Technology has taken over some of the most tedious tasks in healthcare, much to the relief of overworked clinicians—but that doesn’t mean these new software programs should be treated as infallible.
Case in point: A recent recall from Baxter International was hit with the FDA’s most serious rating this week, denoting the risk that the software flaw at the core of the recall could lead to serious injury or death.
That flaw was discovered in Baxter’s Abacus software, which is designed to help hospitals streamline their liquid medication mixing. The system calculates the appropriate amounts of medications for the drug compounding process—based on preset parameters specific to each facility’s prescribing practices—then automatically sends those instructions to a connected compounder and prints out unique labels for each dose.
But, according to the FDA’s safety notice, an issue within the software’s design could cause those labels to be printed with incorrect information.
The improper labeling may occur if a user adjusts one of the label templates offered by the system, whether incorrectly or completely unintentionally, the FDA said.
Whatever the cause, if a label printed with the wrong patient name, drug name or dosage value is placed on a liquid medication bag, the compounded medication could be administered to the wrong person, potentially causing serious harm to high-risk patients.
So far, Baxter and the FDA have cited five complaints linked to the software defect, with no patient injuries or deaths reported.
The recall spans nine iterations of the Abacus system—three versions of the software, each with three separate configurations—that were distributed between May 2013 and September 2019. In total, it affects just over 1,100 customers located around the world.
Those customers may continue using the software, Baxter said, but should follow all instructions in the Abacus user and configuration guides when creating an order and should refrain from making changes to the included label templates. If any changes must be made, facilities should contact Baxter’s technical support team.
The company also recommended that healthcare providers implement pharmacy and nursing checks throughout the compounding process and have a pharmacist review all medications that were mixed and labeled using the technology.
Meanwhile, according to its original June 22 recall notice, Baxter is working on developing a software upgrade that will eliminate the ability to alter the Abacus label templates.