United States: In the US, there are about 90 sterilizing plants that utilize ethylene oxide, which companies have used for decades to sterilize medical products.
Without knowing much about the probable risks involved in using the chemical, many medical device makers are sending their products to the plants in order to sterilize them before shipping them to distribution companies.
On March 1, as finalized by court orders, the Environmental Protection Agency, EPA, is expected to meet and finalize the stricter safety rules regarding toxic gas usage, following various protests and lawsuits complaining about the medical harm, as CBS News reported.
Following a 2016 agency report, proposed changes came to light, which confirmed the long-term exposure dangers of ethylene oxide.
Medical device makers worry about stricter regulations
Medical device makers are apprehensive about the possible increase in costs following stricter regulation. It might put the patients at higher risk of infection from devices, which include surgical kits to catheters, due to deficient sterilization.
Moreover, new rules will not satisfy the concerns of environmentalists or members of the public, as they have already shown their frustration following delays by the federal government in sounding the alarm.
Risks from exposure to ethylene oxide
According to EPA lists, breathing ethylene oxide over an extended period leads to an increase in the chance of cancer, including Breast cancer and white blood cells, including non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia.
As CBS News has recorded, along with the eye, nose, throat, and lung irritation, the damage to the brain and nervous systems and reproduction system may also be the consequences that are caused by the toxification.
As per the EPA officials, children are potentially more prone to side effects of the toxic gas and are regularly exposed to the chemicals.
The rate of risk is directly proportional to the quantity of gas present in the air, the distance of the person from the plant, and the time period for how long the person is exposed.
Number of lawsuits filed against risks by the gas
Many cases of hundreds of personal injuries have been filed near the sterilizing plants.
A lawsuit was filed by New Mexico’s then-attorney general in 2020 against a plant located in Santa Teresa; the case is yet unresolved.
Additionally, last year, a case was settled in suburban Atlanta, a company that agreed to pay USD 35 million to 79 people who complained that ethylene oxide used in the plant caused cancer and other injuries.
In 2022, a jury in Cook County, Illinois, awarded USD 363 million to a woman who allegedly had breast cancer due to exposure to ethylene oxide gas, as per CBS News reports.
However, Greg Crist, chief advocacy officer for the Advanced Medical Technology Association, a medical device trade group, said that it is a reliable sterilant that attributes a number of lawsuits to the litigious nature of trial attorneys.
Some states have already made regulations
As per the EPA, few states, including California and North Carolina, have made regulations for ethylene oxide emissions, besides the existence of regulatory guidelines of the agency and the federal Clean Air Act.
Know more about the proposed rules set by the EPA
The new rules proposed by the EPA are set to be finalized, which would set lower emissions limits for chemical plants and commercial sterilizers. It will also raise some of the safety requirements for workers working in the facilities.
Furthermore, the agency is expected to set an 18-month deadline for
commercial-level sterilizers to comply with the emission rules.
However, the set rules don’t include protection for workers at off-site warehouses where storages of sterilized products take place, where the emission of ethylene oxide might continue to take place.
Furthermore, they did not make it mandatory to perform sir testing around facilities, which led to debate about the effectiveness of efforts to protect the health of nearby residents, as CBS News reports.
Alternatives can reduce the dependence on toxic gas
Darya Minovi, senior analyst with the Union of Concerned Scientists, an advocacy group, said increasing the use of alternatives can reduce industry dependence on “the crutch of ethylene oxide,” as CBS reported.
However, industry officials are not positive about the development of an alternative anytime soon, although they are continuously supporting research on other methods of development.
Currently, alternatives include steam, radiation, and hydrogen peroxide vapor.
Audra Harrison, an FDA spokesperson, said that the FDA, which regulates drugs and medical devices, is closely aware of the updated rules, which could “present some unique challenges” if implementation takes place.
She added further, “The FDA is concerned about the rule’s effects on the availability of medical devices,” as CBS reported.
Tracey Woodruff, a researcher at the University of California-San Francisco who previously worked at the EPA, said, “We continue to discover these chemicals that we’ve already been exposed to were toxic, and we have high exposures,” and, “Regulation is an innovation forcer.”