Despite known problems with contamination and sterilization at a Wisconsin plant that made millions of now-recalled alcohol wipes, government officials didn't consider it a public health hazard — until a hospital reported a life-threatening infection.
Only then did the Food and Drug Administration act aggressively regarding the Triad Group of Hartland, Wis., whose tainted alcohol wipes and sterile lubricating jelly have been blamed for infections, serious complications and the death of a 2-year-old boy in Houston .
“It was reported to our agency on Saturday and we were in that facility on Monday,” said Michael Rogers, the FDA's acting director of the Office of Regional Operations.
That might not have been soon enough, however, to stave off problems that may now extend to a growing number of personal care items — including mouthwash, acne pads and children's cold medicine — and may have left millions of potentially tainted products still in use.
Rogers defended the FDA's actions at Triad, saying the agency had monitored the firm closely during recent inspections in July 2009 and again in April and May 2010.
Government documents obtained by msnbc.com showed FDA inspectors knew about and reported contamination and sterilization issues at the Triad Group plant during those inspections.
But Rogers said the FDA decided to work with the firm to voluntarily correct problems that ranged from worn and broken equipment to trouble with the process used to sterilize intimate care products widely used in hospitals, clinics and homes.
“Neither of those two inspections revealed information or evidence that allowed the agency to make conclusions that there was an imminent health hazard,” Rogers said.
If the agency had evidence to suggest more serious problems with sterilization, “we would have taken different action at the time,” Rogers said.
The FDA issued no warning letters or other consequences to H&P Industries, which does business as Triad Group. Instead, the agency chose to “work closely with the firm to make sure that these corrective actions would be addressed,” Rogers said.
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Triad Group did not respond to msnbc.com requests for comment.
On Nov. 27, however, a Colorado hospital reported to the FDA that it had detected the bacteria Bacillus cereus in Triad wipes, Rogers said. That posed a potentially life-threatening infection for a patient. Rogers would not identify the hospital or discuss the patient's outcome.
Msnbc.com previously reported that infections with Bacillus cereus tied to the wipes led to open-heart surgery for Joe Postich, 55, of Madisonville, Tenn., and to the death of Harrison Kothari, 2, of Houston. In addition, more than 100 people have now reported other potential infections related to the wipes, according to Don Kidd, one of the Houston lawyers representing the Kotharis.
Hospital reports contamination
By Nov. 29, two days after the Colorado report, FDA inspectors were in the Wisconsin plant, confirming that tainted wipes had been distributed to the public, Rogers said.
“Sterile alcohol prep pads were found to be contaminated with … organisms and were released for shipment after the confirmation of the results,” read a Jan. 7 inspection document known as an FDA Form 483.
Although the documents redact the type of contamination, the Triad Group launched a voluntary recall of hundreds of millions — all lots — of its alcohol prep products because of potential contamination with Bacillus cereus.
At the FDA’s urging, the firm also recalled multiple lots of purportedly sterile lubricating jelly linked to dozens of vaginal infections in women who had received medical exams.
The lubricating jelly was “understerilized,” according to the report, which did not identify the type of contamination.
Rogers said the agency responded as soon as officials felt there was a true threat.
“It is a huge recall that quite frankly would not have happened without the FDA’s inspection,” he said. “What the recall achieves is to remove the product from the marketplace.”
Tainted wipes may still be out there
However, Rogers acknowledged that FDA officials have no way of knowing whether the products are truly gone from store shelves, hospital inventories — and people’s homes.
“It’s not instantaneous,” Rogers said. “I can say that the recall efforts are ongoing and we continue to work with the firm.”
As late as this week, six weeks after the wipe recall and two months after the lubricating jelly recall, both products were available for sale on Amazon.com. Officials at Amazon did not respond to repeated requests for comment about the recalled medical supplies.
Rogers did not comment on new problems documented in the latest Triad Group inspection reports that extend to a wider range of products including mouthwash, acne pads and children’s cold medicine. The report cites microbial contamination of water pipes leading to vats that made batches of blue and yellow mouth rinse and glycerin suppositories.
Inspectors also found that employees were packing acne pads into product containers with their bare hands and that a worker who said he added the active ingredient to a batch of children’s multi-symptom cold medicine did not, in fact, add it.
Rogers said the FDA’s investigation remains open and the agency has not decided what final action to take. “We continue to work with the firm,” he said.
But that's small comfort to families like the Kotharis, said Kidd, their lawyer. The blame rests squarely on Triad officials who were "playing Russian Roulette" with contaminated medical products and who chose to disregard FDA requests to correct problems, he said.
"In hindsight, we all wish that the FDA would have acted stronger, sooner," Kidd added.
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