The Infusion System That Safeguards Against Free Flow

The Infusion System That Safeguards Against Free Flow

The Institute for Safe Medication Practices (ISMP) first reported free flow with the use of infusion pumps in the late 1980s and it remains an issue for nurses administering IV medications today. In most cases, free flow is caused by an accidental, uncontrolled flow of IV solutions after the removal of pump tubing from the device while still connected to the patient before closing the set’s manual tubing clamp. This issue can lead to patient injury and even death.¹ In 2003, a National Patient Safety Goal was established to promote and incorporate free-flow protection with all IV infusion pumps used by clinicians. The Joint Commission then evaluated organizations to ensure that all IV pumps have free-flow protection in place.

Legacy IV infusion pumps

Despite free-flow protection mandates, legacy pumps lack modern design updates necessary to ensure free flow does not occur. This is evidenced by the following situations reported in an ISMP article²:

1. A low-risk medication was hung by gravity due to a lack of pumps and a critical medication (heparin) was mixed up with the non-critical medication (an antibiotic), so heparin was infused too quickly.
   ISMP failure mode: Not having an adequate supply of infusion pumps available and only using infusion pumps to deliver “high-risk” medication.
2. The line was not connected to the pump when the patient was being transferred for a procedure. The nurse didn’t notice and unclamped the line, creating a free flow of propofol.
   ISMP failure modes:
   • Starting infusions without confirming the infusion rate
   • Failure to trace infusion lines before opening the clamp on the IV set to start or restart infusions
   • Distractions and time constraints during medication administration
3. When trying to address an air-in-line (AIL) alarm, the line with phenylephrine was removed from the pump and the clamp was opened to remove the air. The tubing was never inserted back into the pump, causing a free flow of phenylephrine. Air in the line can trigger frequent and clinically significant AIL alarms, contributing to alarm fatigue and negatively affecting nurses and patients. When you have several infusions hanging at the same time, frequent AIL alarms can mean patients are not receiving medication while the alarm is being addressed. In some cases, a frustrated clinician will even pull the line off the pump to remove the air.
   ISMP failure mode: Failure to respond appropriately to infusion pump alarms (e.g., “air-in-line” alarm).

Smarter pump technology

By analyzing the faults inherent in legacy smart IV pumps and creating solutions, Fresenius Kabi built the Ivenix Infusion System to reduce the potential for every one of these errors.

• Fleet oversight: Built-in software can locate a missing or “not-in-current-use” pump in a moment and provide a snapshot of how many pumps are needed over time, maximizing the use of the pump fleet.
• Pump supply: The Ivenix pump requires no scheduled downtime for annual performance and maintenance upkeep, which means the institution does not reduce its pump fleet in use throughout the year. Having all the pumps you need at any time reduces the potential for the clinical staff choosing to use a gravity mode IV.
• Manual errors: The Ivenix pump can be quickly disconnected from the pole and the IV medication hung on the side of the pump without limitations of bag, pump, or patient position. The volume is delivered at the intended flow rate. For transport, there is no need to pull the IV setup off the pump, which eliminates one source of the potential for creating IV free flow.
• Free-flow protection: The design of this free-flow protection is based on more than a decade of product development and countless hours of usability studies with nurse users who were trained on the system as well as those naïve to the use of the pump. The result is an easy-to-use flow dial that acts as a regulator, or barrier of flow, when inside the pump. Equally important, when the set is removed from the pump, the flow is automatically stopped. Nurses can be confident that the rate they set up with the administration set and pump are accurate regardless of pump or bag positioning.
• AIL alarm clearance: The Ivenix pump can clear an AIL alarm without removing the line from the patient. By back priming into a syringe or a secondary bag, the pump addresses the issue, eliminating the need to remove the set from the pump to remove the air. In addition, an antisiphon valve approved for use in the Ivenix pump can be placed at the end of the IV tubing to pressurize the infusion and minimize air bubbles. This was found to decrease clinically insignificant AIL alarms.³

From active free-flow protection to the ability to monitor and maintain the entire fleet of pumps from a central location to no head-height requirements, Fresenius Kabi took a stepwise approach to overcoming the challenges posed by legacy smart infusion pumps. The result is an infusion system that changes everything.

Related resources:

• ISMP featured article: Infusion Free-Flow Apparently Still a Risk.
• ISMP featured article: Prevent Uncontrolled, Rapid Infusion Rates: Confirm Infusions Are Connected to Pumps Before Opening the Clamp!
• AAMI Foundation: Managing Smart Pump Alarms. Reducing Alarm Fatigue.
• Clinical Perspectives: The Need for Innovation in Infusion Pump Fluid Delivery.

References:

1. Institute for Safe Medication Practices. Infusion free-flow apparently still a risk. 2007. https://www.ismp.org/resources/infusion-free-flow-apparently-still-risk. Accessed January 20, 2023.

2. Institute for Safe Medication Practices. Prevent uncontrolled, rapid infusion rates: confirm infusions are connected to pumps before opening the clamp! 2022. https://www.ismp.org/resources/prevent-uncontrolled-rapid-infusion-rates-confirm-infusions-are-connected-pumps-opening. Accessed January 20, 2023.

3. Meade K, Catania K, Lopez B, Connell R. Air-in-line alarms: decreasing alarms through antisiphon valve implementation. Clin J Oncol Nurs. 2019;23(2):209-211.