Design for risk control: the role of usability engineering in the management of use-related risks.

The majority of medical device incident reports can primarily be attributed to use error. Greater attention to human factors and usability during development of a medical device could improve this situation. However, recent studies have shown that companies do not find the application of a sound usability engineering process according to international standards a simple task. The purpose of this collaborative research project between a medical device company, two universities and a university hospital was to study the practical application of the International Standard for Application of Usability Engineering to Medical Devices, IEC 62366, by means of a case study in industrial practice. This paper describes the user studies in the case and reveals the factors important to success. Also, the paper demonstrates how to apply an iterative usability engineering process within a linear product development process in industry. Management support and careful planning of resources and activities proved essential. To control use-related risks, the usability engineer should 'design for risk control' in a structured manner, while the risk manager should remain responsible for acceptable levels of residual risk. The paper concludes with recommendations for the improvement of IEC 62366 and ISO 14971, the standard for the risk management of medical devices.

Collaborative co-design of emerging multi-technologies for surgery.

The EU Research Training Network on Augmented Reality in Surgery (ARIS*ER) was established with two aims: (1) to develop next-generation novel image guidance (augmented reality based on medical images) and cross-linked robotic systems (automatic control loops guided by information sensed from the patient) and (2) to educate young researchers in the user-centred, multidisciplinary design of emerging technologies for minimally invasive surgery (MIS) and intervention radiology. Collaborations between engineers, Human Factors specialists, industrial designers and medical end users were foreseen, but actual methodologies had to be developed. Three applications were used as development vehicles and as demonstrators. The resulting teamwork and process of identifying requirements, finding solutions (in technology and workflow), and shifting between these to optimize and speed development towards quality of care were studied. The ARIS*ER approach solves current problems in collaborative teams, taking a systems approach, and manages the overview of requirements and solutions, which is too complex to manage centrally.

Coping with different roles in intensive care nursing: design implications for digital support.

OBJECTIVES: The aim of this study is to arrive at design implications for the digital support of intensive care nurses, with a focus on supporting them in their roles as practitioners, as scholars and in their human response to their work. METHODS: Seventeen nurses from six different Dutch hospitals were interviewed using a newly developed digital prototype designed around these roles. The nurses were questioned about the suitability of four functions: two supporting the practitioner role ('web of actors' and 'timeline and notes'); one supporting the scholar role ('assessment of the patient'); and one supporting the role of human ('perception of the shift'). The remarks of the nurses about these functions were grouped by their relevance to design (ie, the perceived added value of the function, suggestions for other uses, and the perceived negative impact of the function) and by topic. RESULTS: A total of 23 topics emerged: nine topics described the added values of the functions, nine were suggestions for other uses, and five concerned the negative impact of the functions as perceived by the participants. The main points of each topic were summarised, resulting in 23 design implications for digital role-based support.

Endoclamp balloon visualization and automatic placement system.

OBJECTIVES: Aortic occlusion is one of the most important open discussions in minimally invasive cardiac surgery. Different techniques can be employed, and all have benefits and drawbacks. The objective of our work is to improve the safety of internal aortic occlusion with the Port Access technique, which employs an endoclamp balloon catheter. We propose a combined information and positioning system based on augmented reality technology and robotics in which the position of the balloon can be seen at all times and can be automatically controlled by a robotic actuator. METHODS: The system was designed by a multidisciplinary team of engineers, medical doctors, and human factor specialists in a human-centered design approach. We measure the balloon position in real time with a magnetic tracking system. This position is superimposed on a 3-dimensional scan of the patient's thorax, with the balloon in the artery shown at all times. The position measurement is also used to control the robotic catheter inserter that places and maintains the balloon position at a specified target. The system was evaluated in 2 user studies that compared it with other visual aids. RESULTS: The user tests have shown that the system effectively supports the surgeon in the placement task, with an increase in placement accuracy and a reduction in time compared with the current visualization technique. The users also rated the system as supporting them well. CONCLUSIONS: The clinical feasibility of the system was proved. The system provides better visualization and position control and can effectively increase the safety of the procedure. This system has the potential of making Port Access a more attractive technique.

A mobile monitoring system of blood pressure for underserved in China by information and communication technology service.

High blood pressure (BP, hypertension) is a leading chronic condition in China and has become the main risk factor for many high-risk diseases, such as heart attacks. However, the platform for chronic disease measurement and management is still lacking, especially for underserved Chinese. To achieve the early diagnosis of hypertension, one BP monitoring system has been designed. The proposed design consists of three main parts: user domain, server domain, and channel domain. All three units and their materialization, validation tests on reliability, and usability are described in this paper, and the conclusion is that the current design concept is feasible and the system can be developed toward sufficient reliability and affordability with further optimization. This idea might also be extended into one platform for other physiological signals, such as blood sugar and ECG.