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October 29, 2019

FDA warns sterilization facility closures could lead to medical device shortages

Daily Briefing

    FDA on Friday warned that hospitals could face medical device shortages after a number of sterilization facilities that use a gas called ethylene oxide have closed.

    From outbreaks to shortages: How can your hospital prepare for disasters?


    Hospitals and other health care facilities engage in daily sterilization processes to remove bacteria from catheters, medical scopes, surgical kits, and other reusable instruments. Those cleaning methods include heat, steam, and radiation. But according to FDA, ethylene oxide is the only sterilization method for many glass, metal, and plastic medical devices. According to the Associated Press, about 50% of all sterilized medical devices in the United States are cleaned using the gas.

    However, a growing number of state health and environmental officials are raising concerns over ethylene oxide because the gas is hazardous at high levels. For example, NIH has found exposure to ethylene oxide at high levels can cause cancer, including leukemia and lymphoma.

    FDA says sterilization facility closures could result in medical device shortages

    FDA in a statement said two sterilization facilities that use ethylene oxide to clean medical devices recently closed, and a separate facility that uses the gas might soon close. As a result, hospitals could experience a shortage in medical devices needed to perform Cesarean sections, heart surgeries, knee replacements, and other procedures.

    FDA said Illinois authorities closed one of the facilities earlier this year after they detected high levels of the gas outdoors, and the company this month announced that it did not intend to reopen.

    A second facility in Georgia closed in August after state officials found the facility had emitted potentially dangerous levels of ethylene oxide, and the company has been taking steps to reduce the facility's emission levels.

    FDA said a third facility in Georgia also might close.

    Acting FDA Commissioner Ned 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." He added, "Because the number of ethylene oxide contract sterilization facilities in the U.S. is limited, we are very concerned that additional facility closures could severely impact the supply of sterile medical devices to health care delivery organizations that depend on those devices to take care of patients."

    Sharpless said, "The impact resulting from closure of these and perhaps more facilities will be difficult to reverse," and the closures "could compromise patient care."

    FDA said it is teaming up with medical device manufacturers and health care delivery organizations to minimize the effects of the potential shortages. FDA said it might import medical devices from outside of the United States if the potential shortages cannot be addressed domestically.

    FDA urged health care providers to take inventory of their medical supplies and notify government officials if they expect to encounter major shortages. "It's never too early to contact us—the sooner we are aware of a potential shortage, the better we can assist in proactively developing a plan to mitigate its effects on patient care," FDA said.

    In addition, FDA said it will hold a two-day meeting next month to discuss new sterilization processes for affected devices (AP/Modern Healthcare, 10/25; Sookne, Healthcare Packaging, 10/25; FDA release, 10/25).

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