sterigenics Archives - Medical Design Sourcing

New ethylene oxide rules could trigger sterilization consolidation — and new options

Firefighters training on a simulated ethylene oxide leak [Photo via Adobe Stock]

The largest commercial sterilizers will likely absorb the costs of new ethylene oxide (EtO) regulations — and could consolidate smaller competitors, according to a new analysis from Moody’s Investors Services.

Tighter controls on EtO emissions would increase capital spending and operating costs for all commercial sterilizers who use the toxic gas, which is the most commonly used method for eliminating infection-causing microbes from medical devices.

“Large companies have enough liquidity to fund the significant increase in spending without incremental debt,” Moody’s said in a subscribers-only report this week. “But the higher costs and compliance requirements could make the business less attractive for some small companies.”

The largest commercial sterilizers can absorb the cost of new…

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…

MedAccred joins The Irradiation Panel

NEWS RELEASE: MedAccred Program Joins Influential Irradiation Industry Association

MedAccred Sterilization Staff Engineer and Auditor Kim Patton [Photo courtesy of MedAccred]

The MedAccred program has become a member of The Irradiation Panel, a renowned not-for-profit industry association representing global and diverse interests in radiation processing.

The panel is comprised of suppliers and users of irradiated products and irradiation services, regulatory bodies, and consultants. Membership currently consists of 46 companies and nine individual members, including Steris, Sterigenics, BD, Smith & Nephew, NPL, Nelson, IBA, Mevex, and Astra Zeneca.

Established in 1966 and based in the UK, it has members from across Europe and beyond, and provides a forum for discussing the advancement, development, promotion, regulation and practice of radiation processing using electron beam, gamma, and X-ray techno…

Sterigenics to pay $408M to settle Illinois ethylene oxide lawsuits

Sterigenics’ parent company Sotera Health announced that it has agreed to settle more than 870 ethylene oxide lawsuits in Illinois.

The agreements, announced yesterday evening, have Sterigenics paying $408 million to settle the claims filed in the Circuit Court of Cook County and U.S. District Court in northern Illinois.

Sotera Health saw its stock more than double in value today on the settlement news, with SHC shares up 104% to $17.60$ apiece on the Nasdaq.

The settlement comes about four months after a Cook County jury awarded $363 million in a lawsuit that blamed Sterigenics EtO emissions from its now-shuttered Willowbrook facility for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma. The verdict in September 2022 shook the medtech space, which relies on EtO as a major sterilization method for manufactured medical devices. Analysts even wondered whether ethylene oxide liabilities would impact financial results for Sterigenics compet…

Sterigenics to pay $408M to settle Illinois ethylene oxide lawsuits

Sterigenics’ parent company Sotera Health announced that it has agreed to settle more than 870 ethylene oxide lawsuits in Illinois.

The agreements, announced yesterday evening, have Sterigenics paying $408 million to settle the claims filed in the Circuit Court of Cook County and U.S. District Court in northern Illinois.

Sotera Health saw its stock more than double in value today on the settlement news, with SHC shares up 104% to $17.60$ apiece on the Nasdaq.

The settlement comes about four months after a Cook County jury awarded $363 million in a lawsuit that blamed Sterigenics EtO emissions from its now-shuttered Willowbrook facility for a woman’s breast cancer and her son’s non-Hodgkin’s lymphoma. The verdict in September 2022 shook the medtech space, which relies on EtO as a major sterilization method for manufactured medical devices. Analysts even wondered whether ethylene oxide liabilities would impact financial results for Sterigenics compet…

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…

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…

Sotera Health launches educational series covering sterilization, lab testing and more

Sotera Health (Nasdaq: SHC) has launched the Sotera Health Academy to help companies get their products to market faster while navigating regulatory risk.

The Broadview Heights, Ohio-based parent company of Sterigenics, Nordion and Nelson Labs said the program offers more than 100 hours of curated content covering introductory sterilization, lab testing topics and advanced, in-depth learning, plus more than 150 webinars, whitepapers, and e-books from more than 75 industry experts.

Sotera Health’s recent acquisition of Regulatory Compliance Associates (RCA) means more content is on the way, the company said.

“From product conception to commercialization, each stage in the lifecycle of a medical device, pharmaceutical, or commercial product poses unique challenges for manufacturers, especially when patient safety is paramount,” Nelson Labs Chairperson Jeffery Nelson said yesterday in a news release. “The free educational resources contained in t…

Contract manufacturers fuel medtech expansion in Costa Rica

Medical device manufacturing is flourishing in the Central American country, spurred by a host of incentives.

[Image from Unsplash]This year is seeing a wave of expansions by medtech contract manufacturers in Costa Rica.

Medtech OEMs have made the Central American company a manufacturing hub since the 1990s. Major companies operating there include Abbott, Bayer, Boston Scientific, Cardinal Health, Edwards Lifesciences, Hologic, Medtronic, Philips, Smith+Nephew and Wright Medical. Eight of these are among the top 20 exporters in Costa Rica, representing nearly $2.7 million in medical device exports in 2019 — 73% of the total.

Medtech OEMs in Costa Rica want their suppliers nearby, making the Central American country a magnet for contract manufacturers. The addition of medtech sterilization facilities in Costa Rica — BeamOne (now Steris) in 2009 and Sterigenics in 2013 — also helped spur more contract manufacturing. Before that, manufacturers had to ship prod…

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 Mexico AG sues Sterigenics over ethylene oxide emissions

The attorney general of New Mexico has filed a lawsuit against Sterigenics and associated companies claiming a company medtech sterilization plant in Santa Teresa, N.M. has harmed air quality and “materially contributed” to nearby residents’ health risks.

In the claim filed Dec. 22, 2020, attorney general Hector Balderas alleges that Sterigenics has caused “substantial unreported, uncontrolled releases” of the medical device sterilant ethylene oxide (EtO).

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