On Dec. 30, 2014, the Food and Drug Administration (FDA) issued an alert to health care professionals warning them not to use simulated intravenous (IV) products in humans. The agency did so after learning that some of one manufacturer's simulated plastic bags, labeled as 0.9 percent sodium chloride IV solution, had been distributed to health care facilities and used in patients. Real sodium chloride IV solutions are used daily in nearly all health care facilities in the U.S. and have been in short supply over the past year.
San Diego-based Wallcur makes a variety of simulated IV products that are intended only for use in training and educating nurses, pharmacists, paramedics and other health care professionals. These products are not intended for the treatment of patients, as they are neither sterile nor assessed for purity and quality, and their use would pose an immediate, life-threatening hazard. Not surprisingly, the FDA's initial alert stated that there had been reports of serious adverse events associated with use of Wallcur's products in patients.
On Jan. 7, Wallcur announced a voluntary recall of its simulated 0.9 percent sodium chloride IV solution products. However, presumably concerned about an ongoing threat to patient safety, the FDA on Jan. 14 issued an updated alert noting that these Wallcur products had been shipped to about 50 medical clinics, surgical centers and urgent care facilities in numerous states. The agency further reported that more than 40 patients in seven states (Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado) had received infusions of the Wallcur products, resulting in many adverse events in at least 17 patients, including fever, chills, tremor, muscle aches and headache. These reactions developed almost immediately after injection of the simulated IV fluids. Some patients were hospitalized, and one died, though the cause of death is still being investigated.
This situation signals unacceptable lapses in procedures for protecting patient safety and public health at multiple levels. First, although Wallcur's homepage prominently indicates in red, bolded text that its products "ARE FOR TRAINING PURPOSES ONLY AND NOT INTENDED FOR HUMAN OR ANIMAL USE," such an explicit warning does not appear to be stamped on the bags of solution recently distributed to health care facilities across the U.S. The simulated products are meant to appear realistic, but other similar Wallcur products do have a prominent warning label stamped on the plastic simulated IV fluid bags, demonstrating that inclusion of an appropriate warning is clearly feasible. The absence of such warnings on the simulated IV sodium chloride solution products created the potential for dangerous misuse in patients. (The labels did have in very small print "Practi-Products for Clinical Simulation," but this likely went unnoticed or was not understood by health care providers who administered the fluids.) All simulation IV products made by Wallcur -- or any other company -- should carry an explicit warning like the one found on Wallcur's homepage.
Second, the FDA's initial alert to health care professionals on Dec. 30 appears to have been inadequate. Many health care providers routinely miss FDA safety alerts regardless of the time of year, and the release of the Wallcur alert during the holiday season probably further decreased the likelihood that the intended target audience saw it. Since these circumstances represented a public health emergency, the agency should have orchestrated a much more aggressive public relations campaign through national print and broadcast media to alert health care providers and facilities across the country.
Third, distributors that purchased these simulated products from Wallcur never should have introduced them into the supply chain for clinical products intended for patient care. Regulators investigating how this happened should determine whether distributors were more likely to take risks in selecting suppliers because of the ongoing shortage of IV saline products, and work to improve purchasing practices to avoid such serious mistakes during future shortages.
Finally, the health care providers who injected these products failed to use due diligence in assessing whether the simulated products were appropriate for use in patients. While the products appear to have lacked a clear warning and were made to look realistic upon a cursory glance, the product labeling omitted many details typically found on IV fluids, the most important of which being a statement that the product is sterile and nonpyrogenic (free of substances produced by bacteria that can cause fever and inflammatory reactions). The lack of detail should have been a tipoff that something was amiss.
Moving forward, federal regulatory agencies must act promptly to implement additional safeguards to prevent similar life-threatening mistakes from occurring.