The Food and Drug Administration (FDA) plays an important role in ensuring the safety of medical devices. In this cross-sectional study, researchers identified a high risk of future Class 1 FDA recall (the most serious recall designation, indicating serious risks to patient safety) among previously authorized devices (predicates) with prior Class 1 recalls.

Intravenous (IV) smart pumps can improve medication administration safety, but usability issues can compromise that safety. This study compared actual use of smart pumps to the manufacturer’s requirements for operation. Adherence to requirements was low and the authors present several recommendations to smart pump manufacturers. The Institute for Safe Medication Practices issued guidelines for safe use of smart pumps that address several of these safety concerns.

This commentary discusses the use of “safety cases” to communicate the safety of a product, system or service in industry (e.g., aviation, defense, railways). Using an example of a smart infusion pump, the authors discuss how to apply this concept in healthcare to support the safe adoption of digital health innovations.

Smart infusions pumps with built-in dose error reduction software (DERS) are designed to protect against dosing errors that result in patient harm. This alert summarizes recommendations to enhance the effective implementation and use of smart infusion pumps such as drug library maintenance and pump error report monitoring.

The COVID-19 pandemic has led to many changes in health care delivery. This article discusses one common process change – moving medical devices (such as intravenous (IV) infusion pumps) away from the bedside – and how to support nursing clinical decision-making during IV infusion therapy.  

This systematic review catalogued and mapped the types of human errors related to smart pumps and associated error-prevention strategies. Error categories included (1) undocumented errors, (2) drug library errors, (3) programming errors, (4) administration errors, and (5) ancillary equipment errors. The authors mapped these errors to existing, standardized medication error classification and found that some errors (e.g., drug library errors) are introduced by the implementation of smart pump technology and some may be the result of workarounds. A range of prevention strategies were identified and mapped to the error types. These findings can serve as a toolkit for clinical use and development of best practices.  

Smart infusion pumps have the potential to improve medication safety, but research suggests that errors remain common and that careful consideration must be given to both design and implementation of such technology. Researchers conducted a survey of five health systems in Indiana to better understand smart infusion pump users' views and knowledge regarding the drug library update process. They identified significant knowledge gaps, especially around the steps necessary to update the drug library.

This simulation study examined critical care unit nurses' performance in identifying intravenous medications using different equipment types. Researchers found that line labels (attached to each line of tubing) and organizers (which prevent tubing from tangling) significantly improved the accuracy of medication identification compared to usual care. Use of smart pumps required more time and did not improve medication identification accuracy, suggesting that line labels and organizers are an inexpensive and feasible method to enhance medication safety.

Intravenous medication infusions are an important target for safety interventions. Many infused medications, such as opioids and chemotherapy, require vigilant adherence to protocol to prevent harm. Technical solutions to infusion errors such as computerized provider order entry, barcode medication administration, and smart infusion pumps have been implemented with some success. Investigators compared infusion errors in the United States, where all three technical interventions are common, to the United Kingdom, where those technical interventions are rare. Minor errors were common in each country, but only 0.8% of infusions placed patients at serious risk of harm. Although the details of errors in both countries differed in detail, rates of error and harm were similar. A WebM&M commentary described a chemotherapy infusion error that caused renal failure.

Smart infusion pumps store drug safety information, but this data must be periodically updated. This study demonstrated significant delays in updating the drug information for smart infusion pumps. These delays resulted in failure to alert for two high-risk medication cases, but neither case led to patient harm.

This pre–post study of errors in anesthesia compared self-reported errors before and after implementation of a medication safety bundle that included smart infusion devices and barcode medication administration. Wrong-medication errors declined after barcoding was introduced, consistent with prior studies.

Although smart pumps can reduce medication errors, user overrides and workarounds prevent safety features from operating as intended. Researchers used informatics data from 7 hospital systems including a total of 44 hospitals for a 1-year period to determine compliance with built-in dose-error reduction systems and drug libraries. They found differences in compliance both within and across systems. They also found a positive association between pump compliance and type of pump used as well as a positive association between the number of drug library profiles and pump compliance.

Nuisance drug alerts generated by smart infusion pumps can detract from safe care delivery by contributing to alert fatigue and interruptions. This commentary reviews a consensus initiative to decrease insignificant alerts across six health systems. The authors describe how the group standardized smart pump drug library management processes to refine dosage recommendations, policy development, alert review, and data usage to reduce alerts in acute care facilities. A past PSNet perspective discussed the importance of addressing hazards associated with smart pump utilization.