Review Article

Intensive Care Unit Risk Assessment: A Systematic Review


Background: It is of paramount importance to reduce the probability of clinical risks to improve the quality of health care services, make the relationship between service providers and patients more effective, enhance patient satisfaction, and decrease the rate of complaints regarding medical errors in hospitals. This study aimed at detecting potential and unacceptable risks occurring in the hospital ICUs.

Methods: In this systematic review, all studies examining the risk assessment of ICUs in hospitals using Failure Mode and Effect Analysis method were reviewed. Google scholar, PubMed, Scopus, SID, Magiran and Web of Science databases were searched to find relevant articles published from 1980 to 2019.

Results: The most frequent failures detected in the reviewed articles consisted of high risk of infection inwards for medical and nursing operations, high infection rates inwards for medical devices’ operation within the unit, and early discharge. Moreover, the processes through which potential high-risk Failures were examined in these studies were injection or prescription process, suction process, the process of inserting or removing endotracheal tubes, the process of transferring patients from the operation room to the unit or vice versa, pressure ulcers, and processes related to the medical devices’ operation.

Conclusion: There are many possible reasons for failure occurring throughout these processes, and the failure modes occurring in these processes are more probable to cause serious damages to patients, have high repeatability with low probability of failure detection as the failures cannot be discovered by the personnel.

1. Lotfalipour M, Falahi M, Borji M (2012). The effects of Health Indices on Economic Growth in Iran. jha, 14(46): 57-70.
2. Nopasand Asil M, Dostar M, Haji Ali Asgary M (2016). An Investigationinto the Relationship Between Hospital Information System and Hospital Performance by Patient Satisfaction at Rasht Hospitals. Journal of Guilan University of Medical Sciences, 25(98):51-60.
3. Gunning K, Rowan K (1999). Outcome data and scoring systems. BMJ, 319:241.
4. Petrie D, Tang KK (2008). A rethink on measuring health inequalities using the Gini coefficient.
5. Esfahani K, Seyed mazhari M (2016). The importance of developing hospital critical care beds number in health system. Journal of Nursing Faculty of Army of Islamic Republic of Iran, 1(2):54-9.
6. Chiozza ML, Ponzetti C (2009). FMEA: a model for reducing medical errors. Clin Chim Acta, 404(1):75-8.
7. Morelli P, Vinci A, Galetto L, et al (2007). FMECA methodology applied to two pathways in an orthopaedic hospital in Milan. J Prev Med Hyg, 48(2):54-9.
8. Ministry of Health and Medical Education (2019). Comprehensive Guide to National Accreditation Standards for Iranian Hospitals. 4th ed: pp: 144-54.
9. Duwe B, Fuchs BD, Hansen-Flaschen J (2005). Failure mode and effects analysis application to critical care medicine. Crit Care Clin, 21(1):21-30.
10. Cantone MC, Ciocca M, Dionisi F, et al (2013). Application of Failure Mode and Effects Analysis to Treatment Planning in Scanned Proton Beam Radiotherapy. Radiat Oncol, 8:127.
11. Attar JNN, Yousefinezhadi T, Behzadi GF , et al (2015). Clinical risk assessment of intensive care unit by failure mode and effects analysis. JHOSP, 14(2):49-59
12. Asemi A, Safari A, Zavareh AA (2011). The role of management information system (MIS) and Decision support system (DSS) for manager’s decision making process. IJBM, 6(7):164-73.
13. Ghanjal A, Sedaghat A, Motaqhey M, et al (2008). Risk management and assessment of field emergency center using FMEA method. J Mil Med, 10(3):167-174.
14. Kolich M (2014). Using Failure Mode and Effects Analysis to design a comfortable automotive driver seat. Appl Ergon,45(4):1087-96.
15. Van Tilburg C, Leistikow I, Rademaker C, et al (2006). Health care failure mode and effect analysis: a useful proactive risk analysis in a pediatric oncology ward.Qual Saf Health Care, 15(1):58-63.
16. Tofighi SH, Hafezimoghadam P, Maleki M, et al (2010). Risk assessment of processes of rasoule akram emergency department by the failure mode and effects analysis (FMEA) methodology. Hakim Research Journal, 13(3):165-76.
17. Marzban S, Moeini Naini M, Ardehali Sh, et al (2017). Planning the Patient Safety Management System Using Failure Mode and Effect Analysis in ICU Care: A Case Study in Loghman Hakim Hospital Shahid Beheshti University of Medical Sciences in Tehran city. Hospital Journal, 16(1):81-91.
18. Hosseainrezei H, Borji E, Imanmirzadi S , et al (2015). A study on the rate and the types of hospital infection in the trauma ICU departments of Kerman hospitals in the first half of 1393. JOURNAL OF IRANIAN SOCIETY ANAESTHESIOLOGY AND INTENSIVE CARE, 37(91):167-71.
19. Moreno RV, Riera JS-I, Álvarez EM, et al (2016). Improvement of the safety of a clinical process using failure mode and effects analysis: Prevention of venous thromboembolic disease in critical patients. Med Intensiva, 40(8):483-90.
20. Cook D, Crowther M, Meade M, et al (2005). Deep venous thrombosis in medical-surgical critically ill patients: prevalence, incidence, and risk factors. Crit care med, 33(7):1565-71.
21. Geerts WH, Pineo GF, Heit JA, et al (2004). Prevention of venous thromboembolism: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest, 126(3): 338S-400S.
22. Askari R, Shafii M, Rafiei S, et al (2017). Failure mode and effect analysis: improving intensive care unit risk management processes. Int J Health Care Qual Assur, 30(3):208-215.
23. Yarmohammadian MH, Jafarian JM, Khorasani E (2014). Risk, Causes and Preventive Action Assessment in the ICU of a Teaching Hospital. HEALTH INFORMATION MANAGEMENT, 11(5): 633-644
24. Yousefinezhadi T, Nobari FAJ, Goodari FB (2016). A case study on improving intensive care unit (ICU) services reliability: by using process failure mode and effects analysis (PFMEA). Glob J Health Sci, 8(9):52635.
25. Li X, He M, Wang H (2017). Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit. Medicine (Baltimore), 96(51): e9339.
26. Vázquez-Valencia A, Santiago-Sáez A, Perea-Pérez B, et al (2017). Utility of failure mode and effect analysis to improve safety in suctioning by orotracheal tube. J Perianesth Nurs, 32(1):28-37.
27. Al Tehewy M, El Hosseini M, Habil I, et al (2015). A proactive risk management using failure mode and effects analysis for infusion therapy in a tertiary hospital intensive care unit in Egypt. Acta Medica Mediterranea, 31: 195-200.
28. Vafaee Najar A, Ghane H, Ebrahimipour H, et al (2016). Identification of priorities for medication safety in the neonatal intensive care unit via failure mode and effect analysis. IJN, 7(2):28-34.
29. Apkon M, Leonard J, Probst L, et al (2004). Design of a safer approach to intravenous drug infusions: failure mode effects analysis. Qual Saf Health Care, 13(4):265-271.
30. Sanchez-Izquierdo-Riera JA, Molano-Alvarez E, Saez-de la Fuente I, et al (2016). Safety management of a clinical process using failure mode and effect analysis: continuous renal replacement therapies in intensive care unit patients. ASAIO J, 62(1):74-9.
31. Daverio M, Fino G, Luca B, et al (2015). Failure mode and effective analysis ameliorate awareness of medical errors: a 4‐year prospective observational study in critically ill children. Paediatr Anaesth, 25(12):1227-34.
32. Esmail R, Cummings C, Dersch D, et al (2005). Using Healthcare Failure Mode and Effect Analysis tool to review the process of ordering and administrating potassium chloride and potassium phosphate. Healthc Q, 73-80.
33. De Giorgi I, Fonzo-Christe C, Cingria L, et al (2010). Risk and pharmacoeconomic analyses of the injectable medication process in the paediatric and neonatal intensive care units. Int J Qual Health Care, 22(3):170-8.
34. Vafaee Na, Ghane H, Hooshmand E, et al (2016). A study on the analysis of errors and their effects for evaluating the processes of prescribing and consuming drugs in icu for the burns. Journal of North Khorasan University of Medical Sciences , 8(3): 507-521
35. Dennison RD (2007) . A medication safety education program to reduce the risk of harm caused by medication errors. J Contin Educ Nurs, 38(4):176-84.
36. Armitage G, Knapman H (2003). Adverse events in drug administration: a literature review. Journal of Nursing Management, 11(2):130-140.
37. Moyen E, Camiré E, Stelfox HT (2008). Clinical review: medication errors in critical care. Crit Care, 12(2):208.
38. Asefzadeh S, Yarmohammadian MH, Nikpey A, et al (2013). Clinical risk assessment in intensive care unit. Int J Prev Med, 4(5): 592–598.
39. McElroy LM, Collins KM, Koller FL,, et al (2015). Operating room to intensive care unit handoffs and the risks of patient harm. Surgery, 158(3):588-94.
40. Habibzadeh F, Imanipour M, Mohammad Aliha J,, et al (2014). Effect of applying checklist on quality of intra-hospital transport of intensive care patients. Iranian Journal of Cardiovascular Nursing, 3(3):30-7.
41. Shahin ES, Dassen T, Halfens RJ (2008). Pressure ulcer prevalence in intensive care patients: a cross‐sectional study. J Eval Clin Pract, 14(4):563-8.
42. Bansal C, Scott R, Stewart D,, et al (2005). Decubitus ulcers: a review of the literature. Int J Dermatol, 44(10):805-10.
IssueVol 49 No 8 (2020) QRcode
SectionReview Article(s)
Intensive care unit (ICU) Failure mode and effect analysis; Risk assessment

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How to Cite
HOMAUNI A, ZARGAR BALAYE JAME S, HAZRATI E, MARKAZI-MOGHADDAM N. Intensive Care Unit Risk Assessment: A Systematic Review. Iran J Public Health. 2020;49(8):1422-1431.