FDA Considers More Stringent Standards on Sterilization Products

Companies are contesting moves to regulate sterilization products, claiming that there is not enough proof in favor of the move.

The requirement that antiseptic skin preparation products must be sterile would be an unnecessary obligation if approved by the FDA, according to experts analyzing the topic. It also would not cause a drop in infections, but only be burden to companies producing the products.

The FDA is analyzing the importance of medical professionals using topical antiseptic products prior to performing surgeries. While not currently required by the FDA, these products are thought to reduce skin infection following procedures. However, analysts and companies are contesting this belief.

Recently, more than 40 cases of contaminated topic skin products have been reported and recalled, leading the FDA to evaluate the source of skin infections and reduce the risk of contamination.

There is no conclusive data that proves that these products lead to infection or prevent infection. Thus, companies are arguing that without proof either way, more stringent standards would do more harm than good.

The FDA will continue to evaluate the issue, one that it first evaluated in 2009, yet did not reach any conclusion.

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  • OHS Magazine Digital Edition - September 2020

    September 2020

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