How can the collaboration between manufacturers of medical devices and bedside clinicians lead to improved applications of the devices?

Abstract

<h4>Introduction</h4>In late 2019, the leaders of a respiratory department at an academic medical center (AMC) in the Southeastern United States (U.S.) decided to change the humidity delivered to patients via invasive and noninvasive mechanical ventilation from passive to active in the intensive care units (ICUs). The AMC purchased the humidifiers that were new in the U.S. market. The manufacturer provided education and training. Almost a year after implementation, the leaders found the humidifiers turned off or on standby, with a heat moisture exchanger (HME) placed in-line and a water trap by the expiratory filter.<h4>Approach</h4>The leaders requested help from the manufacturer. The manufacturer sent its clinical specialist (CS) twice to the AMC to re-educate and re-train in real time at the bedside. Plan-Do-Study-Act (PDSA) cycles were implemented to troubleshoot problems and improve adherence to active humidity.<h4>Findings</h4>The respiratory therapists (RTs) did not recall the appropriate steps for setting up the heaters. Instead of asking the leaders for help, the RTs took it upon themselves to turn off the humidifiers, use HMEs, and add a water trap by the expiratory filter to collect excess humidity in the circuit and reduce the need for frequent expiratory filter changes. In addition, other issues were discovered during the process. Those issues exacerbated the alarm situations.<h4>Discussion</h4>A knowledge gap and a breakdown in communication led to inappropriate use of humidifiers and the implementation of active humidity in the ICUs. PDSA cycles and the involvement of the manufacturer's CS in real-time training and troubleshooting at the bedside resulted in the intended outcomes.<h4>Conclusion</h4>The process was a learning experience for both the bedside clinicians and the manufacturer. The process led to improvements in the heater's design, its placement on the ventilator cart, the circuit design, and the development of educational materials to guide clinicians.<b>Practice Implications</b> The true test of a product is its release to the market for widespread use. The outcomes of the process improvement demonstrated the importance of collaboration among all stakeholders and that breaking silos across research, design, testing, and implementation is crucial for a successful new device launch.