Updated AAMI standard addresses chemical sterilization safety, compliance
Editor's Note New guidance from The Association for the Advancement of Medical Instrumentation (AAMI) addresses regulatory and safety concerns for hospitals using ethylene oxide (EO) for medical device sterilization—a pressing concern due to EO’s effectiveness but associated health risks. ANSI/AAMI ST58:2024, an update on chemical sterilization and high-level disinfection practices…
Updated ethylene oxide sterilizer standard covers latest technology
Editor's Note The Association for the Advancement of Medical Instrumentation (AAMI) has updated its standard on ethylene oxide (EO) sterilizers for healthcare facilities, according to a June 12 press release. The first update in two decades, the fourth edition ANSI/AAMI ST24:2024 covers labeling, safety, performance, and testing requirements for general-purpose…
EPA rule to limit dangerous emissions from medical sterilization plants
Editor's Note The Environmental Protection Agency (EPA) has finalized a rule to reduce chloroprene and ethylene oxide emissions that will impact over 200 chemical plants across the nation, including medical sterilization plants, according to an April 10 report from USA Today. Under the new rule, the EPA will cut more…
New EPA standards to reduce ethylene oxide emissions
Editor's Note New standards from The Environmental Protection Agency promise to cut nationwide emissions of ethylene oxide—employed to sterilize more than half of US medical devices—by more than 90 percent. According to a March 15 MedPage Today report, the aim is to reduce cancer risk among the 13 to 14…
Session: What to expect from healthcare policy, regulation in 2024
Editor's Note Since the pandemic, the view of the healthcare industry in congress has essentially gone from “hero to zero” – a shift with potentially big implications for the healthcare business leaders gathered at yesterday’s closing session from Soumi Saha, PharmD, JD, senior vice president of government affairs at Premier…
AHA urges EPA to ensure proposed EtO standards don’t disrupt healthcare delivery
Editor's Note In a June 27 letter, the American Hospital Association (AHA) urged the Environmental Protection Agency (EPA) “to avoid disrupting healthcare delivery through the unintentional fracturing” of the medical device supply chain with its proposed ethylene oxide (EtO) standards. The EPA proposes: reducing EtO emissions by 80% adding new…
EPA proposes new standards to lower EtO emissions by 80%
Editor's Note The Environmental Protection Agency, on April 11, proposed new regulations to reduce exposure to ethylene oxide (EtO), which include more stringent air emission standards and protections for workers who are exposed to EtO when sterilizing medical devices. The proposed standards are estimated to cut EtO emissions from commercial…
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