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To what extent does medical device maintenance pose clinical risk?

Abstract Healthcare is a risky business and patient safety is afforded a high profile. Although great lengths are taken to ensure medical devices are intrinsically safe, risks can occur when they are introduced into the clinical setting. A risk assessment tool, Medical Device Risk Assessment (MeDRa) was used to collect quantitative data relating to the contributory factors and control measures associated with using medical devices in the clinical setting. The tool utilizes the responses from healthcare professionals to a set of questions about risk as a basis for the risk assessment. The raw data was exported to SPSS for statistical analysis and mathematical modelling. Pearson's Chi-square tests for association and relative risk calculations formed the basis for the analysis. This paper reports on one aspect of the risk assessment relating to the maintenance of medical devices. There are two categories of maintenance: technical and user maintenance. The analysis showed that although there was a high level of conformity in technical maintenance, user maintenance was highlighted as a potential problem. MeDRa identifies potential risk factors that might impact on patient care.