, Jeremy Probst, “Viewpoints on Medical Device Servicing”provides an in-depth look at what certain groups (i.e., the OEMs and the FDA) are pushing for in regards to equipment servicing. Probst specifically addresses the medical imaging field—and represents the ISO faction—but I believe he does a good job of putting himself in others’ shoes.
After he wrote the article, however, the FDA made a move that could have wide-ranging implications. On June 27, the agency’s Center for Devices and Radiological Health released a guidance concerning diagnostic ultrasound systems and transducers. It in, the CDRH addressed non-OEM replacement transducers and remanufactured transducers, stating: “FDA considers transducers that are processed, conditioned, renovated, repackaged, restored, or subjected to any modification that significantly changes its performance or safety specifications, or intended use to be remanufactured.”
Actions the agency might deem “remanufacturing” could include changing the acoustic stack, electrical component, or patient-contact material, according to the guidance. (The words “might and could” indicate that anyone performing these types of “repairs” would be subject to an on-site FDA inspection to validate compliance.)
Moreover, the CDRH wrote: “Like new OEM transducers, non-OEM, replacement transducers and remanufactured transducers are new medical devices. As such, they are subject to the 510(k) premarket notification regulations (21 CFR 807.81). They are required to have a cleared 510(k) prior to being marketed.”
So, how could the FDA’s recently released ultrasound guidance translate to the entire medical device sector? Please e-mail me your thoughts on this document at [email protected]. I would love to know what you think.
Keri Forsythe-Stephens is chief editor of 24×7 Magazine.
