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FDA provides an update on sterilising medical devices with ethylene oxide

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Ethylene oxide is commonly used to sterilise medical devices. However, recently the levels of ethylene oxide, which is classed as a carcinogen, have been found to be too high at some sterilisation facilities resulting in closure of the plants. The Food and Drug Administration (FDA) has released a statement providing advice on the next steps following this news.

The statement begins by addressing the complexity of this issue: “While potential impacts to the availability of sterile medical devices is a concern given their criticality to our healthcare system, we also recognise the value in reducing over-reliance on ethylene oxide in commercial operations, including for medical device sterilisation.”

The report goes on to mention how the FDA previously focused on two challenges:

  1. To identify new sterilisation methods and technologies that are alternatives to those that use ethylene oxide
  2. To identify strategies or technologies that can significantly reduce the amount of ethylene oxide used to sterilise devices

The FDA received 46 applications and shortlisted these down to 12. The next stage of the process according to the FDA is to, "work directly with these selected applicants to accelerate the development and review of innovative technologies for sterilisation processes.”

Additionally, the FDA held a public advisory committee meeting earlier this month. Speakers at the meeting included representatives from the FDA, the U.S. Environmental Protection Agency (EPA), the Centers for Disease Control and Prevention’s Agency for Toxic Substances and Disease Registry, the Medicines and Healthcare Products Regulatory Agency from the United Kingdom and members of the public. Key recommendations from this meeting included:

  1. To reduce the amount of paper included within sterile device packages e.g. labelling and instruction manuals
  2. To expedite approvals of certain changes that medical device manufacturers make to ethylene oxide sterilisation methods

The statement concludes: “We look forward to seeing what the selected applicants of the innovation challenge do next as well as the outcome of our ethylene oxide pilot program.

“The FDA will continue in our steadfast commitment to develop solutions to avoid potential device shortages and encourage new, innovative ways to sterilise medical devices while reducing adverse impacts on the environment and on the public health.”

The statement can be read in full here.

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