Cleansing Foam Used in Hospitals Linked to Burkholderia cepacia Outbreak
Concerns over contamination of a cleansing product used in hospitals have led to an investigation by the United States Food and Drug Administration (FDA). The product in question is Medline Remedy Essentials No-Rinse Cleansing Foam, which is manufactured by Shadow Holdings. Patients use this product when they cannot wash using water because of health conditions or surgical procedures. The cleansing foam has been linked to an outbreak of Burkholderia cepacia in several states.
B. cepacia is Dangerous to Hospitalized Patients
Burkholderia cepacia is a type of bacteria that can often be found in the environment, for instance in soil or water. Most healthy people are not at risk of being made ill by this bug, but vulnerable populations can develop severe infections, including pneumonia if they are exposed. Because Burkholderia cepacia, or B. cepacia, has the potential to cause severe respiratory infections, it is known to be dangerous to patients who have cystic fibrosis or other lung diseases. Other patients who already have weakened immune systems, such as cancer patients or people who have AIDS, are also more likely to experience complications from this type of infection which is why it is dangerous in a hospital setting. The bacteria can also cause blood infections in certain vulnerable patients.
In many cases, infections caused by B. cepacia are not treatable with the more common antibiotics creating another risk to patients. Patients often contract B. cepacia from contaminated medical products, but it can also be spread from one person to another, from exposure to the bacteria in the environment, or from contact with the bacteria on a contaminated surface.
Outbreaks Due to Contamination
According to the Centers for Disease Control and Prevention (CDC), outbreaks of B. cepacia have been linked to some products over the years, including nasal spray and mouthwash. In 2016, the FDA determined that a 12 states outbreak that led to 63 confirmed B. cepacian infections, and another 45 suspected infections were linked to a product manufactured by PharmaTech. The same manufacturer was the source of an outbreak in 2017 as well. According to the investigation carried out by the FDA, the outbreaks were caused by contaminated oral liquid docusate sodium. This product was water based and not sterile. In addition to the B. cepacia, other bacteria, mold, and yeast were found in the product. The water source used to manufacture the products was also found to be contaminated.
The FDA issued warnings about other contaminated products in 2017 as well. Doctor Manzanilla Cough & Cold and Doctor Manzanilla Allergy & Decongestant Relief Syrup were recalled because they were found to contain B. cepacia. Ninjacof and Ninjacof A, both manufactured by Centurian Labs, were recalled because they were contaminated with the bacteria as well.
Cleansing Foam is a Particular Concern
The FDA has advised consumers and health professionals to stop using recalled cleansing foams manufactured by Shadow Holdings dba Bocchi Laboratories. Laboratory tests have been able to confirm the link between the people suffering from infections and the bacteria found in the product. There have been 15 confirmed cases of infections, all in patients who used the cleansing foam while hospitalized for other conditions. The infections appeared in California, New Jersey, and Pennsylvania.
The product is used as a cleanser for people who are unable to bathe because of surgeries or because of other medical conditions. Because of the intended use of the cleansing foam, the patients using the product are likely to be vulnerable to infections. Additionally, the product is designed to be used without being rinsed off, meaning the contaminants remain on the person’s skin.
The FDA and the CDC are still investigating the outbreak. There is a possibility that the recall will be expanded to include other products or lots as well.
Healthcare-associated Infections Plague Patients in American Hospitals
The CDC says that infections that patients contract while being treated in healthcare facilities are a serious threat to patient health. About one out of every 25 patients being treated in a US hospital suffers from an infection because of something that they were exposed to while receiving medical treatment.
About 722,000 patients in American hospitals are infected with a healthcare-associated illness every year, and about 75,000 people will die as a result of the infection they contracted while in a healthcare facility.
The Impact of a Recall
When a recall is issued for a medical device or healthcare product, the recall is typically issued by the manufacturer on a voluntary basis after the defect has been identified. The manufacturer will realize that the product is in violation of FDA law, choose to issue a recall and will notify the FDA of the issue.
The FDA does have the power to force a company to recall a product, but this is rarely necessary. The FDA does issue warnings to the public and updates concerning the recalled product.
It is important to note that when a company recalls a defective product, this does not mean that they will be able to avoid liability for injuries that occur as a result of the product, but it also does not mean that they are admitting liability for any harm caused. However, if a company refuses to recall a product that is presenting a risk to consumers, this failure to act can be used against a company and have severe consequences for that company in terms of the damages awarded to any injured plaintiffs.
If you or someone you love has suffered from an infection resulting from cleansing foam, or any other defective medical product or device, you could be entitled to compensation for the harm that was done to you.
At Parker Waichman LLP, our Burkholderia Cepacian lawsuit lawyers believe that companies must be responsible for their actions, and we are committed to advocating for people who suffer injuries as a result of corporate negligence.
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