Prevalence of Major Congenital Malformations Among the Insured Population in the United States Using Seven Algorithms

Major congenital malformations (MCM) are critical outcomes in medical product safety surveillance, yet their definitions vary widely across studies due to differences in coding algorithms and interpretation of what constitutes a “major” malformation. This presentation compares seven published or established algorithms to identify key drivers of variation in MCM prevalence estimates. It was presented at the 2025 ISPE Annual Meeting.