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M. Brandon Smith
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Triad Swabs Recall Linked To Dangerous Bacteria: Bacillus Cereus

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Sterilization or Contamination?
A swab or pad is usually associated with sterilization not contamination. Contamination, however, can occur causing serious injuries and even proving fatal. The recall of Triad’s alcohol prep pads is a prime example. Tens of millions of Triad’s pads, wipes and swabs were recalled on January 5, 2010, because of potential contamination with the bacteria Bacillus cereus. And the death of a two-year-old Houston boy from a rare infection has been blamed on the contaminated alcohol wipes. But the boy wasn’t the only one affected. Dozens of other people have come forward with injuries alleged to have to be related to the contaminated swabs. To make matters worse, government documents obtained by msnbc.com showed that FDA inspectors knew about problems with contamination and sterilization at a plant run by the Triad Group as early as July 2009. Yet, there is no record that the FDA sent warning letters typically used to force firms to comply. So just how serious is this recall and the health issues alleged?

Complaints and Health Issues
Another 100 complaints have been logged by the FDA since the recall. In addition, a Tennessee man has filed his own $30 million lawsuit against Triad, claiming he developed an infection from Bacillus cereus from the wipes and had to undergo open-heart surgery as a result.

“That was the most scared I’ve been in my life,” said Donovan Joseph Postich, a 55-year-old ironworker from Madisonville, Tenn., who is permanently disabled after the surgery. “They told me about the tainted pads and you just kind of put two and two together.”

Problematic Evidence
Why didn’t the FDA recall the products sooner? There might be no good answer to that question, especially because there was plenty of reason for concern. Documents show that FDA officials expressed concerns following visits to the Triad plant in July 2009 and again from April 19 to May 18, 2010. During those visits, inspectors were unable to 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.

A report issued by the FDA said, "Specifically, there is no validation of the gamma radiation sterilization process for the Alcohol Swabsticks labeled as sterile." Additionally, according to inspectors, shipments of Triad Plus BZK prep pads that failed to meet specifications were released for distribution. Inspectors also reported worn and broken manufacturing equipment, misidentified batches of hemorrhoid cream, and instances where if a single batch of hemorrhoid ointment or glycerin suppositories failed quality standards, others weren’t tested for the same problem and were released for distribution. Overall, officials concluded the company had no procedures in place for reporting or acting on manufacturing problems.

Triad’s Actions
Triad didn’t help the situation. In fact, Triad failed to evaluate and investigate a complaint from a hospital about high rates of abnormal pap smear results tied to the sterile lubricating jelly. According to investigators, Triad also failed to file proper forms documenting a complaint alleging that more than 30 women reportedly developed vaginal irritation after a doctor used the jelly during exams. Some developed problems that had to be treated with medication for up to three weeks or more. Documents showed that Triad’s response to the observations was listed only as: "Promised to correct."

FDA Investigates
FDA officials launched an investigation last month into problems with Triad products, said spokesman Christopher Kelly. Officials conducted another inspection Jan. 7th at the Triad plant. That inspection revealed “several deviations from our current good manufacturing regulations,” said Kelly, who was unable to provide a copy of the inspection report.

Prior to the recall, FDA had received no reports of adverse events related to Triad alcohol prep products, Kelly said. Between January 5th and 31st, the company received about 100 reports of problems with alcohol prep products. Kelly said that was typical of the number of reports received after most recalls are posted.

Conclusion
Patients are supposed to be able to count on pads, wipes and swabs being sterile. They are not supposed to be concerned that these products might be contaminated. The recall described above reveals that problems associated with unsanitary and contaminated pads, wipes and swabs can potentially cause severe health issues and even death. Those negatively affected by the recalled products should investigate whether their health issues were caused by the recalled swabs and explore available remedies. Childers, Schlueter & Smith, LLC is currently investigating and reviewing Triad Recall injuries and Bacillus cereus infections. If you have questions about your use of these products or would like someone to review your potential claim please let us know.