Situation-Dependent Medical Device Risk Estimation: Design and Evaluation of an Equipment Management Center For Vendor-Independent Integrated Operating Rooms

Abstract

Objectives: The complexity of surgical interventions and the number of technologies involved are constantly rising. Hospital staff has to learn how to handle new medical devices efficiently. However, if medical device-related incidents occur, the patient treatment is delayed. Patient safety could therefore be supported by an optimized assistance system that helps improve the management of technical equipment by nonmedical hospital staff.

Methods: We developed a system for the optimal monitoring of networked medical device activity and maintenance requirements, which works in conjunction with a vendor-independent integrated operating room and an accurate surgical intervention Time And Resource Management System. An integrated situation-dependent risk assessment system gives the medical engineers optimal awareness of the medical devices in the operating room.

Results: A qualitative and quantitative survey among ten medical engineers from three different hospitals was performed to evaluate the approach. A series of 25 questions was used to evaluate various aspects of our system as well as the system currently used. Moreover, the respondents were asked to perform five tasks related to system supervision and incident handling. Our system received a very positive feedback. The evaluation studies showed that the integration of information, the structured presentation of information, and the assistance modules provide valuable support to medical engineers.

Conclusions: An automated operating room monitoring system with an integrated risk assessment and Time And Resource Management System module is a new way to assist the staff being outside of a vendor-independent integrated operating room, who are nevertheless involved in processes in the operating room.