The FDA has launched an investigation into a multistate outbreak of Burkholderia cepacia that has been linked with cleansing foam used in hospitals and home-health care settings.
The US Food and Drug Administration (FDA) has announced that it is currently investigating a multistate outbreak of Burkholderia cepacia that has been linked with Medline Remedy Essentials No-Rinse Cleansing Foam produced by Shadow Holdings dba Bocchi Laboratories.
The skin and perineal care product has been used in hospitals and home health care settings for patients who are unable to wash either due to surgery or other health conditions.
“FDA is particularly confirmed about contamination in this product since product instructions do not include rinsing the product from patient skin,” the announcement read. “This poses a risk to persons who might be immunocompromised or have other underlying medical conditions.”
A total of 10 cases have been confirmed by the Centers for Disease Control and Prevention (CDC) to be associated with the contaminated products, with the majority of infections (7) reported from Pennsylvania. All of the infected patients had already been hospitalized for acute conditions previous to when they acquired B. cepacia.
The contaminated product has since been recalled.
Although B. cepacia is considered somewhat of an “environmental bug,” which means that it is often found in soil, plants, and other moist areas, the complex, Gram-negative aerobic bacilli tend to be found in medically complex and compromised patients, like those with cystic fibrosis. In fact, it’s known to plague intensive care units (ICU) where many patients are already fighting for their lives.
This is not the first time that the bug has contaminated products used in health care facilities; there appears to be an increasing trend of the bacteria findings its way into medicines and medical equipment, as was illustrated with a recent outbreak that sprung up across hospitals in Queensland, Australia.
Health officials are working to collect product samples from several locations, including affected hospitals, according to the FDA. They added that several samples that have been collected have already tested positive for the bacteria.
“Isolates from these product samples match clinical strains isolated from case-patients by Pulsed Field Gel Electrophoresis (PFGE),” the FDA reports. They added that a swab collected at Shadow Holdings, dba Bocchi Laboratories tested positive for a strain of the bacteria.
Due to these findings, the FDA is warning all health care providers as well as consumers to refrain from using the cleansing foam products as they may be contaminated with B. cepacia. As of the date of publish, it is unknown if there are any other products or lots that run the risk of contamination, but the FDA will be looking into this further in the upcoming weeks.
The FDA will continue to update the public on the outbreak situation as more information becomes available.
For the most recent case counts and states affected by the multistate Burkholderia cepacia outbreak linked to cleansing foam, be sure to check out the Contagion® Outbreak Monitor.