Risk Of Sterilization Plant Shutdowns Across US Sends Shockwave Through Industry
While a number of US states are taking actions that could potentially ban or limit ethylene oxide (EtO) sterilization plants in their communities, the FDA, industry and others are raising the alarm that such moves could lead to a shortage of medical devices critical to patients.
You may also be interested in...
The US FDA may launch a pilot program that would allow PMA-holders to submit updated master files to the agency if the manufacturers change sterilization methods.
Under the US FDA’s voluntary 510(k) Sterility Change Master File Pilot Program, nine firms will be selected to send to the agency updated master files that detail novel sterilization processes without the need to submit a new 510(k). The goal is to move industry away from using ethylene oxide (EtO) to sterilize devices.
The company plans to defend itself against the suits, which were brought by people who say EtO emissions caused cancers, miscarriages and other health problems.