Usability and Safety of Software Medical Devices: Need for Multidisciplinary Expertise to Apply the IEC 62366: 2007.

Software medical devices must now comply with the "ergonomics" essential requirement of the Medical Device Directive. However, the usability standard aiming to guide the manufacturers is very difficult to understand and apply. Relying on a triangulation of methods, this study aims to highlight the need to combine various expertises to be able to grasp the standard. To identify the areas of expertise on which the usability standard relies, an analytical review of this document was performed as well as an analysis of a discussion forum dedicated to it and an analysis of a case study of its application for CE marking. The results show that the IEC 62366 is a usability standard structured as a risk management one. It obviously requires Human Factors/Ergonomics expertise to be able to correctly identify and prevent risks of use errors, but it also requires risk management expertise to be able to grasp the issues of the risk analysis and master the related methods.

Usability Flaws in Medication Alerting Systems: Impact on Usage and Work System.

OBJECTIVES: Previous research has shown that medication alerting systems face usability issues. There has been no previous attempt to systematically explore the consequences of usability flaws in such systems on users (i.e. usage problems) and work systems (i.e. negative outcomes). This paper aims at exploring and synthesizing the consequences of usability flaws in terms of usage problems and negative outcomes on the work system. METHODS: A secondary analysis of 26 papers included in a prior systematic review of the usability flaws in medication alerting was performed. Usage problems and negative outcomes were extracted and sorted. Links between usability flaws, usage problems, and negative outcomes were also analyzed. RESULTS: Poor usability generates a large variety of consequences. It impacts the user from a cognitive, behavioral, emotional, and attitudinal perspective. Ultimately, usability flaws have negative consequences on the workflow, the effectiveness of the technology, the medication management process, and, more importantly, patient safety. Only few complete pathways leading from usability flaws to negative outcomes were identified. CONCLUSION: Usability flaws in medication alerting systems impede users, and ultimately their work system, and negatively impact patient safety. Therefore, the usability dimension may act as a hidden explanatory variable that could explain, at least partly, the (absence of) intended outcomes of new technology.

Evidence Based Health Informatics: 10 Years of Efforts to Promote the Principle. Joint Contribution of IMIA WG EVAL and EFMI WG EVAL.

OBJECTIVES: To present the importance of Evidence-based Health Informatics (EBHI) and the ethical imperative of this approach; to highlight the work of the IMIA Working Group on Technology Assessment and Quality Improvement and the EFMI Working Group on Assessment of Health Information Systems; and to introduce the further important evaluation and evidence aspects being addressed. METHODS: Reviews of IMIA, EFMA and other initiatives, together with literature reviews on evaluation methods and on published systematic reviews. RESULTS: Presentation of the rationale for the health informatics domain to adopt a scientific approach by assessing impact, avoiding harm, and empirically demonstrating benefit and best use; reporting of the origins and rationale of the IMIA- and EQUATOR-endorsed Statement on Reporting of Evaluation Studies in Health Informatics (STARE-HI) and of the IMIA WG's Guideline for Good Evaluation Practice in Health Informatics (GEP-HI); presentation of other initiatives for objective evaluation; and outlining of further work in hand on usability and indicators; together with the case for development of relevant evaluation methods in newer applications such as telemedicine. The focus is on scientific evaluation as a reliable source of evidence, and on structured presentation of results to enable easy retrieval of evidence. CONCLUSIONS: EBHI is feasible, necessary for efficiency and safety, and ethically essential. Given the significant impact of health informatics on health systems, care delivery and personal health, it is vital that cultures change to insist on evidence-based policies and investment, and that emergent global moves for this are supported.

Evolution of human factors research and studies of health information technologies: the role of patient safety.

OBJECTIVES: The objective of this survey paper is to present and explain the impact of recent regulations and patient safety initiatives (EU, US and Canada) on Human Factors (HF)/Usability studies and research focusing on Health Information Technology (HIT). METHODS: The authors have selected the most prominent of these recent regulations and initiatives, which rely on validated HF and usability methods and concepts and aim at enhancing the specific process of identification and prevention of technology-induced errors throughout the lifecycle of HIT. RESULTS: The analysis highlights several points of consensus: 1) safety initiatives or regulations applicable to Medical Devices (MD) tend to extend to HIT, 2) Usability is considered a fundamental dimension of HIT safety, 3) HF/Usability methods and the overall Human Centred Design (HCD) approach are considered efficient solutions to ensure the design of safe and usable HIT. However, it appears that MD manufacturers, and a fortiori HIT designers and developers are still far from being able to routinely apply HCD to their products. DISCUSSION AND CONCLUSION: On the research side, we need to analyze manufacturers' difficulties with the application of the HCD process and imposed standards. For each given category of HIT, we need to identify the fundamental usability dimensions and design principles likely to impact patient safety independently of workplace settings or organizations. These should be described in terms of usability flaws, corresponding usage problems experienced by users and related outcomes. This approach requires good quality and well structured reporting of Human Factors / Usability research studies on HIT.

The human factors engineering approach to biomedical informatics projects: state of the art, results, benefits and challenges.

OBJECTIVES: The objective of this paper is to define a comprehensible overview of the Human Factors approach to biomedical informatics applications for healthcare. The overview starts with a presentation of the necessity of a proper management of Human factors for Healthcare IT projects to avoid unusable products and unsafe work situations. The first section is dedicated to definitions of the Human Factors Engineering (HFE) main concepts. The second section describes a functional model of an HFE lifecycle adapted for healthcare work situations. The third section provides an overview of existing HF and usability methods for healthcare products and presents a selection of interesting results. The last section discusses the benefits and limitations of the HFE approach. METHODS: Literature review based on Pubmed and conference proceedings in the field of Medical Informatics coupled with a review of other databases and conference proceedings in the field of Ergonomics focused on papers addressing healthcare work and system design. RESULTS: Usability studies performed on healthcare applications have uncovered unacceptable usability flaws that make the systems error prone, thus endangering the patient safety. Moreover, in many cases, the procurement and the implementation process simply forget about human factors: following only technological considerations, they issue potentially dangerous and always unpleasant work situations. But when properly applied to IT projects, the HFE approach proves efficient when seeking to improve patient safety, users' satisfaction and adoption of the products. CONCLUSIONS: We recommend that the HFE methodology should be applied to most informatics and systems development projects, and the usability of the products should be systematically checked before permitting their release and implementation. This requires the development of Centers specialized in Human Factors for Healthcare and Patient safety in each Country/Region.

Impact of CPOE on mortality rates--contradictory findings, important messages.

OBJECTIVE: To analyze the seemingly contradictory results of the Han study (Pediatrics 2005) and the Del Beccaro study (Pediatrics 2006), both analyzing the effect of CPOE systems on mortality rates in pediatric intensive care settings. METHODS: Seven CPOE system experts from the United States and Europe comment on these papers. RESULTS: The two studies are not contradictory, but almost non-comparable due to differences in design and implementation. They demonstrate the range of outcomes that can be obtained from introducing informatics applications in complex health care settings. Implementing informatics applications is a sociotechnical activity, which often depends more on the organizational context than on a specific technology. As health informaticians, we must not only learn from failures, but also avoid both uncritical scepticism that may arise from drawing overly general conclusions from one negative trial, as much as uncritical optimism from limited successful ones. CONCLUSION: The commentaries emphasize the need to promote systematic studies for assessing the socio-technical factors that influence the introduction of increasingly sophisticated informatics applications within complex organizations. The emergence of evidence-based health informatics will be based both on evaluation guidelines and implementation guidelines, both of which increase the chances of successful implementation. In addition, well-educated health informaticians are needed to manage and guide the implementation processes.

Communication of information in the homecare context.

Organizing the Homecare with new information technologies is nowadays an important challenge. Indeed, some medical evolutions as the improvement of the duration of life, the number of chronic diseases and some social evolutions, such as the quality of patient life, or economic evolutions, such as the reduction of hospitalisation costs, could benefit from homecare. In this paper, we present the problem of the communication of information in the homecare context. Some main phases have been described that compose the two homecare processes: a logistic process and a care process. The communication of information during homecare depends on the concerned phases: first, some exchanges of information from existing Information System to the Homecare Information System; then, some exchanges between the homecare system and the mobile health care actors; and then, some mails during the outcome phase. Coordination architecture is briefly described, and two different implementations for the communication of information during homecare are presented: one is using XML messages to exchange information between Information Systems; the other is using mobile tools for communicating with mobile actors.

A rapid usability assessment methodology to support the choice of clinical information systems: a case study.

We present here an adapted methodology integrating usability engineering and early evaluation procedures to support the choice of a Clinical Information System in the context of a standard Call for Tender. We illustrate the application of this methodology with a case study. We integrated a standard 'contextual task and activity analysis' into the choice process and then drew up usability recommendations for the choice of an application. We organized a one-week on-site exhibition and test for each candidate company. During the test sessions, we performed a rapid usability assessment. The final choice of the application is strongly and positively influenced by the results of the usability assessment.

Information and logistics for homecare.

TELECOS is a regional project whose ambition is to use new cooperation tools, in the context of homecare, in order to facilitate the coordinated cooperative work of health actors. Homecare can improve the quality of life for the patient and reduce costs but it also induces a lot of difficulties during organisation and care. We aim at knowing more about the activity of cooperation in the homecare context and proposing a cooperation platform which answers to the specific needs generated during homecare and which integrates new applications. In this paper, we present the results of our study of homecare. The activity analysis leads us to determine two specific processes: one concerns the implementation of human and material resources and design of the homecare protocol (the logistics process) and the other concerns the coordination of the healthcare actors during effective homecare (the care process). The first process is composed of five main phases during which an healthcare professional is required as coordinator. We then present the Worklow model used to represent the cooperation activity in homecare. We describe the activity: the tasks and subtasks are represented in a declarative way. We then briefly present our prototype, devoted to homecare management, implementing the different phases of the information process, developed in JAVA.

Integrating users' activity modeling in the design and assessment of hospital electronic patient records: the example of anesthesia.

As computers become more and more an aid in the management of medical information, some specialists, such as anesthesiologists, demand tuned applications to support their own activity. The development of these specific applications is based upon the user's requirements analysis, and functional and technical specifications. But some failures show that a better understanding of human factors of acceptance could improve the usability and utility of these tools. In this study, we demonstrated that when the management of medical information is closely intertwined with the physician's activity, it is necessary to perform a precise analysis of this activity in order to identify the cognitive and organizational constraints that affect the usability and acceptance of the tool. We focused our study on the pre-operative anesthetic consultation. After recording and analyzing 50 consultations, we were able to identify the key points to fulfill in order to meet users' acceptance. From this study, we propose some strong recommendations to handle the constraints imposed by the anesthesiologists' activity in their daily working environment. We applied this method to evaluate an electronic patient record (EPR) for the pre-anesthetic consultation. The results of this evaluation validate our hypotheses and the importance of the activity constraints. In conclusion, human factors, and particularly those linked with the activity of healthcare professionals, have to be carefully studied before any development and installation of an EPR into a specialty domain.

Integrating users' activity analysis in the design and assessment of medical software applications: the example of anesthesia.

As the computers become more and more and aid for the management of medical information, some specialists like anesthetists demand specialized applications to support their own activity. Usually, these applications are developed following a Users' Requirements analysis and functional specifications. We demonstrate here that when the management of medical information is closely intertwined with the physician's activity, it is also necessary to perform a precise ergonomics analysis of this activity in order to identify the cognitive and organizational constraints that affect the usability and acceptance of the tool. We report here the results of such an analysis for the pre-operative anesthetic consultation, and illustrate this analysis with the evaluation of a computerized anesthetic record.

The RITHME inter-mediation platform for data exchanges between healthcare professionals.

Data Exchanges between Healthcare Professionals are always limited to paper. For letters, reports, results, the physicians and hospitals are yet using the classical post-office mailing system. With the growing development of Medical Informatics within the Hospital Information Systems and the GPs offices, the way to exchange medical data will be more and more oriented towards the Telematics procedures. If Tele-consultation, video-conferencing applications appear as routine procedures, a safe, protected, and rapid transmission of medical data and records through electronic mailing systems is not yet really available. The Rithme Intermediation Platform is an experimental product, tested in the town of Armentières (in the City of Lille) in the North of France to allow a better, safer, more rapid electronic communication between all the professionals of a geographical sector. One of the mail component of this platform is the "Events Server" which collects and displays all the available information concerning a dedicated patient to the medical authorized correspondents. To realise this task the Rithme Platform takes charge of 4 main functions: formatting the messages, assuring the security, managing the directories, notifying emergencies. Currently experienced with success in the City of Lille, this Platform will be soon customised and commercialized.

Activity modelling for assessing the usability of telematics applications in healthcare.

With the development of Telematics Applications in Healthcare, it becomes obvious that the success of these services is tightly linked with their usability and their acceptance by users. That is why Users Requirements Analysis appears as an essential step before implementation of new computer services. In many cases, particularly when doctors are directly involved in the management of information, there is a strong interaction between their usual activity and the new tasks implied by the computer. In those cases, Activity Modelling can be useful to describe the way people are working, the motivations that underlie this activity, the place of information management in this activity. Moreover, these models can help to forecast possible difficulties or reasons for failure of the data management when computerised. Obviously, these models are highly depending on the healthcare organisation but some basic lines can be transferable. In this paper we illustrate the Activity Modelling Methodology by examples from Telematics exchanges between GPs and Hospitals.

Cognitive evaluation: how to assess the usability of information technology in healthcare.

As the adoption of information technology has increased, so too has the demands that these systems become more adapted to the physicians and nurses environments, to make access and management of information easier. The developers of information systems in Healthcare must use quality management techniques to ensure that their product will satisfy given requirements. This underlines the importance of the preliminary phase where Users Requirements are elicited. Some methodologies, such as KAVAS (E.M.S. Van Gennip, F. Grémy, Med. Inform. 18, 1993, 179) chose to use a continuous assessment protocol as a key strategy for quality management. At each stage of the conception and development of a prototype, the assessment checks that it conforms to the expectation of the users' requirements. The methodology of evaluation is then seen as a dynamic process which is able to improve the design and development of a dedicated system. The purpose of this paper is to demonstrate the necessity to include a cognitive evaluation phase in the process of evaluation by: (1) evaluating the integration (usability) of the I.T. in the activity of the users; and (2) understanding the motives underlying their management of information. This will help the necessary integration of information management in the workload of the healthcare professionals and the compatibility of the prototypes with the daily activity of the users.

Assessment of a cooperative workstation.

Groupware and new Information Technologies have now made it possible for people in different places to work together in synchronous cooperation. Very often, designers of this new type of software are not provided with a model of the common workspace, which is prejudicial to software development and its acceptance by potential users. The authors take the example of a task of medical co-diagnosis, using a multi-media communication workstation. Synchronous cooperative work is made possible by using local ETHERNET or public ISDN Networks. A detailed ergonomic task analysis studies the cognitive functioning of the physicians involved, compares their behaviour in the normal and the mediatized situations, and leads to an interpretation of the likely causes for success or failure of CSCW tools.

[Nutrition survey assisted by computer]. / Enquête alimentaire assistée par ordinateur.

Data processing has made data banks available to the nutritionist, enabled rapid conversion of food data, and supplied detailed even commented listings of eating behaviour. Until now, however, use of the computer has remained the privilege of the dietician. A conversational data programme employing a microcomputer has been developed, enabling patients to establish a dialogue with the calculator, with storage of data concerning their food habits. A double food survey was conducted in 93 adult subjects, one of which involved the dieticians from ISTA, and the other the computer. Good correlation was found between the two estimates of calorific rations (r = 0.84, p less than 0.001) and nutriments. Deviations between the two estimates were less than 20 p. cent in the majority (80 p. cent) of cases. Psychological questioning confirmed the good reception reserved for this type of computerized survey, whatever the initial reservations held against data processing. Performances were not altered by the sociocultural level of the persons surveyed. This type of interactive programme should lead to simplification of the food anamesis, thus favorizing the communication and the counselling role of the nutritionist. It can also be of value in the framework of epidemiological surveys or education of nutrition.