The prominent development of health technologies of the 20 century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical de...

Millions of people use mobile medical devices—more every day. But our understanding of device security and privacy for such devices is incomplete. Man-inthe-middle attacks can be performed on typical Bluetooth-enabled mobile medical devices, compromising the privacy and safety of patients. In response, we developed the Personal Security Device, a portable device to improve security for mobile m...

Hospital buyers of medical devices contract with manufacturers with market power that sell differentiated products. The medical staff strongly influences hospitals' choice of devices. Sellers have sought to limit disclosure of transaction prices. Policy-makers have proposed legislation mandating disclosure, in the interest of greater transparency. We discuss why a manufacturer might charge diff...

Between June 1985 and January 1987, a computer-controlled radiation therapy machine, called the Therac-25, massively overdosed six people. These accidents have been described as the worst in the 35-year history of medical accelerators [6]. A detailed accident investigation, drawn from publicly available documents, can be found in Leveson and Turner [4]. The following account is taken from this ...

Medical devices developed for human application are used for diagnostic or treatment purposes. They may either be an instrument, an apparatus or a material. Moreover, these devices can be used for daily patient care as well as for medical scientific purposes. Risk management involves the identification, understanding, control, and prevention of failures when the medical devices are connected to...