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Disclosure: The authors are employees of CareFusion, which holds many patents, including those associated with clinical device operating parameters. They also were employed by the predecessor companies that were involved in developing modular smart intravenous (IV) infusion safety systems and the associated wireless connectivity. This article reports their firsthand experience of what it took, and their understanding of what hospitals need to know, to achieve reliable, scalable, repeatable, closed-loop IV infusion pump integration with the electronic medical record (EMR). The article is based on their combined 50-plus years of experience in IV infusion safety and on a series of recent interviews with thought leaders and senior personnel at early-adopter healthcare organizations.
The leading cause of patient harm is medications, which account for almost 20% of medical injuries.1 Intravenous (IV) infusion errors, which involve high-risk medications delivered directly into a patient's bloodstream, have been identified as having the greatest potential for patient harm.2-6 Many hospital administrators think that the combination of computerized provider order entry (CPOE) and barcode medication administration (BCMA) protects patients from serious adverse drug events (ADEs)- but neither CPOE nor BCMA safeguards patients against many types of IV infusion errors (Figure 1).
Darren Dworkin, vice president of enterprise information systems and chief information officer of the Cedars-Sinai Health System in Los Angeles, says, "There's no one thing that you can do to prevent errors. We have lots of data that show that having invested and implemented CPOE and BCMA significantly improves medication safety, but we also have data that show we still have room to improve to get to zero IV drug therapy errors. We need to find a way to fix that by tackling the whole problem."
IV infusions present the greatest medication safety challenges because of their high potential for harm and how they are administered. For an oral solid, intramuscular injection, or eye drops, administering a dose is a one-point-in-time event. For an IV infusion, administration is a process that continues over time and may involve many dosage adjustments (titrations) based on patient response.7 A single wrong keystroke in programming the pump can result in a 10- or 100-fold overdose with possibly tragic results ("death by decimal").
The dose error reduction system (DERS) in what have become known as "smart"...