Los dispositivos médicos fallan, claro, pero ¿con qué frecuencia? síntesis de reportes de Estados Unidos el año 2022

Sebastián Lobos A; Pablo Reyes; Alexis  Arriola; Scarlett  Lever; Stéren Chabert

doi:10.5354/2452-5839.2023.70426

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

Authors

Sebastián Lobos A Universidad de Valparaíso https://orcid.org/0000-0002-4870-0474
Pablo Reyes Universidad de Valparaíso https://orcid.org/0000-0001-8218-9852
Alexis Arriola Universidad de Valparaíso https://orcid.org/0009-0002-5949-5549
Scarlett Lever Universidad de Valparaíso https://orcid.org/0009-0001-3161-3980
Stéren Chabert Universidad de Valparaíso https://orcid.org/0000-0002-2890-5077

Vol. 5 No. 2 (2023)

https://doi.org/10.5354/2452-5839.2023.70426

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/

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How to Cite

Lobos A, S., Reyes, P., Arriola, A. ., Lever, S. ., & Chabert, S. (2023). Medical devices fail, sure, but how often? synthesis of reports from the United States in 2022. Revista Chilena De Enfermería, 5(2), 4–6. https://doi.org/10.5354/2452-5839.2023.70426