When you go to a hospital to be treated for an illness, you don’t expect to be given a worse one.
But that’s exactly what has been happening to some people who have been treated with supposedly sterilizing wipes manufactured by Triad. At a Colorado Children’s Hospital late last year, a 10-year-old boy with leukemia was being fitted with a medical port for the delivery of chemotherapy drugs when he fell victim to an all-encompassing bacterial infection that nearly killed him.
Months afterwards, his family was told the bacteria, Bacillus cereus, was introduced to the boy’s system in the hospital via the use of Trius sterilizing alcohol wipes. The hosiptal was using over 2,500 of these wipes a day and was seeing an alarming increase in infections of the unusual bacteria before determining that the wipes were the cause.
The discovery of the contamination and subsequent notification of the FDA has led to a series of recalls of not only the sterile wipes, but of other products manufactured at the Triad plants, including lubricating jelly manufactured as far back as 2007.
The recalls are so widespread, in fact, that any medical product you may use on a regular basis or even have acquired in the last several years should be inspected to determine if it contains any of these Triad products.
What is more troubling, however, is that the FDA had found serious violations of process at the plant where the wipes were manufactured up to 18 months prior to the wipes being recalled – and did nothing about it.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed,” said the FDA inspection report as early as July 2009. But there’s no record of the company being warned about their infractions, and no record of the lapses being fixed.
The FDA is defending their actions, stating there was no indication of any danger prior to the reports from the Colorado hospital of contaminated wipes. However, the obvious question remains that if products that are intended to be used in a sterile environment are not beng made sterile, how can there be no problem?
Hundreds of infections resulting from the use of the sterile wipes have been recorded since the recall, including the case of a man who is now permanently disabled after contracting a Bacillus cereus infection, as well as that of a two-year-old boy who died of meningitis after contracting the same infection.
If you have any Triad products in your home, or if you see Triad products being used in your healthcare facility, stop using them immediately and consult the recall list prior to proceeding. Better to be safe than sorry.
Photo credit: Centers for Disease Control's Public Health Image Library (PHIL), with identification number #1059.