The Environmental Protection Agency on Thursday finalized a rule aimed at sharply reducing emissions of ethylene oxide, a cancer-causing chemical that's essential for sterilizing medical devices.
Why it matters: The FDA has expressed concern about the possibility of resulting device shortages. There are no ready alternatives that can be used at the scale of ethylene oxide, or EtO, at this point, according to the agency.
Zoom in: The new requirements will reduce the amount of EtO coming from commercial sterilizers by an estimated 90% over time. That's an additional 10% over what EPA estimated in its proposed standards.
The final rule extends compliance timelines for sterilizing plants compared to the proposed standards.
Its standards aim to protect people living near sterilizing facilities while "minimizing any potential impacts to the medical device supply chain," the EPA said in a release.
The agency received more than 40,000 comments on its proposed standards and worked closely with the Health and Human Services Department to develop the final regulations, EPA officials said.
State of play: The FDA in April began a pilot program to reduce medical sterilizers' dependence on EtO, and put out guidance last month encouraging companies to use an alternative sterilizing chemical.
FDA estimates that EtO is used on 20 billion devices in the United States.
Flash back: A 2016 report concluded with "high" confidence that ethylene oxide is "carcinogenic to humans." The odorless gas is the subject of many civil claims and lawsuits.
What they're saying: "For years, I have called for environmental justice, urging protections for workers and fenceline communities from the dangers of EtO pollution," HHS Secretary Xavier Becerra said in a news release.
"We will continue to work together with EPA to achieve our shared goals of lowering EtO exposure while also mitigating potential risks of medical device shortages."
"The EPA's final ethylene oxide standards for commercial sterilizers are grounded in science and will save lives," said Senate Environment and Public Works Committee Chair Tom Carper (D-Del.). "I'm grateful for the Biden administration's years of work to develop these strong standards."
Federal regulators' recent approval of anti-obesity drug Wegovy to reduce cardiovascular risks in overweight people opens the door for Medicare to cover the pricey treatment for more people — though takeup is likely to be slow initially.
Why it matters: More than 40% of Medicare enrollees have at least one heart condition, meaning the new Wegovy approval could greatly expand older adults' access to a drug that so far has been limited for this group.
Rising maternal death rates in the U.S. may have been sharply overstated due to flawed record-keeping, according to new research that found mortality held steady and was in line with other developed nations over two decades.
Why it matters: Maternal health statistics have become a critical public health focus with millions of women living in areas with little to no access to maternity care and with more restricted access to abortion.
South Dakota Gov. Kristi Noem (R) is being accused in a lawsuit of breaching D.C. consumer protection laws over online video posts this week that praised a Texas dentist.
We know how ultra-processed foods like chips and sugary cereals affect our bodies. New research is digging into how junk food hits our brains.
Why it matters: Beyond elevating risk of obesity, diabetes and heart disease, heavily processed foods can harm mental health, mess with sleep — and even be addictive like alcohol or nicotine.
Most health providers get very little training on how to care for the millions of Americans with intellectual and developmental disabilities, but a new coalition is trying to change that.
Why it matters: Americans with intellectual or developmental disabilities including autism, Down syndrome and ADHD have more unmet health needs than their peers.
Pharmaceutical interests lost a closely watched battle over the federal drug discount program on Tuesday when a federal appeals court ruled that Arkansas can block manufacturers from limiting the availability of discounted drugs at certain pharmacies.
Why it matters: The decision from the 8th U.S. Circuit Court of Appeals could encourage look-alike state laws that take aim at restrictions on when providers can use discounts from the 340B program.
Why it matters: Hospitals, doctors' offices and pharmacies are still struggling with the fallout of the outage of Change Healthcare's payment system, as they worry emergency measures won't be enough if the disruption drags on.
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