Assessing Use Errors Related to the Interface Design of Electrosurgical Units

Abstract

Medical device use errors, such as instrument connection errors made with electrosurgical units (ESUs), can lead to adverse events. Current device acquisition processes at health care facilities do not typically include a proactive evaluation of use-error risk before device purchase. We conducted an evaluation to identify ESU user interface design features that can help prevent or mitigate instrument connection errors during clinical care. Thirty-six current ESU users participated in the evaluation. We used a randomized crossover design in which each participant used two ESU models in a simulated OR scenario. We compared participants' instrument connection accuracy, efficiency, and subjective feedback regarding the user interface design across the two ESU models. Overall, we found that the ESU model that incorporated more user interface design principles resulted in better performance and increased acceptance from users. Based on the results, we designed a decision-support tool to assess the risk of instrument connection errors before ESU purchase. 3,4 Human factors evaluations involve examining the interactions between people and devices, including how someone perceives and interprets information from the device and operates the device. Human factors evaluation results can help create devices that are easier to use, which improves user understanding of operating the device and reduces the risk of use errors and adverse events. 5Human factors evaluation results can also inform device purchasing decisions. 6 For example, an HF evaluation of critical care ventilators found that one ventilator model demonstrated higher levels of safety and user experience compared with the other three models evaluated. The results of this evaluation can support ventilator purchasing decisions.7 Another HF evaluation of two automated chest compression devices found that the interruption in chest compressions when applying either device to the patient was notably longer than the maximum interruption time recommended by the American Heart Association. The results of this evaluation prevented the purchase of an automated chest compression device at the authors' health care facility. 8 These HF evaluations provided critical data to inform purchasing decisions, but it is difficult to generalize the results to device models other than those evaluated.

Impact of Design on Medical Device Safety

“…This is why MDR 2017/745 addresses Risk Management (RM) and requires evidence of validation of reduced risk based on usability testing [53,63,64]. If we consider the reported rates of adverse events attributable to design faults related to MDs' user interface (UI) [65][66][67][68][69], it becomes obvious why design is essential in a setting where humans are expected to coordinate with MDs and not subjugate them.…”

“…Once a prototype is available, HF validation testing is implemented after a careful definition of the user groups [100]. It is essential for all simulated-use tests to be carried out in conditions relevant to the real-life use of the device [67]. At this stage, a thorough residual risk assessment is required to identify any severe use-related errors and appropriate risk mitigation approaches [87,106].…”

“…Disregarding such principles leads to use errors even by highly trained medical professionals, as, for example, in electrosurgical units where device components are not grouped according to their function, interface symbols do not have commonly understood meanings and receptacles for accessory instruments also fit plugs not intended for them [67]. However, designing MDs according to HFE principles leads not only to safer products and an overall increased user satisfaction [20], but also to devices with a higher degree of usability, which translates into faster market access and increased speed with which a task is performed with the device versus without the device (i.e., efficiency).…”

Unifying Functional User Interface Design Principles

“…These principles present high level concepts and beliefs that allow guiding the software design (Mandel, 1997), while having a positive effect on usability (Folmer & Bosch, 2004). Incorporating UI design principles results in better performance and increased acceptance from users (Estock et al, 2018).…”

Preferred Terms and Icons for Labels on Electrosurgical Units: Survey of VA Nurses

“…Many OR nurses rely on the visual guidance provided by ESU labels to ensure that they are configuring the correct components. 13 Unfortunately, manufacturers of ESUs are inconsistent in their use of terms and icons for labeling components that are common across models. For example, during a review of 25 different ESU models from 10 different manufacturers, it was found that manufacturers use six different terms and 11 different icons to label the monopolar pencil receptacle.…”