Risk Analysis and Assessment of Cardiac Pacemakers
摘要
Cardiac pacemakers have revolutionized heart disease management, yet the increasing number of implantations is accompanied by a rise in complications, both during and after the procedure. While extensive research exists on pacemaker technology, systematic risk analysis methods are lacking. This study aims to identify, analyze, and evaluate risks associated with pacemaker implantation and use, employing elements from Failure Mode and Effects Analysis (FMEA) and the Analytical Hierarchy Process (AHP). The methodology encompassed four stages: risk identification and categorization, adaptation of the FMEA method, risk ranking, and application of the AHP method. Data was gathered from databases, journals, books, and forums to identify complications, which were then classified and analyzed using root causes and presenting them in an Ishikawa diagram. The FMEA method was adapted to calculate the Risk Priority Number (RPN) through the redefinition of the factors that calculate the number. The AHP method complemented the analysis by assigning values to each criterion related to the issue. The results highlighted that complications occurring during the implant procedure and immediately afterward require the most attention. The adapted FMEA and AHP methods ranked bleeding and pocket bruising as the highest priority complication. The study emphasizes the need for continuous monitoring and personalized assessment to mitigate risks. The research will continue to consider additional factors that enhance the depth and detail of these results, thereby improving the understanding of complications and optimizing prevention and management strategies. This approach aims to facilitate effective risk management in pacemaker implantation.