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.

A framework for reporting on human factor/usability studies of health information technologies.

Increasingly, studies are being published on the potential negative effect of introducing poor designed Health Information Technology (HIT) into clinical settings, relating to technology-induced errors and adverse events. Academic research on HIT design and evaluation is an extremely important source of information in providing new insights into factors contributing to successful system (re)design efforts, system user-friendliness and usability issues and safety critical aspects of HIT design. However, these studies have been inconsistent and incomprehensive in their reporting, complicating the appraisal of outcomes, generalizability of study findings, meta-analysis and harmonization of the available evidence. To improve identification of type of use errors and safety related issues regarding design and implementation of HIT, consensus on issues to be reported on in scientific publications is a necessary step forward. This study presents the first approach to a framework providing a set of principles to follow for comprehensive and unambiguous reporting of HIT design and usability evaluation studies with the objective to reduce variation, improve on the publication reporting quality and proper indexation of these studies. This framework may be helpful in expanding the knowledge base not only concerning the application of Human Factors (HF)/Usability studies of HIT but also improve the knowledge base of how to (re)design and implement effective, efficient and safe HIT.

Impact of the context of use analysis for the extension of an existing medical device: an analgesia monitor case study.

The EU revised Medical Device Directive introduces a major change in the CE marking of medical devices (MD) aiming at improving their safety. Manufacturers must now comply with an "ergonomics" essential requirement to prevent risks of use errors. This requirement is characterized by the integration of a usability engineering process in the MD design cycle to be documented in a usability engineering file. This study focuses on the first step of the usability engineering process, i.e. the analysis of the intended context of use of the MD, and shows the benefits of this analysis when performed early in the MD design cycle. Usability experts have conducted an analysis of the intended contexts of use for the extension of an existing device (analgesia monitor) in order to support manufacturer's design choices. Observations and interviews were carried out in two neonatology units (Maternity and Neonatology Intensive Care units) with a particular focus on pain management activities performed by physicians and nursery nurses. The results highlight irreducible differences between the two environments which led to identify different risks of use errors and specific ergonomics requirements. The results provided the manufacturer enough information to make informed decision about the extension of the device.

Software as a medical device: regulatory critical issues.

The revised Medical Device Directive has been adopted by the EU in 2010. A major change is that software for certain purposes is now considered a medical device. This entails that a new view needs to be developed on the design, development, evaluation and post-market surveillance of medical software that meets the definition of a medical device. This paper identifies some issues at stake and discusses them.