EPA starts the clock on new EtO sterilization emissions rule

Commercial sterilization facilities will have two to three years to comply with a new ethylene oxide (also referred to as EtO or EO) sterilization emission rule announced by the EPA today.

However, the EPA said it will not require commercial sterilizers to use lower concentrations of EtO or to limit the use of packaging and pallet material, citing industry feedback.

Addressing the potential for medical device shortages if sterilizers are unable or unwilling to comply, the agency’s final rule also includes presidential authority for two-year exemptions for stationary sterilizers if the commander-in-chief “determines that the technology to implement such standard is not available and that it is in the national security interests of the United States to do so.”

The EPA’s previous proposal would have only allowed 18 months for compliance.

The EPA said the new EtO sterilization limits and air pollution control requirements will …

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FDA backs vaporized hydrogen peroxide as medical device sterilization method

The FDA recently announced that it has classified vaporized hydrogen peroxide (VHP) as an established method of medical device sterilization.

On Jan. 8, the agency said it revised its final guidance to list VHP as an Established Category A method of sterilization.

The FDA’s Category A sterilization methods also include moist heat, dry heat, ethylene oxide (EtO) and radiation. These sterilization methods all have a “long history of safe and effective use on medical devices,” the FDA said.

FDA said adding VHP to Category A should facilitate broader adoption of the sterilization method across the medical device industry. It comes as part of years of work with the EPA and medtech industry to reduce the use of EtO where possible. New EtO rules and regulations are expected in the coming weeks.

The FDA also said its backing of VHP further supports the agency’s efforts to advance medical device supply chain resiliency.

EtO, …

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Court order gives teeth to EPA’s deadline for EtO rule changes

A looming deadline for changes to ethylene oxide (EtO) regulations has new urgency under a consent decree approved by a federal judge this week.

Under the consent decree, the EPA agreed to sign its final review on commercial sterilization standards — including EtO, used for half of all medical device sterilization in the U.S. — by March 1, 2024.

In 2022, a group of plaintiffs including the Sierra Club sued EPA Administrator Michael Regan under the Clean Air Act, accusing the EPA of failing to review sterilization facility emission standards as required every eight years.

The EPA settled that lawsuit this week by agreeing to a court order enforcing the March 2024 deadline. The agreement was signed on Aug. 23 by Judge Reggie Walton in the U.S. District Court for the District of Columbia.

The FDA, commercial sterilizers and medical device manufacturers are working on EtO alternatives to reduce the health risks to workers and communities from emission…

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Sterilization startup Phiex adds ex-Medtronic chief medical and scientific officer as advisor

Phiex advisor Dr. Rick Kuntz was formerly Medtronic’s chief medical and scientific officer. [Photo courtesy o Kuntz]

Retired Medtronic Chief Medical and Scientific Officer Dr. Rick Kuntz has joined Phiex as an advisor as the medical device sterilization startup works toward commercialization.

Phiex is developing a new method for medical device sterilization using dry powder that generates chlorine dioxide gas inside product packaging.

The company sees a big opportunity to offer an alternative to ethylene oxide (EtO) sterilization, which is the most commonly used method in medtech but faces new safety regulations over health risk concerns.

“It’s clear that EtO’s going to have to go away. It’s just not going to be tolerated … and I just think this is the best alternative,” Kuntz said today in an interview with Medical Design & Outsourcing.

Kuntz j…

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