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October 28, 2019

AdvaMed: Neonatal Products Provided to 80 Percent of U.S. Hospitals Threatened by Potential Medline Shutdown

Medela LLC writes: "Medela serves more than 80% of U.S. hospitals and NICUs with sterile ... devices used in the NICU. Sterilization [with ethylene oxide] is the clinical standard of practice in the NICU to keep dangerous bacteria from appearing and affecting our most vulnerable infants."

WASHINGTON – AdvaMed president and CEO Scott Whitaker today released a statement on efforts to close Medline’s ethylene oxide (EO/EtO) medical device sterilization plant in Waukegan, Ill. Tomorrow, the Illinois state legislature's House Energy and Environment Committee is holding a hearing at 2:30 p.m. CT to discuss legislation that would force hospitals and sterilizers to phase out the use of EtO. 

Medela LLC, headquartered in McHenry, Illinois, today wrote to Illinois state house speaker Michael Madigan saying they "respectfully oppose HB 3888 and HB 3885 because their restriction to EO use would lead to the inevitable elimination of EO sterilization in the state and will likely lead to further restrictions in other states. This process is essentially irreplaceable in its effectiveness to combat infection in hospital surgical settings, and is an essential step for Medela to support the most medically fragile in the Neonatal Intensive Care Unit (NICU)."

According to the March of Dimes, in a typical week in the state of Illinois, 2,970 babies are born and 299 are born prematurely.

Whitaker said: “The shutdown of Medline’s sterilization plant in Waukegan will likely have a direct and devastating effect on the patients who are served by 135 Illinois hospitals as well as millions of patients across the country who depend on the safe, clean and critical surgical devices Medline sterilizes – including the most vulnerable newborns in NICUs nationwide.”

Friday, the U.S. FDA announced that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization plants and the possibility of future plant closures. FDA acting Commissioner Sharpless said, “Without adequate availability of ethylene oxide sterilization, we anticipate a national shortage of these devices and other critical devices including feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices. It’s important to note at this time there are no readily available processes or facilities that can serve as viable alternatives to those that use ethylene oxide to sterilize these devices. In short: this method is critical to our health care system and to the continued availability of safe, effective and high-quality medical devices.” See AdvaMed's statement on the FDA announcement. 

And last week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of EtO for medical device sterilization, warning that without EtO sterilization, many medical devices on the market – including those used in critical emergencies – would become unavailable to the patients who need them. Read AdvaMed's statement on the surgeons' letter.

Medical device sterilization techniques utilizing EtO are essential to ensuring the safety of more than 20 billion medical devices every year, approximately 50 percent of all devices sterilized annually. Without this sterilization method, millions of patients simply will not have access to critical, life-saving and life-sustaining treatments.