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Monday, April 6, 2020

Trade group: Misunderstanding of medical sterilization chemical could lead to shortages, harm patients

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By Karen Kidd | Nov 12, 2019

Greg Crist, AdvaMed chief advocacy officer and head of external affairs of the advanced medical technology | Photo courtesy of AdvaMed

WASHINGTON (Legal Newsline) – With possible shortages looming amid debate over environmental impacts of ethylene oxide, a gas used to sterilize billions of medical devices each year, an industry advocate is advocating a more reasoned view of how the gas is used.

"No one is saying that ethylene oxide is not a toxic chemical," said Greg Crist, chief advocacy officer and head of external affairs of the Advanced Medical Technology at AdvaMed. "No one has ever said that. What we are saying, from our perspective of using only .5 percent of the ethylene oxide used in the country, maybe even in the world, is that we can responsibly - and we've been doing it for decades - capture, abate, destroy and remove those emissions to untraceable amounts."

That message has been lost as sterilization facilities have been targeted and closed over environmental concerns and those closures are causing a far wider health crisis in possible shortages of sterilized medical devices, Crist said.

"Look, we fully understand, appreciate and support the emphasis on environmental safety and environmental stewardship and community safety across the board," Crist said. "Yet what is missing, unfortunately, is a 360-degree view of how ethylene oxide is used, that the emissions are used responsibly and destroyed after use."

AdvaMed is the largest medical device trade association in the U.S.

Crist's comments came a few days after an agreement between Georgia and the medical device sterilization company Becton Dickinson following a lawsuit filed by the state over the company's ethylene oxide gas emissions. The agreement and consent order between the company and state ended what turned out to be a temporary closure of the facility.

"We appreciate the hard work and effort that went into the agreement to ensure that health care providers and patients will continue to have access to the critical products we provide," a Becton Dickinson spokesperson said in an email to Legal Newsline.

The company spokesperson otherwise declined comment, saying the "the statement is comprehensive and speaks for itself."

Keeping the Becton Dickinson facility open means sterilization in that facility will continue. AdvaMed estimates that between 20 billion and 25 billion devices are sterilized annually using ethylene oxide. That includes catheters, heart valves, defibrillators, pacemakers, breathing tubes and syringes.

"This is a very complex issue," Crist said. "It's unfortunate that reporters only have only 18, 15, 12, 10 column inches to dedicate to something that really has a very storied past, and an interesting one."

Ethylene oxide isn't used only for medical device sterilization.

"The use of ethylene oxide is a sterilization method, which in the technical sense is called a 'modality,'" Crist said. "Ethylene oxide has been around since the late '30s and it's used to sterilize a number of different commodities. It's used to sterilize cosmetics, it's used to ripen fruit, it's used to sterilize spices such as paprika and others."

The majority of ethylene oxide used in the U.S. is as a chemical building block in the production of resins, plastics and similar material, Crist said.

"Half of 1 percent of all ethylene oxide manufactured in this country is used to sterilize medical devices," Crist said.

Intense scrutiny of that half-percent began in 2016 when the U.S. Environmental Protection Agency released a report, the "Evaluation of the Inhalation Carcinogenicity of Ethylene Oxide," that identified ethylene oxide to be a carcinogenic gas.

There quickly followed aggressive state and federal action against use of the gas in medical device sterilization legislation and against sterilization facilities that use ethylene oxide.

Last year, then-Illinois Attorney General Lisa Madigan and DuPage County State's Attorney Robert Berlin sued Sterigenics, claiming ethylene oxide emissions at its Willowbrook, Illinois, plant created a public health hazard.

Sterigenics and the state reached a deal last summer but the company announced in late September that it would no longer run ethylene oxide sterilization facilities in Illinois, citing "unstable legislative and regulatory landscape."

The settlement and consent order reached between Becton Dickinson and the state of Georgia narrowly avoided what could have been another permanent closure.

The U.S. Food and Drug Administration in March warned about potential medical device shortages over restricted use of ethylene oxide sterilization. Late last month, the FDA warned that "without adequate availability of ethylene-oxide sterilization" to expect a national shortage of medical devices.

The FDA has set up a mailbox for device shortage notifications.

The closures and temporary shutdowns over cancer concerns are forcing questions about the potential result of reducing, eliminating or replacing ethylene oxide from the sterilization chain used by the nation's hospitals and other healthcare providers. There is debate about whether it is practical - if it's even possible - to replace ethylene oxide in medical device sterilization.

Alternatives to ethylene-oxide sterilization do exist and are spelled out in a widely accepted industry white paper issued in 2017.

"Policy makers will say, 'Use something besides ethylene oxide, you have other options,'" Crist said.

The reality is less clear cut.

"Steam was popular a long time ago," Crist said. "However, as these devices become more sophisticated and more electronic, steam becomes a terrible modality for these devices, the more intricate they are."

Steam degrades the integrity of many medical devices, particularly digital devices, and other options such as gamma, e-beam and X-ray sterilization simply can't "provide the very delicate and yet lethal" sterilization of medical devices as well as ethylene oxide, Crist said.

"You want to kill those microbes and decontaminate the product," Crist said. "To do that effectively, reliably, consistently and accurately, ethylene oxide has been found to be the most effective."

Trying to force sterilization alternatives could prompt marketing decisions that no one wants.

"I now need to go back to FDA and get them to approve my new process as part of manufacturing," Crist said. "That could take months. Some companies have told me that 'The way we design this device and the way we manufacture it, if we need to use another sterilization modality, we will either remove the device from the market because it wouldn't be marketable anymore or we will have to redesign the device to be able to accept these more sterilization harsh methods.'"

Using ethylene oxide to sterilize medical devices is not a perfect modality, Crist said.

"Using ethylene oxide is very time-intensive, it's costly, it's very demanding in terms of the processes," Crist said.

More than 50 elements go into preparing the ethylene oxide sterilization chamber, where certain humidity and other conditions must be met.

"It is not the first, best option, and I'll state that on the record," Crist said. "What it is, though, is the most reliable, consistent, accurate and lethal method. It gets rid of the micro-organisms and the microbes that threaten the patient on the back end. And that is a public health concern that we all share."

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Organizations in this Story

Georgia Office of the Attorney GeneralU.S. Food and Drug Administration (FDA)Advanced Medical Technology Association Pac (ADVAMED PAC)