FDA urges development of alternative sterilization methods.

In August 2018, the Environmental Protection Agency identified emissions of ethylene oxide in the environment as a long-term public health concern.  They also identified several industries where ethylene oxide is a primary component, and may indicate cause for concern.  Commercial sterilization facilities which use ethylene oxide sterilization methods became part of this review.

In early 2019, the EPA began requesting certain industrial sterilizers to cease operations until their process can be retooled to mitigate high emissions levels of ethylene oxide.  Since an estimated 50% of medical devices are sterilized with ethylene oxide, the FDA quickly realized the potential impact these closures could have on the medical industry.  The EPA has taken steps to address it, as Plastic News reported in its October 29, 2019 article: FDA Warns Medical Device Shortages

The FDA has challenged the medical device industry to identify and develop new sterilization methods. Several sterilization alternatives are already available, but may not be appropriate for all products. Dry heat sterilization, for example, has the potential to provide the same level of efficacy for metal objects and solid rubber objects. Likewise, steam sterilization can used as an alternative to ethylene oxide sterilization for certain types of items.

As the medical device industry continues to explore these options, M&Q Packaging stands ready to assist with durable, high temperature medical sterilization packaging that can withstand both dry and steam sterilization processes.

For more information, please contact M&Q at 570-385-4991 or email us.

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