OBJECTIVES This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. METHODS Medical device safety information reports were analyzed for 190 cases that took p...

Interoperability of medical devices is a growing need in modern healthcare systems, not just for convenience, but also to preclude potential human errors during medical procedures. Caregivers, as end users, strongly prefer the use of wireless networks for such interconnections between clinical devices due to its seamless connectivity and ease of use/maintenance. In [KSM10], we introduced a Netw...

OBJECTIVE A variety of postmarketing surveillance strategies to monitor the safety of medical devices have been supported by the U.S. Food and Drug Administration, but there are few systems to automate surveillance. Our objective was to develop a system to perform real-time monitoring of safety data using a variety of process control techniques. DESIGN The Web-based Data Extraction and Longit...

Device drivers are known to be a main source of operating system bugs. Several research groups have created driver specification languages that dynamically check preand postconditions on the IO operations of a device driver. The low-level type-safe language, Clay, has the facilities to statically check the safety of a device driver but is difficult to use directly. We have created a new device ...