EPA Archives - Medical Design Sourcing

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 …

Device strategies to prevent healthcare-associated infections

[Image courtesy of the National Institute of Allergy and Infectious Diseases]

Device design, sterilization before use and proper cleaning of reusable equipment can prevent infections and save lives.

By Ted Eveleth, AvantGuard

Nosocomial infections, also commonly known as healthcare-associated infections (HAIs), are a multibillion-dollar problem and a leading cause of morbidity and mortality around the world. On any given day, about 1 in 31 hospital patients has at least one HAI, according to the Centers for Disease Control and Prevention.

A significant cause for many of these HAIs are medical devices that touch or are implanted in the body, such as surgical implants, catheters and endoscopy devices.

For example, 75% of urinary tract infections in healthcare settings are associated with urinary catheters. Central line-associated bloodstream infection (CLABSI), another category of HAIs associate…

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…

How Phiex could revolutionize medical device sterilization

CL Tian is co-founder and CEO of Phiex. [Photo courtesy of Phiex]

MedTech Innovator winner Phiex is working with medical device manufacturers on an alternative to ethylene oxide (EtO) sterilization.

The new method uses dry chlorine dioxide gas generated inside the medical device’s product packaging. The powder turns into a microbe-destroying gas when exposed to light, Phiex co-founder and CEO CL Tian said in an interview.

Medical device manufacturers can either integrate the powder into their product packaging or as a secondary pouch. And so far, most devices that can be sterilized with EtO can be sterilized with the Phiex process, Tian said.

EtO is the leading sterilization method for medical devices. Manufacturers and contract sterilization firms use EtO on more than 20 billion medical devices every year, or approximately half of all devices that require sterilization.

But the medte…

Jury awards $363M verdict in Sterigenics ethylene oxide lawsuit

Illinois officials halted operations at the Sterigenics facility in Willowbrook, Illinois, after analysis of ethylene oxide (EtO) emissions found potential cancer risks for neighbors. [Image courtesy of the EPA Air and Radiation Division, Region 5]

An Illinois jury has awarded $363 million in an ethylene oxide lawsuit that blamed a Sterigenics sterilization facility’s emissions of ethylene oxide for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma.

It’s the first verdict in hundreds of lawsuits against Oak Brook, Illinois-based Sterigenics, which permanently closed the Willowbrook, Illinois facility in 2019 after state officials halted operations due to high emissions of ethylene oxide (EtO).

PREVIOUSLY: Sterigenics failed to report EtO emissions to EPA, report says

The verdict included $38 million in compensatory damages and $325 million in punitive damag…

FDA reports sterilization challenge progress as EPA takes aim at EtO emissions

Ethylene oxide (EtO) gas can penetrate paper and cardboard, doesn’t discolor or harm plastics used in many devices, and can sterilize truckloads of devices at one time. [Photo courtesy of the FDA]

The FDA offered an update on its efforts to make medical device sterilization safer as the EPA identified 23 U.S. facilities where use of ethylene oxide (EtO) presents a risk to communities.

The FDA said it is similarly concerned about unsafe EtO emissions and highlighted work with the medical device industry to reduce EtO usage and develop new sterilization methods.

Those innovation challenges are making “encouraging progress,” FDA said, with some facilities cutting EtO emissions by an estimated 20% to 35%.

“In general, manufacturers are targeting an ethylene oxide cycle concentration that is 11-66% less than the typical ethylene oxide concentration range,” the FDA said in a news…

EPA flags high-cancer-risk EtO sterilization facilities across the country

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices — and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cance…

Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of care, we would clearly have a unique opportunity for a long time …

Sterifre Medical prepares to launch its Aura desktop disinfection device

The Sterifre Aura disinfection system [Photo courtesy of Sterifre]

Sterifre Medical is demonstrating its Aura device and courting investors as it prepares to launch the automatic point-of-care disinfection system.

The Aura is a portable machine that circulates hydrogen peroxide and activated oxygen with the push of a single button to disinfect stethoscopes, sensors, pumps, tablets, phones, keys, badges and anything else you can fit in the chamber. The device emits no harmful chemicals, leaves no residue and can get into the nooks and crannies that are hard to reach with the disinfectant wipes and handheld sprays traditionally used in health care settings.

“About 85% of things that are cleaned and disinfected in the hospital go through disinfection, not sterilization,” Sterifre CEO Rick Shea said in an interview. “We thought if we could take this technology, miniaturize it and get it close to point of car…

Medline, Sterigenics failed to report EtO emissions to EPA, report says

Ethylene oxide (Image from Sterigenics)

Two companies that use ethylene oxide (EtO) to sterilize medical devices failed to report emissions of the toxic gas to the U.S. Environmental Protection Agency, according to a report by the Chicago Tribune.

Medline Industries and Sterigenics, both headquartered in Illinois, have also operated medtech sterilization operations in the state. Medline continues to do so, and Sterigenics decided in September 2019 not to reopen its EtO plant in Willowbrook, Ill., following a state-ordered closure in February of that year.

Get the full story on our sister site, Medical Design & Outsourcing.

New ethylene oxide regulations now expected in 2022

(Image from the U.S. Occupational Safety and Health Administration)

The EPA now estimates that it will issue propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022.

The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal.

Now the EPA’s inspector general wants the agency to conduct a new residual risk and technology review for commercial and industrial sites that use or produce EtO, particularly because some of these facilities are located in areas populated by people of color or low income.

Get the full story on our sister site, Medical Design & Outsourcing.