DEERFIELD, Ill., May 18, 2016 – Baxter International (NYSE: BAX) this week announced the results of a retrospective analysis of data from Sigma Spectrum Infusion System pumps that found 90 percent of programming events with intravenous (IV) “high-alert” drugs are titrations – dose or rate changes made after the infusion has started. Titration (a dose/rate change) helps avoid potential overdoses or adverse events by starting patients on a medication at the lowest possible dose and increasing the dose over time until the desired therapeutic effect is achieved. High-alert medications include drugs such as anesthetics, cardiovascular agents and insulin that carry a larger risk of causing patient harm when used in error. These data were presented during a poster session at INS 2016, the annual meeting of the Infusion Nurses Society, in Ft. Lauderdale, Fla.
“There are no current published data on the frequency of titration programming,” said study co-author Shannon Kayler, RN, BSN, of Baxter’s fluid systems franchise. "Therefore these data will provide vital context in helping guide effective infusion practices that maximize patient safety.”
The analysis evaluated infusion pump data from 20,542 Sigma Spectrum pumps located at 45 hospital sites in the United States and included six months of data per site, which was gathered within the timeframe of October 2014 to July 2015.
Infusions in the study were of high-alert IV medications with more than 2,000 initial infusion programming starts. The study targeted adult patient care in the areas of critical care, operating room, and anesthesia. The most frequently titrated drug in the analysis was norepinephrine, which is used to treat hypotension (low blood pressure) and was titrated on average approximately 15 times during an active infusion, presenting 15 distinct opportunities for programming errors. Other drugs with eight or more titrations per infusion included insulin (11); phenylephrine (10); propofol (9); and epinephrine (8).
Sigma Spectrum Infusion System uses drug libraries to alert clinicians of potential errors before an infusion starts, and is the only pump to include a built-in titration error prevention feature (with Single-Step Dose or Rate Change Limits) to help clinicians protect high-risk infusions during titrations.
“These findings suggest there are multiple opportunities for programming errors to occur during titrations, and emphasize the importance of using protocols and systems to protect against these errors, particularly when infusing high-alert medications,” said study co-author Timothy Hoh, RPh, also of Baxter’s fluid systems franchise. “Most infusion pumps are not designed to identify errors during titrations.”
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This release includes forward-looking statements concerning potential benefits associated with the use of the Sigma Spectrum Infusion System. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: demand for and market acceptance of risks for new and existing products, and the impact of those products on quality or patient safety concerns; product development risks; product quality or patient safety concerns; the impact of competitive products and pricing, including disruptive technologies; breaches or failures of the company’s information technology systems; and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.
Sigma Spectrum Infusion System is Rx Only. For the safe and proper use of the device, refer to the appropriate owner’s manual.
BAXTER and SIGMA Spectrum are trademarks of Baxter International Inc.