Dive Brief:
- The FDA has been warning since Dec. 30 that non-sterile, training IV products have been distributed to healthcare facilities and administered to patients. Now more than 40 patients are reported to have received the practice saline and to have suffered symptoms including fever, chills, tremors and headache. There is one death associated with the use of this saline, but it is not known whether it is directly related to the use of the product.
- Wallcur's simulated IV saline solution, Practi-0.9% sodium chloride solution, was shipped to medical clinics, surgical centers, and urgent care facilities in numerous states. Adverse events have been reported in seven states: Florida, Georgia, Idaho, Louisiana, North Carolina, New York and Colorado.
- The FDA is working with distributors who sold the Wallcur simulation IV solution products to determine how the products entered the supply chain and subsequently were administered to patients. Wallcur initiated a voluntary recall of their Practi-0.9% sodium chloride IV solutions, and most medical facilities reported that they were unaware that the IV solution bags were simulation products.
Dive Insight:
There should have been multiple opportunities for a mistake like this to be caught somewhere along the lines of distribution, receipt at the medical facilities and patient administration.
Clinicians and office staff are being encouraged to visually inspect their inventory and ensure that any IV solution simulation products are removed. Staff should ensure that none of the bags are labeled "Wallcur," "Practi-products," "For clinical simulation" or "Not for use in human or animal patients."
This is a time to consider reviewing your facility's procedures to make sure there is a system in place to inspect future shipments of normal saline products and other medical supplies as needed.