Seguridad del Paciente en Medicina Intensiva. Aspectos bioéticos
DOI:
https://doi.org/10.1344/rbd2020.48.28605Keywords:
seguridad del paciente, medicina intensiva, segundas víctimas, información, evento adversoAbstract
La Seguridad del Paciente se ha convertido en un reto y en una prioridad de todos los sistemas sanitarios. Se ha implantado políticas internacionales con el objetivo de reducir el número de incidentes relacionados con Seguridad del Paciente. Todavía son muchos los pacientes que sufren daños derivados de la atención sanitaria. Además, su impacto se extiende no solo a los familiares y allegados, sino también a los propios profesionales, a las instituciones sanitarias y todo ello con un coste económico y emocional con importantes consecuencias para todos los implicados. La mayoría de estudios realizados han ido dirigidos a conocer la epidemiología de los eventos adversos, a conocer sus causas y sus consecuencias. Se han promovido numerosas prácticas seguras con el objetivo de reducir los riesgos relacionados con la atención sanitaria. Recientemente han cobrado mayor relevancia aspectos relacionados con la actuación posterior a un evento adverso (EA). La gestión del riesgo implica entre otras acciones, la identificación, notificación y el análisis de los EA que señalen los fallos latentes en el sistema y la causa raíz con el objetivo último de establecer acciones de mejora y evitar su recurrencia. De forma paulatina estas estrategias se han ido incorporando en las políticas institucionales y mejorando con ello la cultura de seguridad. Pero todavía existen partes del proceso, que en nuestro ámbito se encuentran en su etapa más inicial, tales como el proceso de información sobre los EA a los pacientes y sus familiares y el soporte a los profesionales tras verse implicados en un EA. Todo ello debe construirse en un marco de confianza y credibilidad.
References
[1] World Alliance for Patient Safety. Disponible en: (último acceso abril 2019). http://www.who.int/patientsafety/en
[2] James JT. A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care: J Patient Saf. septiembre de 2013;9(3):122-8.
[3] De Vries EN, Ramrattan MA, Smorenburg SM, et al. The incidence and nature of in-hospital adverse events: a systematic review. BMJ Qual Saf. 2008;17:216–23.2.
[4] Making Health Care Safer II - An Updated Critical Analysis of the Evidence for Patient Safety Practices. Disponible en: (último acceso abril 2019) http://www.ahrq.gov/research/findings/evidence-based-reports/ptsafetyuptp.html
[5] Merino P, Álvarez J, Cruz Martín M, et al; SYREC Study Investigators. Adverse events in Spanish intensive care units: the SYREC study. Int J Qual Health Care. 2012;24:105-13.
[6] Valentin A, Capuzzo M, Guidet B, et al.; Research Group on Quality Improvement of European Society of Intensive Care Medicine. Patient safety in in- tensive care: results from the multinational Sentinel Events Evaluation (SEE) study. Intensive Care Med. 2006;32:1591-8.
[7] Valentin A, Capuzzo M, Guidet B, et al.; Research Group on Quality Improvement of the European Society of Intensive Care Medicine (ESICM); Sentinel Events Evaluation (SEE) study Investigators. Errors in administration of parenteral drugs in intensive care units: multinational prospective study. BMJ. 2009; 338:814.
[8] Garrouste-Orgeas M, Timsit JF, Vesin A, et al.; OUTCOMEREA Study Group. Selected medical errors in the intensive care unit: results of the IATROREF study, parts I and II. Am J Respir Crit Care Med. 2010;181:134-42.
[9] Anglés Coll R, Fernández Dorado F. Editores. Conferencia de expertos de la SOCMIC. Seguridad del paciente crítico. Merino de Cos P. Incidentes sin daño y eventos adversos en Medicina Intensiva. Edikamed. 2014; 25-34.
[10] SEMICYUC. Indicadores de calidad del enfermo crítico. 2017. http://www.semicyuc.org/sites/default/files/indicadoresdecalidad2017_semicyuc_spa.pdf
[11] Hernández-Tejedor A, Peñuelas O, Sirgo Rodríguez G, Llompart-Pou JA, Palencia Herrejón E, Estella A, et al. Recommendations of the Working Groups from the Spanish Society of Intensive and Critical Care Medicine and Coronary Units (SEMICYUC) for the management of adult critically ill patients. Med Intensiva. 2017;41(5):285-305.
[12] Palomar M, Álvarez-Lerma F, Riera A, Díaz MT, Torres F, Agra Y, et al; Bacteremia Zero Working Group. Impact of a national multimodal intervention to prevent catheter-related bloodstream infection in the ICU: the Spanish experience. Crit Care Med. 2013;41(10):2364-72.
[13] Álvarez-Lerma F, Palomar-Martínez M, Sánchez-García M, Martínez-Alonso M, Álvarez-Rodríguez J, Lorente L, et al. Prevention of Ventilator-Associated Pneumonia: The Multimodal Approach of the Spanish ICU "Pneumonia Zero" Program. Crit Care Med. 2018;46(2):181-8.
[14] Gordo F, Molina R. Evolution to the early detection of severity. Where are we going? Med Intensiva. 2018;42(1):47-9.
[15] Extremera P, Añón JM, García de Lorenzo A. Are outpatient clinics justified in intensive care medicine? Med Intensiva. 2018;42(2):110-3.
[16] Martin Delgado MC, Cabré Pericas LL. Aspectos éticos y legales sobre la Seguridad del Paciente. Revista de Bioética y Derecho 2009 15:6-14. Disponible en: (último acceso abril 2019) http://www.ub.edu/fildt/revista/pdf/RByD15_ArtMartin&Cabre.pdf
[17] Aranaz JM, Mira JJ, Guilabert M, Herrero JF, Vitaller J y Grupo de Trabajo Segundas Víctimas. Repercusión de los eventos adversos en los profesionales sanitarios. Estudio sobre las segundas víctimas. Trauma Fund MAPFRE. 2013;24:54–60.
[18] Astier-Peña MP, Romeo Casanoba CM, Urruela Mora A. Tendiendo puentes entre la regulación jurídica y cultura de seguridad del paciente en el Sistema Nacional de Salud. J. healthc. qual. res. 2018;33(2):65-67.
[19]Astier-Peña MP, Olivera-Cañadas G. [The challange of upholding the culture of patient safety in the health institutions]. An Sist Sanit Navar. 2017 Apr 30;40(1):5-9.
[20] Nieva VF, Sorra J. Institute of Medicine. To err is human: building a safer health system. Safety culture assessment: a tool for improving patient safety in healthcare organizations. Qual Saf Health Care 2003; 12 (suppl II): ii17-ii23.
[21] Joint Comisión on Accreditation of Healthcare Organization. Comprehensive Accreditation Manual for Hospitals: The Official Handbook Illinois: JCHO 2004.
[22] Martín Delgado MC , Fernández Mailló M , Anglés i Coll R , Palencia Herrejón E , Catalán Ibars, RM Díaz-Alersi Rosety R , Gómez Tello V , Cabré i Pericas Ll Información de eventos adversos a pacientes y familiares. Trauma Fund MAPFRE. Trauma Fund MAPFRE (2013) Vol 24 nº 4:239-248.
[23] O’Connor E, Coates HM, Yardley IE, et al. Disclosure of patient safety incidents: a comprehensive review. Int J Qual Health Care. 2010;22:371.
[24] Un proyecto de la Fundación ABIN, la Fundación ACPASIM y la Federación Europea de Medicina Interna. La profesión médica en el nuevo milenio: estatutos para la regulación de la práctica médica. Med Clínica (Barc) 2002;118:704-6.
[25] Delbanco T, Bell SK. Guilty afraid, and alone---struggling with medical error. N Engl J Med. 2007;357:1682-3.
[26] Cleopas A, Villaveces A, Charvet A, Bovier PA, Kolly V, Perneger TV. Patient assessments of a hypothetical medicalerror: Effects of health outcome, disclosure, and staff responsiveness. Qual Saf Health Care. 2006;15:136-41.
[27] Helmchen LA, Richards MR, McDonald TB. How does routine disclosure of medical error affect patients’ propensity to sue and their assessment of provider quality? Evidence from survey data. Med Care. 2010;48:955-61.
[28] Wojcieszac D. Sorry works: Disclosure, apology and relationships prevent medical malpractice. Bloomington: AuthorHouse; 2007.
[29] Mazor KM, Simon SR, Gurwitz JH. Communicating with patients about medical errors: A review of the literature. Arch Intern Med. 2004;164:1690-7.
[30] Garbutt J, Brownstein DR, Klein EJ, Waterman A, Krauss MJ, Marcuse EK, et al. Reporting and disclosing medical errors: Pediatricians’ attitudes and behaviors. Arch Pediatr Adolesc Med. 2007;161:179-85.
[31] Gallagher TH, Garbutt JM, Waterman AD, Flum DR, Larson EB, Waterman BM, et al. Choosing your words carefully: How physicians would disclose harmful medical errors to patients. Arch Intern Med. 2006;166:1585-93.
[32] Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patients’ and physicians’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001-7.
[33] Manser T, Staender S. Aftermath of an adverse event: Supporting health care professionals to meet patient expectations through open disclosure. Acta Anaesthesiol Scand. 2005;49: 728-34.
[34] Bark P, Vincent C, Olivieri L, Jones A. Impact of litigation on senior clinicians: Implications for risk management. Qual HealthCare. 1997;6:7-13.
[35] Aasland OG, Førde R. Impact of feeling responsible for adverse events on doctors’ personal and professional lives: The importanceof being open to criticism from colleagues. Qual Saf Health Care. 2005;14:13-7.
[36] Kaldjian LC, Forman-Hoffman VL, Jones EW, Wu BJ, Levi BH, Rosenthal GE. Do faculty and resident physicians discuss their medical errors? J Med Ethics. 2008;34:717-22.
[37] Kaldjian LC, Jones EW, Wu BJ, Forman-Hoffman VL, Levi BH, Rosenthal GE. Disclosing medical errors to patients: Attitudes and practices of physicians and trainees. J Gen Intern Med. 2007;22:988-96.
[38] Kaldjian LC, Jones EW, Rosenthal GE. Facilitating and impeding factors for physicians’ error disclosure: A structured literature review. Jt Comm J Qual Patient Saf. 2006;32:188-98.
[39] Gallagher TH, Waterman AD, Ebers AG, Fraser VJ, Levinson W. Patient’s and physicians’ attitudes regarding the disclosure of medical errors. JAMA. 2003;289:1001–7.
[40]Mira JJ, Lorenzo S; en nombre del Grupo de Investigación en Segundas Víctimas. [Something is wrong in the way we inform patients of an adverse event].Gac Sanit. 2015 Sep-Oct;29(5):370-4.
[41] White AA, Gallagher TH, Krauss MJ, Garbutt J, Waterman AD, Dunagan WC, et al. The attitudes and experiences of trainees regarding disclosing medical errors to patients. Acad Med. 2008;83:25-6.
[42] Stroud L, McIlroy J, Levinson W. Skills of internal medicine residents in disclosing medical errors: A study using standardized patients. Acad Med. 2009;84:1803-8.
[43] Vincent JL. European attitudes towards ethical problems in intensive care medicine: Results of an ethical questionnaire. Intensive Care Med. 1990;16:256-64.
[44] Iedema RA, Mallock NA, Sorensen RJ, Manias E, Tuckett AG, Williams AF, et al. The National Open Disclosure Pilot: Evaluation of a policy implementation initiative. Med J Aust. 2008;188:397-400.
[45] Studdert, Richardson M. Legal aspects of open disclosure: a review of Australian law. MJA 2010; 193:273-6.
[46] Mastroianni AC, Mello MM, Sommer S, Hardy M, Gallagher TH. The flaws in state 'apology' and 'disclosure' laws dilute. Their intended impact on malpractice suits. Health Aff (Millwood). 2010; 29:1611-9.
[47] Saitta N, Hodge SD. Efficacy of a physician’s words of empathy: An overview of state apology laws. JAQA. 2012;112:5.
[48] Barraclough BH, Birch J. Health care safety and quality: where have we been and where are we going? Med J Aust 2006; 184(Suppl 10):S48-50.
[49] Kachalia A, Shojania KG, Hofer TP, Piotrowski M, Saint S. Does full disclosure of medical errors affect malpractice liability? The jury is still out. Jt Comm J Qual Saf 2003; 29:503-11.
[50] Kachalia A, Kaufman SR, Boothman R, Anderson S, Welch K, Saint S, et al. Liability claims and costs before and alter implementation of a medical error disclosure program. Ann Intern Med 2010; 153:213-21.
[51] Ley 41/2002, de 12 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. L. n.o 41/2002 (12 de noviembre de 2002).
[52] Romeo Casabona CM, Urruela Mora A, Libano Beristain A. Establecimiento de un sistema nacional de notificación y registro de incidentes y eventos adversos: aspectos legales. Tensiones y posibles conflictos de lege data: primer informe, marzo 2007. Madrid: Ministerio de Sanidad y Consumo; 2007.
[53] Wu AW. Medical error: the second victim. The doctor who makes the mistake needs help too. BMJ. 2000; 320(7237): 726-727.
[54] Scott SD, Hirschinger LE, Cox KR, McCoig M, Brandt J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care. 2009; 18(5): 325-330.
[55] Edrees HH, Paine LA, Feroli ER, Wu AW. Health care workers as second victims of medical errors. Pol Arch Med Wewn. 2011; 121: 101-108.
[56] Clarkson MD, Haskell H, Hemmelgarn C, Skolnik PJ. Abandon the term "second victim". BMJ. 2019 Mar 27;364:l1233.
[57] Aranaz-Andrés JM, Aibar-Remón C, Vitaller-Murillo J, Ruiz-López P, Limón-Ramírez, Terol-García E, et al. Incidence of adverse events related to health care in Spain: results of the Spanish National Study of Adverse Events. J Epidemiol Community Health. 2008;62(12):1022-9.
[58] Mira JJ, Carrillo I, Lorenzo S, Ferrús L, Silvestre C, Pérez-Pérez P, Olivera G, Iglesias F, Zavala E, Maderuelo-Fernández JÁ, Vitaller J, Nuño-Solinís R, Astier P; Research Group on Second and Third Victims.The aftermath of adverse events in Spanish primary care and hospital health professionals. BMC Health Serv Res. 2015 Apr 9;15:151. doi: 10.1186/s12913-015-0790-7.
[59] Seys D, Scott SD, Wu AW, et al. Supporting involved health care professionals (second victims) following an adverse health event: a literature review. Int J of Nurs Stud. 2013; 50: 678-687.
[60] Gómez-Durán EL, Vizcaíno-Rakosnik M, Martin-Fumadó C, Klamburg J, Padrós-Selma J, Arimany-Manso J. Physicians as second victims after a malpractice claim: An important issue in need of attention. J Healthc Qual Res. 2018 Sep - Oct;33(5):284-289.
[61] Mira JJ, Lorenzo S, Carrillo I, Ferrús L, Pérez-Pérez P, Iglesias F, Silvestre C, Olivera G Zavala E, Nuño-Solinís R, Maderuelo-Fernández JÁ, Vitaller J, Astier P; Research Group on Second and Third Victims. Interventions in health organisations to reduce the impact of adverse events in second and third victims. BMC Health Serv Res. 2015 Aug 22;15:341. doi: 10.1186/s12913-015-0994-x.
[62] Conway J, Federico F, Stewart K, Campbell M. Respectful management of serious clinical adverse events. IHI Innovation Series white paper. Cambridge, Massachusetts: Institute for Healthcare Improvement 2011. www.IHI.org.
[63] Scott SD. Three‑tiered Emotional Support System generates positive feedback from providers who become “Second Victims” of an unanticipated clinical event. AHRQ Health care innovations exchange 2010.
[64] Burlison JD1, Scott SD, Browne EK, Thompson SG, Hoffman JM.The Second Victim Experience and Support Tool: Validation of an Organizational Resource for Assessing Second Victim Effects and the Quality of Support Resources. J Patient Saf. 2014 Aug 26.
[65] Scott S, Hirschinger L, Cox K, McCoig M, Brand J, Hall LW. The natural history of recovery for the healthcare provider “second victim” after adverse patient events. Qual Saf Health Care. 2009;18:325–30.
[66] Martín-Delgado MC. Seguridad y bioética. En: Luis Cabré. Bioética y Medicina Intensiva. Thomson Reuters. Editorial Aranzadi. 2012. Pág 169-193M ISBN 978-84-470-3940-1.
[67] Martín-Delgado MC, Fernández-Maillo M, Bañeres-Amella J, Campillo-Artero C, Cabré-Pericas L, Anglés-Coll R, Gutiérrez-Fernández R, Aranaz-Andrés JM, Pardo-Hernández A, Wu A.[Consensus conference on providing information of adverse events to patients and relatives].Rev Calid Asist. 2013 Nov-Dec;28(6):381-9.
[68] Ministerio de Sanidad, Servicios Sociales e Igualdad. Estrategia de Seguridad del Paciente del Sistema Nacional de Salud. Periodo 2015-2020. http://www.seguridaddelpaciente.es/es/informacion/publicaciones/2015/estrategia-seguridad-del-paciente-2015-2020/
[69] Sistema Español de Notificación en Seguridad en Anestesia y Reanimación (SENSAR). [Recommendations for institutional response to an adverse event].Rev Calid Asist. 2015 Sep 17. pii: S1134-282X(15)00109-8. doi: 10.1016/j.cali.2015.07.001. [Epub ahead of print
[70] Recomendaciones para ofrecer una adecuada respuesta al paciente tras la ocurrencia de un evento adverso y atender a las segundas y terceras víctimas https://www.seguridaddelpaciente.es/resources/documentos/2015/Guia-de-recomendaciones_sv-pdf.pdf. Disponible en: (último acceso abril 2019).
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