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Communication breakdown between users and suppliers of clinical technology.

The demands of learning to operate and maintain health care technology put considerable strain on the relationships between patients, clinicians, biomedical technicians, clinical engineers and suppliers. For instance, the increasing complexity of several applications can make it difficult for biomedical technicians and clinical engineers to diagnose causes of an adverse event. 1, 2 They must understand not only the device characteristics but also the precise manner in which clinical staff were operating the device when the problem arose. Given the pressures on clinical staff, it can be difficult for them to provide detailed information for support staff to diagnose the causes of a mishap. Often biomedical technicians and clinical engineers must also rely upon advice from suppliers to resolve device-related problems. These suppliers typically were not involved in the initial development of the device. They, in turn, must talk to component providers and equipment integrators. At each stage of the process, information about an adverse event can become confused or lost. For example, clinicians may not know precisely which version of a device has been involved in an adverse event. Similarly, manufacturers may fail to elicit information about the manner in which their device was used. National and international regulatory requirements govern the reporting of adverse events involving medical technology. 3, 4 These regulations are, however, largely concerned with high-consequence adverse events. For example, an end-user facility must use form FDA3500A to report any device-related deaths or serious injury to the Food & Drug Administration (FDA) and the manufacturer within 10 working days. Very few regulations say anything about the “quality” of the dialogue that should take place between users and suppliers in the aftermath of lower severity incidents. In consequence, there are wide variations in the mechanisms that suppliers and manufacturers use to respond to user queries about possible and actual device problems. As we shall see, in extreme cases this leads to a breakdown of communication between clinicians and suppliers. In other situations, clinicians, biomedical technicians and clinical engineers and manufacturers must explore “ad hoc” communications mechanisms to resolve device failures. These arguments can be illustrated by incidents from the Manufacturer and User Facility Device Experience (MAUDE) database, maintained by the FDA. MAUDE is updated every quarter with reports of adverse events involving medical devices. The data from MAUDE consists of all voluntary reports since June 1993; user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996. The following excerpts are from MAUDE; bold font indicates words that have been added to the submissions to clarify the meaning of particular sentences. In the following report, a clinician C.W. Johnson