Dissertations - Medical Device Technology & Business
Permanent URI for this collection
Browse
Recent Submissions
Item Comparative Analysis of Global Access to Computed Tomography (CT) Services: Radiographers’ Experiences in Ireland and Sub-Saharan Africa(2024) Creedon, JillBackground: Nigatu et al. (2023) reported only 14% of developing countries have one CT scanner per million inhabitants, compared with 100% of developed countries. This research aims to address access disparities in CT imaging between developed and developing regions, taking Ireland and Sub-Saharan Africa as representative regions. The research examines the user experience of CT radiographers in each region to determine whether demographic and contextual factors may influence the user experience and/or access to CT imaging services. The research subsequently seeks to assess whether region-specific solutions could address access issues and usability challenges in each region, while advocating for inclusivity in medical imaging equipment design. Methodology: This research employed a positivist framework and an abductive approach to examine the user experience of CT radiographers in Ireland and Sub-Saharan Africa. This was achieved through a semi-structured online questionnaire containing 30/31 questions which covered attitude, behavioural, classification and pre-coding questions. The questionnaire contained primarily closed questions, with some optional open questions to add contextual information, and covered demographic and contextual factors, usability assessments and ranking questions to address critical needs and priorities. The questionnaire was sent to CT radiographers in Ireland and SSA via social media and email distribution, achieving 52 responses in total, 31 from Ireland and 21 from Sub-Saharan Africa. Results: Several notable commonalities and differences were observed between the examined regions, both in terms of CT system usability and accessibility. However, the increased abundance of CT scanners in Ireland relative to SSA meant their shared challenges were of differing impacts in each region. Radiographers in both regions were generally satisfied with their overall user experience, although they identified both shared and unique areas for improvement when asked. Both cohorts identified issues with CT scanner hardware, particularly the scan table weight limit and gantry bore size. Others identified confusing or problematic user interface features. The most significant differences were in respondents’ rankings of critical needs and priorities, specifically CT access barriers, CT-related issues, and CT system features. Radiographers in Ireland were primarily concerned with workforce and training-related issues, as well as achieving diagnostic and technical accuracy. In contrast, radiographers in SSA were focused on financial and infrastructural challenges, also demonstrating a strong commitment to patient-centred care. Conclusion: This research underscores the need to implement region-specific strategies to enhance CT imaging services in both regions, with a focus on addressing their most critical needs and priorities rather than focusing on usability challenges. This is essential to improve patient care in both regions and ensure that progress is made toward achieving equitable healthcare.Item Post Market Surveillance: Exploring Healthcare Professionals’ perception and engagement in post market surveillance of medical devices(2024) Leneghan, TheresaObjective: 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.Item An evaluation of orthopaedic knee implant FDA recalls (from manufacturing to market release): 2019-2023(2024-05) Selvaganapathi , ThennarasuBackground: In recent years, the medical device sector has been positioned for consistent expansion, with worldwide yearly sales predicted to increase by more than 5% annually, reaching close to $800 billion by the year 2030 (van den Heuvel et al., 2018). In parallel to this growth, there is ongoing debate around the need for increased regulations and higher standards for medical device manufacturers, particularly as recalls have not decreased in frequency. The orthopaedic devices sector represents nearly 20% of the medical devices available on the global market and 16% average of these devices undergo recalls. Nonetheless, there exists a gap in the literature around investigations on orthopaedic knee implant recalls. (DeRuyter et al., 2023) This study aims to evaluate FDA recalls associated with orthopaedic knee implants, seeking to comprehend current orthopaedic knee implant recall’s trends and the reasons behind these recalls, and to determine the effectiveness of the current manufacturing quality standards and regulatory systems. Methods: A quantitative monomethod was utilized, involving the distribution of an online survey to subject matter experts on recalls within the orthopaedic implant industries. The survey, administered via Microsoft Forms, comprised of 18 questions, encompassing both closed- and open-ended formats assessing the factors contributing to orthopaedic knee implant device recalls and the effectiveness of the current system and to provide suggestions and recommendations regarding Orthopaedic manufacturing standards, regulatory frameworks, and other relevant areas. Responses from a total of 71 participants were collected and data analysis undertaken to investigate the reasons behind recalls, contributors to these recalls, and the efficiency of the current manufacturing standard and regulatory system. Secondary research was also undertaken to detect prevailing trends in the recall of orthopaedic knee implant devices. Data was sourced from the FDA database, specifying the years 2019 to 2023, and filtered for details such as manufacturer, approval process, implant type, recall classification, recall dates, reasons determined by the manufacturer, quantity affected, and more. These data points were then analyzed utilizing histograms to visualize the frequency of recalls across each year. Findings: FDA recall data has shown a significant increase in the number of recalls involving orthopaedic knee implants in recent years from different manufacturers. This increasing trend in recalls has raised concerns from both the medical community and among patients as they rely on these implants to regain mobility and improve their quality of life. These recalls, often attributed to issues such as manufacturing defects, material failures, or design flaws, underscore the challenges faced by manufacturers in ensuring the reliability and safety of these critical medical devices. Survey responses further highlight key factors contributing to orthopaedic recalls as perceived by participants. Manufacturing defects stand out as the primary concern, with a majority of respondents identifying them as the main contributors to orthopaedic recalls. This underscores the importance of addressing issues within the manufacturing process, including production errors, design flaws, and lapses in quality control, to uphold the reliability and safety of orthopaedic devices. Additionally, some respondents point to a lack of stringent FDA regulation as a significant factor contributing to orthopaedic recalls. This suggests apprehensions regarding the adequacy of regulatory oversight and enforcement, potentially resulting in compromises in product safety and quality standards. The response underscores the necessity for more robust regulatory measures to mitigate risks associated with orthopaedic devices. Conclusions: The research findings emphasize the urgent need for a comprehensive and proactive approach to managing recalls of orthopedic knee implants, highlighting the deficiencies in the current system. Stakeholder feedback reveals diverse opinions on the necessary changes in the medical device landscape. Some stakeholders are satisfied with the current system when properly followed and advocate for no changes. However, others suggest improvements such as eliminating the predicated equivalent approval process, establishing a dedicated recall committee to review and refine the approval process as needed, and improving alignment between different international Quality Management System (QMS) standards, including ISO 13485 and FDA regulations. Additionally, stakeholders recommend integrating principles from ISO 14971 into QMS requirements to help manufacturers systematically identify, assess, and mitigate risks throughout the product lifecycle. Strengthening collaboration with small and medium-sized enterprises (SMEs) is also suggested, as suppliers often do not adhere to QMS certifications. Emphasis is placed on incorporating risk management ISO 14971 principles into QMS requirements, enhancing post-market surveillance, clinical evidence requirements, and regulatory measures, particularly in competitive and dynamic industries.Item An investigation into the impact of the MDR Clinical Data Requirement for Legacy Devices & Transitional Provisions set out in Regulation EU 2023/607 on Medical Device manufacturers.(2024-05) Duggan , ManusOBJECTIVE: This study investigated the impact of the Medical Device Regulation requirement of clinical evidence for legacy devices and the transitional timelines on medical device manufacturers in Ireland. The MDR legislation which came in force on 26th May 2021, sets out the legal regulatory framework for medical device manufacturers, who wish to place their product on the EU market. Four key objectives were identified; firstly, to establish the current status regarding obtaining CE mark certification for medical devices. Secondly, to determine the status of products needing re-certification under MDR. Thirdly, to determine if the manufacturer in their opinion considers the transitional provisions set out under Regulation (EU) 2023/607 is sufficient. And finally, to obtain recommendations from industry as to improvements needed to improve the process of MDR certification. METHODS: Secondary research was conducted of peer-reviewed journals, books, newspaper articles, and organisational websites, using the terms MDR, clinical data, medical device, and legacy medical devices. Primary research was conducted by means of a survey questionnaire, which was answered by 27 people with significant knowledge of medical devices in Ireland. One of the survey respondents worked in academia. Interviews took place with two individuals one from academia, and the other with a regulatory background in a medical device company. RESULTS: In this study it was found that the introduction of the MDR legislation has had a negative impact on the medical device industry. Start-up and SMEs have been severely impacted by the requirements of the MDR, particularly the financial cost of clinical trials and access to Notified Bodies for MDR assessment. The clinical evidence requirement is ambiguous and impacts even the larger companies. Access to Notified Bodies, and the time taken by Notified Bodies to assess devices is taking much longer than under previous legislation. There have been device shortages and withdrawals warning from industry sources, but the consequence of this is unclear, and close monitoring of the situation is needed. Orphan and paediatric device shortages have already happened in the EU. CONCLUSIONS: In this study, the author found that the primary research data broadly corresponded with what was found in the secondary research data. Clinical evidence is causing the most issues for companies. The EU have not been pro-active in their response to issues encountered by the medical device industry. The primary research sample size was limited, and warrants further study with a larger sample sizeItem Staying Ahead in Patient Safety and Compliance: Assessing the awareness of Regulatory Requirements in an Irish Medical Devices Distributor(2024-05) Tyndall, CathySafety 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