AdvaMed CEO and President Scott Whitaker said all of the listed facilities are in compliance with regulations and warned against closures.
“The shutdown of medical device sterilization facilities due to misinformed political pressure, as well as the uncertainty regarding which regulations the facilities must adhere to as EPA works to update the federal rule, would be disastrous to public health under the best of circumstances; it could be catastrophic, in light of the fragile global supply chain, which hospitals are already strained to address,” he said in a news release.
Whitaker said some sterilization facilities are voluntarily cutting emissions, and many “capture emissions beyond federal and state requirements because their No. 1 priority is the safety of their employees and neighbors.”
RELATED: FDA reports sterilization challenge progress as EPA takes aim at EtO emissions
He agreed with the EPA on the need for further research to understand background levels of EtO outdoors, safe levels for health, and ways to make EtO safer while balancing the needs of patients and medical device manufacturers.
“It is critical that the EPA get this right,” Whitaker said. “Too much is at stake, as the FDA notes: this is a ‘vital process for helping to prevent serious infections’ and ‘other methods of sterilization cannot currently replace the use of EtO for many [medical] devices.’”
Advamed has more information about EtO and sterilization at its website.