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.

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  • 4 Practices To Build Self-Worth That Lasts

    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.

    Self-worth is internal, based on who you are, not what you do or external validation. It differs from self-esteem, which is more performance-based. High self-worth doesn’t necessarily mean arrogance, but can lead to more confidence and success. Most importantly, it’ll help you to thrive in what’s actually most important to you, rather than being swept along by what other people want.

    A stable foundation

    A strong sense of self-worth shapes how you handle boundaries, what you believe you deserve, and what you pursue in life. This matters, because life is unpredictable, so having a resilient internal foundation (like a secure “house”) helps you to weather challenges.

    1. Self-acceptance and compassion:
      • Accept both your positive and negative traits with compassion.
      • Don’t judge yourself harshly; allow yourself to accept imperfections without guilt or shame.
    2. Self-trust:
      • Trust yourself to make choices that benefit you and create habits that support long-term well-being—especially if those benefits are cumulative!
      • Balance self-care with flexibility to enjoy life without being overly rigid.
    3. Get uncomfortable:
      • Growth happens outside your comfort zone. Step into new, challenging experiences to build self-trust.
      • However! Small uncomfortable actions lead to greater confidence and a stronger sense of self. Large uncomfortable actions often doing lead anywhere good.
    4. Separation of tasks:
      • Oftentimes we end up overly preoccupying ourselves with things that are not actually our responsibility. Focus instead on tasks that genuinely belong to you, and let go of trying to control others’ perceptions or tasks.
      • Seek internal validation, not external praise. Avoid people-pleasing behavior.

    Finally, three things to keep in mind:

    • Boundaries: respecting your own boundaries strengthens self-worth, avoiding burnout from people-pleasing.
    • Validation: self-worth is independent of how others perceive you; focus on your integrity and personal growth.
    • Accountability: take responsibility for your actions but recognize that others’ reactions are beyond your control.

    For more on all of these things, enjoy:

    Click Here If The Embedded Video Doesn’t Load Automatically!

    Want to learn more?

    You might also like to read:

    Practise Self-Compassion In Your Relationship (But Watch Out!)

    Take care!

    Share This Post

  • Coughing/Wheezing After Dinner?

    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.

    The After-Dinner Activities You Don’t Want

    A quick note first: our usual medical/legal disclaimer applies here, and we are not here to diagnose you or treat you; we are not doctors, let alone your doctors. Do see yours if you have any reason to believe there may be cause for concern.

    Coughing and/or wheezing after eating is more common the younger or older someone is. Lest that seem contradictory: it’s a U-shaped bell-curve.

    It can happen at any age and for any of a number of reasons, but there are patterns to the distribution:

    Mostly affects younger people:

    Allergies, asthma

    Young people are less likely to have a body that’s fully adapted to all foods yet, and asthma can be triggered by certain foods (for example sulfites, a common preservative additive):

    Adverse reactions to the sulphite additives

    Foods/drinks that commonly contain sulfites include soft drinks, wines and beers, and dried fruit

    As for the allergies side of things, you probably know the usual list of allergens to watch out for, e.g: dairy, fish, crustaceans, eggs, soy, wheat, nuts.

    However, that’s far from an exhaustive list, so it’s good to see an allergist if you suspect it may be an allergic reaction.

    Affects young and old people equally:

    Again, there’s a dip in the middle where this doesn’t tend to affect younger adults so much, but for young and old people:

    Dysphagia (difficulty swallowing)

    For children, this can be a case of not having fully got used to eating yet if very small, and when growing, can be a case of “this body is constantly changing and that makes things difficult”.

    For older people, this can can come from a variety of reasons, but common culprits include neurological disorders (including stroke and/or dementia), or a change in saliva quality and quantity—a side-effect of many medications:

    Hyposalivation in Elderly Patients

    (particularly useful in the article above is the table of drugs that are associated with this problem, and the various ways they may affect it)

    Managing this may be different depending on what is causing your dysphagia (as it could be anything from antidepressants to cancer), so this is definitely one to see your doctor about. For some pointers, though:

    NHS Inform | Dysphagia (swallowing problems)

    Affects older people more:

    Gastroesophagal reflux disease (GERD)

    This is a kind of acid reflux, but chronic, and often with a slightly different set of symptoms.

    GERD has no known cure once established, but its symptoms can be managed (or avoided in the first place) by:

    And of course, don’t smoke, and ideally don’t drink alcohol.

    You can read more about this (and the different ways it can go from there), here:

    NICE | Gastro-oesophageal reflux disease

    Note: this above page refers to it as “GORD”, because of the British English spelling of “oesophagus” rather than “esophagus”. It’s the exact same organ and condition, just a different spelling.

    Take care!

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  • More Salt, Not Less?

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    It’s Q&A Day at 10almonds!

    Have a question or a request? We love to hear from you!

    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’m curious about the salt part – learning about LMNT and what they say about us needing more salt than what’s recommended by the government, would you mind looking into that? From a personal experience, I definitely noticed a massive positive difference during my 3-5 day water fasts when I added salt to my water compared to when I just drank water. So I’m curious what the actual range for salt intake is that we should be aiming for.❞

    That’s a fascinating question, and we’ll have to tackle it in several parts:

    When fasting

    3–5 days is a long time to take only water; we’re sure you know most people fast from food for much less time than that. Nevertheless, when fasting, the body needs more water than usual—because of the increase in metabolism due to freeing up bodily resources for cellular maintenance. Water is necessary when replacing cells (most of which are mostly water, by mass), and for ferrying nutrients around the body—as well as escorting unwanted substances out of the body.

    Normally, the body’s natural osmoregulatory process handles this, balancing water with salts of various kinds, to maintain homeostasis.

    However, it can only do that if it has the requisite parts (e.g. water and salts), and if you’re fasting from food, you’re not replenishing lost salts unless you supplement.

    Normally, monitoring our salt intake can be a bit of a guessing game, but when fasting for an entire day, it’s clear how much salt we consumed in our food that day: zero

    So, taking the recommended amount of sodium, which varies but is usually in the 1200–1500mg range (low end if over aged 70+; high end if aged under 50), becomes sensible.

    More detail: How Much Sodium You Need Per Day

    See also, on a related note:

    When To Take Electrolytes (And When We Shouldn’t!)

    When not fasting

    Our readers here are probably not “the average person” (since we have a very health-conscious subscriber-base), but the average person in N. America consumes about 9g of salt per day, which is several multiples of the maximum recommended safe amount.

    The WHO recommends no more than 5g per day, and the AHA recommends no more than 2.3g per day, and that we should aim for 1.5g per day (this is, you’ll note, consistent with the previous “1200–1500mg range”).

    Read more: Massive efforts needed to reduce salt intake and protect lives

    Questionable claims

    We can’t speak for LMNT (and indeed, had to look them up to discover they are an electrolytes supplement brand), but we can say that sometimes there are articles about such things as “The doctor who says we should eat more salt, not less”, and that’s usually about Dr. James DiNicolantonio, a doctor of pharmacy, who wrote a book that, because of this question today, we’ve now also reviewed:

    The Salt Fix: Why the Experts Got It All Wrong—and How Eating More Might Save Your Life – by Dr. James DiNicolantonio

    Spoiler, our review was not favorable.

    The body knows

    Our kidneys (unless they are diseased or missing) do a full-time job of getting rid of excess things from our blood, and dumping them into one’s urine.

    That includes excess sugar (which is how diabetes was originally diagnosed) and excess salt. In both cases, they can only process so much, but they do their best.

    Dr. DiNicolantino recognizes this in his book, but chalks it up to “if we do take too much salt, we’ll just pass it in urine, so no big deal”.

    Unfortunately, this assumes that our kidneys have infinite operating capacity, and they’re good, but they’re not that good. They can only filter so much per hour (it’s about 1 liter of fluids). Remember we have about 5 liters of blood, consume 2–3 liters of water per day, and depending on our diet, several more liters of water in food (easy to consume several more liters of water in food if one eats fruit, let alone soups and stews etc), and when things arrive in our body, the body gets to work on them right away, because it doesn’t know how much time it’s going to have to get it done, before the next intake comes.

    It is reasonable to believe that if we needed 8–10g of salt per day, as Dr. DiNicolantonio claims, our kidneys would not start dumping once we hit much, much lower levels in our blood (lower even than the daily recommended intake, because not all of the salt in our body is in our blood, obviously).

    See also: How Too Much Salt Can Lead To Organ Failure

    Lastly, a note about high blood pressure

    This is one where the “salt’s not the bad guy” crowd have at least something close to a point, because while salt is indeed still a bad guy (if taken above the recommended amounts, without good medical reason), when it comes to high blood pressure specifically, it’s not the worst bad guy, nor is it even in the top 5:

    Hypertension: Factors Far More Relevant Than Salt

    Thanks for writing in with such an interesting question!

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  • The Inflamed Mind – by Dr. Edward Bullmore

    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.

    Firstly, let’s note that this book was published in 2018, so the “radical new” approach is more like “tried and tested and validated” now.

    Of course, inflammation in the brain is also linked to Alzheimer’s, Parkinson’s, and other neurodegenerative disorders, but that’s not the main topic here.

    Dr. Bullmore, a medical doctor, psychiatrist, and neuroscientist with half the alphabet after his name, knows his stuff. We don’t usually include author bio information here, but it’s also relevant that he has published more than 500 scientific papers and is one of the most highly cited scientists worldwide in neuroscience and psychiatry.

    What he explores in this book, with a lot of hard science made clear for the lay reader, is the mechanisms of action of depression treatments that aren’t just SSRIs, and why anti-inflammatory approaches can work for people with “treatment-resistant depression”.

    The book was also quite prescient in its various declarations of things he expects to happen in the field in the next five years, because they’ve happened now, five years later.

    Bottom line: if you’d like to understand how the mind and body affect each other in the cases of inflammation and depression, with a view to lessening either or both of those things, this is a book for you.

    Click here to check out The Inflamed Mind, and take good care of yours!

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  • Our family is always glued to separate devices. How can we connect again?

    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 Saturday afternoon and the kids are all connected to separate devices. So are the parents. Sounds familiar?

    Many families want to set ground rules to help them reduce their screen time – and have time to connect with each other, without devices.

    But it can be difficult to know where to start and how to make a plan that suits your family.

    First, look at your own screen time

    Before telling children to “hop off the tech”, it’s important parents understand how much they are using screens themselves.

    Globally, the average person spends an average of six hours and 58 minutes on screens each day. This has increased by 13%, or 49 minutes, since 2013.

    Parents who report high screen time use tend to see this filtering down to the children in their family too. Two-thirds of primary school-aged children in Australia have their own mobile screen-based device.

    Australia’s screen time guidelines recommended children aged five to 17 years have no more than two hours of sedentary screen time (excluding homework) each day. For those aged two to five years, it’s no more than one hour a day. And the guidelines recommend no screen time at all for children under two.

    Yet the majority of children, across age groups, exceed these maximums. A new Australian study released this week found the average three-year-old is exposed to two hours and 52 minutes of screen time a day.

    Some screen time is OK, too much increases risks

    Technology has profoundly impacted children’s lives, offering both opportunities and challenges.

    On one hand, it provides access to educational resources, can develop creativity, facilitates communication with peers and family members, and allows students to seek out new information.

    On the other hand, excessive screen use can result in too much time being sedentary, delays in developmental milestones, disrupted sleep and daytime drowsiness.

    Tired boy looks out the window
    Disrupted sleep can leave children tired the next day.
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    Too much screen time can affect social skills, as it replaces time spent in face-to-face social interactions. This is where children learn verbal and non-verbal communication, develop empathy, learn patience and how to take turns.

    Many families also worry about how to maintain a positive relationship with their children when so much of their time is spent glued to screens.

    What about when we’re all on devices?

    When families are all using devices simultaneously, it results in less face-to-face interactions, reducing communication and resulting in a shift in family dynamics.

    The increased use of wireless technology enables families to easily tune out from each other by putting in earphones, reducing the opportunity for conversation. Family members wearing earphones during shared activities or meals creates a physical barrier and encourages people to retreat into their own digital worlds.

    Wearing earphones for long periods may also reduce connection to, and closeness with, family members. Research from video gaming, for instance, found excessing gaming increases feelings of isolation, loneliness and the displacement of real-world social interactions, alongside weakened relationships with peers and family members.

    How can I set screen time limits?

    Start by sitting down as a family and discussing what limits you all feel would be appropriate when using TVs, phones and gaming – and when is an appropriate time to use them.

    Have set rules around family time – for example, no devices at the dinner table – so you can connect through face-to-face interactions.

    Mother talks to her family at the dinner table
    One rule might be no devices at the dinner table.
    Monkey Business Images/Shutterstock

    Consider locking your phone or devices away at certain periods throughout the week, such as after 9pm (or within an hour of bedtime for younger children) and seek out opportunities to balance your days with physical activities, such kicking a footy at the park or going on a family bush walk.

    Parents can model healthy behaviour by regulating and setting limits on their own screen time. This might mean limiting your social media scrolling to 15 or 30 minutes a day and keeping your phone in the next room when you’re not using it.

    When establishing appropriate boundaries and ensuring children’s safety, it is crucial for parents and guardians to engage in open communication about technology use. This includes teaching critical thinking skills to navigate online content safely and employing parental control tools and privacy settings.

    Parents can foster a supportive and trusting relationship with children from an early age so children feel comfortable discussing their online experiences and sharing their fears or concerns.

    For resources to help you develop your own family’s screen time plan, visit the Raising Children Network.The Conversation

    Elise Waghorn, Lecturer, School of Education, RMIT University

    This article is republished from The Conversation under a Creative Commons license. Read the original article.

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  • Shoulders Range – by Elia Bartolini

    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.

    Shoulder flexibility and mobility can be a big deal, especially when it starts to decline—more so than other kinds of flexibility. Most seniors can get through the day without doing the splits against a wall, for example, but shoulder tightness can be more of a problem if you can’t easily get into or out of your clothes.

    If you think it couldn’t happen to you: the great Jane Fonda has a now-famous photoset of her looking glamorous in a dress at a red carpet event, and then looking frazzled making breakfast in the same dress in her kitchen the next morning, because, as she wrote, “I couldn’t get my dress unzipped so I slept in it”.

    Now, “to avoid ending up like Jane Fonda” is not a series of words that usually precedes advice, but in this case: this book delves into the science of one of the most quirky joints of the human body, and how to leverage this to maximize shoulder mobility, while maintaining adequate strength (because flexibility without strength is just asking for a dislocation) without doing anything that would actually bulk up our shoulders, because it’s just about progressing through passive, active, and tensed stretching, static, dynamic, and loaded stretching, as well as PNF stretching and antagonist stretching.

    If that seems like a lot of stretching, don’t worry; the author presents a series of workouts that will take us through these stretches in a very small amount of time each day.

    The style is instructional like a textbook, with clear diagrams where appropriate, and lots of callout boxes, bullet points, emboldening for key points, etc. It all makes for every easy learning.

    Bottom line: if you’d like to improve and maintain your shoulder mobility, this is an excellent book for that.

    Click here to check out Shoulders Range, and perfect your shoulders and upper body flexibility!

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