How ethylene oxide became a public safety concern: A timeline

In recent months, several medical device sterilization plants have been forced to shut down among rising concerns that ethylene oxide, a chemical used to sterilize more than half of the country's medical devices, can cause cancer. 

The U.S. Environmental Protection Agency and some state policymakers have been pushing for regulations to reduce emissions of ethylene oxide. 

But the FDA has warned that shutting down plants will cause shortages of critical medical devices, such as feeding tubes used in neonatal intensive care units, catheters and shunts, since there aren't any other known, reliable ways for medical devices to be sterilized. 

A timeline of plant closures, FDA warnings and policy changes reported since last year by Becker's Hospital Review

Feb. 15: Illinois EPA shuts down sterilization operations at Sterigenics plant 
The Illinois EPA shuts down sterilization operations at Sterigenics' plant in Willowbrook, Ill.,  after determining it was releasing excessive amounts of ethylene oxide. 

March 27: FDA takes steps to prevent device shortages after sterilization plant shuts down
The FDA sends out a notice that it is actively working to prevent medical device shortages after sterilization operations were shut down at Sterigenics' Willowbrook plant. 

April 15: Medical device deliveries stalled after sterilization plant closes
The FDA says that several medical devices are in short supply, despite its efforts to prevent shortages. 

Sept. 6: Another Sterigenics plant shuts down 
A Sterigenics plant in Atlanta temporarily shuts down after signing a consent order with the Georgia EPA to reduce ethylene oxide emissions. 

Sept. 10: Judge approves reopening of Sterigenics' Willowbrook plant
An Illinois judge signs a consent agreement to allow Sterigenics to reopen its sterilization plant in Willowbrook on the condition that Sterigenics installs additional emission control systems that allow the plant to meet the state's new standards.

Sept. 27: EPA says it is considering putting new regulations on ethylene oxide
The U.S. Environmental Protection Agency says it is considering creating new regulations for ethylene oxide emissions. The medical device industry pushes back, arguing that restricting ethylene oxide will harm patients. 

Sept. 30: Sterigenics won't reopen Illinois plant
Sterigenics says it won't reopen its Willowbrook plant because it can't reach an agreement to renew the facility's lease. Sterigenics also cites an "unstable legislative and regulatory landscape in Illinois" as a reason it won't reopen the plant.

Oct. 25: Georgia Gov. tries to close sterilization plant
Georgia Gov. Brian Kemp tries to shut down the Becton Dickinson sterilization plant in Covington, Ga., arguing it emits too much ethylene oxide. But AdvaMed, which represents 97 percent of the country's medical devicemakers, claims medical procedures are in jeopardy if the plant closes.

Oct. 28: FDA warns of critical medical device shortages
The FDA sends out a warning that the two Sterigenics plant closures and the possibility of the Becton Dickinson plant closing could mean hospitals will soon face shortages of critical medical devices. 

Oct. 30: Proposed Illinois bill threatens to close Medline sterilization facility
Illinois lawmakers propose a bill that would close a Medline sterilization facility in Waukegan, Ill., threatening further device shortages.

Nov. 6: FDA panel searching for alternative medical device sterilization techniques
The FDA holds a two-day meeting with the General Hospital and Personal Use Devices Panel to develop strategies to reduce reliance on ethylene oxide to sterilize medical devices.

Nov. 25: FDA touts efforts to cut devicemaker reliance on ethylene oxide 
The FDA says it has picked proposals from 12 companies to cut down on ethylene oxide reliance and will work with the companies to implement them. 

Dec. 4: Viant to shut down sterilization operations at Michigan facility
Viant Medical signs a consent order with the state of Michigan to end its sterilization operations in Grand Rapids by the end of the year.

Dec. 13: Elevated levels of carcinogen found in neighbors of Medline sterilization plant
Researchers at the University of Illinois at Chicago say they found that people who live close to  Medline's sterilization plant in Waukegan have higher levels of ethylene oxide in their blood.

Dec. 13: 22 more lawsuits are filed against Sterigenics over ethylene oxide concerns
Almost two dozen more lawsuits are filed against Sterigenics, bringing the total number to 73. The new lawsuits accuse the company of causing leukemia, lymphoma, breast cancer, miscarriages and other medical conditions.

Jan. 10: Georgia device sterilizer fined $3K per day over ethylene oxide emissions 
Sterilization Services of Georgia is fined $3,000 per day for failing to install new filters to reduce ethylene oxide emissions by its deadline.

Jan. 17: EPA backs down on ethylene oxide queries after FDA marks turf
The U.S. Environmental Protection Agency backs down on its request to find out more about how medical sterilization facilities use ethylene oxide after the FDA claims jurisdiction in the matter.

Jan. 22: Medline halts sterilization at Illinois facility over ethylene oxide concerns 
Medline says it hasn't been sterilizing medical equipment at its Waukegan facility since mid-December because it didn't meet new state standards for ethylene oxide emission. 

Copyright © 2022 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars