FDA November Discussion on Ethylene Oxide Replacement

Ethylene oxide (EtO) medical device sterilization has come under fire recently. Thirty-two people have filed claims against ethylene oxide sterilizing company Sterigenics, believing emissions has led to cause cancer in their bodies. The Chicago Sun Times reports:

“They’ve known for 34 years and they willfully pumped this out in our communities ...,” said Jeanne Hochhalter. "Nobody should have to go through anything like this." Hochhalter, who grew up in Burr Ridge, was one of 32 people who filed suit in the Circuit Court of Cook County this week against Sterigenics, which has a plant in Willowbrook where medical instruments are sterilized. In February, the Illinois Environmental Protection Agency shut down the facility after air quality monitoring recorded spikes of the gas ethylene oxide in surrounding neighborhoods (Esposito 2019).

Despite the environmental concern and public outrage, Sterigenics was allowed to reopen the Willowbrook facility in July.  However, the risk is still found in ethylene oxide sterilization.  In 2016, EPA published an updated Information on the Integrated Risk Information System determination which classified ethylene oxide to be a carcinogenic gas. Now, there is a consideration for an alternative sterilization method to be found, however due to the high level of use, it will be a great feat to switch, plus there is a risk of not having the proper ability to handle the workload either.

Ethylene oxide currently bears the brunt of the medical device sterilization in the country:

Currently, ethylene oxide is used to sterilize more than half of medical devices that need sterilization due to its chemical compatibility with many different device materials and ability to treat devices that are heat- or moisture-sensitive.

The second most common method to sterilize medical devices is radiation, such as gamma irradiation, X-ray radiation and electron beam radiation, which collectively represents about 45% of devices currently being sterilized.

The other common method currently is using pressurized steam, constituting about 5% of sterilization, according to FDA (BioMed Tech, Lim, 2019).

The FDA organized regulators from public health agencies, medical device manufacturers and expert physicians gathering Wednesday November 6th and Thursday November 7th at a two-day meeting to discuss how to address challenges with ethylene oxide. The FDA is looking to determine if there is a viable alternative for large scale medical device sterilization. There are many determinants, but one is if there is an elimination of ethylene oxide, what the FDA can do to prevent device shortages if reduced sterilization capabilities come to pass. New concerns present many challenges to an industry, but offer many opportunities for advancement in the possible use of even greater technology as well.

ClorDiSys Solutions Inc’s Director of Operations, Paul Lorcheim, is a panel member presenting an alternative sterilization technology method, chlorine dioxide.  Chlorine dioxide has long been determined safe for use on medical devices, particularly because it does not leave residues and it is an EPA registered sterilant. The FDA has the webcast day one of the meeting here, and day two is webcast here.

Sources

Esposito, Stefano. “Lawsuits Filed against Medical Supply Sterilization Plant Linked to

Increased Cancer Rates.” Chicago Sun-Times, Chicago Sun-Times, 20 Aug. 2019, https://chicago.suntimes.com/metro-state/2019/8/20/20814132/lawsuit-medical-supply-sterilization-company-linked-increased-cancer-rates-sterigenics-willowbrook.

Lim, D. (2019, November 6). 7 questions about ethylene oxide as FDA panel convenes.

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