A Systems Theoretic Application to Design for the Safety of Medical Diagnostic Devices
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A Systems Theoretic Application to Design for the
Safety of Medical Diagnostic Devices
ABSTRACT
In today’s environment, medical technology is rapidly advancing to deliver
tremendous value to physicians, nurses, and medical staff in order to support them
to ultimately serve a common goal: provide safe and effective medical care for
patients. However, these complex medical systems are contributing to the
increasing number of healthcare accidents each year. These accidents present
unnecessary risk and injury to the very population these systems are designed to
help. Thus the current safety engineering techniques that are widely practiced by
the healthcare industry during medical system development are inadequate in
preventing these tragic accidents. Therefore, there is a need for a new approach to
design safety into medical systems.
This thesis demonstrated that a holistic approach to safety design using the Systems
Theoretic Accident Model and Process (STAMP) and Causal Analysis based on
STAMP (CAST) was more effective than the traditional, linear chain-of-events model
of Failure Mode Effects and Criticality Analysis (FMECA). The CAST technique was
applied to a medical case accident involving a complex diagnostic analyzer system.
The results of the CAST analysis were then compared to the original FMECA
hazards. By treating safety as a control problem, the CAST analysis was capable of
identifying an array of hazards beyond what was detected by the current regulatory
approved technique. From these hazards, new safety design requirements and
recommendations were generated for the case system that could have prevented
the case accident. These safety design requirements can also be utilized in new
medical diagnostic system development efforts to prevent future medical accidents,
and protect the patient from unnecessary harm.
Safety of Medical Diagnostic Devices
ABSTRACT
In today’s environment, medical technology is rapidly advancing to deliver
tremendous value to physicians, nurses, and medical staff in order to support them
to ultimately serve a common goal: provide safe and effective medical care for
patients. However, these complex medical systems are contributing to the
increasing number of healthcare accidents each year. These accidents present
unnecessary risk and injury to the very population these systems are designed to
help. Thus the current safety engineering techniques that are widely practiced by
the healthcare industry during medical system development are inadequate in
preventing these tragic accidents. Therefore, there is a need for a new approach to
design safety into medical systems.
This thesis demonstrated that a holistic approach to safety design using the Systems
Theoretic Accident Model and Process (STAMP) and Causal Analysis based on
STAMP (CAST) was more effective than the traditional, linear chain-of-events model
of Failure Mode Effects and Criticality Analysis (FMECA). The CAST technique was
applied to a medical case accident involving a complex diagnostic analyzer system.
The results of the CAST analysis were then compared to the original FMECA
hazards. By treating safety as a control problem, the CAST analysis was capable of
identifying an array of hazards beyond what was detected by the current regulatory
approved technique. From these hazards, new safety design requirements and
recommendations were generated for the case system that could have prevented
the case accident. These safety design requirements can also be utilized in new
medical diagnostic system development efforts to prevent future medical accidents,
and protect the patient from unnecessary harm.