Pending regulation on EtO puts California patient care at risk

OPINION – A pending state regulatory update on a substance used to sterilize medical devices could cause devastating harm to timely health care for Californians.

Ethylene oxide (EtO) is used in specialized facilities across California and nationwide to sterilize critical medical equipment, including surgical kits, syringes, pacemakers, and heart valves, to name a few. EtO sterilizes 20 billion, roughly half, of all medical devices in the U.S. annually. It’s the only viable method for many devices, key to preventing serious and even fatal infection in just about every medical procedure.

While some risk exists from this substance at high levels under certain circumstances, regulating it out of use for this purpose would be far worse for public health.

That’s why state and federal regulators are looking to strike the right balance between regulating EtO in the air and preserving access to lifesaving, life-enhancing sterilized medical supplies. Facilities using EtO for sterilization are highly regulated at multiple levels of government, and the medical technology industry supports workable and reasonable regulations that support overall public health. However, state regulations based on misguided federal findings can increase negative effects for patients. The California Office of Environmental Health Hazard Assessment’s (OEHHA) recently proposed updated draft cancer inhalation unit risk factor for EtO is the latest example.

If allowed to proceed, and incorporated into existing regulations, this updated risk factor could seriously hamstring or shutter critical medical device sterilization facilities throughout California. The resulting shortfalls in sterile medical equipment would jeopardize public health through disruptions and delays in medical care – from routine exams to life-saving surgeries – for the 39 million Californians and countless residents of other Western states who rely on sterile medical supplies from the Golden State.

While some risk exists from this substance at high levels under certain circumstances, regulating it out of use for this purpose would be far worse for public health.

Unfortunately, OEHHA based its update on a U.S. EPA assessment that sought and resulted in an overly conservative acceptable risk value. To arrive at the risk value, the agency relied on a single study from years ago and overlooked many more recent studies showing a lack of any statistically significant association between EtO and cancer. Hence, despite recommendations from the National Research Council and the National Academies of Science to avoid relying on single studies, EPA did exactly that.

Further, the EPA itself notes it purposely chose to over-estimate risk to protect the public from worst-case, unrealistic exposures. The EPA’s acceptable risk level is many magnitudes below EtO levels in the everyday air around us. By that logic, EPA and agencies such as OEHHA would have to ban all EtO, everywhere, to achieve the unrealistically low levels in air – which would be impossible because EtO is both naturally occurring and manufactured. In fact, EtO is produced in the human body as part of digestion, as well as by decaying leaves, automobiles, and burning charcoal, among others.

As the South Coast Air Quality Management District commented on the OEHHA proposal, “It is unclear how much ethylene oxide found at background levels throughout the nation is naturally occurring and what are the key contributing man-made sources.” What’s more, the district also notes that sterilizing facilities are not the cause of observed background levels.

These comments acknowledge the reality: No matter how much medical device sterilization facilities are regulated, those regulations won’t materially change EtO background levels because medical device sterilizers use less than half of one percent of all commercial EtO.

Sadly, patients who rely on sterile medical technology are likely to be the most profoundly affected by OEHHA’s proposed regulations. Because sterilization is at or near capacity, reducing the capacity of any sterilization facility, even temporarily, could cause serious disruptions across the entire medical device supply chain, just as both the U.S. EPA and FDA have warned.

California, like the nation, is aging,  which will drive increased demand for medical procedures and equipment to fight hospital-acquired infections. Those facts demand protecting patients with balanced regulations that preserve timely access to adequate supplies of sterile, lifesaving, life-enhancing medical technology. Anything less would force patients to wait or pay more for health care as sterile supplies decrease, harming Californians and increasing health care inequities.

The better course of action is a much more measured approach keeping sterilization facilities open, ensuring patients have the care they need without interruption.

Lucy H. Fraiser is a board-certified toxicologist (Diplomate of the American Board of Toxicology) with over 30 years of experience. She regularly works on chemical issues in states across the country, including in California, and at the federal level.