Predictive risk analysis. A tool to improve leads reliability

Reliability has become a need for all products the consumer may buy today, but for life supporting or depending devices, like implantable pacing leads, it is a mandatory requirement. Until now, Reliability was considered as an intrinsic property of a product achievable through a smart design, a careful selection of components, a good manufacturing practice and an accurate test screening on subassembly and finished device. This is not completely true. Even a perfect device may provoke a serious injury up to death of the patient or user if its original conception is affected by some misunderstanding or lacks in considering potential side effects linked to its use or misuse. Other negative consequences may arise if the device is not carefully handled, or is used by untrained physicians or subjected to improper application. A proactive tool to improve Reliability is the Predictive Risk Analysis. It takes in consideration and makes an analysis of all intrinsic and external factors that may affect the final Reliability of a device and provides suggestion about all actions to be taken in order to forecast and achieve the required Reliability, including those depending on human error. Purpose of this paper is to give a concise landscape on this proactive tool and on the way it works in predicting and correcting all potential risks which may affect the long term reliable performance of a device.