From the May 2021 issue of HealthCare Business News magazine
Nevertheless, a healthcare facility can learn a lot by examining a device's recall history. For instance, a spate of recalls could indicate a history of underlying design issues. With the clinical demand for infusion pumps remaining high, especially in the midst of the ongoing global pandemic, an unreliable pump model may prevent the facility from addressing its patients' clinical needs.
But be careful about how you interpret this information. A substantial recall history could instead be a sign of a responsive manufacturer — one that reports problems conscientiously and actively addresses issues that arise. To get a feel for what type of customer service you could expect from a supplier, look at their recommendations in alerts and recalls. Offers of on-site training or service, loaner units, training and competency aides, or other enticements can reduce the headaches of responding to a device issue. A responsive manufacturer can make all the difference to the continuity of your clinical care.
Common infusion pump problems
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ECRI, a nonprofit research organization committed to identifying and addressing patient safety challenges, has a 50-year history of investigating infusion pump-related safety problems and providing recommendations for reducing the risks. Several of those investigations have led to recalls, and several have been highlighted in editions of ECRI's annual Top 10 Health Technology Hazards list. (ECRI issues its Top 10 list each year to help healthcare facilities identify and remediate key technology safety challenges.)
Following are five common types of pump issues that ECRI has encountered, along with an overview of the organization's recommendations. Awareness of the potential sources of error like these can aid with managing a current pump fleet, and can inform future pump purchases.
1. Plastics cracking — a cosmetic crack or a significant performance issue
ECRI has frequently received reports about the cracking of various plastic infusion pump components, such as the door or chassis. While at a glance a minor crack may not seem like a huge deal, a crack in a sensitive location, even just a minor crack, can cause a significant performance issue with an infusion pump. Specifically, cracking of an infusion pump door hinge can result in a failure condition where fluid flow is uncontrolled.
While not all cracks will impact the operation of the device itself, it can be difficult, if not impossible, to determine whether a particular crack is just cosmetic or will create a significant performance-altering hazard. The infection control risks related to any cracked components should also be assessed.