Assessment of the Current Status of Post-Market Surveillance of Medical Devices, its Regulatory Challenges and Future Perspective in Ethiopia
| dc.contributor.advisor | Belete, Anteneh( PhD) | |
| dc.contributor.author | Giragn,Meaza | |
| dc.date.accessioned | 2024-04-23T10:52:33Z | |
| dc.date.available | 2024-04-23T10:52:33Z | |
| dc.date.issued | 2023-03 | |
| dc.description.abstract | Background: Beside their significance in improving the diagnosis and intervention of disease, medical devices (MD) have the potential for adverse events, hazards, or malfunctions with serious consequences for patients and users. In Ethiopia, post-market surveillance (PMS) of medical devices does not get enough attention, despite the fact that it plays a crucial role in protecting the patient by ensuring the continued quality, safety, and effectiveness of the MDs in use. Objective: To assess the current status of post-market safety surveillance of medical devices, its regulatory challenges, and future perspectives in Ethiopia. Methods: An explanatory sequential mixed method design approach was followed i.e. the quantitative data was first collected and analyzed, and then the qualitative data was collected and analyzed based on the quantitative result. Data was collected using a checklist adapted from Word Health Organization (WHO) and Global Harmonization Task Force (GHTF) guidelines, and interview guide questions were used to identify the regulatory challenges and proposed strategies associated with poor implementation of the PMS of MD. Results: The current practice of PMS of MDs at the National Regulatory Authority and importers is in its infancy stage. Major regulatory challenges in the implementation of PMS for MD include: a mix-up of the regulatory structure of MDs and medicines, resource constraints, a lack of awareness, and poor collaboration between stakeholders. Poor implementation results in: patient exposure to unsafe, ineffective, and low-quality MDs; loss of trust in healthcare professionals and National Regulatory Authority (NRA); and economic failure for the country. Separating MD regulation; capacity building for the NRA; creating awareness among all responsible stakeholders; developing an adverse event reporting system for MD; and engaging stakeholders in ensuring patient safety are all recommended improvement strategies. Conclusion: The current practice of PMS of MDs at regulatory authority and MAHs, two key essential players are at infancy stages. Most of the regulatory requirements utilized to implement were either not present or just existed on paper. In general, to create a robust and effective post- market surveillance system for MDs, it requires ongoing, continuous work. | |
| dc.identifier.uri | https://etd.aau.edu.et/handle/123456789/2780 | |
| dc.language.iso | en_US | |
| dc.publisher | Addis Ababa University | |
| dc.subject | Medical Device Regulation | |
| dc.subject | Post Market Safety Surveillance | |
| dc.subject | Patient Safety | |
| dc.subject | Adverse Event | |
| dc.title | Assessment of the Current Status of Post-Market Surveillance of Medical Devices, its Regulatory Challenges and Future Perspective in Ethiopia | |
| dc.type | Thesis |