Staying Ahead in Patient Safety and Compliance: Assessing the awareness of Regulatory Requirements in an Irish Medical Devices Distributor

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Tyndall, Cathy
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Safety is paramount in the medical device industry. The main aim of Medical Device Regulation (MDR) is to improve patient safety. The primary aim this study was to investigation the level of awareness and perception of MDR within an Irish Medical Distributor. A mixed methodology was used in this study. Seventy four surveys and four interviews were completed to obtain qualitative and quantitative data from managers and employees at every level of the organisation. This study show a significant level of awareness and understanding of MDR among employees, particularly in the areas of adverse event reporting and CE (Conformite Europeenne) marking. However, variations in the perceived importance of MDR across different roles within the organisation suggest the need for tailored training and communication strategies to ensure uniform understanding and compliance. The research also revealed a positive overall perception of MDR among both employees and management.Qualitative findings from interviews with management highlight a positive attitude towards MDR, and recognising the commercial advantages of excellence in MDR awareness. Based on the findings of this study, several recommendations for future research and practice emerge. Firstly, there is a need for comparative research focusing on non-managerial roles across the spectrum of the medical device industry. Secondly, a longitudinal study could assess the effectiveness of formal training programs over time, tracking knowledge retention and identifying areas for improvement. Additionally, the study could be expanded to examine MDR awareness and perception levels alongside assessment of organisational culture within a company to see if there is correlation. It could also be valuable to assess the level of awareness and perception in MDR among those in the manufacturing sector of medical devices and among healthcare professionals using or implanting medical devices. In conclusion, this research contributes valuable insights into the level of MDR awareness and perception among employees and manager within an Irish Medical Devices Distributor and highlights the importance of a positive organisational culture and tailored training and communication strategies to ensure regulatory compliance and optimise patient safety

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