With more than 40 people sick and at least one confirmed dead, the U.S. Food and Drug Administration (FDA) is investigating how saline bags meant for training ended up being used on actual patients.
Saline bags are given to patients for various reasons, but mostly they are administered to address dehydration or prevent it.
To get health workers ready to face an actual patient, they practice on mannequins or dummies using saline solutions during training. These training products are cheaper than the real thing because they don't use the same formulations. However, they will look the same to facilitate the training process. To differentiate saline solutions for training and those for actual administration, though, labels are in place.
The FDA is still figuring out where the error in the incident began.
Working with the FDA, the Centers for Disease Control and Prevention (CDC) have so far traced the training products in question to a distributor. The CDC is not naming the company yet but says around 50 clinics received saline solutions meant for training.
Dr. Alexander Kallen, a medical officer with the CDC, estimates that hundreds of saline bags were shipped. However, it is not clear whether the products were shipped by mistake or clinic workers ordered saline solutions for training thinking they are the same as the real thing.
According to Paul Delmore, lawyer for Wallcur, the manufacturer of the saline solutions in question, the company only produces training products so it could not have made the mistake of switching saline solutions on its end. Wallcur also does not sell to hospitals and clinics, just nursing schools, training schools and distributors. The company has no knowledge who the distributor clients are.
The FDA issued a warning last Dec. 30, 2014 about the dangers of using saline solutions for training purposes by mistake on actual patients, noting that some Wallcur products had been distributed to healthcare facilities.
In response, Wallcur initiated a voluntary recall of its Practi-0.9% sodium hydrochloride IV solutions in January. Many medical facilities were not aware that they were given saline solutions that were meant for training purposes. At least one, however, recognized that they were given Wallcur products so they promptly returned the saline solutions to their distributor to be replaced.
The FDA advises medical personnel to be more mindful of labels, noting anything labeled as "Wallcur," "For clinical simulation," "Not for use in human or animal patients," or "Practi-products" must not be administered to actual patients.
