Antiseptic Wipes Scrutinized by FDA Following Contamination Reports

Posted on December 7, 2012

One would think that antiseptic wipes would be free of bacteria that could do harm to a patient, and indeed, this was the common wisdom in the 70s.  At that time, regulators figured that the contamination risk would be pretty much offset by the antiseptic solutions that lend the products their name.  Alcohol wipes and the like have thus not been subjected to sterility standards that certain other items have to meet.

That could change, though, now that the Food and Drug Administration is moving forward with a public hearing designed to get a wide array of thoughts about these products.  The move was prompted by recent reports of contamination compromising the safety of the antiseptic wipes.

It would appear that the rules written in the 70s failed to take into account certain bacteria that can thrive even in the antiseptic environment.  Concerns were raised following the untimely death of a child in 2010.  The boys parents claimed that the alcohol wipe that was utilized prior to the boy’s surgery was in fact contaminated with Bacillus cereus.  They allege that this in turn led the child to incur bacterial meningitis.

The makers of the products, H & P Industries and the Triad Group, have since been the target of a couple dozen lawsuits alleging that the wipes provided to care facilities were not adequately protected from bacteria.  The safety of wipes and swabs is being widely scrutinized, with some calling into question manufacturing methods and others blaming the FDA for a lack of oversight.

In the most recent edition of the New England Journal of Medicine, FDA experts stated their belief that the prevalence of bacteria in these types of wipes might be greater than a consumer might expect.  Although reports of contamination are fairly rare, they believe that many infections in the wake of a medical procedure are not attributed to the wipes because of a mistaken belief among healthcare professionals that a contamination of such items is impossible.  As such, there’s a chance that underreporting is the norm.

The FDA looked into this issue back in 2009, but the investigation came to nought when an advisory committee disagreed over the severity of the problem and the cost of making severity mandatory.  Manufacturers also largely fought the measure at the time.

Until a decision can be made, doctors are advised to use caution and to look out for infections.  Should one occur, healthcare professionals should keep in mind the possibility that the antiseptic pads could be to blame.  Aside from that, it appears we’ll have to wait a little longer to see if the FDA decides to act on this potential threat to patient safety.

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