Identifying risks using a new assessment tool: the missing piece of the jigsaw in medical device risk assessment.

Introduction There is an increasing expectation for the NHS to deliver a constantly up-to-date health service that is both safe and patient-oriented. This paper outlines the findings of a new risk assessment tool implemented across the organization targeted specifically to medical devices. Method The process employs a new medical devices risk assessment tool (MeDRa) to collect quantitative data relating to the contributory factors and control measures associated with medical devices used in the clinical setting. The tool utilises the responses from healthcare professionals as the 'real experts' in assessing risk to compute risk ratings for each device. Consequently the risk assessments are validated through the professional judgement of the clinical staff. Results As the data is inputted, the software tool computes the individual risk profiles for device categories in the particular clinical setting. A macro perspective of medical device risk is produced through statistical analysis and mathematical modelling using cross-tabulations. Risk perceptions are influenced by the differences in professional roles of nursing and medical staff. The outcome of the analysis is a report on medical device risks across the organization and an associated action plan, which identifies ways of mitigating those risks. Conclusions This approach efficiently produced risk assessments for each clinical area across the whole Trust in a matter of weeks. The MeDRa tool collated evidence to satisfy many of the criteria necessary for the external assurance framework. The subsequent statistical analysis and mathematical modelling highlighted a number of issues across the Trust that required interventions. [ABSTRACT FROM AUTHOR]