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 system operators. They must match device behaviour to the operating characteristics described during training sessions or within supporting documentation. When operators are uncertain about what their system is actually doing then they frequently resort to coping strategies. This threatens patient safety in many healthcare applications. For example, clinicians often reboot monitoring systems as this can return the system to proper operation. This behaviour, however, is not always safe to the patient, as the power-down can create problems if the device is left in an inconsistent state on power-up or if critical data is lost when the device is restarted. Conversely, when manufacturers receive reports about adverse events, they often find it difficult to reproduce the error 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 technologies that 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 systems are beginning to document a growing number of adverse events that stem from the distributed monitoring and treatment of large numbers of patients. The following pages illustrate this argument using reports submitted to the Food and Drugs Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database over the last twelve months. These incidents show that uncertainty about device behaviour can undermine attempts to establish a new ‘safety culture’ based on communication between clinicians, technicians and device manufacturers.