Intravenous medications represent an important source of risk to the patient.
As the Institute of Healthcare Improvement (IHI) states: “When intravenous medications are involved in adverse drug events (ADEs), the harmful effects to the patient may occur more rapidly and be more severe than errors with oral medications, due to the direct administration into the bloodstream.” However, the degree of risk reduction with smart pumps is highly dependent upon integration into the hospital’s information systems, and the degree of improvement may be limited if the hospital does not yet have all of its patient information in integrated electronic systems.
On July 31 the FDA issued a safety alert encouraging health care facilities to stop using Hospira Symbiq pumps due to cybersecurity concerns. This is not the first alert concerning hospital equipment cybersecurity and certainly will not be the last. If a hospital must temporarily continue using Symbiq pumps until replacements are in place, the following temporary measures should be taken (FDA, 2015):
Maddox RR, Danello S, Williams CK, et alAdvances in Patient Safety: New Directions and Alternative Approaches (Vol. 4: Technology and Medication Safety). Rockville (MD): Agency for Healthcare Research and Quality (US); 2008 Aug
This article describes the need to improve IV infusion medication safety at the point of care, developing a culture of safety and team approach, and the capabilities of IV infusion safety systems to help avert errors and monitor patient respiratory response.
This study evaluates the impact of intelligent IV infusion pumps on patient safety and nursing satisfaction. Intelligent IV infusion pumps can alert nurses if parameters (such as drug dose, dosing unit, dosing rate, etc) and prevent unintentional over-delivery of fluids or medications.
Tran M, Ciarkowski S, Wagner D, Stevenson JG.Jt Comm J Qual Patient Saf. 2012 Mar;38(3):112-9.
As with the use of any therapy involving opioids, patient-controlled analgesia (PCA)–related errors can lead to overdose and even death. “Smart” (computerized) pumps have medication safety enhancements, particularly those related to operator errors during administration, to improve overall safety and efficacy. After the occurrence of PCA–related errors that occurred at a tertiary care academic medical center, an analysis of PCA errors was conducted. The introduction of smart pumps was identified as a possible solution, and the medical center adopted the technology in 2006.
The FDA CDRH (Center for Devices and Radiologic Health) is embarking on an initiative to reduce adverse events from external infusion pumps. The FDA is planning to significantly revamp the way in which it evaluates applications for new pumps.
Medication errors are the most significant cause of medical injuries, representing 19.4% of all adverse events1. Intravenous (IV) infusions have been identified as frequent contributors to medication errors, and the injuries that result from them2, 3, 4. General infusion pumps were designed to improve accuracy and continuity of IV infusions by allowing nurses to program an hourly rate and volume. However, studies have shown that these devices are involved in 35-60% of the estimated 770,000 Adverse Drug Events (ADEs) that occur
each year5,6,7,8.
Computerized prescriber order-entry and bar-code applications for drug dispensing and administration are capable of reducing medication errors. Yet, even if these technologies are fully implemented, serious medication errors remain possible, especially errors associated with the administration and titration of intravenous (IV) high-alert medications such as dopamine, heparin, and insulin. Even if the right drug and dosing information are at hand, a mis-programmed infusion pump can leave a patient only a button press away from harm.
Ontario Health Technology Advisory Committee (OHTAC) RecommendationJuly 2009
The Ontario Health Technology Advisory Committee (OHTAC) engaged the University Health Network’s (UHN) Healthcare Human Factors Group (HHFG) to collect evidence on the effectiveness, and safety of smart infusion systems. To this end, HHFG conducted both lab and field evaluations. This document presents a summary of recommendations based on results from these evaluations.
Intravenous infusion pumps are used to deliver parenteral medications at precise rates or in specific amounts. This technology is not new, but for several years, infusion pumps have been manufactured with software that can alert users to potential errors. The pumps with this additional software are often referred to as “smart pumps” or “intelligent infusion devices.” This software allows an organization to create a library of medications that provides medication.
To view the up to date ISMP guidelines, click on the link below.
