BD & Ethylene Oxide (EtO)
Why EtO?
From urinary catheters, PICC lines, oncology ports, breast biopsy needles, vascular and ureteral stents, feeding tubes, and more, EtO is the ONLY option of sterilization for a large number of the medical devices manufactured and sterilized by BD due to material sensitivities and/or design complexity.
Setting the Record Straight: The Facts
Environmental Protection Agency Study
In November 2019, the EPA released results of a comprehensive nationwide analysis of EtO levels across the country and found the average amount of EtO present in the air nationwide (also known as background levels) was between 0.2 and 0.4 micrograms of EtO per cubic meter of air1.
EtO levels measured in Covington by the Georgia EPD and BD are consistent with the average background levels
the EPA found nationwide in urban and rural areas that are not near sterilization facilities.
This means that people who work in, live near or drive by BD facilities in these communities every day are exposed to the same low levels of EtO found in every community sampled by the U.S. EPA.
1See Nov. 6, 2019 EPA update and data summary.
Average Background Levels of EtO Across the United States
Green: The Covington, Ga. average is the average of both EPD monitoring data from areas near BD’s sterilization facility and data from a third-party engineering company performing air monitoring around BD’s GDC in Covington, as required by EPD.
Average concentrations of EtO in Covington’s ambient air samples were 0.258 µg/m3, according to the combined results of data collected by the Georgia EPD and data from a third-party engineering company as required by GA EPD.
The May 12, 2022 and November 30, 2023 Ethylene Oxide Monitoring Reports concluded that levels of EtO measured in the areas near BD facilities are generally comparable to the concentrations measured at locations where there are no known commercial sources of EtO, including a state park that is nearly 200 miles away.
Usage in Perspective
The vast majority of ethylene oxide in our air comes from organic and industrial sources other than medical device sterilization facilities.
EtO is a byproduct of combustion, meaning it is produced by campfires, grills, cigars and cigarettes, auto exhaust, lawn mowers and many other sources. EtO is found in rural areas where there are swamps and decaying debris.
Even our own bodies produce EtO.
EtO is Everywhere
U.S. EPA’s preliminary study of normal, background levels of EtO in communities around the country that don’t have industrial sources of EtO are 10X to 20X higher than their screening threshold. In addition, many everyday activities, even breathing would produce EtO levels well above the screening threshold.
