MPO’s Most-Read Stories H1

Regulatory ruled thus far this year.

FDA-related news was most favored by MPO’s digital guests during the first six months of 2024, according to website analytical data. The top choice, not surprisingly, concerned the medtech industry’s struggle to contend with the U.S. Environmental Protection Agency’s (EPA) crackdown on ethylene oxide emissions. In January, the FDA announced that it considers vaporized hydrogen peroxide (VHP) to be an “established method of sterilization” for medical devices. The agency revised its final guidance Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile to list VHP as an example of an Established Category A method of sterilization. The FDA hopes the update will bring about broader VHP adoption, part of its multi-pronged approach to reducing ethylene oxide (EtO) use.

The medical device sector is scrambling to find alternative sterilization options in light of the EPA’s mandate to cut EtO emissions at commercial sterilizers by 90%. Industry trade group AdvaMed has repeatedly noted there are no viable substitutes for many medtech products and has warned of supply chain shortages for critical devices. Moreover, finding other cleaning methods won’t be easy or quick, and the validation process necessary for new methods could be particularly troublesome. 

Ranking behind the FDA’s EtO-related recommendation was the agency’s springtime clearance of AIOMEGA’s obstructive sleep apnea treatment device, AIO BREATHE. The new mandibular repositioning device designed by Tyler, Texas-based board-certified sleep physician and AIOMEGA Founder/CEO Raghavendra V. Ghuge, M.D., functions as an antero-vertical mandibular repositioner when used during sleep. 

Garnering the third-most pageviews through June 30 was the Class I designation in January (by the FDA) of ResMed’s safety notice for its AirFit and AirTouch CPAP masks. ResMed issued the safety notice in December 2023, warning patients about potential magnetic interference when the masks’ magnets are near some implants and devices in the body. The AirFit and AirTouch masks are non-continuous ventilatory devices, intended to be used by patients weighing over 66 pounds who have been prescribed non-invasive positive airway pressure (PAP) therapy such as CPAP or bi-level therapy. The masks are meant for reuse by one person at home or by multiple people in hospitals.

Other high first-half traffic drivers included Integer’s $140 million acquisition of Pulse Technologies shortly after the new year, and the magazine’s in-depth look at full-service outsourcing in May.
 

1. FDA Encourages Vaporized Hydrogen Peroxide as Possible EtO Alternative

2. FDA Clears AIOMEGA’s Sleep Apnea Treatment Solution

3. ResMed’s CPAP Mask Recall for Magnetic Interference is Class I

4. Integer Buys Pulse Technologies for $140M

5. Partner Preference in Full-Service Medical Device Outsourcing