by
Thomas Dworetzky, Contributing Reporter | October 30, 2019
If Sterigenics stays closed, she added, this could put them “out of commission.”
The Center for Devices and Radiological Health is putting together a database of replacement products for equipment not sterilized with ethylene oxide, she stated, but is hampered by the fact that makers don't have to inform them about shortages, unlike drug makers.
Another hurdle: makers need agency approval to change sterilization sites for Class III medical devices — although the review will be fast-tracked at this point from 180 to 30 days.
Jeff Sauter with Steri-Tek in California, which sterilizes with e-beam and X-ray radiation, told WABE that some makers are looking into using a different technique but that it is not trivial to switch from a regulatory point of view.
“There are companies scrambling. It’s a big deal — a big, big deal,” Sauter told WABE of the facility closures, adding, “there has not been a big driver to create better technology,” and noting that “with these emissions, it’s coming to the fore.”
It is forcing the industry to take a fresh look at sterilization. “It had to come to this point of a crisis,” he said. “Now it’s a crisis.”
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