Abstract:
Safety and reliability are essential issues in modern sciences. Modern devices and systems
should meet technical, safety and environmental protection requirements. The risk is a measure
of harm or loss associated with the human activity and it can appear as personal injury or death,
mission degradation, property technical damage or destruction.
There are evidences and claims that the public hospitals of Ethiopia are suffering from a lot of
problems related to medical device risk management. Jimma University specialized Hospital
(JUSH) is one of these public hospitals in the country facing the same problems related to
medical device risk management.
In this thesis risk assessment of medical device on safety in Jimma University Specialized
hospital has been conducted which is used as an input for the system. A structured questionnaire,
interview of key informants and medical device maintenance were used to collect data from the
hospital. From the collected data combined percentage rating of different functions of medical
device risk and operational performance of medical device were calculated.
The study reveals that there were medical device risks on safety caused from patients, health
professionals, from medical device itself and the environment in which the health care is
delivered.
This study deals with modelling and design of fuzzy logic reasoning for medical device risk
assessment model to enhance the Risk Assessment (RA) process while considering uncertainties
in each phase of RA. The main advantage of using fuzzy reasoning approach is limitations of
subjectivity in RA.
This model makes risk assessment more convenient in the absence of suitable data. In addition,
decision-making will be easier, since its results are more understandable than the results of
classical methods. The proposed framework develops a model that optimizes the risk constraints.
