Healthcare Failure Mode and Effect Analysis (HFMEA) in Reducing Patient Safety Incidents Risk at Hospital: Literature Review


  • Anggika Yelzi Pratiwi Faculty of Public Health, Universitas Indonesia, Depok, West Java, Indonesia
  • Masyitoh Basabih Faculty of Public Health, Universitas Indonesia, Depok, West Java, Indonesia


Healthcare Failure Mode and Effect Analysis (HFMEA), Patient Safety, Risk Management, Literature Review


Patient safety is a priority in hospital services, but patient safety incidents such as adverse events frequently occur in hospitals. Healthcare Failure Mode and Effect Analysis (HFMEA) is one of the hospital’s strategies to reduce patient safety incident risks through risk management. This study aims to describe the use of the HFMEA method in various countries and its role in reducing patient safety incident risks. This study began with searching data using four databases and selecting scientific article sources using the Preferred Reporting Items for Systemic Reviews and Meta-Analysis (PRISMA) method, where 15 articles were found that met the research objectives, inclusion, and exclusion criteria. The result shows that HFMEA has been applied in hospital services and management in various countries. HFMEA reduced the risk of failure and patient safety incidents in the hospital. However, this can be effective if the hospital implements all steps of HFMEA and routine monitoring and evaluation of interventions to prevent the occurrence of patient safety incident risk.


Ismainar H. Keselamatan Pasien Di Rumah Sakit [Internet]. Deepublish. 2019 [cited 2023 May 11]. Available from:

Nur Sa’adah Nashifah, Agus Aan Adriansyah. Analisis Pelaporan Insiden Keselamatan Pasien: Studi Kasus di RS Islam Jemursari Surabaya. MOTORIK Journal Kesehatan. 2019; [Internet]. 2019 [cited 2023 May 23]; Available from:

Pertiwiwati E, Wibowo H, Fakhrudin M, Arif MN, Pratiwi AA, Akmal MF. Efektifitas Penggunaan Metode Health Care Failure Mode And. 2023;8(April):101–9.

Jain K. Use of failure mode effect analysis (FMEA) to improve medication management process. Int J Health Care Qual Assur [Internet]. 2017 [cited 2023 Sep 3];30(2):175–86. Available from:

World Health Organization. Towards eliminating avoidable harm health care [Internet]. Global patient safety action plan 2021–2030. 2021. 1689–1699 p. Available from:

Joint Commission International (JCI). Survey Process Guide for Hospitals [Internet]. 2021. 424 p. Available from:

Komisi Akreditasi Rumah Sakit. Instrumen Survei Akreditasi KARS sesuai Standar Akreditasi RS Kemenkes RI 2022. 2022. 317.

Raymond J. Mikulak, Robin McDermott MB. The Basics of FMEA 2nd Edition [Internet]. CRC Press. 2008 [cited 2023 May 11]. Available from:

VHA National Center for Patient Safety (NCPS). Healthcare Failure Modes and Affects Analysis (HFMEA) Guidebook. 2021.

Liu HC, Chen XQ, Duan CY, Wang YM. Failure mode and effect analysis using multi-criteria decision making methods: A systematic literature review. Comput Ind Eng. 2019 Sep 1;135:881–97. Available from DOI: 10.1016/J.CIE.2019.06.055

Shen J, Wang X, Deng D, Gong J, Tan K, Zhao H, et al. Evaluation and improvement the safety of total marrow irradiation with helical tomotherapy using repeat failure mode and effects analysis. Radiation Oncology [Internet]. 2019 [cited 2023 Apr 5]; Available from:

Haroun A, AL- Ruzzieh M, Hussien N, Masa’ad A, Hassoneh R, Abu Alrub G, et al. Using Failure Mode and Effects Analysis in Improving Nursing Blood Sampling at an International Specialized Cancer Center. Asian Pacific Journal of Cancer Prevention [Internet]. 2021 Apr 1 [cited 2023 Apr 5];22(4):1247–54. Available from: DOI:10.31557/APJCP.2021.22.4.1247

Zhafirah Salsabila, Masyitoh,Amal C Sjaaf LP. Healthcare Failure Mode And Effect Analysis Design For Indonesia Hospital Laboratories: A Literature Review. Jurnal Administrasi Kesehatan Indonesia. 2021; Available from:

Utami AS, Fahmy R, Putri ZM. Peran Metode Failure Mode and Effect Analysis (FMEA) terhadap Mutu Pelayanan Rumah Sakit: Systematik Review. Jurnal Ilmiah Universitas Batanghari Jambi. 2020;20(3):2549–4236. Available from doi : 10.33087/jiubj.v20i3.1080

Scorsetti M, Signori C, Lattuada P, Urso G, Bignardi M, Navarria P, et al. Applying failure mode effects and criticality analysis in radiotherapy: lessons learned and perspectives ofenhancement. Radiother Oncol. [Internet]. 2010 Mar [cited 2023 May 15];94(3):367–74. Available from:

Thornton E, Brook OR, Mendiratta-Lala M, Hallett DT, Kruskal JB. Application of Failure Mode and Effect Analysis in a Radiology Department1. DOI: 101148/rg311105018. 2011 Jan 19;31(1).

Bonfant G, Belfanti P, Paternoster G, Gabrielli D, Gaiter AM, Manes M, et al. Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit. J Nephrol. 2010;23(1):111–8. Available from:

Arenas Jiménez MD, Ferre G, Álvarez-Ude F. Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system). Nefrologia. 2017 Nov 1;37(6):608–21. Available from DOI: 10.1016/j.nefro.2017.04.007

Dastjerdi HA, Khorasani E, Yarmohammadian MH, Ahmadzade MS. Evaluating the application of failure mode and effects analysis technique in hospital wards: a systematic review. J Inj Violence Res. 2017 [cited 2023 May 13];9(1):51–60. Available from:

Asefzadeh S, Yarmohammadian MH, Nikpey A, Atighechian G. Clinical Risk Assessment in Intensive Care Unit. Int J Prev Med. [Internet]. 2013 [cited 2023 May 15];4(5). Available from:

Alba Mesa F, Angel Sanchez Hurtado M, Miguel Sanchez Margallo F, Gomez Cabeza de Vaca V, Komorowski AL. Application of Failure Mode and Effect Analysis in Laparoscopic Colon Surgery Training. World J Surg. 2014;

Wardhani V, Andarini S, Sakit Al Huda Banyuwangi R, Timur J, Ilmu Kesehatan Masyarakat B, Kedokteran F, et al. Healthcare Failure Mode And Effect Analysis: Proses Pelayanan Operasi Di Rumah Sakit Healthcare Failure Mode And Effect Analysis: Surgery Care Procedures In Hospital. Jurnal Manajemen Pelayanan Kesehatan. 2012;15(4).

Rosen MA, Sampson JB, Jackson E V., Koka R, Chima AM, Ogbuagu OU, et al. Failure mode and effects analysis of the universal anaesthesia machine in two tertiary care hospitals in Sierra Leone. Br J Anaesth. 2014;113(3):410–5.

Najafpour Z, Hasoumi M, Behzadi F, Mohamadi E, Jafary M, Saeedi M. Preventing blood transfusion failures: FMEA, an effective assessment method. Available from:

Cheng CH, Chou CJ, Wang PC, Lin HY, Kao CL, Su CT. Applying HFMEA to prevent chemotherapy errors. J Med Syst. [Internet]. 2012 Jun 11 [cited 2023 May 16];36(3):1543–51. Available from:

Ashley L, Dexter R, Marshall F, McKenzie B, Ryan M, Armitage G. Improving the Safety of Chemotherapy Administration: An Oncology Nurse-Led Failure Mode and Effects Analysis. Number 6 / November 2011. [Internet]. 2011 Oct 29 [cited 2023 May 16];38(6):E436–44. Available from:

Xu AY, Jagdish Bhatnagar |, Bednarz G, Flickinger J, Arai Y, Vacsulka J, et al. Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery. J Appl Clin Med Phys [Internet]. 2017 [cited 2023 Apr 5];18(6):152–68. Available from:

Martínez CS, Amery L, De Paoli G, Elofsson U, Fureby AM, Kwok S, et al. Examination of the Protein Drug Supply Chain in a Swedish University Hospital: Focus on Handling Risks and Mitigation Measures. J Pharm Sci. [Internet]. 2023 May [cited 2023 May 10]; Available from:

Anjalee JAL, Rutter V, Samaranayake NR. Application of failure mode and effects analysis (FMEA) to improve medication safety in the dispensing process-a study at a teaching hospital, Sri Lanka. BMC Public Health [Internet]. 2021 [cited 2023 Apr 5]; Available from:

Liao CJ, Ho CC. Risk management for outsourcing biomedical waste disposal - using the failure mode and effects analysis. Waste Manag. 2014 Apr 13 [cited 2023 May 16];34(7):1324–9. Available from:

Ofek F, Magnezi R, Kurzweil Y, Gazit I, Berkovitch S, Tal O. Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards. 2016; DOI: 10.1186/s13584-016-0090-7

Teklewold B, Anteneh D, Kebede D, Gezahegn W. Use of failure mode and effect analysis to reduce admission of asymptomatic covid-19 patients to the adult emergency department: An institutional experience. Risk Manag Healthc Policy [Internet]. 2021 [cited 2023 Apr 5];14:273–82. Available from:

Ullah E, Baig MM, GholamHosseini H, Lu J. Failure mode and effect analysis (FMEA) to identify and mitigate failures in a hospital rapid response system (RRS). Heliyon. 2022 Feb 1;8(2). DOI: 10.1016/j.heliyon.2022.e08944

Levy N, Zucco L, Ehrlichman RJ, Hirschberg RE, Hutton Johnson S, Yaffe MB, et al. Development of Rapid Response Capabilities in a Large COVID-19 Alternate Care Site Using Failure Modes and Effect Analysis with In Situ Simulation. Anesthesiology [Internet]. 2020 Nov 1 [cited 2023 May 18];133(5):985–96. Available from:

Sorrentino P. Use of failure mode and effects analysis to improve emergency department handoff processes. Clinical Nurse Specialist [Internet]. 2016 [cited 2023 May 18];30(1):28–37. Available from:

Simamora H. Manajemen Sumber Daya Manusia. Bagian Penerbitan STIE YPKN; 2018.

Lee H, Lee H, Baik J, Kim HJ, Kim R. Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct. Drug Des Devel Ther. 2017 Oct 19;11:3035–43. doi: 10.2147/DDDT.S145310

Yu X, Gan T, Zhu Y, Cao J, Yang X, Jin B, et al. Healthcare failure mode and effect analysis (HFMEA) for improving the qualification rate of disinfection quality monitoring process. J Infect Public Health. 2020 May 1;13(5):718–23.

Van Hoof V, Bench S, Soto AB, Luppa PP, Malpass A, Schilling M, et al. Failure Mode and Effects Analysis (FMEA) at the preanalytical phase for POCT blood gas analysis: proposal for a shared proactive risk analysis model. Clin Chem Lab Med [Internet]. 2022 [cited 2023 May 5];60(8). Available from:

Plebani M, Sciacovelli L, Aita A, Pelloso M, Chiozza ML. Performance criteria and quality indicators for the pre-analytical phase. Clin Chem Lab Med [Internet]. 2015 May 1 [cited 2023 May 18];53(6):943–8. Available from:

Imani B, Jalal SB. Surgical Technologists’ Live Experiences of Professionalization: A Phenomenological Study. Journal of Qualitative Research in Health Sciences. [Internet]. 2022 Dec 1 [cited 2023 May 18];11(4):231–6. Available from:

Hung SH, Wang PC, Lin HC, Chen HY, Su CT. Integration of Value Stream Map and Healthcare Failure Mode and Effect Analysis into Six Sigma Methodology to Improve Process of Surgical Specimen Handling. Journal of Healthcare Engineering ·. 2015;6(·):377–98. DOI: 10.1260/2040-2295.6.3.377

Clemente F, Faiella G, Rutoli G, Bifulco P, Romano M, Cesarelli M. Critical failures in the use of home ventilation medical equipment. Heliyon. 2019 Dec 1;5(12). doi: 10.1016/j.heliyon.2019.e03034



How to Cite

Pratiwi, A. Y., & Basabih, M. (2023). Healthcare Failure Mode and Effect Analysis (HFMEA) in Reducing Patient Safety Incidents Risk at Hospital: Literature Review. Poltekita : Jurnal Ilmu Kesehatan, 17(2), 459–469.



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