why does the fda want to learn more about hand sanitizers

While hospitals and other medical facilities have adopted some cutting edge approaches to combating the spread of infections over the years, they still rely heavily on such time-tested techniques as surgical scrubs, hand soap and hand sanitizers.

Interestingly enough, however, one of these three weapons in the never-ending fight against germs is now the subject of an investigation by the Food and Drug Administration.

Just last week, the FDA published a proposed rule calling for the manufacturers of hand sanitizers — Gojo Industries Inc., 3M Co., Ecolab Inc., among others — to conduct comprehensive testing to collect the following:

  • Data on absorption rates, toxicology, blood levels, and any cancer or hormonal issues related to hand sanitizers.
  • Data outlining any links between the use of hand sanitizers and the proliferation of antibiotic-resistant bacteria.

In addition, the proposed rule dictates that if a manufacturer cannot demonstrate that a particular hand sanitizer is safe and effective by 2018, it would either need to be reformulated or no longer offered for sale.

In total, the FDA estimates that affected manufacturers could spend between $64-$90 million performing the necessary testing and ensuring product safety.

This drive for more information concerning hand sanitizers was driven primarily by a lawsuit filed several years ago by the Natural Resources Defense Council, which alleged that officials had needlessly prolonged the review of dangerous chemicals.

As part of its settlement with the NRDC, the FDA agreed to various timetables for conducting reviews of these chemicals, including one dedicated solely to hand sanitizers.

It should be noted that the FDA was very careful to stress that the proposed rule did not mean that it found hand sanitizers to be dangerous or ineffective, and that they should continue to be deployed in healthcare settings.

Stay tuned for updates …

If you’ve suffered irreparable harm or lost a loved one to a hospital-acquired infection, consider speaking with an experienced legal professional as soon as possible to learn more about your legal options.

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