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Medical devices fail, sure, but how often? synthesis of reports from the United States in 2022

Authors

References

Polisena J, Gagliardi A, Urbach D, Clifford T, Fiander M. Factors that influence the recognition, reporting and resolution of incidents related to medical devices and other healthcare technologies: a systematic review. Syst Rev 2015;4:37. https://doi.org/10.1186/s13643-015-0028-0

Salazar JW, Redberg RF. Leading the Call for Reform of Medical Device Safety Surveillance. JAMA Intern Med 2020;180(2):179-180. https://doi.org/10.1001/jamainternmed.2019.5170

Pane J, Verhamme KMC, Villegas D, Gamez L, Rebollo I, Sturkenboom MCJM. Challenges Associated with the Safety Signal Detection Process for Medical Devices. Med Devices (Auckl) 2021;14:43-57. https://doi.org/10.2147/MDER.S278868

Instituto de Salud. Ministerio de Salud Chile. Boletines de tecnovigilancia. https://www.ispch.cl/andid/tecnovigilancia/boletines-de-tecnovigilancia/.

Universidad de Valparaíso Chile. Observatorio de Rendimiento de Dispositivos Médicos https://observatorioddmm.uv.cl/

U.S. Department of health al human services. FDA. MAUDE - Manufacturer and User Facility Device Experience. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm

ECRI. Emergency Care Research Institute. https://www.ecri.org/