The U.S. Food & Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) currently are investigating multiple instances of Wallcur simulated IV saline, which was prepared for training purposes only, being distributed and used with patients in numerous states. According to the FDA, “these products are not sterile and should not be injected in humans or animals” and “more than 40 patients have received infusions of the simulated saline products.” Several adverse events have been reported. The FDA reports that “some patients were hospitalized, and there is one death associated with use of these products; it is not known whether the death is directly related to use of the product.” Adverse effects have been reported in seven states: Colorado, Florida, Georgia, Idaho, Louisiana, New York and North Carolina. The FDA notes that surgery centers, urgent care centers and clinics are among those who received Wallcur’s simulated IV saline solution, Practi 0.9% sodium chloride solution.
The FDA recommends health care providers and their office staff “ensure IV solution simulation products are removed from office inventory to eliminate the possible injection of Wallcur simulated products”; the wording on the bag may include “Wallcur,” “Practi-products,” “For clinical simulation” or “Not for use in human or animal patients.” The FDA is working with distributors to determine how these training solutions actually entered the supply chain and were administered to patients. The FDA also recommends health care providers visually inspect future shipments of normal saline products to make sure they are for clinical use.
In addition to checking current and future shipments of saline products, if any product problems are found, next steps may include internal investigation, assessment of possible FDA/state reporting obligations, a root cause analysis, and communications with government agencies, accreditation organizations and possibly affected patients. We regularly assist clients with these issues, as well as product recalls and crisis management. If we can assist you with any of these issues, please let us know.
Further information can be found on the FDA’s website at: http://www.fda.gov