Since 2007, a Sandy medical device manufacturing plant has used a chemical called ethylene oxide, or EtO, to sterilize the IV catheters, valves and other medical devices it produces.
Now BD Medical Systems’ use of the odorless, flammable gas is causing concern because of new data about its ability to cause cancer after prolonged exposures.
To address these concerns, the U.S. Environmental Protection Agency (EPA) is hosting an online meeting Thursday evening to share the findings of a risk analysis it has completed on the plant, located at 9450 S. State.
Officials are quick to assure residents that the plant is operating within current federal regulations and its state permits, and its emissions remain too low to result in short-term health effects associated with EtO, such as nausea, dizziness and breathing problems. The concern is with long-term exposure. which is linked to cancers of the blood, lymphatic system and breast, according to Madeline Beal, senior risk communication adviser with EPA.
“The risk in Sandy, Utah, is too high,” she said at an Aug. 17 virtual public meeting with Mayor Monica Zoltanski and officials with the Utah Department of Environmental Quality. The agency is in the process of tightening emission standards for EtO and is working on separate regulations for worker exposure inside the plants that use the gas.
A global medical technology company headquartered in New Jersey, BD Medical Systems, or Becton, Dickinson and Co., acquired Sandy’s former Desert Pharmaceuticals facility in 1986. The plant has since been expanded to a sprawling 650,000-square-foot complex and now employs 1,260, following $276 million in investments over the past decade, according to company spokesman Troy Fitzpatrick.
The site produces more than 3 billion IV catheters, blood collection devices and surgical products a year. Before they are shipped, these products must be sterilized so they don’t introduce bacteria into patients’ veins, which is why EtO is used at the plant. Other processes that use heat or radiation could make these devices brittle and dangerous to use on patients.
According to a recent stack test, Fitzpatrick said, the plant’s EtO emissions were so low they could not be detected. EPA’s current rules allow plants like BD Medical Systems’s to emit 1 pound for every 100 pounds it uses.
“We emit about two grams,” Fitzpatrick said. “That’s 200 times more efficient than what’s required of us.”
Still, the company is in the midst of a $15 million upgrade to reduce stack emissions by 95%. The new equipment should be operational by the end of the year. Fitzpatrick said BD Medical Systems has asked to participate in both the Aug. 17 and Thursday’s meetings but was turned down.
Each year, EtO is applied to 20 billion medical and dental devices, according to the Food and Drug Administration. The gas also is used to make chemicals needed in processes to produce other products, like antifreeze, adhesives and detergents, and used to sterilize spices, dried fruit and other food products.
“Medical sterilization conducted at facilities like BD Medical is a critical service that protects public health,” DEQ director Kim Shelley said. “There are many pieces of medical equipment that can only be safely and effectively sterilized using ethylene oxide, which is why we are committed to partnering with BD to ensure that they can continue to provide this service in a way that is in line with our new understanding of the risk of ethylene oxide use.”
The EPA’s risk threshold calculates the number of cancers that would result among people who are exposed every day, all day from birth to age 70. The health standard is 100 cancer cases among 1 million people who experienced that level of exposure.
For the August presentation, the DEQ released a map showing an oval extending a few blocks around the plant. Inside the oval is where BD Medical Systems’ current level emissions are believed to exceed that risk threshold. About 700 people live within that zone.
“EtO is not a chemical that lasts for a long time in the environment,” Beal said. “This means that if we can reduce the amount of EPO that is coming out of the facility, it will reduce risk almost right away.”
BD Medical Systems used to outsource its sterilization processes, but to improve efficiency and cut costs, it built its own facility in 2007. It uses a three-step process to sterilize most of the products from the Sandy plant and some from a BD Medical Systems plant in Nogales, Mexico.
After the devices are packaged, boxed and secured to wooden pallets, they are run through a series of sealed six chambers. In the first step they are subject to steam. Then they are exposed to EtO for 12 to 40 hours, depending on the product, then subject to aeration where the residual EtO is sucked from the packaging.
The gas is put through a catalytic process to break it down into carbon dioxide and water.
Fitzpatrick said his company developed an even more refined emission-reduction system using “dry bed” filtration media at its Georgia plant, which was recently validated and is now being installed at Sandy. BD Medical Systems’ goal is to proactively get in front of EPA’s new emission standards before they are finalized, he said.
In the meantime, the Utah Division of Air Quality has initiated a monitoring program to determine ambient levels of EtO along the Wasatch Front and the plant’s potential contribution to them. EtO is also released into the environment from burning fossil fuels and decomposing organic matter.
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