Designing the design phase of critical care devices: a cognitive approach.

In this study, we show how medical devices used for patient care can be made safer if various cognitive factors involved in patient management are taken into consideration during the design phase. The objective of this paper is to describe a methodology for obtaining insights into patient safety features--derived from investigations of institutional decision making--that could be incorporated into medical devices by their designers. The design cycle of a product, be it a medical device, software, or any kind of equipment, is similar in concept, and course. Through a series of steps we obtained information related to medical errors and patient safety. These were then utilized to customize the generic device design cycle in ways that would improve the production of critical care devices. First, we provided individuals with different levels of expertise in the clinical, administrative, and engineering domains of a large hospital setting with hypothetical clinical scenarios, each of which described a medical error event involving health professionals and medical devices. Then, we asked our subjects to "think-aloud" as they read through each scenario. Using a set of questions as probes, we then asked our subjects to identify key errors and attribute them to various players. We recorded and transcribed the responses and conducted a cognitive task analysis of each scenario to identify different entities as "constant," "partially modifiable," or "modifiable." We compared our subjects' responses to the results of the task analysis and then mapped them to the modifiable entities. Lastly, we coded the relationships of these entities to the errors in medical devices. We propose that the incorporation of these modifiable entities into the device design cycle could improve the device end product for better patient safety management.