The FDA today warned of “years of spot or nationwide shortages” of a number of surgical kits and implantable medical devices due to the closure of two medtech sterilization plants that use ethylene oxide (EO) and efforts in Georgia to close a third.
Potentially affected surgical kits include those used in emergency Caesarean sections and other emergency surgeries, and in routine procedures such as cardiac surgery and hip or knee replacement surgeries, the agency said. Other devices that could go into short supply include feeding tube devices used in neonatal intensive care units, drug-eluting cardiac stents, catheters, shunts and other implantable devices.
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