PG Student School of Pharmaceutical Science, Lovely Professional University mayiladuthurai, India
Background: This Safety review aims to investigate the clinical Case reports of cardiovascular medical device adverse events (CMD-AEs).
Objectives: A safety review of clinical adverse events associated with cardiovascular medical devices under materiovigilance would be to assess the safety and effectiveness of these medical devices and identify any potential risks and adverse events related to their use. The study will review existing literature to provide an overview of the incidence, types, and contributing factors of CMD-AEs, as well as the impact on patient outcomes.
Methods: The review included a comprehensive search of electronic databases like Embase, PubMed, Elsevier, Springer, Cochrane library, and manual searches of relevant journals. The research will also assess the current approaches for detecting, reporting, and mitigating CMD-AEs, and suggest potential strategies to improve patient safety.
Results: The results of the review showed that CMD-AEs is a significant problem, with a high incidence of adverse events reported in patients who have undergone implantation of cardiovascular devices like peacemakers, stents, heart valves, implantable pulmonary artery (PA) sensors, etc. The causes of CMD-AEs were found to be multifactorial, including device design, patient, and technical factors. The consequences of CMD-AEs can range from mild symptoms to severe complications, including death. and inform the development of evidence-based policies and guidelines to reduce their occurrence and improve patient outcomes.
Conclusions: The findings of this review highlight the importance of continued monitoring and improvement of medical device safety to reduce the burden of CMD-AEs globally.
