Safe Use of Refurbished Infusion Pumps

Infusion pumps deliver fluids, medications, and nutrition with a level of precision that manual gravity infusion cannot match, which is why they have become standard equipment in hospitals worldwide. However, infusion pumps have also been linked to persistent safety problems, including over- or under-infusion and missed or delayed therapy, prompting the U.S. FDA to launch a dedicated Infusion Pump Improvement Initiative in 2010 (FDA, Infusion Pump Improvement Initiative). This article outlines the common hazards associated with infusion pumps and the practical steps biomedical engineers, importers, and clinical staff should take to operate refurbished pumps safely.

Why Infusion Pump Safety Deserves Special Attention

The FDA's infusion pump initiative was launched after receiving tens of thousands of adverse event reports associated with infusion pumps over a several-year period, many traced to design deficiencies in software, user interface, and mechanical components (FDA Infusion Pump Improvement Initiative). As part of that initiative, FDA:

• Issued final guidance requiring manufacturers to submit detailed engineering and risk-mitigation information ("safety assurance cases") for new infusion pump submissions.
• Began direct inspections of infusion pump manufacturers starting in November 2011.
• Funded research (the Generic Infusion Pump Project) into software verification methods specific to infusion pump safety (FDA Infusion Pump Improvement Initiative).

For hospitals using secondary-market pumps, this history underscores why acceptance testing, correct set selection, and staff training are non-negotiable steps before clinical deployment.

Common Infusion Pump Hazards

Free-Flow Protection: A Critical Safety Feature

Free flow is one of the best-documented and most dangerous infusion pump hazards. It occurs when the administration set is removed from the pump (or improperly loaded) and gravity allows uncontrolled fluid delivery. Modern administration sets and pumps incorporate free-flow protection mechanisms — often a clip or valve integrated into the tubing set that engages automatically when the set is removed from the pump (B. Braun, Infusomat Space Pump Sets).

Practical steps to prevent free flow:

1. Always use the administration set specified by the pump manufacturer — generic or mismatched sets may lack compatible free-flow protection.
2. Keep the roller clamp closed until the set is fully and correctly loaded into the pump, and do not reopen it until the pump prompts.
3. Do not reposition or bypass the free-flow protection clip supplied with the set.
4. When removing a set from the pump, confirm the free-flow clip engages and the roller clamp is closed before disconnecting from the patient line.
5. Train staff to recognize that alarms and pump displays are not substitutes for physically confirming the set is loaded and clamped correctly.

Pre-Use Acceptance Checklist for Refurbished Infusion Pumps

Safe Programming and Operating Practices

• Independent double-check of pump programming for high-alert medications (e.g., insulin, heparin, vasoactive drugs, chemotherapy, pediatric/neonatal infusions) before starting the infusion.
• Use dose-error reduction software (DERS)/drug libraries where the pump supports them, with hospital-specific dosing limits configured rather than left at factory defaults.
• Verify the units displayed (mL/hr vs. mcg/kg/min) match the prescribed order — unit mismatches are a well-documented source of medication errors.
• Respond to occlusion alarms immediately — do not silence and ignore repeated alarms without identifying and correcting the cause (kinked line, closed clamp, positional occlusion).
• Do not bypass or disable safety alarms to "get the pump to run"; if a pump repeatedly alarms, remove it from service and have biomedical engineering investigate.
• Label multi-pump setups clearly, tracing each line from pump to patient connection point, especially in ICU settings with multiple concurrent infusions.

Preventive Maintenance and Retirement Criteria

Pumps that repeatedly fail occlusion or flow-accuracy testing, or for which manufacturer-validated administration sets are no longer obtainable, should be retired rather than kept in service, consistent with the life-cycle risk management approach FDA expects manufacturers and users to apply (FDA Infusion Pump Improvement Initiative).