Recalled Alcohol Prep Pad Problems Lead to Senate Inquiry of FDA Handling

Two U.S. senators are asking the FDA why it failed to take immediate action after discovering that Triad Group medical products had sterility problems a year and a half before millions of contaminated wipes were recalled earlier this year after causing infections and at least one death.

On March 31, Senators Michael Bennet and Lamar Alexander sent a letter to FDA Commissioner Margaret Hamburg looking to confirm that the FDA knew that Triad Group products could be contaminated in July 2009, but took no actions to recall products until The Children’s Hospital in Colorado reported that children were falling ill after using alcohol prep pads and swabs made by the company.

Senator Bennet, a democrat from Colorado, and Senator Alexander, a republican from Tennessee, are calling for the FDA to review its oversight procedures for medical product manufacturing in light of the Triad alcohol prep pad problems.

A Triad alcohol pad recall was issued in early January 2011, after it was discovered that tens of millions of prep pads, swabs and swabsticks may be tainted with the bacteria Bacillus cereus. The alcohol prep pads and wipes were commonly used in hospitals and packaged with a number of medications. They were sold under the Triad brand name, as well as under a variety of other labels, including CVS, Walgreens and Cardinal Health.

In recent months, the manufacturer has also issued a Povidine Iodine Prep Pads recall and a sterile lubricating jelly recall due to sterility problems and concerns that the products may cause infections.

“In light of this recall and the health consequences to patients being exposed to contaminated products, we urge the Food and Drug Administration (FDA) to carefully review its oversight of medical product manufacturing to ensure that manufacturers comply with the voluntary compliance measures suggested by FDA inspectors,” the senators wrote.

FDA inspectors reported production problems back in 2009 at a Triad Group production plant in Wisconsin, which could compromise the sterility of the company’s products. However, there was no Triad recall or other agency action until a November 2010 investigation by The Children’s Hospital in Colorado revealed that bacterial contamination on Triad alcohol prep pads, swabs and wipes were causing infections in their patients. The hospital found that two-thirds of the supposedly sterile wipes it tested were contaminated with dangerous bacteria.

There have been at least three Triad alcohol prep pad lawsuits filed against the manufacturer in recent weeks; one by the parents of a two-year-old Houston boy who died due to a Bacillus cereus infection, another by a Tennessee man who alleges that a Triad alcohol prep pad infection left him permanently disabled, and a third that was filed by a 31-year-old Colorado woman with multiple sclerosis who alleges she contracted a life-threatening infection. The parents of a 10-year-old boy with leukemia who fell ill at The Children’s Hospital have also said they intend to file a lawsuit.