External Physical and Technical Influences on Medical Devices for Diabetes Therapy.

Abstract

Home and work situations can expose diabetes medical devices to a number of environmental factors that may influence their function and safety. In accordance with regulatory requirements, manufacturing companies take great care in the construction and design of their products so that environmental factors encountered on a daily basis have as little influence as possible. However, more intense environmental conditions, such as undergoing magnetic resonance imaging (MRI), require patients to remove personal electronic medical devices beforehand. During product development, manufacturers thoroughly investigate how various environmental factors may impact a new medical device. Corresponding operational documents and manufacturer guarantees accompany each device. Similarly, manufacturers investigate any adverse interactions that may occur during communications between medical devices, such as those required with another product, smartphone, or another personal medical device, such as a pacemaker. Questions that arise from patients or medical professionals about a medical device's safety or quality, particularly because of environmental factors, are made to the manufacturer. Manufacturers then often refer to the operating instructions, even though these contain information, such as electromagnetic compatibility, that are difficult to understand for people lacking special technical or physical knowledge. This review highlights the effects of various physical and technical influences on medical devices used in diabetes therapy.