The FDA said today that it will hold an advisory meeting on November 6 and November 7, 2019, to discuss the role of ethylene oxide (EO) sterilization of medical devices in public health, as well as the risks of the sterilization process. The general hospital and personal use devices panel of the FDA’s medical devices […]
ethylene oxide
These 7 trends matter the most for medtech in 2019
The medical device industry is experiencing another eventful year in 2019. Medtech companies face many headwinds, from the U.S.-China trade war to an FDA under fire. But the industry is also seeing the rise of new technologies — especially robot-assisted surgery. In fact, so many major companies are getting involved in robot-assisted surgery that some […]
FDA is looking for options amid medtech’s sterilization crisis
The FDA has issued a pair of challenges to encourage the development of new approaches to medical device sterilization. The first challenge focuses on identifying alternatives to ethylene oxide (EO) sterilization methods. The second seeks input on reducing EO emissions. The agency warned of possible medical device shortages in March following the abrupt closure of a Sterigenics EO plant in Willowbrook, […]