FDA Considers New Regulations After Contaminated Prep Pad Recall
Harrison Kothari was a two-year-old with a sunny smile when he was diagnosed with a benign cyst near the top of his spine. Harrison underwent routine surgery to remove the cyst. Everything was going well when Harrison fell ill. Harrison’s condition quickly deteriorated. On December 1, 2010, Harrison died from a rare form of meningitis caused by the bacteria Bacillus cereus.
Bacillus cereus isn’t a bacteria known to be associated with hospital infections. In fact, it had only been known to cause rare outbreaks of food poisoning. Doctors wondered how the bacteria made Harrison ill.
It didn’t take long to get an answer. In January 2011, the Triad Group of Hartland, Wisconsin issued a voluntary recall of all its swabs, swab sticks, and alcohol prep pads because of potential contamination with Bacillus cereus. Triad alcohol preps had been used during Harrison’s surgery.
Under federal rules, alcohol pads and other antiseptic products are not required to be sterile. In the past, doctors believed that antiseptics such as alcohol, iodine, ammonia, and cholorhexidine gluconate were strong enough to kill all germs. However, we now know that many viruses, fungi, and bacteria are resistant to these products. After dozens of reports of contaminated antiseptic wipes causing illness, the U.S. Food and Drug Administration (FDA) has begun the process of determining whether or not antiseptic skin prep products, such as the alcohol wipes that caused Harrison Kothari’s death, should be required to be sterile. A public hearing was scheduled on December 12, 2012. Until a decision is made, the FDA is urging all doctors, nurses, and other healthcare professionals to consider antiseptic skin preps as potential sources of dangerous infection.
In 2012, Harrison’s parents, Shanoop and Sandra Kothari, settled a defective medical device lawsuit against the Triad Group for Harrison’s wrongful death. More than 25 others have filed similar claims for injuries and illnesses caused by contaminated Triad products.
Since graduating magna cum laude in 2005 from the University of Memphis School of Law, Thomas has helped make a difference in the lives of victims of serious personal injury, wrongful death, and professional negligence. Thomas has extensive trial experience in both state and federal court. Among other victories in the courtroom, Thomas obtained several impressive jury verdicts and settlements
Read more about Thomas R. Greer