The attorney general of New Mexico has filed a lawsuit against Sterigenics and associated companies claiming a company medtech sterilization plant in Santa Teresa, N.M. has harmed air quality and “materially contributed” to nearby residents’ health risks.

In the claim filed Dec. 22, 2020, attorney general Hector Balderas alleges that Sterigenics has caused “substantial unreported, uncontrolled releases” of the medical device sterilant ethylene oxide (EtO). Among its claims, the lawsuit says that Sterigenics employees:

• Allowed sterilization chamber doors to be left ajar between sterilization cycles, and when indoor EtO levels got too high, the company “caused shipping bays and large facility doors to be left open for hours, or entire days, releasing excess EtO into the atmosphere in an uncontrolled and unfiltered manner.”
• Regularly used a hose to wash EtO and ethylene glycol residues built up within the sterilization chambers down an ordinary drain, causing the uncontrolled release of EtO and ethylene glycol into the environment.
• Regularly used the Santa Teresa plant as an aeration site for devices sterilized at its San Diego plant, enabling EtO to off-gas during shipping, receiving and loading at the Santa Teresa plant.
• Allowed EtO emisssons to escape the Santa Teresa Plant from vents that were not routed through an emission control system until 2014. The Santa Teresa Plant is a 105,000 sft2 facility located in a business park six miles from New Mexico’s border with Mexico. It opened in 1989.

The U.S Environmental Protection Agency and the U.S. Department of Health and Human Services both consider EtO a human carcinogen. The medical device industry relies on EtO to sterilize about 50% of all devices sold in the U.S. that require sterilization — more than 20 billion medical devices per year, according to the FDA.

“Industrial companies must follow the law and maintain the highest safety standards for all communities and it is not fair to exploit poor communities of color when they deserve protection with their health and safety,” Balderas said in a news release. “My office will
always fight to hold companies accountable for jeopardizing the health and safety of all New Mexicans, especially those most vulnerable communities.”

Balderas asked the court to require Sterigenics to immediately cease uncontrolled emissions of EtO from the Santa Teresa Plant pending trial and to fund a state-supervised public health monitoring program to detect, assess and treat medical disorders associated with EtO exposure.

Sterigenics denied the lawsuit’s claims, saying they are unfounded.

“We operate safely and are committed to protecting public health. Our Santa Teresa facility performs the vital sterilization of medical products for healthcare providers and patients who need them — including life-saving medical products that are used to respond to the COVID-19 pandemic — and we consistently comply with all applicable laws and regulations in our operations,” a company representative told Medical Design & Outsourcing in an email. “We will vigorously defend our essential and safe operations against this baseless lawsuit.”