We also encourage health care facilities to perform similar inventory assessments of critical medical supplies that undergo contract terminal sterilization via ethylene oxide prior to shipping and reach out to the FDA so we can assist in any way we can to help identify sources of potential substitute devices. Hospitals and other health care delivery organizations should also work with their purchasing departments, group purchasing organizations and distributors, as appropriate, to help obtain product needed for patient care. So as to not exacerbate anticipated product availability concerns, we urge facilities to work together and not hoard product or attempt to purchase larger quantities of devices beyond their normal purchase volume.

We also encourage device manufacturers and health care providers to provide us with information on potential supply issues. We have a device shortages mailbox so that any user, patient, manufacturer, or organization within the supply chain that is aware of a delay in distribution of new product, and/or anticipates a shortage, can notify us. 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.


Since we first became aware of this issue earlier this year, we have continued to focus intently on addressing the immediate impacts of these closures and potential closures to help ensure patients can have access to the safe, effective, and high-quality medical devices they need today. We continue to communicate directly with manufacturers and monitor the supply of devices sterilized in facilities that have closed or that may close, paying special attention to life-saving, life-sustaining, and other critical devices. For instance, in the case of Smiths Medical’s Bivona tracheostomy breathing tubes that were processed at the now-closed Sterigenics facility in Illinois, we helped mitigate that shortage by helping the manufacturer get a timely site change that kept supply interruptions to a minimum.

We share the public’s objective to reduce over-reliance on ethylene oxide for medical device sterilization. And therefore, in addition to our shortage mitigation efforts, we have also been addressing the broader need for innovation and improvements to medical device sterilization techniques in general. For example, earlier this year we announced two new innovation challenges to encourage ideas from stakeholders, academics, industry and others about novel solutions for improving sterilization processes. This includes a call to identify new or alternative sterilization methods and technologies that are alternatives to those that use ethylene oxide, and another to develop new strategies to reduce ethylene oxide emissions.

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