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Bacteria in antiseptic skin prep? FDA ponders sterility

Kothari family

Harrison Kothari, 2, of Houston died two years ago after a meningitis infection his parents said was caused by alcohol prep wipes tainted with bacteria. Now, federal officials are asking whether antiseptic skin preparation products should be required to be sterile.

Two years after the death of a Texas toddler that focused national attention on the contamination of alcohol wipes used widely in hospitals and homes, federal health regulators are considering whether such skin prep products should be required to be sterile.

The Food and Drug Administration will hold a public hearing next week to discuss ways to reduce potentially dangerous bacteria in antiseptic wipes, swabs, pads and solutions, which have been linked to massive product recalls -- and infections blamed for illness and death.

“We think a sterile wipe should be used in health care,” said Susan Dolan, a registered nurse and epidemiologist at Children’s Hospital Colorado in Aurora. “I’m thrilled that FDA is getting people to the table.”

Under current rules, the prep products used to swab the skin before shots or surgeries are not required to be sterile. When the regulations were written in the 1970s, experts thought the antiseptic solutions were strong enough to kill any bugs. But recent reports of contamination in widely used antiseptics have raised new worries, said Dr. Christina Y. Chang and Dr. Lesley-Anne Furlong of the FDA.

“Since that time, there have been sporadic reports of unusual bacteria that are able to live and grow in these products,” the doctors wrote in a statement to NBC News. “These reports are the reason we are moving forward to discuss this sterility issue.”

One of the most high-profile reports of bacterial contamination in prep products followed the Dec. 1, 2010 death of Harrison Kothari, a Houston 2-year-old who developed lethal bacterial meningitis after surgery. His parents, Shanoop and Sandra Kothari, sued the Triad Group and H&P Industries of Hartland, Wis., claiming that the alcohol wipes used on the boy transmitted the Bacillus cereus bacterium that caused his infection.

More than 25 others nationwide also sued the sister companies for harm they said was caused by tainted Triad and H&P products.

The Kotharis settled their claim in April and the shuttered Wisconsin companies filed for bankruptcy in August. But for more than a year, the case riveted attention on the possible contamination of tens of millions of recalled sterile and non-sterile wipes and swabs, the firms’ failure to follow safe manufacturing practices and the FDA’s lax oversight of the firms, all detailed in an NBC News investigation.

“The Triad episode supports our concern,” the FDA experts said.

However, the Triad case was only one among dozens of outbreaks involving infections tied to tainted swabs, pads or solutions dating back decades.

Antiseptics made with alcohol, iodine, CHG or cholorhexidine gluconate, and ammonia have been contaminated with a range of bacteria – including Bacillus cereus -- and implicated in problems ranging from injection site infections to death.

Existing reports probably vastly underestimate the scope of the problem, the experts say.

“Reports of these infections are rare, but we don’t know how common the infections may be,” said Chang and Furlong, who addressed the question in this week’s New England Journal of Medicine. 

That’s because consumers and even clinicians may assume, wrongly, that the antiseptic products can’t be contaminated because they kill all bacteria.

“They don’t always think to test these products when someone develops an infection days after surgery or injection,” the experts said.

Also, some single-use products, like the wipes used on Harrison Kothari, are discarded, so there’s no way to test them. Although Bacillus cereus was confirmed in some Triad wipes, no direct link could be made between the pads used on the boy and the bacterium that caused his infection.

Some infection control experts believe it’s high time the FDA required that antiseptic products be sterile. Dr. Ann-Christine Nyquist, a Colorado infection control director who blew the whistle on the Triad problem, has said there’s no place in any hospital for non-sterile prep pads.

Her colleague, Susan Dolan, a said she’s excited that the FDA is talking about the problem. “We were pleased that someone is listening,” she said.

This isn’t the first time the FDA has tackled the issue of whether to require that antiseptic skin prep products be sterile. In 2009, an FDA advisory committee tabled a vote on sterility after members couldn’t agree about the costs and benefits of a new regulation and wondered if there was enough of a problem to warrant such broad change. There were questions, too, about whether requirements for sterility might affect the purity and potency of the finished products.

Manufacturing experts at the time voiced vigorous opposition, according to a meeting transcript. “Going all the way to sterile is a huge jump,” said Patricia Tway, an analytical chemist for CMC Technical Navigator who was speaking on behalf of the pharmaceutical industry.

One of the goals of the new discussion is to encourage manufacturers to move to sterile products voluntarily, the New England Journal piece points out.

While regulators sort out the issue, the FDA experts are urging health care workers and consumers to consider antiseptic pads and solutions as possible sources of unusual infections.

Meantime, Harrison Kothari’s father said the FDA should also focus on enforcing the existing regulations. “It could have prevented a lot of pain if they made them adhere to the standards they had,” he said.

The FDA public hearing is set for Dec. 12-13. Requests for oral presentations will be accepted through Friday. Comments can be submitted through Feb. 12, 2013.

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