There are dangers involved in the manufacture of some medical supplies. Most companies will take adequate protection of the process to manufacture. At times the safety measures do become outdated as the manufacturing process changes due to new product. Then it becomes a matter of cost to improve safety measures. The article states ethylene oxide usage was in 2003. I believe I can vouch for its usage back to the mid-seventies. As the story states, ethylene oxide is used to sterilize medical supplies such as filters, dialyzers, etc. They product is placed in an enclosed area and the gas is released. How long it is kept in the room, I am not sure. The gas is released in the atmosphere. Baxter Travenol used in Round Lake and it was used in their
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Bill Haskell considers the following as important: ethylene oxide, Healthcare, Sterilization
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There are dangers involved in the manufacture of some medical supplies. Most companies will take adequate protection of the process to manufacture. At times the safety measures do become outdated as the manufacturing process changes due to new product. Then it becomes a matter of cost to improve safety measures.
The article states ethylene oxide usage was in 2003. I believe I can vouch for its usage back to the mid-seventies. As the story states, ethylene oxide is used to sterilize medical supplies such as filters, dialyzers, etc. They product is placed in an enclosed area and the gas is released. How long it is kept in the room, I am not sure. The gas is released in the atmosphere.
Baxter Travenol used in Round Lake and it was used in their plants in Puerto Rico. I had not heard of any issues with its usage. I was told it was very dangerous so when they were using it, I stayed elsewhere in the facility. There is more to the story if you wish to read the rest of it.
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An industrial worker got one whiff of ethylene oxide. Twenty years later, he still hasn’t recovered. The community is searching for answers.
Dulce’: How a sweet-smelling chemical upended life in Salinas, Puerto Rico,
by Lylla Younes, Naveena Sadasivam, & Joaquín A. Rosado Lebrón
Grist
Henry Morales woke up in the emergency room in Salinas, Puerto Rico, not knowing where he was. A doctor appeared beside him and gestured toward a dark-haired woman with a worried expression. “Do you know who this is?” he asked. Morales blinked, but didn’t answer. Words seemed to belong to some faraway place, and he was too tired to reach for them. “Who is this?” the doctor repeated. After a few minutes, Henry heard himself respond. “That is my wife,” he said.
The memory of what led him to the hospital returned in blurry snapshots that he continues to piece together more than 20 years later. He’d been working a regular shift at Steri-Tech, a company that sterilizes medical devices, where he’d been an operator technician for five years. His job was to move boxes of medical supplies in and out of the sterilization chambers and to check the small vials of biological material placed in each box as a way to verify that it had all been successfully sterilized. In the normal course of Morales’ work, he typically wore a respirator to protect himself from the toxic gas. Ethylene oxide is used to sterilize the medical products.
On the day of his hospitalization, Morales and several coworkers had just removed a pallet of sterilized equipment from the chamber. Once the door to the chamber was closed, Morales and the others took off their gas masks, as was standard. Morales noticed that one vial of biological material was missing. He identified the box he’d overlooked and to be sure that it was sterilized, he opened it.
One memory that has always remained vivid for Morales is what he smelled when he opened the box. “Dulce,” Morales said to describe the scent; it was sweet, unlike anything he’d smelled before.
Steri-Tech uses the gas ethylene oxide. It has a unique ability to penetrate porous surfaces and destroy microorganisms without damaging heat-sensitive materials like heart valves, pacemakers, catheters, and intubation tubes. EO fumigates the products it sterilizes. It’s what Morales smelled when he opened the box.
As he arranged the box back on the pallet, Morales began to feel lightheaded, and he stumbled through the rest of his shift.
Once he clocked out, anxious to pick up his wife and go home, he made his way to his car. As soon as he opened the door, his “mind went out.”
A coworker found him convulsing with a seizure in the driver’s seat. His arm was lodged between the seat and the center console, his shoulder dislocated. The coworker quickly called an ambulance, and Morales was rushed to the hospital. The medical staff ran MRI and CT scans and found a portion of the left side of Henry’s brain had died. He was diagnosed with epilepsy and prescribed the anti-seizure drug Dilantin, which he continues to take four times a day.
When they spoke after the accident, Steri-Tech founder and CEO Jorge Vivoni assured Morales that the plant was safe. According to Morales, Vivoni told him that his condition was the result of congenital epilepsy, not workplace exposure. But during his recovery, Morales decided to read about the effects of inhaling ethylene oxide and recognized that he had experienced all the symptoms of acute exposure: headaches, dizziness, twitchiness, and seizures.
“Henry was never sick,” his wife, Jannette, said. “Everything changed that day. Before that, he was a healthy man.”
At the time of his accident in 2003, the dangers of breathing in ethylene oxide were not fully known, so neither Morales nor any of his peers consistently wore protective gear while working. Ethylene oxide is a volatile organic compound, a synthetic gas that breaks down over the course of a few months after it’s released into the atmosphere. Since Morales’ incident, research has shown that ethylene oxide can damage DNA structures, an ability that makes it both an effective sterilizer and a carcinogen. When it is inhaled by humans, it can irritate the respiratory pathways and increase the risk of cancer and negative health effects in unborn children. About 50 percent of the medical equipment in the U.S. and its territories is sterilized this way.
In 2016, the Environmental Protection Agency published its analysis of an epidemiological study of more than 18,000 workers in sterilization facilities that assessed the cancer risk associated with the inhalation of ethylene oxide. The researchers found the chemical to be 30 times more toxic to adults and 60 times more toxic to children than previously known, making it the second most toxic federally regulated air pollutant. The study found links between the exposure to ethylene oxide and multiple types of cancer, including lymphoma and female breast cancer. In response to the EPA’s analysis, some communities in the continental U.S. began to rally against the sterilizers in their backyards. In 2019, a wealthy suburb of Chicago even managed to shut one down.
But it wasn’t until 2022 that Puerto Ricans learned about the toxic emissions that they worked with and lived near. That summer, the EPA released a modeling analysis finding the island to be an epicenter for ethylene oxide pollution. Four of Puerto Rico’s seven sterilization plants exceed the agency’s cancer risk threshold. The Steri-Tech facility where Morales worked, which has been in operation since 1986, was determined to be the most dangerous sterilizer in the U.S. and its territories. In contrast, the modeling showed that none of California’s 12 sterilizers violated federal standards. The EPA scheduled a community meeting to be held that August in Salinas, at which Jose Font, the agency’s deputy director of its Caribbean division, would answer questions about ethylene oxide and the community’s exposures.
On the night of the meeting, the community center was packed with people who wanted to know why they were only just finding out about the toxic emissions they had lived next to for three decades. Mistrust of local and federal authorities runs deep in the municipality of 25,000, where more than half the population lives in poverty and families bring home on average $20,000 per year. Instead of apologizing, Font mischaracterized the risks to residents’ long-term health. Referring to the 2016 EPA study, he assured the community members that they could only develop cancer from the emissions if exposed for 70 years.
Jose Fonte explained in the meeting . . .
“If you are exposed to a given concentration during 70 years, seven days a week, 24 hours a day, you could develop, or there could be the potential for you to develop, cancer. That is what this means. It is very important to understand that. We are talking about the long term, 70 years, seven days, 24 hours a day exposed to that concentration. These studies are extremely conservative.”
Speaking next, Steri-Tech general manager Andres Vivoni, who is Jorge’s son, said that number should be doubled to 140 years, since the plant only operates for 12 hours a day.
Tracey Woodruff, an environmental and reproductive health scientist at the University of California, San Francisco, said.
“That’s not how it works — 70 years and then boom, you get cancer,”
Jennifer Jinot, the former EPA scientist who led the EPA’s ethylene oxide study, explained that an individual’s risk of developing cancer increases the longer they are exposed to the chemical. The EPA’s 70-year benchmark, she said, is the agency’s estimation of the length of an average lifetime, across which exposure — and cancer risk — increases.
Angela Hackel, a spokesperson for the EPA, said that the agency “will not respond to the alleged mischaracterization of risk” and that, “in general, EPA agrees with how risk was communicated at the Salinas meeting.” Steri-Tech did not respond to multiple requests for comment.
“We are dying here,” said long-time resident José Santiago when the community members were given an opportunity to speak at the 2022 meeting. “We are dying. And whoever does not live here, who lives elsewhere, who makes the money, is not impacted, does not worry.” Santiago’s sentiment would prove to be far more accurate than what Font and Vivoni had to say. Subsequent air monitoring by the EPA in the vicinity of Steri-Tech would show that residents were being exposed to levels more than 1,000 times above the agency’s threshold for acceptable risk.
Working conditions at Steri-Tech expose a legacy of negligence by local and federal environmental regulators. Six former plant workers described “inadequate” protective equipment, chronic safety issues that were met with “light” inspections that were “not thorough,” and a work culture that put profits before all else. One employee even found that an important pollution-control device had been turned off at night, confirming rumors he’d heard from workers at the plant. (Several of the workers interviewed for this story asked that their names be withheld for fear of legal retribution from the plant owners or concerns about their friends and family who still work at the facility.) The family that owns and runs the plant are “arrogant and domineering,” said one former worker. “It doesn’t matter to them if their employees get sick. They would implement rules and say, ‘If you want to work, then work, and if you can’t accept things here, then leave.’”