Toxic Gas That Sterilizes Medical Devices Prompts Safety Rule Update

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Over the past two years, Madeline Beal has heard frustration and even bewilderment during public meetings about ethylene oxide, a cancer-causing gas that is used to sterilize half of the medical devices in the U.S.

Beal, senior risk communication adviser for the Environmental Protection Agency, has fielded questions about why the agency took so long to alert people who live near facilities that emit the chemical about unusually high amounts of the carcinogenic gas in their neighborhoods. Residents asked why the EPA couldn’t close those facilities, and they wanted to know how many people had developed cancer from their exposure.

“If you’re upset by the information you’re hearing tonight, if you’re angry, if it scares you to think about risk to your family, those are totally reasonable responses,” Beal told an audience in Laredo, Texas, in September 2022. “We think the risk levels near this facility are too high.”

There are about 90 sterilizing plants in the U.S. that use ethylene oxide, and for decades companies used the chemical to sterilize medical products without drawing much attention. Many medical device-makers send their products to the plants to be sterilized before they are shipped, typically to medical distribution companies.

But people living around these facilities have been jolted in recent years by a succession of warnings about cancer risk from the federal government and media reports, an awareness that has also spawned protests and lawsuits alleging medical harm.

The EPA is expected to meet a March 1 court-ordered deadline to finalize tighter safety rules around how the toxic gas is used. The proposed changes come in the wake of a 2016 agency report that found that long-term exposure to ethylene oxide is more dangerous than was previously thought.

But the anticipated final rules — the agency’s first regulatory update on ethylene oxide emissions in more than a decade — are expected to face pushback. Medical device-makers worry stricter regulation will increase costs and may put patients at higher risk of infection from devices, ranging from surgical kits to catheters, due to deficient sterilization. The new rules are also not likely to satisfy the concerns of environmentalists or members of the public, who already have expressed frustration about how long it took the federal government to sound the alarm.

“We have been breathing this air for 40 years,” said Connie Waller, 70, who lives with her husband, David, 75, within two miles of such a sterilizing plant in Covington, Georgia, east of Atlanta. “The only way to stop these chemicals is to hit them in their pocketbook, to get their attention.”

The EPA says data shows that long-term exposure to ethylene oxide can increase the risk of breast cancer and cancers of the white blood cells, such as non-Hodgkin lymphoma, myeloma, and lymphocytic leukemia. It can irritate the eyes, nose, throat, and lungs, and has been linked to damage to the brain and nervous and reproductive systems. Children are potentially more vulnerable, as are workers routinely exposed to the chemical, EPA officials say. The agency calculates the risk based on how much of the gas is in the air or near the sterilizing facility, the distance a person is from the plant, and how long the person is exposed.

Waller said she was diagnosed with breast cancer in 2004 and that her husband was found to have non-Hodgkin lymphoma eight years later.

A 2022 study of communities living near a sterilization facility in Laredo found the rates of acute lymphocytic leukemia and breast cancer were greater than expected based on statewide rates, a difference that was statistically significant.

Beal, the EPA risk adviser, who regularly meets with community members, acknowledges the public’s concerns. “We don’t think it’s OK for you to be at increased risk from something that you have no control over, that’s near your house,” she said. “We are working as fast as we can to get that risk reduced with the powers that we have available to us.”

In the meantime, local and state governments and industry groups have scrambled to defuse public outcry.

Hundreds of personal injury cases have been filed in communities near sterilizing plants. In 2020, New Mexico’s then-attorney general filed a lawsuit against a plant in Santa Teresa, and that case is ongoing. In a case that settled last year in suburban Atlanta, a company agreed to pay $35 million to 79 people who alleged ethylene oxide used at the plant caused cancer and other injuries.

In Cook County, Illinois, a jury in 2022 awarded $363 million to a woman who alleged exposure to ethylene oxide gas led to her breast cancer diagnosis. But, in another Illinois case, a jury ruled that the sterilizing company was not liable for a woman’s blood cancer claim.

Greg Crist, chief advocacy officer for the Advanced Medical Technology Association, a medical device trade group that says ethylene oxide is an effective and reliable sterilant, attributes the spate of lawsuits to the litigious nature of trial attorneys.

“If they smell blood in the water, they’ll go after it,” Crist said.

Most states have at least one sterilizing plant. According to the EPA, a handful, like California and North Carolina, have gone further than the agency and the federal Clean Air Act to regulate ethylene oxide emissions. After a media and political firestorm raised awareness about the metro Atlanta facilities, Georgia started requiring sterilizing plants that use the gas to report all leaks.

The proposed rules the EPA is set to finalize would set lower emissions limits for chemical plants and commercial sterilizers and increase some safety requirements for workers within these facilities. The agency is expected to set an 18-month deadline for commercial sterilizers to come into compliance with the emissions rules.

That would help at facilities that “cut corners,” with lax pollution controls that allow emissions of the gas into nearby communities, said Richard Peltier, a professor of environmental health sciences at the University of Massachusetts-Amherst. Stronger regulation also prevents the plants from remaining under the radar. “One of the dirty secrets is that a lot of it is self-regulated or self-policed,” Peltier added.

But the proposed rules did not include protections for workers at off-site warehouses that store sterilized products, which can continue to emit ethylene oxide. They also did not require air testing around the facilities, prompting debate about how effective they would be in protecting the health of nearby residents.

Industry officials also don’t expect an alternative that is as broadly effective as ethylene oxide to be developed anytime soon, though they support researching other methods. Current alternatives include steam, radiation, and hydrogen peroxide vapor.

Increasing the use of alternatives can reduce industry dependence on “the crutch of ethylene oxide,” said Darya Minovi, senior analyst with the Union of Concerned Scientists, an advocacy group.

But meeting the new guidelines will be disruptive to the industry, Crist said. He estimates companies will spend upward of $500 million to comply with the new EPA rules and could struggle to meet the agency’s 18-month timetable. Sterilization companies will also have difficulty adjusting to new rules on how workers handle the gas without a dip in efficiency, Crist said.

The Food and Drug Administration, which regulates drugs and medical devices, is also watching the regulatory moves closely and worries the updated emissions rule could “present some unique challenges” if implemented as proposed, said Audra Harrison, an FDA spokesperson. “The FDA is concerned about the rule’s effects on the availability of medical devices,” she added.

Other groups, like the American Chemistry Council and the Texas Commission on Environmental Quality, the state’s environmental agency, assert that ethylene oxide use isn’t as dangerous as the EPA says. The EPA’s toxicity assessment has “severe flaws” and is “overly conservative,” the council said in an emailed statement. Texas, which has several sterilizing plants, has said ethylene oxide isn’t as high a cancer risk as the agency claims, an assessment that the EPA has rejected.

Tracey Woodruff, a researcher at the University of California-San Francisco who previously worked at the EPA, said it can be hard for the agency to keep up with regulating chemicals like ethylene oxide because of constrained resources, the technical complications of rulemaking, and industry lobbying.

But she’s hopeful the EPA can strike a balance between its desire to reduce exposure and the desire of the FDA not to disrupt medical device sterilization. And scrutiny can also help the device sterilization industry think outside the box.

“We continue to discover these chemicals that we’ve already been exposed to were toxic, and we have high exposures,” she said. “Regulation is an innovation forcer.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Subscribe to KFF Health News’ free Morning Briefing.

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  • Mammography AI Can Cost Patients Extra. Is It Worth It?

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    As I checked in at a Manhattan radiology clinic for my annual mammogram in November, the front desk staffer reviewing my paperwork asked an unexpected question: Would I like to spend $40 for an artificial intelligence analysis of my mammogram? It’s not covered by insurance, she added.

    I had no idea how to evaluate that offer. Feeling upsold, I said no. But it got me thinking: Is this something I should add to my regular screening routine? Is my regular mammogram not accurate enough? If this AI analysis is so great, why doesn’t insurance cover it?

    I’m not the only person posing such questions. The mother of a colleague had a similar experience when she went for a mammogram recently at a suburban Baltimore clinic. She was given a pink pamphlet that said: “You Deserve More. More Accuracy. More Confidence. More power with artificial intelligence behind your mammogram.” The price tag was the same: $40. She also declined.

    In recent years, AI software that helps radiologists detect problems or diagnose cancer using mammography has been moving into clinical use. The software can store and evaluate large datasets of images and identify patterns and abnormalities that human radiologists might miss. It typically highlights potential problem areas in an image and assesses any likely malignancies. This extra review has enormous potential to improve the detection of suspicious breast masses and lead to earlier diagnoses of breast cancer.

    While studies showing better detection rates are extremely encouraging, some radiologists say, more research and evaluation are needed before drawing conclusions about the value of the routine use of these tools in regular clinical practice.

    “I see the promise and I hope it will help us,” said Etta Pisano, a radiologist who is chief research officer at the American College of Radiology, a professional group for radiologists. However, “it really is ambiguous at this point whether it will benefit an individual woman,” she said. “We do need more information.”

    The radiology clinics that my colleague’s mother and I visited are both part of RadNet, a company with a network of more than 350 imaging centers around the country. RadNet introduced its AI product for mammography in New York and New Jersey last February and has since rolled it out in several other states, according to Gregory Sorensen, the company’s chief science officer.

    Sorensen pointed to research the company conducted with 18 radiologists, some of whom were specialists in breast mammography and some of whom were generalists who spent less than 75% of their time reading mammograms. The doctors were asked to find the cancers in 240 images, with and without AI. Every doctor’s performance improved using AI, Sorensen said.

    Among all radiologists, “not every doctor is equally good,” Sorensen said. With RadNet’s AI tool, “it’s as if all patients get the benefit of our very top performer.”

    But is the tech analysis worth the extra cost to patients? There’s no easy answer.

    “Some people are always going to be more anxious about their mammograms, and using AI may give them more reassurance,” said Laura Heacock, a breast imaging specialist at NYU Langone Health’s Perlmutter Cancer Center in New York. The health system has developed AI models and is testing the technology with mammograms but doesn’t yet offer it to patients, she said.

    Still, Heacock said, women shouldn’t worry that they need to get an additional AI analysis if it’s offered.

    “At the end of the day, you still have an expert breast imager interpreting your mammogram, and that is the standard of care,” she said.

    About 1 in 8 women will be diagnosed with breast cancer during their lifetime, and regular screening mammograms are recommended to help identify cancerous tumors early. But mammograms are hardly foolproof: They miss about 20% of breast cancers, according to the National Cancer Institute.

    The FDA has authorized roughly two dozen AI products to help detect and diagnose cancer from mammograms. However, there are currently no billing codes radiologists can use to charge health plans for the use of AI to interpret mammograms. Typically, the federal Centers for Medicare & Medicaid Services would introduce new billing codes and private health plans would follow their lead for payment. But that hasn’t happened in this field yet and it’s unclear when or if it will.

    CMS didn’t respond to requests for comment.

    Thirty-five percent of women who visit a RadNet facility for mammograms pay for the additional AI review, Sorensen said.

    Radiology practices don’t handle payment for AI mammography all in the same way.

    The practices affiliated with Boston-based Massachusetts General Hospital don’t charge patients for the AI analysis, said Constance Lehman, a professor of radiology at Harvard Medical School who is co-director of the Breast Imaging Research Center at Mass General.

    Asking patients to pay “isn’t a model that will support equity,” Lehman said, since only patients who can afford the extra charge will get the enhanced analysis. She said she believes many radiologists would never agree to post a sign listing a charge for AI analysis because it would be off-putting to low-income patients.

    Sorensen said RadNet’s goal is to stop charging patients once health plans realize the value of the screening and start paying for it.

    Some large trials are underway in the United States, though much of the published research on AI and mammography to date has been done in Europe. There, the standard practice is for two radiologists to read a mammogram, whereas in the States only one radiologist typically evaluates a screening test.

    Interim results from the highly regarded MASAI randomized controlled trial of 80,000 women in Sweden found that cancer detection rates were 20% higher in women whose mammograms were read by a radiologist using AI compared with women whose mammograms were read by two radiologists without any AI intervention, which is the standard of care there.

    “The MASAI trial was great, but will that generalize to the U.S.? We can’t say,” Lehman said.

    In addition, there is a need for “more diverse training and testing sets for AI algorithm development and refinement” across different races and ethnicities, said Christoph Lee, director of the Northwest Screening and Cancer Outcomes Research Enterprise at the University of Washington School of Medicine. 

    The long shadow of an earlier and largely unsuccessful type of computer-assisted mammography hangs over the adoption of newer AI tools. In the late 1980s and early 1990s, “computer-assisted detection” software promised to improve breast cancer detection. Then the studies started coming in, and the results were often far from encouraging. Using CAD at best provided no benefit, and at worst reduced the accuracy of radiologists’ interpretations, resulting in higher rates of recalls and biopsies.

    “CAD was not that sophisticated,” said Robert Smith, senior vice president of early cancer detection science at the American Cancer Society. Artificial intelligence tools today are a whole different ballgame, he said. “You can train the algorithm to pick up things, or it learns on its own.”

    Smith said he found it “troubling” that radiologists would charge for the AI analysis.

    “There are too many women who can’t afford any out-of-pocket cost” for a mammogram, Smith said. “If we’re not going to increase the number of radiologists we use for mammograms, then these new AI tools are going to be very useful, and I don’t think we can defend charging women extra for them.”

    KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

    Subscribe to KFF Health News’ free Morning Briefing.

    Share This Post

  • Easing Lower Back Pain

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Lower back pain often originates from an unexpected culprit: your pelvis. Similar to how your psoas can contribute to lower back pain, when your pelvis tilts forward due to tight hip flexors, it can misalign your spine, leading to discomfort and pain. As WeShape shows us in the below video, one simple stretch can help realign your pelvis and significantly ease lower back pain.

    Why Your Pelvis Matters

    Sitting for long periods causes your hip flexors to shorten, leading to an anterior pelvic tilt. This forward tilt puts pressure on your spine and SI joint, causing pain and discomfort in the lower back. To help resolve this, you can work on correcting your pelvic alignment, helping to significantly reduce this pressure and alleviate related pain. And no, this doesn’t require any spinal cord stimulation.

    Easy Variations for All

    A lot of you recognise the stretch in this video; it’s quite a well-known kneeling stretch. But, unlike other guides, WeShape also provides a fantastic variation for those who aren’t mobile enough for the kneeling variation

    So, if you can’t comfortably get down on the ground, WeShape outlines a brilliant standing variation. So, regardless of your mobility, there’s an option for you!

    See both variations here:

    Excited to reduce your lower back pain? We hope so! Let us know if you have any tips that you’d like to share with us.

    Share This Post

  • Cucumber vs Lychee – Which is Healthier?

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    Our Verdict

    When comparing cucumber to lychee, we picked the lychee.

    Why?

    In terms of macros, the lychee has more carbs and more fiber, but both are low glycemic index foods. Functionally a tie, though we could consider it a nominal win for cucumber.

    In the category of vitamins, cucumber has more of vitamins A, B1, B5, and K, while lychee has more of vitamins B2, B3, B6, B9, C, E, and choline. In particular, cucumber has a lot more vitamin K and lychee has a lot more vitamin C. Nevertheless, in terms of overall vitamin coverage, lychee is the clear winner here.

    Looking at minerals, cucumber has more calcium, magnesium, manganese, and zinc, while lychee has more copper (especially rich in this), iron, phosphorus, potassium, and selenium. Another clear win for lychee.

    Both have an abundance of anti-inflammatory polyphenols, but we could find no strong argument for one being better than the other in this category, just different.

    In short, both are fine options, but the more nutritionally dense is the lychee, so that’s our choice!

    Want to learn more?

    You might like to read:

    Cucumber Extract Beats Glucosamine & Chondroitin… At 1/135th Of The Dose?!

    Take care!

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  • The Best Menopause Advice You Don’t Want To Hear About

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    Nutritionist and perimenopause coach Claudia Canu, whom we’ve featured before in our Expert Insights segment, has advice:

    Here’s to good health

    When it comes to alcohol, the advice is: don’t.

    Or at least, cut back, and manage the effects by ensuring good hydration, having an “alcohol curfew” and so forth.

    What’s the relation to menopause? Well, alcohol’s not good for anyone at any time of life, but there are some special considerations when it comes to alcohol and estrogenic hormonal health:

    • The liver works hard to process the alcohol as a matter of urgency, delaying estrogen processing, which can increase the risk of breast and uterine cancer.
    • Alcohol has no positive health effects and is also linked to higher risks of breast and colorectal cancer.
    • Alcohol can also trigger some menopausal symptoms, such as night sweats and hot flashes. So, maybe reaching for that “cooling drink” isn’t the remedy it might seem.
    • During menopause, the body becomes more insulin-resistant, making it more susceptible to blood sugar spikes caused by alcohol. Also not good.

    Common reasons women turn to alcohol include stress, frustration, the need for reward, and social pressure, and all of these can be heightened when undergoing hormonal changes. Yet, alcohol will ultimately only worsen each of those things.

    For more on the science of some of the above, plus tips on how to make positive changes with minimum discomfort, enjoy:

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    Want to learn more?

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    Take care!

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  • How Tight Are Your Hips? Test (And Fix!) With This

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    Upon surveying over half a million people; hips were the most common area for stiffness and lack of mobility. So, what to do about it?

    This test don’t lie

    With 17 muscles contributing to hip function (“hip flexors” being the name for this group of 17 muscles, not specific muscle), it’s important to figure out which ones are tight, and if indeed it really is the hip flexors at all, or if it could be, as it often is, actually the tensor fasciae latae (TFL) muscle of the thigh. If it turns out to be both, well, that’s unfortunate but the good news is, now you’ll know and can start fixing from all the necessary angles.

    Diagnostic test for tight hip flexors (Thomas Test):

    1. Use a sturdy, elevated surface (e.g. table or counter—not a bed or couch, unless there is perchance room to swing your legs without them touching the floor).
    2. Sit at the edge, lie back, and pull both knees to your chest.
    3. Return one leg back down until the thigh is perpendicular to the table.
    4. Let the other leg dangle off the edge to assess flexibility.

    Observations from the test:

    1. Thigh contact: is the back of your thigh touching the table?
    2. Knee angle: is your knee bent at roughly 80° or straighter?
    3. Thigh rotation: does the thigh roll outward?

    Interpreting results:

    • If your thigh contacts the surface and the knee is bent at around 80°, hip mobility is good.
    • If your thigh doesn’t touch or knee is too straight, hip flexor tightness is present.
    • If your thigh rolls outwards from your midline, that indicates tightness in the TFL muscle of the thigh.

    Three best hip flexor stretches:

    1. Kneeling lunge stretch:
      • Hips above the knee, tuck tailbone, engage glutes, press hips forward, reach arm up with a slight side bend.
    2. Seated hip lift stretch:
      • Sit with feet hip-width apart, hands behind shoulders, lift hips, step one foot back, tuck tailbone, point knee away.
    3. Sofa stretch:
      • Kneel with one shin against a couch/wall, other foot forward in lunge, tuck tailbone, press hips forward, lift torso.

    It’s recommended to how each stretch for 30 seconds on each side.

    For more on all of the above, and visual demonstrations, enjoy:

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  • Can Home Tests Replace Check-Ups?

    10almonds is reader-supported. We may, at no cost to you, receive a portion of sales if you purchase a product through a link in this article.

    It’s Q&A Day at 10almonds!

    Have a question or a request? You can always hit “reply” to any of our emails, or use the feedback widget at the bottom!

    In cases where we’ve already covered something, we might link to what we wrote before, but will always be happy to revisit any of our topics again in the future too—there’s always more to say!

    As ever: if the question/request can be answered briefly, we’ll do it here in our Q&A Thursday edition. If not, we’ll make a main feature of it shortly afterwards!

    So, no question/request too big or small

    ❝I recently hit 65 and try to get regular check-ups, but do you think home testing can be as reliable as a doctor visit? I try to keep as informed as I can and am a big believer in taking responsibility for my own health if I can, but I don’t want to miss something important either. Best as a supplemental thing, perhaps?❞

    Depends what’s being tested! And your level of technical knowledge, though there’s always something to be said for ongoing learning.

    • If you’re talking blood tests, urine tests, etc per at-home test kits that get sent off to a lab, then provided they’re well-sourced (and executed correctly by you), they should be as accurate as what a doctor will give, since they are basically doing the same thing (taking a sample and sending it off to a lab).
    • If you’re talking about checking for lumps etc, then a dual approach is best: check yourself at home as often as you feel is reasonable (with once per month being advised at a minimum, especially if you’re aware of an extra risk factor for you) and check-ups with the doctor per their recommendations.
    • If you’re talking about general vitals (blood pressure, heart rate, heart rate variability, VO₂ max, etc), then provided you have a reliable way of testing them, then doing them very frequently at home, to get the best “big picture” view. In contrast, getting them done once a year at your doctor’s could result in a misleading result, if you just ate something different that day or had a stressful morning, for example.

    Enjoy

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