Calling it a threat to the planet, the Biden administration is restricting use of a popular and critical hospital disinfect, which is prompting warnings of vast deadly consequences.
Ethylene oxide, or EtO, is widely used by hospitals to disinfect tools and instruments that would be damaged by heat sterilization.
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The Food and Drug Administration reports that approximately 20 billion medical devices, or half of all those used, and 95 percent of surgical kits are sterilized each year using EtO. For most of these devices, EtO is the only validated and viable sterilization method, the U.S. House Energy and Commerce Committee Committee notes.But under a proposed rule from the Biden administration, hospitals would be strong-armed into drastically reducing its use. Many warn the consequences could be widespread harm and death from a surge in hospital infections.
Three lawmakers, Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA), Environment, Manufacturing, and Critical Materials Subcommittee Chair Bill Johnson (R-OH), and Health Subcommittee Chair Brett Guthrie (R-KY) are among those sounding the alarm, sending a letter to the White House warning of the potentially deadly results.
They write:
“The FDA attests to the high scientific standards of EtO use as a sterilizer in preventing the growth of harmful microorganisms relative to other sterilization methods and acknowledges that inadequate sterilization can lead to life-threatening infections and poor health outcomes in patients seeking medical care. Furthermore, we share FDA’s concerns that EPA’s proposed actions will cause significant disruptions in patient access to emergency care, including surgery instrumentation and pacemakers, and threaten patient safety with increasing hospital-borne infections.”
[…]
“On June 27, 2023, the American Society for Health Care Engineering, the American Society for Health Care Risk Management, the Association for Health Care Resource and Materials Management, and the American Hospital Association wrote to the EPA to: ‘Urge caution and thoughtfulness in EPA’s approach to avoid disrupting health care delivery through the unintentional fracturing of the already fragile medical device supply chain. Such fracturing could put patients at risk of serious harm . . . [s]pecifically, we are concerned that moving too quickly to implement and enforce new standards will result in the unexpected consequence of reducing EtO sterilization capacity, ultimately leading to delays in patient care.’”
