The Interaction Between Safety Culture and Uncertainty Over Device Behaviour:The Limitations and Hazards of Telemedicine

摘要

The introduction of new technology carries with it a degree of uncertainty on the part of systemoperators. They must match device behaviour to the operating characteristics described duringtraining sessions or within supporting documentation. When operators are uncertain about whattheir system is actually doing then they frequently resort to coping strategies. This threatenspatient safety in many healthcare applications. For example, clinicians often reboot monitoringsystems as this can return the system to proper operation. This behaviour, however, is not alwayssafe to the patient, as the power-down can create problems if the device is left in an inconsistentstate on power-up or if critical data is lost when the device is restarted. Conversely, whenmanufacturers receive reports about adverse events, they often find it difficult to reproduce theerror conditions that are described by clinicians and healthcare technicians and other end-users.These problems are exacerbated when these end-users do not fully understand the technologiesthat they are using. This paper argues that such uncertainty threatens the safety of‘telemedicine’. We are interested in this class of applications because incident reporting systemsare beginning to document a growing number of adverse events that stem from the distributedmonitoring and treatment of large numbers of patients. The following pages illustrate thisargument using reports submitted to the Food and Drugs Administration (FDA) Manufacturer andUser Facility Device Experience (MAUDE) database over the last twelve months. Theseincidents show that uncertainty about device behaviour can undermine attempts to establish a new‘safety culture’ based on communication between clinicians, technicians and devicemanufacturers.