How to Optimize Smart Pumps for Greater Patient Safety


Most drugs administered intravenously are high-alert medications, meaning IV infusion errors can significantly compromise care quality. This can result in patient harm, including death. For hospitals, physicians, and nurses, the consequences of IV medication errors may include loss of patient and community trust, lawsuits, medical board discipline, and even criminal charges.

Introduced in 2001, “smart” infusion pumps enhanced with computer technology have improved the safety of intravenous infusions. Smart pumps are now used in more than 80% of US hospitals. Like other electronic infusion pumps, smart pumps offer precise control over dosages and flow rates. Unlike standard infusion pumps, smart pumps incorporate advanced technology designed to minimize error during clinician programming and throughout each infusion.

Smart Pump Safety Features

The dose error reduction system (DERS), EHR integration, and bar-coded medication administration (BCMA) are primary features of many smart pumps currently on the market.

What is DERS?

A smart pump’s dose error reduction system (DERS) integrates with a customized drug library to verify that programmed infusions fall within defined concentration and dosage parameters. When the DERS identifies a dosage input outside these parameters, it sends a real-time alert.

The DERS features “soft” limits, which the clinician can override, and “hard” limits, which can’t be overridden. The system also monitors the progress of each infusion and sends alerts when it detects a problem.

What is EHR Integration?

In recent years, EHR integration has become a primary feature of DERS. Connectivity with EHR allows the smart pump to access prescribing information directly from patient records, eliminating the need to program the pump manually. Bi-directional smart pumps can also communicate infusion data wirelessly to the EHR.

What is Bar-Coded Medication Administration?

Bar-coded medication administration (BCMA) verifies that the correct patient receives the right medication. The pharmacy scans the bar code on each unit of medicine it dispenses. At the point of care, the clinician scans the bar code on the unit package, then scans the patient’s wristband. The system verifies the combination and records administration of the drug in the patient’s electronic records.

It’s clear that, statistically, smart pumps do decrease the overall rate of medication errors.

However, research shows that their effectiveness depends on several variables, such as proper implementation, usage, and maintenance. It’s therefore critical that organizations optimize smart infusion pumps for safety to reap the benefits of these ubiquitous medical devices.

Smart Pump Safety Risk Factors

The primary factors that reduce the safety of smart infusion pumps are human error and technical issues.

Human Error

Human mistakes at the point of care continually affect accurate drug dosing and delivery. Common problems that lead to user errors include:

  • Distraction
  • Physical fatigue
  • Stress
  • Miscommunication

Busy, overworked nursing staff are highly susceptible to alert fatigue, resulting in frequent, problematic overrides of soft limits. Additionally, pump design flaws and inefficient clinical workflows often increase the chances of human error.

Technical Issues

All brands and models of smart pumps are susceptible to technical issues. They may occur due to product design, maximized device usage, cleaning procedures, and many other reasons.

Examples of technical risk factors include:

  • Software defects
  • Inadequate user interface design ("human factors" issues)
  • Damaged mechanical parts (e.g., doors and latches)
  • Battery failures

Technical issues aren't strictly the domain of OEM equipment. Faulty 3rd-pary replacement components and low-quality repairs can also cause technical problems. Seek out ISO Certified, FDA-registered 3rd-party parts manufacturers and values-driven repair partners to minimize issues throughout the lifecycle of your smart infusion pumps.

Organizational Risk Reduction Strategies

The first step in creating an organization-specific smart pump safety policy is a facility-wide evaluation of incidents, recurring issues, and device data. This information allows for targeted protocols that address departmental and patient population factors that influence medication errors or device failures.

Following this evaluation, Set up a quarterly review of adverse events, medication errors, and data analytics. Determine action steps based on data trends to improve:

  • DERS compliance
  • Drug libraries
  • Interoperability
  • Workflows
  • Staff training
  • Preventive maintenance
  • Response to recalls and hazard alert

Establish an Infusion Safety Committee to develop protocols and oversee process revisions, database updates, maintenance plans, and system upgrades.

Purchasing New Smart Pumps

The 2020 ISMP Smart Pump Guidelines recommend renting or purchasing smart pumps capable of wireless drug library updates and data transmission, as well as bi-directional EHR communication. Create a purchasing team that includes clinical, pharmaceutical, and technical experts to evaluate brands and models under consideration.

Building and Improving Drug Libraries

Designate another team to customize and update the facility’s drug library: select physicians and experts from information systems, pharmacy, clinical engineering, and nursing.

Drug library best practices include:

  • Standardized formats for drug names, dosage units, and dose rates
  • Defined concentrations and limits for care areas/patient profiles
  • A formal drug library change request process
  • Requiring an independent double-check of data entry for all modifications
  • Limits on manual programming capabilities for continuous infusions
  • Customized clinical alerts

At minimum, the drug library should be updated each quarter, according to the ISMP Guidelines.

Refining Clinical Workflows

Streamlining clinical workflows can have a considerable impact on reducing programming errors. Establish protocols for infusion set up, reconnection, and in-treatment adjustments, as well as patient transfers. Rigorous staff training increases the likelihood that providers will follow these protocols in the field.

Enhanced workflows should include independent or automated programming double checks and compliance with manufacturer guidelines for all components, such as:

  • Tubing
  • Bags, bottles, and syringes
  • Batteries
  • Cleaning procedures

When transferring patients between units, nurses must ensure the drug library, care area, and patient profile meets the requirements of the receiving unit.

Recalls, Hazard Alerts, and Adverse Events

Clinical engineering must respond promptly to alerts and recalls. Always comply fully with the manufacturer’s instructions for any recalled smart pumps in the hospital inventory. Be sure to monitor affected devices after addressing the recall.

Hospital staff should take care to follow organizational protocols for reporting safety concerns, user errors, device failure, and adverse events that occur within the facility. Filing a voluntary FDA report when appropriate can help improve patient safety in the future.

With proper optimization, smart infusion pumps help enhance hospital care while keeping patients safe from harm. For further information, review the Joint Commission’s Sentinel Event Alert 63: Optimizing Smart Infusion Pump Safety with DERS, the FDA’s Infusion Pump Improvement Initiative, and the FDA Infusion Pump Risk Reduction Strategies for healthcare professionals.

Elite Biomedical Solutions is an ISO Certified, FDA-registered US manufacturer of biomedical equipment parts. Contact us for information about OEM+ quality replacement parts for leading smart infusion pumps.

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