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…

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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…

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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.

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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).

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6 Georgia residents suing Sterigenics, BD over ethylene oxide exposure

Ethylene oxide (Image from Sterigenics)

The first six of what attorneys said could be more than 100 lawsuits were filed recently in Georgia against Sterigenics and Becton Dickinson (NYSE:BDX) by people who have lived, worked or attended school near those companies’ medical device sterilization plants.

The plants use ethylene oxide (EtO) to sterilize millions of devices per year and reportedly have emitted  thousands pounds of the gas into the atmosphere over the past. The U.S. Environmental Protection Agency named EtO a Level 1 carcinogen in 2016. Two years later, the EPA’s National Air Toxics Assessment identified 12 areas of the country with elevated levels of EtO emissions and associated cancer risk, including the areas of Georgia where BD and Sterigenics have EtO plants.

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600 new ethylene oxide lawsuits filed against Sterigenics in Illinois

Ethylene oxide (Image from Sterigenics)

More than 600 lawsuits were filed last week against Sterigenics, claiming that emissions from the company’s now-shuttered Willowbrook, Ill., ethylene oxide (EtO) plant caused health problems in people who lived or worked nearby.

The filings bring the total of personal-injury lawsuits against the Oak Park, Ill.-based company to more than 700, according to one of more than a dozen Chicago-area law firms that have filed lawsuits against Sterigenics; its parent company, Sotera Health; previous parent company Griffith Foods; current investor, private equity firm GTCR; and two managers.

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Sterigenics sues Ga. county officials over EtO-related property tax devaluations

Sterigenics has filed a lawsuit against the members of a Georgia county tax board, claiming that the board’s decision to lower valuations on properties near the company’s medical device sterilization plant has harmed its reputation.

The federal lawsuit, filed in Atlanta, also claims that the members of the Cobb County Board of Tax Assessors unfairly and arbitrarily pinned their April 15, 2020, tax valuation decision on Sterigenics’ use of ethylene oxide (EtO) to sterilize medical devices at the plant. The county lowered assessments by 10% on properties within 2 miles of the plant, citing “environmental air quality concern surrounding the Sterigenics plant,” the complaint says.

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Dems seek to force EPA action on ethylene oxide monitoring

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

Democrats in both houses of Congress have introduced legislation that would force the U.S. Environmental Protection Agency to better monitor emissions of ethylene oxide (EtO) from plants that manufacture the toxic gas or use it to sterilize medical devices.

The Public Health Air Quality Act of 2020, sponsored by Sen. Tammy Duckworth (Ill.) and Rep. Lisa Blunt Rochester (Del.), would require immediate EPA action to monitor emissions at “facilities contributing to high local cancer rates and other health threats from dangerous pollutants.” The list includes eight medtech sterilization plants included among 25 EPA-designated, EtO-using or -producing facilities:

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Ga. warehouse workers sue Sterigenics, ConMed over EtO exposure

Fifty-three people who worked in an Atlanta-area warehouse that stored medical devices sterilized by ethylene oxide (EtO) filed suit this week against Sterigenics and its parent company over exposure to the gas.

The plaintiffs or their families claim that long-term EtO exposure to the sterilized devices, which they unloaded, handled, warehoused and distributed, caused multiple deaths, cancer, tumors, respiratory, pulmonary, epidermal, hematological, cardiological, neurological and other serious medical conditions. The U.S. Environmental Protection Agency considers EtO a human carcinogen, and news of its use has sparked an outcry among residents and workers in neighborhoods surrounding EtO plants in Illinois, Michigan and Georgia.

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