Objectives: This study aimed to develop the actual pathway to reporting and information transfer in operating theatres in relation to medical technology malfunction/failure. This with the aim of understanding the differences with the pathway published by NHS Improvement and identification of points for improvement.
Design: This is a qualitative study involving stakeholder interviews with doctors, nurses, manufacturers, medical device safety officer and Medicines and Healthcare products Regulatory Agency.
Setting: Data were collected on reporting pathway used in operating theatres. Clinical staff who took part worked in different trusts throughout UK while manufacturers provided devices in UK and EU/USA.
Participants: Semistructured interviews were completed with 15 clinicians and 13 manufacturers. Surveys were completed by 38 clinicians and 5 manufacturers. Recognised methods of pathway development were used. The Lean Six Sigma principles adapted to healthcare were used to develop suggestions for improvement.
Main outcome measures: To identify the differences between the set pathway to reporting and information transfer to what is occurring on a day-to-day basis as reported by staff. Identify points in the pathway where improvements could be applied.
Results: The developed pathway demonstrated great complexity of the current reporting system for medical devices. It identified numerous areas that give rise to problems and multiple biases in decision making. This highlighted the core issues leading to under-reporting and lack of knowledge on device performance and patient risk. Suggestions for improvement were deduced based on end user requirements and identified problems.
Conclusions: This study has provided a detailed understanding of the key problem areas that exist within the current reporting system for medical devices and technology. The developed pathway sets to address the key problems to improve reporting outcomes. The identification of pathway differences between 'work as done' and 'work as imagined' can lead to development of quality improvements that could be systematically applied.
Keywords: active surveillance; device evaluation; device safety; process assessment (health care); technology assessment, biomedical.
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