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Posted at 07:00 AM ET, 04/07/2011

Tainted alcohol wipes saga continues

Unless you have occasion to use pre-packaged alcohol prep pads, you probably haven’t paid much attention to the situation involving contaminated alcohol wipes that’s been unwinding over the past several months.

These pads, typically used to sanitize skin before an injection, turned out to have been contaminated with potentially deadly bacteria — at least to those with weakened immune systems. Two Wisconsin-based companies, H&P Industries and the Triad group (both run by the same people), manufacture the wipes, along with such products as vaginal lubricants, nasal sprays, suppositories and a host of other medical supplies.

The FDA apparently had been aware that the companies’ manufacturing practices were faulty since 2009, according to a news report by MSNBC. The article said the agency didn’t consider those problems a public-health threat.

But the scene shifted dramatically when a 2-year-old boy died in a Houston hospital, where he had undergone surgery to remove a benign cyst near his brain and spinal column. A bacterial meningitis infection overwhelmed his body. Nobody could figure out where the bacteria came from, nor has it yet been established. But according to documents filed in U.S. District Court in Houston, the boy’s parents have filed suit against the manufacturer, having learned that Triad had recalled contaminated wipes and that such wipes were used in their son’s care.

Other serious infections have been blamed on the wipes, including the life-threatening infection of a 10-year-old boy being treated for leukemia in a Colorado hospital. In March the U.S. Centers for Disease Control and Prevention investigated both incidents. The CDC concluded that wipes (which were not marked as either “sterile” or “non-sterile”) used in the hospitals contained bacillus cereus and other bacteria. The CDC report neither confirmed nor ruled out a link between the wipes and the infections.

According to MSNBC, which has led the reporting on this matter, “FDA inspections at the plant led to three voluntarily recalls of Triad Group products since December 2010, including massive recalls of alcohol prep pads, povidone iodine prep pads and lubricating jelly because of problems with microbial contamination.”

The FDA announced the Triad Group’s voluntary recall for the wipes and related products in early January. On Wednesday the FDA seized millions of dollars worth of products from the manufacturing plant, after having asked the companies to voluntarily cease shipping their products.

That may be too little, too late; in March, two U.S. senators took the FDA to task for its half-hearted response and asked FDA Commissioner Margaret Hamburg to explain the agency’s actions (or lack thereof).

I first got wind of the infected pads a few months ago, when I received a mail-order shipment of the drug I inject daily to manage my multiple sclerosis. Stupidly, I didn’t think much of the notice I received soon after in the mail telling me not to use the wipes that had come with my medicine and offering me the opportunity to request a supply of uncontaminated wipes. For some reason, I didn’t follow through. I didn’t use those wipes, because I had plenty left over from earlier shipments. Looking back, that was really dumb: The old ones might just as easily have been contaminated as the new ones.

On Thursday I got a new three-month supply of my meds, accompanied by three unofficial-looking baggies, each containing a month’s worth of another alcohol brand of alcohol pads.

I can’t help feeling I may have dodged a bullet.

By  |  07:00 AM ET, 04/07/2011

 
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