Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters.
Kadakia K, Bikdeli B, Gupta A, Dhruva S, Ross J, Krumholz H. Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals Of Internal Medicine 2024 PMID: 39556835, DOI: 10.7326/annals-24-00089.Peer-Reviewed Original ResearchMedical device regulationDetect adverse eventsDevice regulationInferior vena cavaPatient safetyFood and Drug AdministrationDevice safetyOutcome definitionsStudy protocolPatient deathClinical study protocolAdverse eventsProfessional societiesCourt documentsClinical practiceRegulatory reformCliniciansInferior vena cava perforationDevice labelingPrevention of pulmonary embolismPublished literaturePublic recordsInaccurate informationCelect IVC filtersMedical devices