A federal Food and Drug Administration official says the agency is “very concerned” about detection of new, potentially dangerous bacteria in iodine prep pads made by a Wisconsin firm already under scrutiny for tainted alcohol wipes tied to infections and death.
But it will take more time and more analysis to decide what action to take regarding H&P Industries, Inc., the parent company of the Triad Group of Hartland, Wis., said Michael Rogers, the FDA’s acting director of the Office of Regional Operations.
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“It’s a lot of information to evaluate. This is a very large company,” said Rogers, adding: “Our interest is to insure that there are safe and effective products on the market."
Rogers’ comments followed the voluntary recall this week of all lots of povidine iodine prep pads manufactured by H&P Industries Inc. after FDA tests indicated they may be contaminated with Elizabethkingia meningoseptica, rare bacteria tied to life-threatening infections in newborns, people on ventilators and others who may be very ill.
“Those are significant pathogens,” said Rogers. “The agency is very concerned about those findings."
The iodine wipes are used to prevent infection from cuts, scrapes and burns and also to prevent infection in surgery. Although the over-the-counter pads are marketed as non-sterile, they’re supposed to be free of organisms that could cause infection, medical experts say.
A press release by H&P Industries indicated that a raw material component of the iodine pads could be responsible for the contamination with the bacteria normally associated with frogs, fish and other environmental sources, but not with human infection. The company began distributing the pads in March 2008.
FDA officials posted a recall notice Friday and H&P Industries added the notice to its Triad Group website. The notices include information about the brands under which the iodine pads were distributed.
The latest recall comes more than two months after a massive recall of alcohol wipes and pads potentially contaminated with the bacteria Bacillus cereus, which has been blamed for serious infections and at least one death. Triad also recalled potentially contaminated lubricating jelly used in medical procedures and exams in December.
Jim Perdue Jr., a Houston lawyer representing families with children allegedly infected by Bacillus cereus in the wipes that were first recalled, said the new recall "comes as no surprise" given the history of problems with contamination and sterilization documented at the firm.
He said FDA officials didn't take problems seriously soon enough.
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"You hate to have a situation where someone has to get hurt to have action," he said.
Perdue said he was contacted Friday by someone who may have contracted an infection caused by the bacteria in the new recall after using iodine prep pads.
FDA officials have visited the Triad plant in Hartland several times since an inspection that concluded in January confirmed serious problems with sterilization and contamination, Rogers said.
There is no evidence now of contamination with additional types of bacteria, he added.
The agency is waiting for final analysis to decide what action to take, but so far has issued no warnings or sanctions to Triad. Under FDA protocol, the agency could issue warning letters, seize products or seek a permanent injunction to stop the plant from making or distributing contaminated products.
FDA 'interactions' led to changes
FDA consultations with H&P Industries have led the company to voluntarily close the lines that produce the alcohol wipes and lube jelly, and to recall potentially unsafe product.
“The firm’s actions have been as a result of FDA’s interactions with the firm,” Rogers said.
He denied that H&P Industries' move to close down lose lines was part of any negotiation with FDA to garner less stringent sanctions.
“We’re going to take the appropriate action regardless,” Rogers said.
Rogers said he couldn’t say how long the investigation would last or when a decision about H&P Industries’ future would be decided.
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