The Illinois EPA has delivered a blow to one of the world’s biggest sterilization groups...and flagged a major opportunity for PuriflOH’s FRG.
The EPA has shut down Sterigenics’ large Willowbrook, IL contract sterilization facility “due to the presence of levels of ethylene oxide higher than the EPA found to be acceptable in air around the facility”.
And in Michigan, contract sterilizer Viant is due to shutter its Grand Rapids ethylene oxide facility at the behest of the Michigan Department of Environmental Quality.
After finding Viant ethylene oxide emissions to be “higher than expected”, MDEQ issued a series of Violation Notices followed by enforcement action.
According to the US Environmental Protection Agency, ethylene oxide is a chemical that causes cancer.
Studies of people that work with ethylene oxide show an increased risk of breast cancer and blood cancers including multiple myeloma, leukemia, and non-Hodgkin’s lymphoma.
Ethylene oxide gas is currently used to sterilize some 50% of the medical devices in the US.
In Australia, there is a key ethylene oxide sterilizer that would be anxiously monitoring the US ethylene oxide crisis.
That contract sterilizer is the privately-owned, Melbourne-based, Steritech. Sterigenics is controlled by private equity. The News section of its website is silent on the Willowbrook disaster.
According to the FDA’s Establishment Registration & Device Listing database, Sterigenics has 594 types of devices that have undergone ethylene oxide sterilization process at the Willowbrook facility and therefore could be affected by the closure.
These include products such as sutures, clamps, knives, stents and needles.
Device shortages are emerging.
Right now, Sterigenics client, Smiths Medical, has some 28,000 Bivona tracheostomy tubes awaiting sterilization. These tubes are used to facilitate breathing.
According to the FDA Device database, Viant lists a total of 46 types of devices that undergo an ethylene oxide process at Grand Rapids.
These include devices such as catheters and surgical mesh.
The Viant sterilization facility is some 220 km from Novi, Detroit where PuriflOH is ramping up its FRG instrument sterilization operations under the leadership of directors Bill Parfet and Steve Annear and Lead Sterilization Adviser, Jim Heath, ex-Stryker Corp.
The three men would be aware of the troubles facing Sterigenics and Viant.
And they would be aware that the FDA has deep and wide concerns about the role of ethylene oxide in US medical instrument disinfection.
Indeed, the FDA is searching for sterilization alternatives.
“We’re working with stakeholders—including sterilization experts, medical device manufacturers and other government agencies—to identify innovative ways to sterilize medical devices that don’t raise the same concerns as those identified at the Willowbrook facility”, the FDA says.
“About half of all sterilized medical devices undergo sterilization using ethylene oxide.
“In view of the concerns about the environmental impact of this method, we recognize the importance of identifying new and improved ways of sterilizing medical devices.”
This may be a crucial meeting for PuriflOH. Attendees will discuss “how best to advance innovations in medical device sterilization”.
The FDA will announce the meeting, including details about how to participate, on the FDA Advisory Committee calendar web page and in a Federal Register notice prior to the scheduled date.
Leaders at PuriflOH, Somnio Global and Stryker Corp may have a big opportunity - to place the FRG’s non-chemical disinfection solution squarely in front of FDA officials at the Atlanta meeting.
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