Before every injections…before every catheter insertion…before anytime the skin needs to be punctured, the first step is to wipe the skin with an alcohol prep pad. Those are the little packets of rubbing alcohol-soaked gauze that are ever-present in hospitals and doctors’ offices. The alcohol pads sterilize the skin so that an injection is as safe as can be—last thing anyone wants is for dirt, bacteria, or other organisms to enter the body through the injection site.
So imagine what would happen if the pads were full of bacteria, if instead of sterilizing the skin, the pads themselves were a source of infection.
Unfortunately, we don’t have to imagine it. The worst did, indeed, happen.
In January, the U.S. Food and Drug Administration (FDA) announced the recall of Triad alcohol prep pads, alcohol swabs, and alcohol swab sticks due to potential microbial contamination. (Later, the recall was extended to include sterile lubricating jelly, used during vaginal examinations.)
The specific infecting bacteria were Bacillus cereus, which is rare, but most typically found in food poisoning, not hospital infections.
In April, the FDA took further action and seized more than $6 million in products distributed by Triad Group, including cough and cold products, nasal sprays, suppositories, medicated wipes, antifungal creams, and hemorrhoidal wipes. This action was taken after an FDA inspection found multiple violations of manufacturing safety practices.
NOT SOON ENOUGH
JoNel Aleccia, a reporter with MSNBC, has been tracking this story from the beginning, and is conducting her own investigation into the problems caused by the tainted wipes. (To read all related articles, click here: MSNBC’s investigation.) It’s a lot of information, so we’ll summarize the major points.
- The FDA claims that the severity of the contamination wasn’t known until a Colorado hospital reported a life-threatening infection in November 2010. [MSNBC-1]
- Then, on December 1, 2010, a lively 2-year-old boy in Houston died of acute bacterial meningitis caused by Bacillus cereus. [MSNBC-2]
- By July 1, 2011, the FDA had received reports of a total of 8 deaths, 11 infections, and about 250 other health problems all linked to Triad Group products. Bacillus cereus was specifically cited as the cause of death of a 66-year-old man who was being treated for skin cancer and diabetes. [MSNBC-3]
- Just this week, there was another heartbreaking story of a child whose life was permanently altered by an infection, possibly caused by a Triad wipe. Twin boys were born on September 1, 2007. One twin has developed normally, while his brother cannot walk or speak and must be fed through a stomach tube. He suffers from cerebral palsy and mental delays. And all his problems have been linked to a bacterial infection with Bacillus cereus, which damaged portions of his brain shortly after birth.
It is possible that Triad wipes were to blame. According to an MSNBC article:
An msnbc.com review of the documents shows that FDA inspectors in 2006 found that an H&P Industries Inc. plant in Mukwonago, Wis., “failed to adequately address potential contamination in raw material” used for drug products. In 2002, the firm was cited for failing to “verify the effectiveness of the sanitation process.” An investgation in 2000 found similar problems, inspectors reported.
According to the article, a top DFA official admitted to members of Congress that the agency should have issued a formal warning letter to the firm in August 2010, instead of allowing voluntary compliance.
It’s almost enough to make a person lose faith in the ability of the FDA to properly protect the public.
The contaminated products were made by Triad, but could be marketed under a variety of different names and different packaging kits, including:
- Cardinal Health
- PSS Select
- Moore Medical
- Smith & Nephew
- Arixtra Starter Kit
- Betaseron pack
- Boniva pack
- Fuzeon pack
- Nutropin A.Q. Pen pack
- Pegasys Pak
- TNKase pack
- Extavia pack
- Trelstar pack
- Forteo starter kit
- Churchill Medical Systems’ Skin-Prep Wipes
To read the initial FDA recall notice, and to learn how to report adverse effects, click here: FDA recall notice
If you believe that you or someone you love has been injured as the result of infection caused by one of these products, the lawyers of HensonFuerst Attorneys can help you investigation your legal options. Someone is available 24/7 at 1-800-4-LAWMED. If you have questions, HensonFuerst has answers.