Adverse Event Management Tool for Hospitals: A Game-Changer for Patient Safety

Abstract:

As medical technology continues to advance, concerns about associated risks to both patients and healthcare providers arise. Ensuring high-quality healthcare delivery stands as a paramount objective for every healthcare institution. Among the essential attributes required to meet this goal is the safety of all stakeholders. Nevertheless, numerous instances arise wherein unintended incidents occur involving healthcare personnel during the delivery of patient care. This study utilized a mixed-methods approach incorporating interviews, observations, and statistical analysis to investigate the occurrence of adverse events related to medical equipment in hospitals. The findings reveal that, despite 84% of surveyed nursing personnel indicating no experience with adverse events caused by medical equipment, factors such as inadequate preventive maintenance, lack of training, budget constraints, and staff shortages support the need for the development of patient safety support tools, as all the aforementioned factors increase the likelihood of unintentional errors during patient care. Based on these findings, a tailored reporting tool was developed to streamline the documentation of equipment failures and adverse events within hospitals. Designed based on identified needs and characteristics, this tool aims to facilitate timely notification of critical events, especially those with the potential to impact patient safety.

• Periodical: Journal of Biomimetics, Biomaterials and Biomedical Engineering (Volume 66)
• Pages: 93-104
• DOI: https://doi.org/10.4028/p-6Gqip0
• Online since: September 2024
• Authors: Reyna Valle*, Gabriela Cribas, Ana Laura Ramírez
• Keywords: Adverse Event, Failures, Medical Device, Technology Surveillance

References

[1] The Dalkon Shield. FDA Consum. 1975 Feb;9(1):21. PMID: 10308671.

[2] Information on the World Health Organization. (2019). Retrieved from https://www.who.int/es/news-room/fact-sheets/detail/patient-safety#:~:text=Los%20eventos%20adversos%20debidos%20a,recibe%20atenci%C3%B3n%20hospitalaria%20(2)

[3] Kohn, L. T. (2000). To Err Is Human: Building a Safer Health System. Washington, DC.

[4] Maria Pilar Astier-Peña. (2021). El Plan de acción mundial para la seguridad del paciente 2021-2030: identificando acciones para una atención primaria más segura. ELSEVIER

DOI: 10.1016/j.aprim.2021.102224

[5] Information on CONAMED. (2015). Conamed-OPS. Retrieved from http://www.conamed.gob.mx/gobmx/boletin/pdf/boletin3/eventos_adversos.pdf

[6] Vries, E. N. (2008). The incidence and nature of in-hospital adverse events: a systematic review. Qual Saf Health Care

[7] Improving Health Care Worldwide. (2018). Crossing the Global Quality Chasm.

[8] Gutierrez, I. (2006). Efectos Adversos en una Unidad de Cuidados Intensivos. Retrieved from https://zaguan.unizar.es/record/4549/files/TESIS-2010-024.pdf

[9] González Vargas, A. M. (2017). La Tecnovigilancia y la Gestión de Riesgos como Herramientas para Mejorar Seguridad de los Pacientes en las Instituciones de Salud Colombianas. Revista Ingeniería Biomédica

DOI: 10.24050/19099762.n21.2017.1173

[10] Noble. (2015). Los 10 Principales Peligros Tecnológicos del Sector Salud. Retrieved from http://asegurados.descargas.nobleseguros.com/download/posts/November2017/ew4T3VTWGtK7WpG60fEH.pdf

[11] Anders, J. C. (2019). Facilities and Difficulties of Health Professionals Regarding the Adverse Event Reporting Process. Scielo

DOI: 10.1590/1980-265X-TCE-2018-0040

[12] Pimentel, A. C. (2019). La notificación y análisis de los eventos adversos: experiencia en el HONADOMANI San Bartolomé. Scielo

DOI: 10.31403/rpgo.v65i2151

[13] OMS. (2016). Retrieved from https://www.who.int/publications/i/item/WHO-HIS-SDS-2016.2

[14] Guijarro, F. (2015). Manual de Tecnovigilancia.

[15] Agencia Española de Medicamentos y Productos Sanitarios. (2022). Ministerio de Salud. Retrieved from https://www.aemps.gob.es/la-aemps/quienes-somos/

[16] Agencia Española de Medicamentos y Productos Sanitarios. (2019). Retrieved from https://www.aemps.gob.es/vigilancia/productosSanitarios/docs/vig-prof-nota.pdf?x42382

[17] Agencia Española de Medicamentos y Productos Sanitarios. (2016). Ministerio de sanidad, consumo y bienestar social. Retrieved from https://www.aemps.gob.es/publicaciones/tripticos-divulgativos/docs/TRIPTICO_VIGILANCIA_PPSS.pdf?x42382

[18] Aranaz, J. (2005). Estudio Nacional sobre los Efectos Adversos ligados a la Hospitalización. Retrieved from https://seguridaddelpaciente.es/resources/contenidos/castellano/ 2006/ENEAS.pdf

[19] Menéndez, M., Rancaño, & García, V. (2010). Uso de diferentes sistemas de notificación de eventos adversos: ¿mucho ruido y pocas nueces? doi:

DOI: 10.1016/j.cali.2010.02.001

[20] Rojas-Armadillo, M., Jiménez, M., Chávez-Hernández, M., & Fondón, A. (2015). Validación de un sistema de registro de eventos adversos en atención primaria. Retrieved from https://www.medigraphic.com/pdfs/imss/im-2016/im163j.pdf

[21] COFEPRIS. (2017). Retrieved from https://www.gob.mx/cofepris/acciones-y-programas/antecedentes-tecnovigilancia

[22] Mucito-Varela, E., & Sánchez-Oviedo, F. V. (2020). Tecnovigilancia en los laboratorios clínicos: una herramienta para la seguridad del paciente. doi:

DOI: 10.35366/97337

[23] Instituto de Salud Pública de Chile. (2022). Instituto de Salud Pública. Retrieved from https://www.ispch.gob.cl/andid/tecnovigilancia/

DOI: 10.34052/rispch.v6i1

[24] Pacheco, M., Donoso, P., & Valdés León, C. (2021). Guía del Sistema Nacional de Tecnovigilancia. Retrieved from https://www.ispch.cl/wp-content/uploads/2021/02/ GuiaTecnovigilancia01-01022021A.pdf

[25] Administración de Alimentos y Medicamentos. (2022). Medical Device Reporting (MDR): How to Report Medical Device Problems. Retrieved formhttps://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems

DOI: 10.1887/0750307684/b1067b4

[26] Cáceres, Y. (2022). Ex director de ARSA. (A. Ramírez, & G. Cribas, Entrevistadores)

[27] Otero-Ortega, A. (2018). Enfoques de Investigación. Retrieved from https://www.researchgate.net/publication/326905435_ENFOQUES_DE_INVESTIGACION

[28] Díaz Bravo, L., Torruco García, U., Martínez Hernández, M., & Varela Ruiz, M. (2013). La entrevista, recurso flexible y dinámico. Retrieved from https://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S2007-50572013000300009#:~:text=La%20entrevista%20es%20una%20t%C3%A9cnica,al%20simple%20hecho%20de%20conversar.&text=Es%20un%20instrumento%20t%C3%A9cnico%20que%20adopta%20la%20forma%20de%20un%20.

DOI: 10.1016/s2007-5057(13)72706-6

[29] Information amoCRM (2012). Retrieved from https://www.amocrm.com.co/index.html