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F.D.A. Begins Inquiry After Death and Illnesses From Saline Bags Meant for Training

WASHINGTON — How could hundreds of bags of intravenous saline solution meant for training health care workers have been given to real patients?

That is the question health authorities were scrambling to answer this week after Wallcur, a San Diego-based company, recalled different-size bags of its saline solution and distilled water on Jan. 7.

As of Thursday, 17 patients had fallen ill and one person — a hospice patient — had died after being given the solution, health officials said, though they could not say conclusively whether the saline solution was the cause. Patients in seven states reported symptoms, including chills, fever, tremors and headaches.

The company said it began shipping the saline, in bags labeled “for clinical simulation,” on May 22, 2014. It said the products were not intended for people or animals because they were not sterile.

Someone, somewhere, screwed up. From reading the article it doesn’t appear that the fault lies with the manufacturer. Not that this fact will stop someone, probably several someones, from suing. Looking at several products on their website, every product is labelled not for human or animal use. The company has been around for over 40 years, so it’s not like they are new to the market.

Part of the fault might lie with a distributor or even the purchasing agents for the clinical sites.

He said it was still unclear whether the bags, which he estimated to be in the hundreds, were shipped in error, or whether clinic workers ordered them without understanding that they were for training.

“It seems like it’s not just one single mistake,” Dr. Kallen said. “There could have been instances where ordering was done by office staff who didn’t know the difference, as well as instances where the right product was ordered but they received the wrong stuff.”

That being said, there is one place where the fault absolutely lies.

With the people that used this product in a clinical setting.

Depending on where and how a medical provider was taught there are six, eight, ten, or twelve “Rights of Medication Administration”. No matter which one of these a person might subscribe to, “right medication” is included. To make sure it’s the right medication, the provider has to read the label on the drug or IV solution. If a person actually reads the label, they are very likely to notice that it is is labeled “Not for human or animal use”, or “For simulation only”. Which should be a warning that whatever is in the bag or vial is not a real drug.

Sadly, people were harmed, one died, and that means litigation. It also probably means that several nurses or other medical providers are going to be fined or lose their licenses and thus their jobs.

My sympathy for people losing their livelihood is severely limited by the fact that if they followed the the rules for medication administration, none of this would have happened.

The whole sorry mess is sad on so many levels.

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After a long career as a field EMS provider, I'm now doing all that back office stuff I used to laugh at. Life is full of ironies, isn't it? I still live in the Northeast corner of the United States, although I hope to change that to another part of the country more in tune with my values and beliefs. I still write about EMS, but I'm adding more and more non EMS subject matter. Thanks for visiting.