There is More to Error in Healthcare than the Care Provider

Author(s):  
Marilyn Sue Bogner

Typically when an error occurs in healthcare, the care provider is considered the cause. Because that person committed the act that lead to the adverse outcome efforts to address the error are directed to that person. Indeed, human factors practitioners have developed remedial training and their medical device design activities have emphasized user interface design. This paper presents the case for expanding that focus based on the realization that the act of committing an error is a behavior and behavior reflects the interaction of the person and factors in the environment. The counterintuitive findings that more errors occur in prescribing medications with computer order entry than with handwritten script are discussed in terms of this approach.

1992 ◽  
Vol 36 (3) ◽  
pp. 222-226 ◽  
Author(s):  
Daryle Jean Gardner-Bonneau

The purpose of this paper is to present a case for the development of a user interface design guideline or standard for interactive voice response applications, to be widely disseminated throughout business and industry. A number of sample problems are cited, based on the author's consulting experience in this area, which serve to demonstrate that many of the problems encountered in IVR application development, particularly in scripting/dialogue design and use of automated speech recognition as a front-end, are not only solvable, but easily avoidable, given the current human factors knowledge base. The paper also discusses the Specification Document developed by the Voice Messaging User Interface Forum (1990, April), and the reasons why it cannot be applied, as written, to the user interface design of more complex IVR applications. Finally, the author proposes an approach to developing the proposed guideline/standard.


2018 ◽  
Author(s):  
Laura Pickup ◽  
Alexandra Lang ◽  
Lara Shipley ◽  
Caroline Henry ◽  
James Carpenter ◽  
...  

BACKGROUND A novel medical device has been developed to address an unmet need in standardising and facilitating heart rate recording during neonatal resuscitation. In a time critical emergency resuscitation, where failure can mean death of an infant, it is vital that clinicians are provided with information in a timely, precise and clear manner to capacitate appropriate decision making. This new technology provides a hands free, wireless heart rate monitoring solution that easily fits the clinical pathway and procedure for neonatal resuscutation. To understand the requirements of the interface design for this new device, a human factors approach was implemented. This combined a traditional user-centred design approach with an Applied Cognititive Task Analysis (ACTA) to understand the tasks involved, the cognitive requirements and the potential for error during a neonatal resusciation scenario. OBJECTIVE 1. To understand the cognitive requirements of clinicians for a novel medical device to facilitate neonatal resuscitation; 2. To apply a human factors approach and a traditional user-centred design approach to provide a device interface specification. METHODS Fourteen clinical staff were involved in producing the final design requirements. Two paediatric doctors supported the development of a visual representation of the activities associated with neonatal resucitation. This was used to develop a scenario based workshop. Two workshops were carried out in parallel and involved three paediatric doctors, three neonatal nurses, two advance neonatal practitioners and four midwives. Both groups came together at the end to reflect on the findings which emerged during the separate sessions. RESULTS The outputs of this study have provided a comprehensive description of information requirements during neonatal resuscitation, and enabled product developers to understand the core and preferred requirements of the user interface design for the device. The study raised three key areas for the designers to consider, which had not previously been highlighted. These related to interface layout and information priority, size and portability of the device and auditory feedback. CONCLUSIONS This study demonstrates the value of the ACTA approach to inform the development of resuscitation devices, and more generally for medical device development.


10.2196/15581 ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e15581
Author(s):  
Stephan Wegner ◽  
Quentin Lohmeyer ◽  
Dimitri Wahlen ◽  
Sandra Neumann ◽  
Jean-Claude Groebli ◽  
...  

Background In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. Objective Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. Methods A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. Results In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. Conclusions This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors.


Author(s):  
Merrick F. Kossack ◽  
Andrew W. Gellatly

To meet the FDA's Quality System Regulation, medical device manufacturers must include design validation as part of their design and development activities. However, the regulation does not specify which product requirements must be validated or what methods satisfy a proper design validation process. This paper outlines an approach that device manufacturers can follow to determine which product requirements should undergo design validation testing and what types of testing methods should be used.


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