The current outcry from exposed communities has federal regulators and device makers seriously rethinking a question that’s been hanging over the sterilization industry for decades: Can ethylene oxide be replaced?
. Federal lobbying disclosures show medical device makers and sterilizers have spent more than $1 million over the past 12 months lobbying Congress and the EPA on ethylene oxide issues.“Nobody in the last 40 years has been pressuring from the outside that there are community exposures from this,” said Peter Orris, MD, a professor and chief of occupational and environmental medicine at the University of Illinois at Chicago.
The outrage from exposed communities has federal regulators and device makers seriously rethinking a question that’s been hanging over the sterilization industry for decades: Can ethylene oxide be replaced?pending before the American Medical Association’s Board of Trustees urges the nation’s doctors to push for substitutes to ethylene oxide sterilization “that are currently available” and do not cause cancer.
In public statements, Phil Macnabb, president of Sterigenics, likes to point to vascular catheters as an example of a medical device that can’t be sterilized with anything but ethylene oxide. In 2017, Hemmerich was chairman of a 40-member working group for the Association for the Advancement of Medical Instrumentation that created a guide to help medical device engineers understand which sterilization methods could be used with different kinds of materials.“In some limited number of cases, it’s going to be difficult to switch,” Hemmerich says. He estimates that only 20% of medical supplies need to be sterilized with ethylene oxide.
Still, Crist says his pitch to lawmakers is simple: “As you consider regulating this, please bear in mind the public health impact of potential device shortages.’’ Other kinds of radiation -- like electron beams and X-rays -- can also kill germs, but they’re not as commonly used. Not all materials can withstand radiation.
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