Development and Evaluation of a Knowledge-Based Method for the Treatment of Use-Oriented and Technical Risks Using the Example of Medical Devices

摘要

Rapidly evolving technological progress in the field of medical devices not only leads to a potential enhancement of therapeutic results but also to a change of the Human-Machine-Interaction characteristics, causing deficiencies in the use process and bringing along high potential for hazardous human-induced failures. This implicates higher risks for patients, medical professionals and third parties. In order to support the usability engineering and risk management process of medical devices, a new methodology for risk control has been developed and evaluated. The aim is to implement appropriate counteractions in the risk control process, reducing errors in the Human-Machine-Interaction process as well as system-inherent technological risks. Accessing information from the method's knowledge base enables the operator to detect the most suitable countermeasures for the respective problem. 41 approved generic countermeasure principles have been indexed as a resulting combination of root causes and failures that might appear during Human-Machine-Interaction or manufacturing and developmental process. The method has been tested in comparison to conventional approaches. Evaluation of the matrix and reassessment of the risk priority numbers by a blind expert demonstrated a substantial benefit of the new mAIXcontrol method.