Ethylene oxide (EtO) is a chemical that is used to sterilize more than 50% of all medical device types and is crucial for preventing infection in patients undergoing surgeries and other medical treatments. For active implantable medical devices, EtO is pretty much the only option for sterilization. Alternative methods such as steam, radiation, or other sterilants either damage the device or do not achieve the needed levels of sterility assurance.
The US Environmental Protection Agency has been waging a war against the use of EtO by establishing an unreasonably low value for EtO concentration in its Integrated Risk Information System (IRIS). AdvaMed (the Advanced Medical Device Association) has urged the EPA to reassess its EtO value for one that is more feasible, based on the best available science and that will not potentially endanger the public health by threatening the availability of needed medical technologies.
AdvaMed President and CEO Scott Whitaker stated:
“… EPA’s EtO risk assessment standard is unworkable and not based on the best available science. The agency’s failure to address these valid scientific concerns surrounding their value threatens not only the medical technology supply chain but the tens of millions of American patients that rely on EtO-sterilized devices. We ask the agency to follow its own scientific recommendations and develop a revised EtO risk assessment standard that will effectively protect the public health and not disrupt patient access to needed medical technology.”
Click here to read AdvaMed’s complete response to the EPA.