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title pic Massive Recall of Tainted Medical Products Raises Concern Over FDA Response Time

Posted by Fiona Cole on March 17, 2011

Massive Recall of Tainted Medical Products Raises Concern Over FDA Response Time

A massive recall of tainted alcohol wipes and lubricating jelly manufactured by the Triad Group has raised serious concerns about the delayed actions of the FDA following investigations of a plant known to have problems. The alcohol wipes — used in many medical procedures and household products — and the lubricating jelly — used in medical exams — have been blamed for serious infections, health complications and even death.

An investigation has shown that there were known sterilization and contamination problems at the Triad Group’s plant in Wisconsin, yet FDA officials did not identify it as a public health hazard until an associated life-threatening infection was reported by a Colorado hospital. The hospital reported that it had found Bacillus cereus, a potentially deadly bacteria, in wipes manufactured by the Triad Group.

In the time lapse created by the actions of the FDA, there is concern that contamination issues at the plant have spread more widely into an increasing number of personal care products, including acne pads, mouthwash and children’s cold medicine, which may still be on the market and in use.

According to the FDA’s acting director of the Office of Regional Operations, Michael Rogers, inspectors from the FDA visited the plant in Wisconsin shortly after the report from the Colorado hospital and confirmed that tainted alcohol wipes had been widely distributed to the general public.

The massive recall involved millions of the Triad Group’s alcohol prep products which were at risk of being contaminated with Bacillus cereus. In addition, multiple reports of vaginal infections in women following medical exams have been linked to the Triad Group’s allegedly sterile lubricating jelly which has now also been recalled. The FDA report referred to the jelly as “understerilized” but the type of contamination was not identified.

Rogers defended the FDA, saying that the agency acted as soon as investigators felt there was a serious threat.

“It is a huge recall that, quite frankly, would not have happened without the FDA’s inspection,” Rogers said. “What the recall achieves is to remove the product from the marketplace.”

But Rogers acknowledges that the FDA has no way of ensuring that all of the tainted products are removed from medical facilities and homes and many feel that the FDA should have acted sooner. According to Rogers, the recall efforts are ongoing.

While the FDA receives heat for not acting quickly enough and the Triad Group drags its heels in the clean-up effort, it is important for us all to be aware of the possibility of contaminated medical products still lurking in bathroom cabinets. Check the manufacturer of any wipes, jelly, acne pads, mouthwash and children’s cold medicine that you may still have amongst your supplies at home.

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