ECRI Update

Spotting Infusion Pump Damage Before Patient Care is Affected

Infusion pumps are a common fixture in many care settings – a facility could have hundreds of pumps in near-constant use. Not surprisingly, these devices can become damaged; and if the damage is not identified and remediated, medication errors and patient harm can result. ECRI addressed this issue as Hazard No. 3 in its 2022 Top 10 Health Technology Hazards report. Keys to preventing harm include recognizing the signs of damage and responding appropriately.

It’s not controversial to suggest that a damaged infusion pump should be removed from service rather than remaining in clinical use. Infusion pumps are expected to deliver fluids or medications – potentially life-sustaining ones – with high accuracy over a specified time interval; damage to the pump could hinder its ability to perform that function reliably.

But what’s simple in theory – removing damaged infusion pumps from service – is not always simple in practice. ECRI continues to receive reports of damaged infusion pumps being used during patient care, sometimes with tragic consequences. Several factors could explain such incidents.

One is that users may not appreciate the risks posed by seemingly minor damage. The risks are real, however: ECRI has investigated several incidents in which damage to an infusion pump prevented the pump from regulating the flow of medication. As a result, too much medication was delivered to the patient (overinfusion), leading to patient harm. The reverse is also a concern: Damage to the pump may result in too little medication being delivered to the patient (underinfusion), or even cessation of the infusion altogether. Patient care could be impacted in those situations as well, particularly if a critical medication was to be delivered.

Another explanation is that pump damage can be hard to identify. “Damage may not be visibly apparent,” explains Juuso Leinonen, a principal project engineer in ECRI’s Device Evaluation group. A small crack or a corroded connector may be hard to spot or in a location that it is obscured from view. “Also, and this is important to note: the damage may not result in an alarm condition,” adds Leinonen.

In either case, BMETs and health technology managers can play a vital role in preventing dangerous, and possibly fatal, medication administration errors. Key actions include helping users recognize the signs of infusion pump damage and educating them about what to do if damage is suspected.

RECOGNIZING SIGNS OF DAMAGE Infusion pumps can be used in many patient care areas and for a variety of infusion applications, from relatively low-risk fluid delivery to the high-risk delivery of critical medications. The manner and frequency of use can lead to pump damage, whether through wear and tear, mishandling, misuse, poor device design, or the use of improper cleaning agents or methods.

Not all forms of damage will impact the operation of the pump; but distinguishing between a cosmetic crack, for instance, and a dangerous flaw can be difficult. “That’s why any signs of damage should be investigated,” advises Leinonen. Adverse events related to infusion pumps are the most common type of incident investigated by ECRI’s accident and forensic investigation team. Often, the use of a damaged pump is found to have played a role in such incidents.

Following are a few commonly reported areas of damage and the potential consequences for device operation: • A door that doesn’t seat correctly when closed could impact the flow control mechanism. (Excessive resistance when closing the door could be a sign of trouble.) • Broken or cracked door hinges could alter the door positioning, affecting its ability to compress the administration set (see Figure 1). • Broken door latches could interfere with the activation of the pump’s free-flow protection mechanism. • The integrity of plastic pump components could be compromised by environmental stress cracking. This type of cracking can be caused by the repeated use of incompatible cleaning agents. (ECRI has worked with several facilities where the failure to follow manufacturer cleaning guidance led to frequent pump issues.) • Corrosion of battery pack contacts (see Figure 2) or other electrical connectors – such as those used to connect pump modules to the control unit or for data communication – can interrupt the pump connection with the battery or with the brains of the module. This could cause the infusion system to shut down, delaying infusion

Figure 1. Cracked platen door hinge inside the pumping module

Figure 2. Corroded battery pack connectors

therapy. (ECRI recommends inspecting external connectors for damage during a periodic performance verification and stressing the importance of following manufacturer cleaning and disinfection instructions.)

KNOWING HOW TO RESPOND Clinical staff are the last line of defense when it comes to spotting infusion pump damage. Instruct staff not to use an infusion pump if: • Visible damage is identified during initial setup – for example, if the user notices a crack in the door or door hinge. • Any part of the setup seems abnormal, such as a door that is hard to close or unexplained air in the chamber. • An unexpected malfunction alarm condition occurs. If damage is suspected, staff should: • Tag the pump as faulty, with a short description of the problem, and take it out of clinical use. • Notify the unit manager and clinical engineering.

Other staff play a role as well. Clinical engineering departments can track pump-related damage, identify potential failure patterns, and be on the lookout for unseen or previously unobserved damage when investigating pump-related incidents. Nurse educators can train staff on common failure modes and how to recognize signs of damage. Central equipment distribution staff should carefully follow manufacturer instructions for cleaning and disinfection, and should visually inspect pumps for signs of damage before distributing them for use. Even pump manufacturers can do more, designing devices that are less prone to damage given their environment of use. The bottom line, according to ECRI’s Leinonen: “Failure to remove a damaged pump from clinical use can lead to patient harm, or even death. It takes a team effort to keep patients safe.”

TO LEARN MORE . . . This article is adapted from ECRI’s Top 10 Health Technology Hazards for 2022—Hazard No. 3: “Damaged Infusion Pumps Can Cause Medication Errors.” An Executive Brief version of the Top 10 report is available for complimentary download at www.ecri. org/2022hazards. The full report, accessible to ECRI members, provides detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at (610) 825-6000, ext. 5891, or by e-mail at clientservices@ecri.or