FDA touts efforts to cut devicemaker reliance on ethylene oxide

The FDA said Nov. 25 it has taken several steps to reduce medical devicemakers' reliance on ethylene oxide to sterilize their products, after concerns that the chemical could cause cancer have prompted the closure of several sterilization plants and caused device shortages across the country. 

In July, the federal agency introduced two innovation challenges for academics and industry players to propose new sterilization methods that don't use ethylene oxide or to significantly reduce the amount of the chemical needed to sterilize devices. That challenge yielded 46 proposals from large and small companies, and the agency said it picked a dozen proposals to pursue. 

The FDA will work with the 12 companies to speed up development and review of their proposals, which included using nitrogen dioxide and vaporized hydrogen peroxide for sterilization, reducing sterilant concentration and using ethylene oxide-flexible chamber technology.

The agency said its Nov. 6 panel meeting, a gathering of members of the FDA, Environmental Protection Agency, the CDC and others, also produced several recommendations on reducing ethylene oxide use in device sterilization. 

One recommendation the agency said it will pursue is encouraging devicemakers to reduce the amount of paper they use in labels and instruction manuals included in sterile device packaging. Using a lot of paper makes it harder for ethylene oxide to get to devices and means more of the chemical has to be used for effective sterilization, the FDA said. Reducing the amount of paper would reduce the amount of ethylene oxide needed to sterilize. 

In response to another panel meeting suggestion, the FDA said it created a program to ease device shortages by speeding its approval of changes that devicemakers make to their sterilization methods. 

"By facilitating more efficient review and feedback, this pilot program should also result in sterilization facilities using a reduced amount of ethylene oxide several months sooner than they otherwise would," the FDA wrote. 

Read the full news release here

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