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BACKGROUND: In December 2014, New York State Department of Health (NYSDOH) learned of 2 residents hospitalized after administration of simulation saline intravenous solution. Simulation intravenous fluids are nonsterile products not meant for human or animal use; they are intended for nonclinical use by health care trainees. We investigated to understand the situation and prevent further administration of simulation saline products to patients.
METHODS: Review of customer orders from a distributor revealed product distribution to clinical facilities in multiple states. Public health officials contacted affected facilities, redistributors, and the manufacturer. Information was collected regarding procurement, product use, and adverse events.
RESULTS: Forty-three clinical facilities in 23 states purchased the simulation saline during May 22, 2014–January 6, 2015. Preliminarily, 10 facilities reported potential administration of simulation intravenous product to 45 patients; adverse events involved 25 persons, including 11 hospitalizations and 2 deaths. It is not known if the deaths were directly related to use of the product. All clinical facilities were outpatient settings; at the time of purchase none was aware this product was not intended for human use and believed they were purchasing regular saline. On December 30, 2014, FDA issued an alert warning against using these simulation products in human or animal patients; the manufacturer initiated a recall on January 6, 2015.
CONCLUSIONS: This investigation demonstrates the potential for simulation medical products to enter the clinical supply chain, be inadvertently used on patients, and cause harm. Health care providers should remain aware that simulation products exist and carefully examine product labeling to ensure safety for clinical use. Clear labeling of simulation products and segregation from products intended for clinical use can help avoid misuse.