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Brett Emison
Brett Emison
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Bacteria Infection Blamed In Death

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Could it be that the very thing we counted on to keep us sterile is the thing that passed on a deadly infection? This strange event is blamed for the death of 2-year-old boy in Houston.

The family was baffled by their son’s death after a successful surgery to remove a benign cyst from near his brain and spinal cord. Recovery was going well and he was due to be released when he was suddenly hit with a severe infection. The infection resulted in multiple-organ failure and, ultimately, the boy’s death on December 1, 2010.

Cultures revealed the culprit—bacterial meningitis caused by the bacteria Bacillus Cereus. And this was the mystery. This bacteria shows up in rare food poisoning cases, not hospital stays. How did this bacteria get introduced to their son? “They had no explanation as to how he contracted it,” said the boy’s mother according to a MSNBC report. “They know it’s rare in the hospital.”

The mystery may have remained unsolved. But a relative ran across an obscure FDA recall. The recall was for alcohol wipes, the kind used repeatedly in hospitals and sick rooms across the country to keep patients safe from infection.

“These wipes were used in his care every single day, multiple times a day,” said the boy’s father.

The hospital confirmed that the wipes used to care for Harrison were a part of the recall: All lots of alcohol prep wipes, perhaps tens of millions of swabs and pads manufactured by the Triad Group, a Wisconsin medical product supplier, were being recalled. Triad issued the recall after hearing of one non-life threatening case of a skin infection caused by the rare virus, but admitted in their recall:

Use of contaminated Alcohol Prep Pads, Alcohol Swabs or Alcohol Swabsticks could lead to life-threatening infections, especially in at risk populations, including immune suppressed and surgical patients.

According to second report, Donovan Joseph Postich, a 55-year-old ironworker from Madisonville, Tenn., has also claimed to have been infected by the same wipes. His infection with Bacillus Cereus resulted in open-heart surgery. “That was the most scared I’ve been in my life,” said Postich. He is now permanently disabled after the surgery. “They told me about the tainted pads and you just kind of put two and two together.”

Triad’s recall covers all lots of its alcohol prep pads, wipes and swabs, totaling perhaps hundreds of millions of products sold in the U.S., Canada and Europe. Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks are used to disinfect prior to an injection. They were also distributed nationwide to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The recall states: The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, or Conzellin.

H&P Industries, which does business as the Triad Group, is among the largest providers in the U.S. of generic medical products often sold under private labels of grocery stores such as Safeway and Kroger and drugstores such as CVS and Walgreens.

According to the MSNBC report, “documents show that FDA officials expressed concerns following visits to the Triad plant from July 15 to July 17, 2009, and again from April 19 to May 18, 2010. Inspectors reported that the company could not validate the processes used to ensure quality or sterility not only of alcohol prep pads and wipes, but also other products used for intimate care. Those include hemorrhoid creams, infant and adult glycerin suppositories and sterile lubricating jelly widely used in homes, as well as in clinics and hospitals for medical exams.”

The MSNBC report goes into extensive detail about FDA problems with Triad’s sterilization processes. However, a lack of follow up allowed potentially dangerous products to still reach the consumers and patients most at risk.

For at least one family, the failures of Triad and the FDA may have been deadly.

(c) Copyright 2011 Brett A. Emison