The latest global regulatory news, changes and updates affecting medical devices and technologies, including: CRS: Supply chain for testing still under pressure; AHRQ eyes provider-to-provider telehealth; Health Canada emphasizes nursing homes in report on testing; Advamed, Georgia Bio sound off on EtO.
The latest global regulatory news, changes and updates affecting medical devices and technologies, including: EPA posts ethylene oxide rule on OMB agenda; HHS announces sustained support for testing; FTC gives nod to Stryker/Wright deal.
The response from industry regarding the Environmental Protection Agency’s (EPA) draft rule for ethylene oxide (EtO) varied considerably, but the Advanced Medical Technology Association (Advamed) argued a fundamental methodological point in its comments to the docket. Advamed’s Ruey Dempsey said the EPA approach to determining safe levels of EtO relies on “a single epidemiological study,” an approach Dempsey said has drawn fire from the National Academies of Science.
The U.S. Environmental Protection Agency (EPA) has posted an advanced notice of proposed rulemaking for control of ethylene oxide emissions (EtO), which would update a 2006 final rule that declared no additional controls for EtO were necessary. However, the agency’s latest proposed rule makes note of several technological advances that allow for greater control of EtO, a fact that could drive a greater regulatory requirement for containment and destruction of EtO emissions at medical device sterilization plants.
Sterigenics US LLC, of Oak Brook, Ill., has announced it will not reopen its ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., a development that could strain the capacity for sterilization of devices such as duodenoscopes. Illinois is not the only state that is taking action on EtO, however, a predicament that suggests the U.S. federal government may have to insert itself into the discussion in order to avoid a shortage of critical, life-saving devices.