FDA Considers New Regulations After Antiseptic Skin Wipe Recalls

Two years ago, two-year-old Harrison Kothari died after contracting meningitis. The meningitis was caused by Bacillus cereus, a bacterium that causes rare outbreaks of food poisoning and is not known to be associated with hospital infections.
Eventually, the infection was traced to contaminated alcohol preps produced by Triad. Shortly after Harrison’s death, Triad recalled all its alcohol prep pads, swabs, and swab sticks because of potential contamination with Bacillus cereus.
Harrison’s parents, Shanoop and Sandra Kothari, filed a defective product claim against the Triad Group and its sister company H&P Industries for Harrison’s wrongful death. More than 25 others filed similar suits for injuries and illnesses caused by the contaminated products.
Under current federal rules, alcohol pads and other antiseptic products used to swab the skin before injections or surgeries are not required to be sterile. That’s because in the 1970’s doctors believed the antiseptic solutions such as alcohol, iodine, CHG or cholorhexidine gluconate, and ammonia that are used in these products were strong enough to kill all germs. Now we know that many bacteria and viruses are resistant to these products. In fact, there have been dozens of reports of contamination in antiseptic wipes causing illness. Last month, the Food and Drug Administration (FDA) began the process of determining whether or not skin prep products such as alcohol wipes should be required to be sterile. A public hearing was scheduled for December 12-13.
But this isn’t the first time the FDA has addressed the issue of antiseptic skin prep product sterility. In 2009, an FDA advisory committee tabled a vote on sterility because members of the committee could not agree whether a problem existed and whether the benefits of sterility outweighed the costs. Manufacturers were vigorously opposed to the idea.
Until a decision is made, the FDA is urging healthcare professionals to consider antiseptic skin preparations as potential sources of infection.