FDA Warns Of Potential Shortage Of Critical Surgical Tools Because Plants Used To Sterilize Them Have Been Shut Down
The closures revolve around the facilities' use of ethylene oxide, a gas that, while critical for cleaning the equipment, can be hazardous at elevated levels.
The Associated Press:
Cleaning Plant Troubles Could Lead To Hospital Tool Shortage
Hospitals could soon face shortages of critical surgical tools because several plants that sterilize the equipment have been shut down, government health officials said Friday. The Food and Drug Administration flagged the issue in an online statement to medical professionals, saying the result could be years of shortages of supplies used in heart surgery, knee replacements, C-sections and many other procedures. (Perrone, 10/25)
Georgia Health News:
Feds Warn Ethylene Oxide Crackdown Could Cause Shortages Of Medical Devices
“It’s kind of like a tipping point right now. If there were to be any more closures then the likelihood is we will not only see spot or local shortages, it will have a ripple effect nationally,” said Dr. Suzanne Schwartz, the acting director of the Office of Strategic Partnerships & Technology Innovation at the FDA’s Center for Devices and Radiological Health (CDRH).(Goodman and Miller, 10/25)
Atlanta Journal-Constitution:
BD Says Covington Plant Poses No Risk To The Community
A medical sterilization company fired back at Georgia regulators seeking to shut down its Covington facility, saying in a court filing Friday that its operations are safe and that there’s no scientific proof its emissions are harmful to the public. If a court orders the Becton Dickinson plant to halt sterilizations with the carcinogenic gas ethylene oxide, it could cause far greater harm to the millions of patients in need of the medical devices it sterilizes each year, lawyers for the company said in the filing. (Trubey and Edwards, 10/25)
