Developing and refining methods to assess medical product utilization, safety, and effectiveness during pregnancy is a focus of FDA’s Sentinel System. The Sentinel Common Data Model (SCDM) includes a Mother-Infant Linkage (MIL) table that enables routine evaluation of the effects of medical product exposures during pregnancy on infant outcomes. Descriptions of efforts led by the Center for Drug Evaluation and Research are shown below. Please visit the links to learn more about each area of activity.
The purpose of this report was to compare the frequency of diagnoses for diabetes mellitus with pregnancy using International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) versus International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes. ICD-10-CM code definitions were determined by mapping from ICD-9-CM code definitions using the Centers for Medicare and Medicaid Services (CMS) General Equivalence Mappings (GEMs). Simple forward mapping (SFM) and forward-backward mapping (FBM) were used to map ICD-9-CM to ICD-10-CM codes. (1)
(1) Fung, K. W., et al. (2016). "Preparing for the ICD-10-CM Transition: Automated Methods for Translating ICD Codes in Clinical Phenotype Definitions." EGEMS (Wash DC) 4(1): 1211.