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Lake County Gazette

Tuesday, November 5, 2024

Trade association official calls EtO production crucial to providing sanitary medical equipment

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The top syringe before being sterilized by radiation. The lower two have had significant damage to the materials caused by radiation. | Submitted

The top syringe before being sterilized by radiation. The lower two have had significant damage to the materials caused by radiation. | Submitted

Suddenly, sterilization is on everyone’s mind.

As the COVID-19 crisis continue to raise concerns about testing, medical care and safe medical equipment, the use of ethylene oxide (EtO) has resurfaced. It plays a crucial role in providing doctors, nurses and other health care workers with sanitized devises.

EtO, is a colorless gas, is used to sanitize half the medical equipment produced and used in America, according to Jim Jeffries of the AdvaMed. That’s 10 billion devices annually.


Jim Jeffries of the Advanced Medical Technology Association. | AdvaMed

Jeffries is a senior vice president and head of public affairs for Advanced Medical Technology Association (AdvaMed), a trade association that represents more than 400 medical technology innovators and companies that produce medical devices, diagnostic products and digital health technologies.

The pandemic has raised the need for additional production and use of EtO to ensure safe medical equipment is readily available, Jeffries said.

“Sterilization capacity is about 90 percent and could very likely increase significantly with the resumption of essential medical procedures as hospital systems around the country begin to open back up,” he said. “It’s crucial that the EtO sterilization process remain fully operational.”

EtO is the preferred method because of problems that arise with the use of radiation, steam and other sanitary efforts.

“Approximately 50 percent of medical devices in the U.S. are sterilized safely and responsibly using EtO, and many of those devices cannot be sterilized at scale using any other method — devices such as ventilator components, syringes, catheters, certain PPE, and other medical technologies essential to the COVID crisis,” Jeffries said.

It seems highly likely that the demand for EtO sterilization will grow as the health care system recovers.

“There is currently no method known to science capable of safely and effectively sterilizing medical devices at the scale EtO is capable of,” Jeffries said. “As hospitals across the nation are beginning to resume essential scheduled procedures that have been put on hold the past two months, demand for these devices sterilized by EtO — especially surgical kits — will increase significantly in the coming weeks.”

He said if and when a vaccine for COVID-19 is developed, along with other treatments, there will be a tremendous need for syringes, and EtO can sanitize them much faster and more safely than other methods, which can cause damage, .

“Syringes are going to become vital to administer the treatments that come online,” Jeffries said. “We could need hundreds of millions of syringes very soon.”

The production of EtO has become a public issue, and the industry has responded by investing millions to ensure emissions are controlled and captured. He said they are concerned about the health of people and locations near their facilities and also determined to keep producing the chemical.

On March 27, Medline Industries resumed sterilization operations at its Waukegan facility after its $10 million upgrade in emission controls was approved by the state.

Medline spokesman Jesse Greenberg said in a release the company wants to pitch in to help during this crisis.

“The investment in Waukegan is part of our dedication to the health and safety of Medline employees and our neighbors,” Greenberg said. “Illinois is leading the nation with the most stringent ethylene oxide emission standards in the country. At this critical time for the national public health, we are gratified that we can help supply sterile medical equipment to Illinois healthcare professionals working on the frontlines and to clinicians battling COVID-19 across America.”

Sterigenics voluntarily closed its Atlanta medtech sterilization plant last year to install emission upgrade. Cobb County, Gerogia, declined to allow it to reopen and produce EtO until it granted a 21-day period for production of personal protective equipment in March.

The company has since obtained judicial approval to remain open while it continues its legal case with the county. Federal officials also are pressuring Cobb County to allow the facility to stay in production at this time.

U.S. Department of Health & Human Services Secretary Alex Azar wrote in a letter that Sterigenics needs to continue to sterilize medical equipment.

“We don’t think that one county should be allowed to jeopardize the nation’s response to an unprecedented national pandemic,” 

Azar wrote, “My understanding is that this particular plant represented 4 percent of the total U.S. capacity for ethylene oxide sterilization. If it remains shuttered, there are national implications.

“We hope you will use whatever communication channels you have to encourage the county to expand the decree to full production of all medical items and extend it until the nation’s threat and need is over. Conversations on next steps from the federal government are occurring at the highest levels, should the situation not change.”

Jeffries said EtO could be needed for a long time to sterilize even more devises than the 10 billion it currently treats. The CIVID-19 pandemic, and the need for much more medical equipment, could be with us for a long time.

“And we don’t know how far off that is,” he said. 

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