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.
