Integrating Human Computer Interaction Testing into the Medical Device Approval Process

Medical devices that utilize computer software are becoming common place in today’s health care environment. In this paper we examine device failures in the area of the human computer interaction—a failure of the interface between the hardware/software in the medical device, and the person using the device. We make the case that human computer interaction testing—starting early on in the product development life cycle—should be required before medical devices are approved by the FDA. Use of human computer interaction testing of medical devices can improve device quality and user experience, and most importantly, has the potential to reduce serious health care outcome

Medical device design in context: a model of user–device interaction and consequences

The practice of evaluating interaction with devices is embedded in disciplines such as human-computer interaction and cognitive ergonomics, including concepts such as affordances, error analysis, skill, rule and knowledge based behaviour and decision making biases. This paper considers the way in which the approach that has been routinely applied to displays and control design within the control and transport domains can be transferred to the context of medical devices. The importance of considering the context in which medical devices are used and implemented is presented, and the need for a systems approach to medical device design is emphasised. Five case studies from medical device control and display design are presented as an aide to developing an understanding of the relationship between device design and resultant behaviours. On the basis of these case studies, four types of mediating factors (catalysts, enablers, facilitators and enhancers) are proposed and a model to describe the link between device design, user, context and consequences is presented

Evaluation of AI-Supported Input Methods in Augmented Reality Environment

Augmented Reality (AR) solutions are providing tools that could improve applications in the medical and industrial fields. Augmentation can provide additional information in training, visualization, and work scenarios, to increase efficiency, reliability, and safety, while improving communication with other devices and systems on the network. Unfortunately, tasks in these fields often require both hands to execute, reducing the variety of input methods suitable to control AR applications. People with certain physical disabilities, where they are not able to use their hands, are also negatively impacted when using these devices. The goal of this work is to provide novel hand-free interfacing methods, using AR technology, in association with AI support approaches to produce an improved Human-Computer interaction solution

Glove-based systems for medical applications: review of recent advancements

Human hand motion analysis is attracting researchers in the areas of neuroscience, biomedical engineering, robotics, human-machines interfaces (HMI), human-computer interaction (HCI), and artificial intelligence (AI). Among the others, the fields of medical rehabilitation and physiological assessments are suggesting high impact applications for wearable sensing systems. Glove-based systems are one of the most significant devices in assessing quantities related to hand movements. This paper provides updated survey among the main glove solutions proposed in literature for hand rehabilitation. Then, the process for designing glove-based systems is defined, by including all relevant design issues for researchers and makers. The main goal of the paper is to describe the basics of glove-based systems and to outline their potentialities and limitations. At the same time, roadmap to design and prototype the next generation of these devices is defined, according to the results of previous experiences in the scientific community

Demonstrating that Medical Devices Satisfy User Related Safety Requirements

One way of contributing to a demonstration that a medical device is acceptably safe is to show that the device satisfies a set of requirements known to mitigate hazards. This paper describes experience using formal techniques to model an IV infusion device and to prove that the modelled device captures a set of requirements. The requirements chosen for the study are based on a draft proposal developed by the US Food and Drug Administration (FDA). A major contributor to device related errors are (user) interaction errors. For this reason the chosen models and requirements focus on user interface related issues.FEDER - Federación Española de Enfermedades Raras(000062)This work has been funded by the EPSRC research grant EP/G059063/1: CHI+MED (Computer–Human Interaction for Medical Devices). J. C. Campos was funded by project NORTE-07-0124-FEDER-00006

Hand Gestures Recognition using Thermal Images

Master's thesis in Information- and communication technology (IKT590)Hand gesture recognition is important in a variety of applications, including medical systems and assistive technologies, human-computer interaction, human-robot interaction, industrial automation, virtual environment control, sign language translation, crisis and disaster management, en-tertainment and computer games, and robotics. RGB cameras are usually used for most of these applications. However, their performance is limited especially in low-light conditions. It is challenging to accurately classify the hand gestures in dark conditions. In this thesis, we propose the robust hand gestures recognition based on high resolution thermal imaging. These thermal images are captured using FLIR Lepton 3.5 thermal camera which is a high resolution thermal camera with a resolution of 160×120 pixels. Thereafter, we feed the captured thermal images to a deep CNN model to accurately classify the hand gestures. We evaluate the performance of the proposed model with the benchmark models in terms of accuracy as well as the inference time when deployed on edge computing devices such as Raspberry Pi 4 Model B and NVIDIA JETSON AGX XAVIER

Reusing models and properties in the analysis of similar interactive devices

"Published online: 03 Apr. 2013"The paper is concerned with the comparative analysis of interactive devices. It compares two devices by checking a battery of template properties that are designed to explore important interface characteristics. The two devices are designed to support similar tasks in a clinical setting but differ in a number of respects as a result of judgements based on a range of considerations including software. Variations between designs are often relatively subtle and do not always become evident through even relatively thorough user testing. Notwithstanding their subtlety these differences may be important to the safety or usability of the device. The illustrated approach uses formal techniques to provide the analysis. This means that similar analysis can be applied systematically.This project was partly funded by the CHI+MED project: Multidisciplinary Computer Human Interaction Research for the design and safe use of interactive medical devices (UK EPSRC Grant EP/G059063/1). Patrick Oladimeji of Swansea University provided help with the Alaris pump and Chris Vincent of UCL provided access to the B. Braun simulation. We are grateful to reviewers for helpful comments

Quid Pro Quod: Enhancing Patient Safety Via Minimizing Human-Computer Interactions Errors

The present describes an initial research project aiming at enhancing pa- tient safety. The overall goal is to minimize human-computer interactions errors that may occur via the use of Medical Information Systems (MIS) in health care units. The main idea is to extend the approach on design of usability and safety issues of generic medical devices, or safety critical systems design, to the problem domain of patient safety in the design of MIS. An understanding of errors and patient safety issues is presented and how these issues contribute to interaction errors in MIS. A plan of the research programm and related questions is presented. Is is expected that the outcome of a case study will be used for testing an evaluation framework, in development, that will take into account a rapid method for improving these aspects regarding the software development process