Vancouver teams awarded for pump breakthrough

VANCOUVER – Lower Mainland Biomedical Engineering, which is part of the Provincial Health Services Authority, and Vancouver Coastal Health, were honoured in November 2020 for their joint effort to identify the root cause of over-infusions involving a commonly used brand of infusion pump. The investigative efforts and persistence of the team members improved patient safety not only within their area of responsibility, in BC, but worldwide, too.

The award was given by ECRI, which is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific.

“The collaborative effort between VCH and LMBME during the investigation led to our identifying the tubing defect before the manufacturer,” said Brendan Gribbons (pictured), PEng, MEng, CCE, regional engineering team manager. “This unprecedented discovery contributed towards improving patient safety on a global scale, and potentially explains years of unexplained over-infusions.”

In response to more than 30 over-infusion events involving the same brand of infusion pump in healthcare facilities across British Columbia, representatives from Lower Mainland Biomedical Engineering and Vancouver Coastal Health led a systematic 10-month, multidisciplinary investigation into the root cause of the incidents. Key steps included the following:

• Implementing measures to improve the quality of information available for analysis when an over-infusion was suspected, including educating staff about the steps to take to sequester the infusion system in such instances.
• Executing a proactive communication strategy that kept staff informed, offered guidance to reduce the risks, and set the tone for a culture of learning at a time of uncertainty and ambiguity surrounding use of the pump.
• Following the evidence until the root cause could be identified. The manufacturer initially focused on user education to reinforce proper set-loading procedures, stating that this strategy had been successful in decreasing over-infusion incidents at other hospitals. But the investigation team was skeptical that user error was the cause of the incidents it was seeing and continued digging. The team’s persistence was rewarded when new evidence led to a breakthrough: Nurses identified incidents of unintentional medication flow and immediately secured the equipment and engaged the investigation team. The team was able to interrogate the infusion system in collaboration with the infusion pump manufacturer and ECRI – a process that led to a critical discovery.

The collaborative examination of the system revealed that the tubing was a contributing factor toward the uncontrolled flow. When the investigation team scanned the tubing with a micro-CT scanner, they discovered that the tubing was not concentric. That is, the tubing wall was thicker on one side of the lumen than the other.

As a result, when the tubing was oriented a specific way within the pump, the increased wall thickness on one side could prevent the pump from fully occluding the tubing, thus allowing flow. When the tubing was oriented in other ways, however, the pump could fully occlude the tubing, as intended.

This discovery eventually led to a global recall affecting hundreds of millions of tubing sets. It also may help explain years of reports of unexplained over-deliveries of medications with this brand of infusion pump. Through persistence and sound investigative practices, the team members improved patient safety not only within their area of responsibility, but throughout the world. The team’s evidence-driven investigation earned the organizations top honors in ECRI’s 14th Health Devices Achievement Award competition.

ECRI presents the Health Devices Achievement Award to recognize outstanding initiatives undertaken by member healthcare institutions to improve patient safety, reduce costs, or otherwise facilitate better strategic management of health technology. For details about the other submissions that achieved recognition, see The Health Devices Achievement Award: Recognizing Exceptional Health Technology Management.

“Infusion errors, which are a frequent source of patient harm, can take many forms and have many causes,” said David Jamison, executive director of selection and evaluation at ECRI. “Evidence-driven investigations that identify root causes and improve patient safety are the kind of initiative we are proud to recognize with our award.”