Training IVs Used by Mistake Proved Fatal

A few weeks ago, the FDA learned that intravenous fluids intended to be used for training medical personnel in fact were given to patients as treatment. Last week, the agency announced that many people had gotten sick as a result, and one person died. This preventable situation occurred only because commercial, medical and government interests were not paying attention.

As Reuters reported, the FDA initially instructed physicians not to use the products, manufactured by Wallcur LLC for simulating the administration of an IV, and had reported that serious adverse events had resulted from the use of some of the company’s products. But it certainly didn’t seem overly concerned about patient safety.

Nor did the company, which issued a news release the first week in January recalling its products. In part, it read: “As you know, all of Wallcur’s products are intended for training, simulation, and educational purposes only. Recently some of Wallcur’s training products were not used for their intended purpose. Specifically, despite the fact that the products are intended ‘for clinical simulation’ only, we are aware of reports that these products have been used outside of their intended use and administered to patients. Because these products are not intended for human or animal administration, and are not sterile, administration of these products could result in adverse events.”

But, apparently, either medical practitioners did not know Wallcur supplied drugs only for training, or the products were so poorly labeled as to make their origin or contents unclear. If that’s the case, why would anyone use them on a patient?

In its announcement last week, the FDA said that more than 40 patients had been infused with simulated saline solution sent to medical clinics, surgical centers and urgent care facilities in seven states – Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.

The adverse reactions included fever, chills, tremors and headache. Some patients were hospitalized. Officials at the FDA said they didn’t know if the death of the patient among the group that got the IVs was related directly to the product.

Most medical facilities that received and used the solution as a treatment indicated that they weren’t aware that it was for simulation only, but one clinic did, and returned it to the distributor.

The FDA is trying to figure out how the Wallcur products got into the supply chain, and has urged patients receiving IV saline to check to see that the bag is labeled as sterile.

According to USAToday.com, Wallcur doesn’t sell its products to hospitals, only to medical and nursing schools that it has determined are legitimate teaching centers. It also sells to distributors. Company officials said they didn’t know how training products found their way from a distributor to a hospital.

The Wallcur product is Practi-0.9 percent sodium chloride IV solution. Medical-grade versions of 0.9 percent sodium chloride – that is, IV solution intended to treat patients, not to train caregivers – is known as normal saline. Recently, there has been a shortage of the drug, which is used widely to treat dehydration and other medical conditions. That prompted the FDA last year temporarily to allow one manufacturer to distribute normal saline from its manufacturing facility in Norway, and the feds also are OK with the temporary distribution of additional normal saline from other sources.

But no one thought that a needy market for saline treatments might cause so many players to overlook their responsibilities to patients.

Michael Carome, director of Public Citizen’s Health Research Group, told USAToday that the situation was “outrageous.” He’s a physician, and made clear that injecting someone with a fluid that wasn’t sterile could cause serious bloodstream infections, if the fluids are contaminated with bacteria or the toxins that bacteria produce.

A couple of years ago, contaminated steroid injections manufactured by New England Compounding Center that caused 64 deaths from meningitis.

With regard to the Wallcur products ending up inside human bodies, Carome told USAToday, “The system for protecting patients failed at multiple levels.” He said such products should be labeled with bold, red letters to make it almost impossible for anyone to mix up a simulated solution with normal saline.

He also criticized the FDA’s failure to aggressively notify both hospitals and consumers of the problem. Its first alert was released Dec. 30, when the holidays probably prevented many people from noticing it.

Carome said the people responsible for distributing the practice saline put patients at risk, as well as hospital staffers, who should have noticed that the practice bags weren’t sterile.

Stay tuned for further developments.

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