EPA considers new requirements for toxic chemicals used in disinfecting medical equipment at Coventry facility – ecoRI News

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COVENTRY, RI – Proposed Environmental Protection Agency (EPA) reporting requirements for a hazardous chemical used to sterilize medical equipment could put a loop in the medical supply chain in the event of a pandemic, and a local facility is listed on the list of those who might feel the effects.

Last month, the EPA 31 establishments alerted nationally they could face new reporting requirements next year related to the use of ethylene oxide, a carcinogenic chemical widely used to sterilize medical devices. The requirements, which were reported by the Food and Drug Administration (FDA) in 2019 as a potential threat to disinfection procedures, could impact Boston Scientific Corporation’s Coventry facilities.

“The EPA believes this facility can meet the TRI [Toxics Release Inventory] reporting thresholds for on-site activities involving ethylene oxide and ethylene glycol, and the public would benefit from increased disclosure of information relating to these releases ”, according to one EPA letter sent to Boston Scientific on October 1.

Boston scientist had 30 days to respond to the EPA’s request for comment before the reporting requirements were finalized. Boston Scientific provided a response to the EPA, but both parties declined to share the communication with ecoRI News. EPA public affairs specialist Emily Bender said relevant documents will be made public once deliberations are complete and action is taken.

Ethylene oxide is a flammable, colorless gas used to sterilize medical equipment and in the production of ethylene glycol – a clear, colorless liquid used in antifreeze and hydraulic brake fluids, which can cause serious health problems in the event of ingestion.

According to a 2016 EPA Assessment, ethylene oxide is “carcinogenic to men” if inhaled and has been associated with an increased risk of lymphohematopoietic cancers and breast cancer in women. Ethylene oxide has also been shown to be genotoxic and mutagenic, which means that it can interact with and alter cellular DNA.

“Because [ethylene oxide] is mutagenic… and children may be more sensitive to the harmful effects of mutagens, the proximity of young children to a facility using ethylene oxide concerns the EPA ”, according to October 1 letter

According to the EPA, 71,144 people, including more than 3,500 children under the age of 5, live within 5 miles of the Coventry facility. Data from National Center for Education Statistics show that at least 16 schools are also located within a 5 mile radius of the Industrial Drive facility.

The Rhode Island Department of Environmental Management (DEM) Office of Air Resources authorized operations at the Coventry facility from Boston Scientific as of 2010, after it was purchased of STERIS Corp. According to a permit issued in May, ethylene oxide emissions are reduced thanks to two primary plate aerators, which treat the wastewater produced during the sterilization process. Process air is also routed through a wet acid scrubber, which removes gases and particles and reduces smoke opacity, and a series of dry bed scrubbers, which are said to have reduced emissions by 99 , 9%.

The DEM caps the facility’s emissions at 67 pounds per day and 1,298 pounds per year, and the facility’s use of ethylene oxide must drop to less than 1,500 pounds per day, according to the permit .

Karen Slattery, deputy administrator of DEM’s Office of Air Resources, said the state agency requires Boston Scientific and other ethylene oxide users “to report information on the processes and the amount used so that an estimate of emissions can be made “.

If the EPA decides to act, Boston Scientific would be required to submit annual ethylene oxide and ethylene glycol information to the EPA. Toxic release inventory. TRI collects data related to the release and waste management of 770 toxic chemicals.

The EPA has long reported ethylene oxide and ethylene glycol – produced using ethylene oxide – as potentially hazardous chemicals, both listed on the TRI since 1987. According to Bender, l ‘EPA is also revising the rules for commercial ethylene oxide sterilizers, which were established in 1994 and last updated in 2006.

Boston Scientific was required to report data for ethylene oxide and ethylene glycol up to 2005. The requirements have since been dropped, but if reinstated, the reports would include information on the amount of regular releases. and accidental ethylene oxide and ethylene glycol, and releases of ‘catastrophic or other one-time events. Reports on the maximum amount of ethylene oxide and glycol stored on-site in a calendar year, as well as the amount contained in the waste both on-site and off-site, would also be required.

Boston Scientific spokeswoman Kate Haranis said the company had “no concerns with the EPA letter regarding reporting requirements.” She said the facility will comply with all report requests from the EPA, DEM and other agencies.

“When ethylene oxide is used in our sterilization process, we regularly monitor exposure levels and comply with all legal and environmental regulations, including the parameters of our Rhode Island State permit,” said she declared.

Haranis said no disruption to Boston Scientific’s operations is expected due to the pending report changes.

The medical industry has warned that tightening environmental regulations related to ethylene oxide could trigger a shortage of disinfected equipment available to medical facilities already stretched due to the coronavirus pandemic. Even before COVID, in 2019, FDA officials told MedTech Dive that a pause in facility operations could lead to medical logistics shortages and failures.

“We would be concerned if even one more facility closed,” Suzanne Schwartz, director of the FDA’s office of strategic partnerships and technological innovation, told MedTech Dive. “We will start to see one-off shortages; there is no doubt. In terms of the more catastrophic national impact, with two facility closures, it’s almost a certainty. “

According to an article in Clinical Oncology News in May 2020, the offline status of several ethylene oxide facilities, with operations halted to improve safety functions and eliminate emissions, may have contributed to equipment shortages. at the start of the pandemic. The EPA has agreed to return some ethylene oxide facilities to service during the pandemic to meet demand.

Ethylene oxide is used to sterilize about 50 percent of all medical devices in the United States, according to the FDA, including gowns, dressings, syringes, surgical kits, catheters, and ventilators.

Alternative sterilization techniques exist, including heat, radiation and vaporized hydrogen peroxide, which have been used in facilities across the country to sterilize N95 masks for reuse during the pandemic. But for many medical devices, ethylene oxide is the only method capable of sterilizing effectively without risking damage to delicate parts.


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