Bacillus cereus is a gram positive bacteria listed by the FDA as a bad bug. It is typically associated with food poisoning. Hence, you can imagine the initial confusion at a Houston hospital when, following surgery, a two year old boy’s cultures revealed that the boy had acute bacterial meningitis caused by Bacillus cereus, which is typically not found in hospital infections. The infection killed the little boy, who passed on December 2, 2010.
On January 5, 2011, the FDA announced the recall of Triad Alcohol Prep Pads, Acohol Swabs, and Alcohol Swabsticks because they were contaminated with Bacillus cereus. These products are used to disinfect prior to an injection. The Houston hospital eventually connected the dots and determined that the alcohol products its staff used on the little boy were made by Triad. According to the FDA, "use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients."
These products were distributed nationwide not only to hospitals, but also to retail pharmacies and are packaged in individual packets and sold in retail pharmacies in a box of 100 packets. The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either "Triad Group," listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
It is crucial that products labeled as "sterile" are indeed sterile. I learned this years ago on a series of cases involving a blood product used during open-heart surgery. After a number of deaths and serious infections at one hospital following open-heart surgeries, investigators identified the cause. The compounding pharmacy that sold the allegedy sterile blood product was guilty of violating numberous sterility standards designed to prevent microbiological contamination. The blood products contained bad bugs similar to the bacteria that killed the Houston boy.
This Triad problem is eerily similar in that Triad and the FDA knew about the bacterial contamination problem long before the little boy died. As early as July 2009, FDA inspectors reported that Triad had problems with contamination and sterilization. FDA regulators chided Triad in inspection reports, saying, “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” but officials never followed up by sending the warning letters “typically used to force firms to comply” to standards. Additionally, ”inspectors reported that 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.” FDA documents show that “Triad had received six similar complaints between July 2009 and May 2010,” and “more than 30 women reportedly developed vaginal irritation after a doctor used the jelly during exams, with some developing problems that had to be treated with medication for up to three weeks or more.”
Not only should the FDA have issued warning letters, it also had the power to seize the tainted product, demand that violations of sterility standards be cured, and issue an injunction closing down operations if Triad failed to comply. Why wasn’t this done? The FDA is grossly understaffed. It’s not an excuse, but do not believe any politician who tells you we need to defund or reduce the size of the FDA. It already struggles to keep safe our food, drug, and medical device supply. And, don’t believe any politician who tells you we can simply rely on private manufactureres to police themselves. Triad is bold proof that this will never happen.
According to the FDA, other products about which Triad cannot ensure quality or sterility include hemorrhoid creams, infant and adult glycerin suppositories, and sterile lubricating jelly. Another 100 reports of problems with alcohol prep pads have been logged with the FDA since the recall and dozens of patients have come forward alleging serious injuries and another death. One Tennessee man claims Triad alcohol wipes exposed him to Bacillus cereus which got into his blood stream, infected his heart, and caused him to require open-heart surgery.