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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DeviceTalks Boston 2024: Our favorite panels and new additions

Our team picks favorites from our upcoming show, including some new additions to the program.

Leaders from CMR Surgical, the developer of the Versius surgical robotics system, will speak at DeviceTalks Boston 2024. [Photo courtesy of CMR Surgical]

I enjoy reading bookstore staff recommendations. It’s nice to see how people in the know like to spend their time.

But if you asked me to pick my favorite panels on the agenda for DeviceTalks Boston, taking place May 1–2, 2024 at the Boston Convention & Exhibition Center, I couldn’t do it.

In fact, I won’t do it. Sorry, dear reader, I’ve put too much into this agenda to pick one favorite session. Plus, I owe neutrality to our speakers — amazing professionals willing to give up two days to help me create something. That’s a covenant that I cannot violate by selecting a favorite.

But I can put our editorial team on the spot to pick their favorites. And…

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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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FDA accepts Steris as first contract sterilizer in Radiation Sterilization Master File Pilot to reduce ethylene oxide use

The FDA has accepted Steris as the first contract sterilizer for its Radiation Sterilization Master File Pilot Program.

That program is part of the agency’s initiative to promote new and existing alternatives to ethylene oxide (EtO). EtO is the most commonly used sterilization method for medical devices due to its ability to permeate packaging in bulk quantities. But the medtech industry faces EtO sterilization capacity limits and new regulations that could increase sterilization costs or wait times.

Steris Applied Sterilization Technologies (AST) customers can now use the contract sterilizer’s master file with the FDA to change the way their devices are sterilized, making it easier for them to move from EtO sterilization to gamma radiation.

The master file would also simplify sterilization site changes or processing redudancy additions, moves to non-gamma radiation medthods such as X-ray or electron beam sterilization, and reduced ga…

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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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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…

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AdvaMed warns Biden of threat from EtO facility closures

AdvaMed CEO and President Scott Whitaker [Photo courtesy of AdvaMed]

The Advanced Medical Technology Association (AdvaMed) shared industry concerns over new ethylene oxide (EtO) regulations with President Joe Biden, warning that sterilization facility closures could cause device shortages.

In a new letter to Biden, AdvaMed President and CEO Scott Whitaker said the medtech industry welcomes updated regulations for EtO sterilization facilities and reiterated patient safety warnings.

“With 20 billion medical devices sterilized using EtO each year in the U.S. at about only 100 facilities, the closure of even a small percentage of facilities could harm patient access to health care,” Whitaker wrote. “EtO sterilization is at capacity. With 80 percent of surgical kits alone sterilized using EtO, any shutdown-induced disruption could reverberate from screening to the operating room to post-oper…

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Steris stock downgraded as analysts expect lawyers to seek more ethylene oxide lawsuits

Steris (NYSE: STE) stock was downgraded today by Needham from buy to hold following the $363 million jury verdict against its primary competitor, Sterigenics, over ethylene oxide (EtO) emissions.

Needham analysts said they expect attorneys to target communities near EtO facilities with ads to find people willing to file more lawsuits against sterilization plant operators past and present.

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

The analysts believe Steris can manage any EtO legal liabilities due to the company’s size, diversification and balance sheet, but said investors are looking forward to Steris estimating and reserving cash for potential liabilities.

“Since breast and blood cancers are relatively common, we worry that attorneys could have success in finding additional people willing to file more lawsuits,” the analysts wrote. “We expect the risk of lawsuits and any n…

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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…

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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…

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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…

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Cardinal Health subsidiary faces federal lawsuit over EtO plant in Georgia

[Image from U.S. Occupational Health and Safety Administration]

Nearly two dozen people who have lived in the Augusta, Ga. area are suing Cardinal Health subsidiary Kendall Patient Recovery U.S. over ethylene oxide emissions from a medical device sterilization plant in the city.

The people suing KPR U.S. in U.S. District Court in Southern Georgia lived and worked within miles of the Augusta facility over the decades and claim that they never had any notice that they were inhaling air that was potentially endangering their health. Industrial users of EtO, according to the plaintiffs’ lawyers, knew of EtO’s potential dangers by the early 1980s. (The EPA classified ethylene oxide as a human carcinogen in December 2016.)

The people suing KPR U.S. suffered a host of cancers, including breast cancer, B-cell lymphoma, ovarian cancer and colon cancer — as well as miscarriages. In a separately filed l…

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