Health care providers must provide precision care, perform highly complex procedures and treatments, and cope with increasingly stressful care environments. To support their work, a variety of innovations have been devised to increase patient safety by decreasing preventable harm related to human factors, technological advances, and complex care environments. Certain types of infusion pumps, often called “smart pumps,” are one such innovation. These medical devices are designed to make the delivery of medications, fluids, and nutrition safer for patients and more streamlined for care providers.
However, because these pumps are often utilized in the administration of high-risk medications, any mistakes or failures related to the use or functionality such devices can have devastating consequences for patients, families, and caregivers alike. While increased patient safety is the driver for utilizing programable smart pumps, we must be mindful of the potential patient safety risks associated with their use — risks such as:
- Increased alarm fatigue, as these devices can add to the cacophony of clinical alarms in hospitals
- Human factors, such as failing to program the pump correctly or incorrectly connecting infusion lines and ports
- Mechanical device failures, including loss of power due to battery depletion
- Medication errors related to under-infusion, over-infusion, or free flow of medications
Recently, CHPSO hosted a safe table for its members to discuss patient safety and quality improvement issues related to these types of devices. CHPSO Safe Tables are designed to provide members with a protected space to share lessons learned, which in turn provide others with insight to take back to their own organizations to drive patient safety and quality improvements efforts aimed at the elimination of preventable harm.
The issues raised during the meeting on smart pumps included safety risks associated with:
- Accessibility to high-potency narcotics in patient-controlled analgesia devices
- Delayed or missed doses of antibiotics related to roller clamps not having been opened
- Missed or delayed pump software updates
- Pump failures or malfunctions (e.g., battery depletion, weakened plastic components)
- Pump programming errors (e.g., weight-based dosing, concentration errors)
CHPSO member organizations have adopted several best practices, ranging from simple to complex, to mitigate these potential risks. For example, one small, critical access hospital was struggling with delayed medication administration due to roller clamps left closed. After interviewing staff, they found that simply adding a small light source to their IV poles made staff more likely to recheck the roller clamp on the night shift. This was discovered when the frontline staff told leadership that they were hesitant to go back into patient rooms for fear of waking the patient by turning on the lights. This simple, low-cost intervention has helped the organization decrease missed and late antibiotics and had the added benefit of increasing trust between leadership and frontline staff because the staff felt that they were being heard, rather than simply blamed for the missed or delayed medication administration.
Other organizations shared much more complex recommendations, including one large, tertiary care facility that shared its approach to decreasing medication errors related to certain high-risk medications including norepinephrine, epinephrine, and phenylephrine through the elimination of non-weight-based dosing. This intervention required significant coordination of multiple interdisciplinary groups including pharmacy, nursing, physician staff, and the clinical informatics teams.
As a general practice, CHPSO recommends that organizations review their safety event reports and talk with their frontline staff about possible safety issues related to infusion pumps. Organizations should consider making changes to improve patient safety and decrease risk of preventable harm.
In particular, one issue raised during the Safe Table warrants a closer look — the way device recall information is communicated throughout their systems. For example:
Is there a good communication plan for information regarding recalls that needs to move from the biomedical department to the impacted areas?
How are nursing units, quality departments, pharmacy, and clinical informatics notified of a recall of a model of infusion pumps?
Ensuring an adequate communication structure and process in place will decrease the likelihood of recalls falling through the cracks and, in turn, decrease the likelihood of patient harm.
References and Resources
DeLaurentis, P., Walroth, T. A., Fritschle, A. C., Yu, D., Hong, J. E., Yih, Y., & Fuller, J. (2019). Stakeholder perceptions of smart infusion pumps and drug library updates: A multisite, interdisciplinary study. American Journal of Health-System Pharmacy, 76(17), 1281-1287.
Institute for Safe Medication Practices (ISMP) – Guidelines for Optimizing Safe Implementation and Use of Smart Infusion Pumps (2009 versions is available here, and the 2019 draft guidelines are available here.)
U.S. Food and Drug Administration (FDA) – 2019 recalls are available here and a searchable database of recalls for medical devices maintained by the FDA.