Clarification: Medical Devices-Shortage story

Clarification: Medical Devices-Shortage story

WASHINGTON -- In an Oct. 25 story about medical devices, The Associated Press reported on the closure of several facilities that use a carcinogenic gas to sterilize medical equipment, including a Georgia facility. The story should have made clear that the plant's owner, Sterigenics, voluntarily closed it to speed up installation of emission controls and that the plant was operating within the limits of its state-issued permits.

An updated version of the story is below.

Cleaning plant troubles could lead to hospital tool shortage

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.

The warning follows the recent closure of several sterilization facilities that use ethylene oxide. The gas is critical for cleaning medical equipment, but it can be hazardous at elevated levels and is increasingly being scrutinized by state health and environmental officials.

"The impact resulting from closure of these and perhaps more facilities will be difficult to reverse," said FDA acting commissioner Ned Sharpless, in a statement, adding that the shortages "could compromise patient care."

The FDA urged hospitals to inventory their supplies and alert government officials if they face major shortages. The agency said regulators could help identify alternative devices for those impacted by the issue.

Sterilization is a daily process at hospitals and many other health care facilities, used to remove bacteria from medical scopes, catheters, surgical kits and other reusable instruments. Hospitals use various cleaning methods, including heat, steam and radiation. But the oxide gas is the only method for cleaning many devices made from plastic, metal or glass, according to the FDA. About half of all sterilized medical devices in the U.S. are cleaned with the gas, according to studies cited by the agency.

Exposure to dangerous levels of ethylene oxide can cause cancer including leukemia and lymphoma , according to the National Institutes of Health. Factories that emit the gas are subject to safety standards by both state and federal environmental laws.

Earlier this year, Illinois authorities closed a large plant owned by sterilization company Sterigenics after detecting high outdoor levels of the gas. This month, the company announced the plant would not reopen.

Another Sterigenics plant in Georgia has been closed for maintenance since August after state officials detected potentially dangerous emissions at the Atlanta facility. The company voluntarily closed the plant to speed up the installation of technology to reduce gas emissions. State officials said the plant was operating within the emission limits of its government-issued permits.

The FDA will hold a two-day meeting next month to discuss new sterilization techniques for devices.


Follow Matthew Perrone on Twitter: @AP—FDAwriter


The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute's Department of Science Education. The AP is solely responsible for all content.