Post Market Surveillance: Exploring Healthcare Professionals’ perception and engagement in post market surveillance of medical devices
| dc.contributor.author | Leneghan, Theresa | |
| dc.date.accessioned | 2024-10-30T12:39:31Z | |
| dc.date.available | 2024-10-30T12:39:31Z | |
| dc.date.issued | 2024 | |
| dc.description.abstract | Objective: Medical devices are essential to patient care. However, their use can cause unintentional harm to patients. It was this risk of harm which led the European Commission to harmonise and update regulations that govern their use and publish new regulations in 2017 known as EU MDR. A key focus within EU MDR is the post-market surveillance of medical devices once they become commercially available. Healthcare professionals use these devices daily in their work and it is their experience of device use that is critical in contributing to the post-market surveillance data. Despite this, research shows that device incidents are under reported, and that healthcare professionals make a very low level of contribution to the report rates. The objective of this research was to explore the knowledge healthcare professionals in the Irish public healthcare sector have of EU MDR and in particular post-market surveillance and its processes. It also aims to determine, what if any barriers exist to reporting medical device incidents and what they feel would support their engagement with post-market surveillance. Methods Ten qualitative interviews were conducted with experienced Irish healthcare professionals working in the Health Service Executive across a range of specialities and roles. They were asked about their knowledge of EU MDR, post-market surveillance and device serious incidents. Their opinion on device feedback and reporting of device incidents was gathered as were suggestions on the optimal approach to support their engagement with regulations and a post-market surveillance system. Results Knowledge of EU MDR and post-market surveillance was generally low. All participants recognised the relevance of monitoring and surveillance of devices and felt they would contribute to the process. However, fear of blame and consequences, time constraints, a lack of knowledge on the process and poor communication from suppliers may impact the rates of incident reporting. Healthcare professionals generally were open to learning about the regulations, providing robust solutions on how to achieve this (including increased training and awareness from the HSE, academic institutions and the regulator, the HPRA). Easy to use, intuitive and accessible systems would increase engagement with post-market surveillance. Conclusion Healthcare professionals in the Irish public healthcare system have a low level of knowledge of the medical device regulations, EU MDR. They recognise the relevance of the regulations and device incident reporting and, provided with the correct systems, education, training and awareness they could be encouraged to increase their engagement and therefore provide for more effective medical device port-market surveillance. | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/213 | |
| dc.title | Post Market Surveillance: Exploring Healthcare Professionals’ perception and engagement in post market surveillance of medical devices | |
| dc.type | Thesis |