This article has been updated with a comment from the trade group AdvaMed.
The FDA today announced steps it wants the medtech industry to take to reduce its reliance on ethylene oxide (EtO) as a sterilant.
Based on testimony it received at a recent advisory panel meeting on the sterilant gas, which the EPA considers carcinogenic, the FDA is recommending that medtech companies reduce the amount of paper (such as the labeling and instructions for use manuals) included in a sterile device package and move to delivering that information electronically. A large amount of paper in an EtO sterilization chamber hinders the gas getting to the device and results in higher EtO usage, the agency explained. The FDA said it is working with medtech manufacturers to make the switch where feasible and safe for patients.