Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Abstract

Human errors in medical device use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical device use is critical for developing interventions to reduce such errors either by redesigning the devices or, if redesign is not an option, by training the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices with integral information technology, then applied and tested them on several infusion pumps. The first method is a modified discount-usability method called heuristic evaluation. The method was used to evaluate and compare the safety of two 1-channel volumetric infusion pumps. The results show that heuristic evaluation, when modified for medical devices, is a useful, efficient, and low-cost method for evaluating patient safety features of medical devices through the identification of usability problems and their severities. The second method is an extended hierarchical task analysis (EHTA), devised to predict medical errors in medical device use. EHTA divides the task space between the external world of the device interface and the internal cognitive world of the user, allowing for descriptive predictions of potential user errors at the human device level. Its use is demonstrated in the analysis of two infusion pumps. The estimates of the likelihood of user errors with the two pumps are consistent with the corresponding reported use errors in the Federal Drug Administration (FDA)'s Manufacturer and User Device Experience (MAUDE) database, thus demonstrating the usefulness of this tool for predicting medical device use errors.

Model-driven tools for medical device selection

“…Zhang et al observe that "human errors in medical device use account for a large portion of medical errors. Most of these errors are due to inappropriate designs for user interactions" [27]. A number of errors due to mixups, as well as malfunctions and mal-use of devices (syringe pumps, infusion pumps and epi-pens) are reported by Cohen [15], who stresses the need to focus on human factors in device design.…”

Making Human-Computer Interaction Usable: Thinking from Healthcare Perspective

“…Jiajie Zhang et al [5] discussed about improving the patient safety in healthcare. David Wood [9] revealed some of the human factors which will lead to the system failure and patient safety from the HCI technician's perspective.…”

“…Hence, it is ideal to consider both types of users in the HCI testing process [6]. The Food and Drug Administration (FDA) published the guidelines for interface design and usability testing and has produced an education article that specifically covers usability issues [5]. The HCI designers can consider those guidelines and regulations in the development process for improving the usability of the medical device.…”

“…The Journal of the American Medical Association [3] has reported that the computers increase the error risk in clinical medical devices and it added that the computerized medical devices are not designed to reflect the real life scenario which is being followed. FDA data shows that nearly half of the withdrawals of medical device were due to the poor user interface design [5]. It is the goal of the interface designers to verify 'what if' anything unexpected happens and how the system responds in that situation [6].…”

“…The design should meet the needs, capabilities and limitations of users, rather than expecting the users to adapt the design to make it useful [5].…”