Ensuring Patient Safety: Navigating EU MDR Compliance and Global Policy in HealthcareAllison, Renee Vanessa (2024) Ensuring Patient Safety: Navigating EU MDR Compliance and Global Policy in Healthcare. Master Essay, University of Pittsburgh.
AbstractEnsuring patient safety remains the forefront priority in healthcare, pushing for a deeper understanding of regulatory frameworks, epidemiological methods, and the broader socioeconomic contexts shaping healthcare practices. This essay navigates the complexities of patient safety within the framework of European Medical Device Regulation (EU MDR) compliance and global healthcare policies, addressing three key competencies: applying epidemiological methods, interpreting data analysis, and discussing underlying organizational and stakeholder actions. Emphasizing the critical role of regulatory compliance and global policy initiatives, this essay begins by exploring the significance of patient safety within the medical device landscape. The discussion of epidemiology practices, such as surveillance, risk analysis, and intervention evaluation, in ensuring the safety of medical devices will shape the broader discourse. In addition, the interpretation of real-world evidence is a crucial component in informing evidence-based decision-making in public health research, policy formulation, and practice. EU MDR embodies how data identified trends impact regulatory decisions and guide healthcare interventions. Lastly, the influence of organizational, industry, and stakeholder actions greatly impact care decisions and patient safety. The varying perspectives of political influence, economic incentives, ethnic disparities, and historical context shape healthcare practices and policies. The evolution of EU MDR provides a comprehensive framework of these factors that influence patient safety initiatives. Share
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