FDA Slow To Act on Tainted Wipes

After receiving 161 reports of adverse events related to Triad Group’s<"http://www.yourlawyer.com/practice_areas/defective_medical_devices"> tainted alcohol prep products, pads, wipes, and swabs, the U.S. Food and Drug Administration (FDA) says it is “very concerned,” but has not moved into action.

Even after a number of recalls, contamination with the Bacillus cereus pathogen, allegations of a number of illnesses and one death, and news that the Triad Group of Harland, Wisconsin just shut down the line that manufactured the tainted alcohol prep products, pads, wipes, and swabs, the FDA is not taking stronger steps. This although it said that yet another pathogen found on another wipe product is potentially dangerous.

The bacteria Elizabethkingia meningoseptica was found in iodine prep pads made by Triad, said MSNBC. But, according to Michael Rogers, the FDA’s acting director of the Office of Regional Operations, more time and study is needed to determine how to handle the ongoing situation with Triad’s parent company, H&P Industries, Inc., said MSNBC. “It’s a lot of information to evaluate. This is a very large company,” said Rogers, quoted MSNBC. “Our interest is to insure that there are safe and effective products on the market,” Rogers added.

All lots of H&P’s povidine iodine prep pads were recalled following FDA tests that found the pads could be tainted with a bacteria linked to what MSNBC described as “life-threatening infections” to some vulnerable populations, such as newborn infants and ventilator patients. “Those are significant pathogens…. The agency is very concerned about those findings,” said Rogers.

Despite the concern, stronger measures have not been taken and many feel that Triad, H&P, and the FDA have not moved swiftly and thoroughly to eradicate these contamination issues. For instance, the agency could issue warnings, sanctions, or injunctions or could seize products but is, instead, continuing to analyze products and decide how to proceed.

The most recent recall involves iodine prep wipes meant for use in infection prevention for cuts and burns, as well as in surgery, said MSNBC. The wipes are marketed as nonsterile, but are, according to experts, meant to be free from infection-causing organisms. In its press release, H&P said a raw material, part of the pad, could be the origin of the contamination it said is generally connected to “frogs, fish, and other environmental sources,” not typically with human infection, said MSNBC. H&P noted it began distributing the prep pads in early 2008.

As we’ve previously written, use of Triad’s previously recalled, contaminated alcohol prep pads, wipes, and swabs could also lead to life-threatening infections. Triad also recently stopped production of sterile lubricating jelly following a December 27, 2010 recall and links to vaginal infection reports in women prescribed the defective medication, said MSNBC.

Meanwhile, FDA officials said there was no “imminent health hazard,” quoted MSNBC last week concerning contaminated Triad wipes, despite that some children at The Children’s Hospital in Denver developed bloodstream infections that were determined to be from Bacillus cereus, later cultured from the contaminated wipes, said MSNBC. Two lawsuits have been filed against Triad over one toddler who died from meningitis and a man who suffered significant injury mandating cardiac surgery. Both contracted infections linked to Bacillus cereus infection, which can also cause meningitis, and both were treated with the recalled pads.

ABC News noted that the FDA’s Triad wipe recall was a Class 2, not the more serious Class 1.

This entry was posted in Defective Medical Devices. Bookmark the permalink.

© 2005-2016 Parker Waichman LLP ®. All Rights Reserved.