The European Medical Devices Directive outlines the essential requirements for placing interactive medical devices (such as infusion pumps) onto the market and putting them into service. Requirements relate to audit, production, risk assessment and post-marketing surveillance.
Although essential requirements include:“reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)” and “consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users)” when manufacturers comply fully with the regulation, the user can still miss out. This is because there may not be sufficient ergonomic data to support developers, or typical users may not be involved throughout the development process. As part of the infusion pump improvement initiative, the US Food and Drug Agency (FDA) prompts manufacturers to consider human factors from the outset and show how these principles have been applied during product development. CHI+MED’s Dr Chris Vincent has explored how the appropriate user-centred requirements embedded within regulations can lead to improved usability and safety, and how human computer interaction (HCI) specialists can work with device manufacturers to enhance interface design.
Vincent, C (2010) Mind the gap: what interactive medical device manufacturers need Interfaces 84: 14-15.