In wake of EtO sterilization plant closures, FDA issues innovation challenges
The recent closure of two contract ethylene oxide (EtO) sterilization facilities, causing disruption in the medical device supply chain, prompted FDA to issue two “public innovation challenges” on July 15. The announcement posted on the agency’s website called on qualified parties to identify new sterilization methods and technologies for medical devices that do not rely on EtO and, second, to suggest strategies or technologies to reduce EtO emissions.
The Viant sterilization facility in Grand Rapids, MI, and Sterigenics plant in Willowbrook, IL, were closed in March because of air quality issues. The closures reportedly resulted in a temporary shortage of Smith Medical tracheostomy tubes in April.
About half of all sterile medical devices in the United States are sterilized with EtO, according to FDA. It is the sterilization method of choice for devices made from certain polymers, metals or glass and that have multiple packaging layers or hard-to-reach places such as catheters.
The Environmental Protection Agency (EPA) classified ethylene oxide as a human carcinogen in December 2016, and outdoor air monitoring near the Sterigenics facility found high levels of EtO. The American Chemistry Council (ACC), however, disputes EPA’s findings on the potential hazards of EtO. The agency “deems [EtO] unsafe at levels far below levels found in the environment and ignoring the natural levels of [EtO] in humans created by normal breathing. In fact, the cancer value derived from EPA’s modeling is 19,000 times lower than the normal, naturally-created levels of [EtO] in the human body,” said the ACC in a press release on June 21, 2019.
The Chicago Tribune reported today that Sterigenics has reached an agreement with state regulators that will allow it to resume operations at the Willowbrook facility. The company has agreed to install equipment that will dramatically reduce EtO emissions into the environment. It will also spend $300,000 during the next year on “environmental improvements, or educational scholarships or programs,” reported the Tribune. There have been no announcements regarding the re-opening of the Viant facility.
The deadline for the FDA challenge submissions is Oct. 15, 2019. Judges will select solutions that merit consideration—there is no limit to the number of selections—which will be announced in December. For additional information on the two challenges, click on the links below:
So, what’s on your mind, Elon?
I remember reading somewhere—it might have been in the Beatles Anthology tome—about John Lennon asking producer George Martin if it was possible to directly "mike" his brain so that he wouldn’t have to articulate words via his mouth and sing them into an external microphone. It was a time when the Beatles were at the height of their experimentation, musical and otherwise. That came to mind as I was reading about Elon Musk’s latest quest, Neuralink.
The details are rather murky, but the Neuralink system consists of hundreds of flexible polymer threads implanted in the brain that would allow exceptionally fast data-transfer rates. A surgical robot (pictured), likened to a sewing machine by FierceBiotech, would knit the implants into neural tissues.
The initial goal is “to develop a system that allows people with paralysis or brain disorders to control smartphone apps or restore motor function,” writes FierceBiotech. Ultimately, and this is so Musk, it would lead to a convergence of the human mind and artificial intelligence. Allowing people to mentally connect to the Internet could become a civilization-level imperative, said Musk during a live streaming announcement earlier this week.
The system has been tested on rats and monkeys, and the billionaire CEO of Tesla Motors and SpaceX expects to begin tests on human volunteers by the end of 2020. The path to FDA approval and commercialization, however, will be a long time coming, Musk conceded during the presentation.
GE infant warmers recalled
FDA announced this week on its website that GE Healthcare is recalling the Giraffe and Panda i-Res Infant Warmers because the bedside panels and latch areas of the warmers can crack or break if the unit is moved using the bedside panels instead of the front or rear maneuvering handle. If an infant comes in contact with a bedside panel with a cracked or broken latch, the panel can disengage and fall open, no longer protecting the infant from falling from the warmer.
FDA has identified this as a Class I recall, its most serious designation.
GE Healthcare has received 338 complaints related to the panels, according to FDA. Two infants have fallen from the warmers and fractured their skulls. No deaths have been reported.
The recall affects all Giraffe and Panda i-Res Infant Warmers manufactured between Oct. 1, 2007, and Feb. 28, 2019. In the United States, 25,204 of these devices have been recalled.