Patient safety and interactive medical devices: Realigning work as imagined and work as done

摘要

Medical devices are essential tools for modern healthcare delivery. However, significant issues can arise if medical devices are designed for ‘work as imagined’ when this is misaligned with ‘work as done’. This problem can be compounded as the details of device design, in terms of usability and the way a device supports or changes working practices, often receives limited attention. The ways devices are designed and used affect patient safety and quality of care: inappropriate design can provoke user error, create system vulnerabilities and divert attention from other aspects of patient care. Current regulation involves a series of pre-market checks relating to device usability, but this assumes that devices are always used under the conditions and for the purposes intended (i.e. work as imagined); there are many reasons for devices being used in ways other than those assumed at development time. Greater attention needs to be paid to learning points in actual use and user experience (i.e. work as done). This needs to inform manufacturers’ designs, management procurement decisions and local decisions about how devices are used in practice to achieve co-adaptation; without these, we foster risks and inefficiencies in healthcare.