07.08.2020 0

Why is the EPA restricting ventilator sterilization chemical ethylene oxide when we need it the most in the middle of the pandemic?

By Rick Manning

The Environmental Protection Agency is making a mistake.  They are moving forward with the process of further regulating something called ethylene oxide [EtO] upon a harshly contested assumption that the chemical’s emissions may contribute to cancer.

So what’s not to like?

It just so happens that the chemical ethylene oxide is the only thing which sufficiently sterilizes medical equipment like ventilators, so that they can be re-used in new patients.  Yet, in the midst of the on-going Chinese-originated virus pandemic, the bureaucrats at the EPA are trying to subject vulnerable patients to unsafe medical devices due to them not being as clean as they should be.

Former Food and Drug Administration Commissioner Scott Gottlieb put it like this in a March 19, 2019 statement, “Certain medical devices need to be sterilized to reduce the risk of those devices causing infections in patients from living microorganisms. Sterilization of medical devices is a well-established and scientifically-proven method of preventing harmful microorganisms from reproducing and transmitting infections. It’s critical to our health care system.  And ethylene oxide is a commonly used method of medical device sterilization. It’s considered a safe and effective method that helps ensure the safety of medical devices and helps deliver quality patient care. Devices sterilized with ethylene oxide range from wound dressings to more specialized devices, like stents, as well as kits used in routine hospital procedures or surgeries that include multiple components made of different materials.”

And the science on whether this unique and important sterilizing agent is carcinogenic is hardly settled, as Dr. Gail Charnley, PhD, who serves as the Senior Toxicologist for HealthRisk Strategies plainly states, “There is no cancer threat from the tiny amounts of ethylene oxide released from these sterilization plants.”

Lucy Fraiser, a board-certified toxicologist and a Diplomate of the American Board of Toxicology agrees, “To be clear – there are no actual scientific data that show that these [EtO] exposure levels result in cancer.”

While different scientists might disagree about the relative health risk of the very low current exposure levels of [EtO] coming from sterilization plants, what is indisputable is that the loss of these plants is a medical disaster.

Already a sterilization plant was forced to temporarily close in the state of Illinois as the state EPA knee-jerked to the latest scare by imposing standards that could not be met without $10 million of upgrades to the facility.

This precedent has the president and CEO of the ECRI Institute Dr. Marcus Schabacker worried, “If there’s an ubiquitous ban on ethylene oxide today, we’re going to have a health crisis on our hands, because in very short time and order, sterile products won’t be available, and we don’t have an alternative to replace that today.”

And it should have each of us worried as experts like Gary Secola who is on the FDA’s General Hospital and Personal Use Panel of the Medical Devices Advisory Committee assert that “There are avenues that might lead to replace ethylene oxide, but the standards aren’t there yet. If we’re going to get rid of [EtO] it’s going to take 10-20 years.”

President Trump has made it clear to agency heads that he expects them to be very cautious in issuing regulations, and the EPA itself is still considering instituting a wise policy to make all the science they rely upon to make regulatory determinations transparent so that others can subject it to the scientific method of re-testing to insure that the results and conclusions are valid.

With the on-going scientific contention that the science behind the EPA’s push to regulate this extremely important sterilization tool, it would behoove them to release all the records and methodology for any studies which support this conclusion.  The very idea of having a non-sterile ventilator or stent or heart valve put into a patient’s body because the EPA used junk science to come to a determination and then failed to adequately balance the damage done to human health by a ban against the risk of doing nothing is almost inconceivable in 2020, when Americans have been subjected to many or our worse health fears.

It is time for EPA Administrator Andrew Wheeler to slow his Agency’s roll.  After all, it would seem logical for them to follow one of the first rules of medicine when it comes to this important tool for sterilizing medical devices which is to do no harm. It would be wise for the EPA to assume this posture when it comes to further regulation ethylene oxide.

Rick Manning is the President of Americans for Limited Government.

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