Skip to main content
SpringerLink
Log in

FMEA for Proactive Healthcare Risk Analysis: A Systematic Literature Review

  • Chapter
  • First Online:
Improved FMEA Methods for Proactive Healthcare Risk Analysis

Abstract

FMEA is a valuable reliability management tool that can preemptively identify the potential failures of a system and assess their causes and effects, thereby preventing them from occurring.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 189.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 249.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 249.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  • Abbasgholizadeh Rahimi S, Jamshidi A, Ait-Kadi D, Ruiz A (2015) Using fuzzy cost-based FMEA, GRA and profitability theory for minimizing failures at a healthcare diagnosis service. Qual Reliab Eng Int 31(4):601–615

    Google Scholar 

  • Abujudeh HH, Kaewlai R (2009) Radiology failure mode and effect analysis: what is it? Radiology 252(2):544–550

    Google Scholar 

  • Adachi W, Lodolce AE (2005) Use of failure mode and effects analysis in improving the safety of i.v. drug administration. Am Soc Health-Syst Pharmacist 62(9):917–920

    Google Scholar 

  • Alamry A, Al Owais SM, Marini AM, Al-Dorzi H, Alsolamy S, Arabi Y (2017) Application of failure mode effect analysis to improve the care of septic patients admitted through the emergency department. J Patient Saf 13(2):76–81

    Google Scholar 

  • Alba Mesa F, Sanchez Hurtado MA, Sanchez Margallo FM, Gomez Cabeza de Vaca V, Komorowski AL (2015) Application of failure mode and effect analysis in laparoscopic colon surgery training. World J Surg 39(2):536–542

    Google Scholar 

  • Apkon M, Leonard J, Probst L, DeLizio L, Vitale R (2004) Design of a safer approach to intravenous drug infusions: failure mode effects analysis. Qual Saf Health Care 13(4):265–271

    Google Scholar 

  • Aranaz-Andres JM, Bermejo-Vicedo T, Munoz-Ojeda I, Delgado-Silveira E, Chamorro-Rubio S, Fernandez-Puentes A, Garcia-Collia M, Guerra-Alia EM (2017) Failure mode and effects analysis applied to the administration of liquid medication by oral syringes. Farmacia Hosp 41(6):674–677

    Google Scholar 

  • Arenas Villafranca JJ, Sánchez AG, Guindo MN, Felipe VF (2014) Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition. Am J Health-Syst Pharm 71(14):1210–1218

    Google Scholar 

  • Armitage G, Hodgson I, Wright J, Bailey K, Mkhwana E (2011) Exploring the delivery of antiretroviral therapy for symptomatic HIV in Swaziland: threats to the successful treatment and safety of outpatients attending regional and district clinics. BMJ Qual Saf 20(1):52–59

    Google Scholar 

  • Asefzadeh S, Yarmohammadian MH, Nikpey A, Atighechian G (2013) Clinical risk assessment in intensive care unit. Int J Prev Med 4(5):592–598

    Google Scholar 

  • Ashley L, Armitage G (2010) Failure mode and effects analysis: an empirical comparison of failure mode scoring procedures. J Patient Saf 6(4):210–215

    Google Scholar 

  • Ashley L, Dexter R, Marshall F, McKenzie B, Ryan M, Armitage G (2011) Improving the safety of chemotherapy administration: an oncology nurse-led failure mode and effects analysis. Oncol Nurs Forum 38(6):E436–E444

    Google Scholar 

  • Askari R, Shafii M, Rafiei S, Abolhassani MS, Salarikhah E (2017) Failure mode and effect analysis: improving intensive care unit risk management processes. Int J Health Care Qual Assur 30(3):208–215

    Google Scholar 

  • Babiker A, Amer YS, Osman ME, Al-Eyadhy A, Fatani S, Mohamed S, Alnemri A, Titi MA, Shaikh F, Alswat KA, Wahabi HA, Al-Ansary LA (2018) Failure mode and effect analysis (FMEA) may enhance implementation of clinical practice guidelines: an experience from the Middle East. J Eval Clin Pract 24(1):206–211

    Google Scholar 

  • Bagnasco A, Tubino B, Piccotti E, Rosa F, Aleo G, Di Pietro P, Sasso L (2013) Identifying and correcting communication failures among health professionals working in the emergency department. Int Emerg Nurs 21:168–172

    Google Scholar 

  • Bambi F, Spitaleri I, Verdolini G, Gianassi S, Perri A, Dori F, Iadanza E (2009) Analysis and management of the risks related to the collection, processing and distribution of peripheral blood haematopoietic stem cells. Blood Transfus 7(1):3–17

    Google Scholar 

  • Barends DM, Oldenhof MT, Vredenbregt MJ, Nauta MJ (2012) Risk analysis of analytical validations by probabilistic modification of FMEA. J Pharm Biomed Anal 64–65:82–86

    Google Scholar 

  • Bonfant G, Belfanti P, Paternoster G, Gabrielli D, Gaiter AM, Manes M, Molino A, Pellu V, Ponzetti C, Farina M, Nebiolo PE (2010) Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit. J Nephrol 23(1):111–118

    Google Scholar 

  • Bonnabry P, Cingria L, Sadeghipour F, Ing H, Fonzo-Christe C, Pfister R (2005) Use of a systematic risk analysis method to improve safety in the production of paediatric parenteral nutrition solutions. Qual Saf Health Care 14(2):93–98

    Google Scholar 

  • Bonnabry P, Cingria L, Ackermann M, Sadeghipour F, Bigler L, Mach N (2006) Use of a prospective risk analysis method to improve the safety of the cancer chemotherapy process. Int J Qual Health Care 18(1):9–16

    Google Scholar 

  • Bonnabry P, Despont-Gros C, Grauser D, Casez P, Despond M, Pugin D, Rivara-Mangeat C, Koch M, Vial M, Iten A, Lovis C (2008) A risk analysis method to evaluate the impact of a computerized provider order entry system on patient safety. J Am Med Inform Assoc 15(4):453–460

    Google Scholar 

  • Boulé M, Lachapelle S, Collin-Lévesque L, Demers E, Nguyen C, Fournier-Tondreau M, Thibault M, Lebel D, Bussières JF (2018) Failure mode, effect, and criticality analysis of the parenteral nutrition process in a mother-child hospital: the AMELIORE study. Nutr Clin Pract 33(5):656–666

    Google Scholar 

  • Brodie A, Kinross J, Bailey M, Aggarwal R, Vincent C (2009) Using failure mode and effects analysis to identify hazards within resuscitation. Int J Risk Saf Med 21(4):201–215

    Google Scholar 

  • Broggi S, Cantone MC, Chiara A, Di Muzio N, Longobardi B, Mangili P, Veronese I (2013) Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy. J Appl Clin Med Phys 14(5):265–277

    Google Scholar 

  • Burgmeier J (2002) Failure mode and effect analysis: an application in reducing risk in blood transfusion. Jt Comm J Qual Improv 28(6):331–339

    Google Scholar 

  • Cantone MC, Ciocca M, Dionisi F, Fossati P, Lorentini S, Krengli M, Molinelli S, Orecchia R, Schwarz M, Veronese I, Vitolo V (2013) Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy. Radiat Oncol 8:127

    Google Scholar 

  • Capunzo M, Cavallo P, Boccia G, Brunetti L, Pizzuti S (2004) A FMEA clinical laboratory case study: how to make problems and improvements measurable. Clin Leadersh Manage Rev 18(1):37–41

    Google Scholar 

  • Chan DTM, Ng SSM, Chong YH, Wong J, Tam YH, Lam YH, Chan CK, Wong DSY, Wan IYP, Wong SKH, Ng BKW, Cho AMW, Yu KH, Chan HS, Li WS, Ng A, Wu TSF, Chiu A, Fong ASL, Liu YW, Lai PBS (2010) Using failure mode and effects analysis to design a surgical safety checklist for safer surgery. Surg Pract 14(2):53–60

    Google Scholar 

  • Chanamool N, Naenna T (2016) Fuzzy FMEA application to improve decision-making process in an emergency department. Appl Soft Comput 43:441–453

    Google Scholar 

  • Chang DS, Chung JH, Sun KLP, Yang FC (2012) A novel approach for evaluating the risk of health care failure modes. J Med Syst 36(6):3967–3974

    Google Scholar 

  • Chin KS, Wang YM, Ka Kwai Poon G, Yang JB (2009) Failure mode and effects analysis using a group-based evidential reasoning approach. Comput Oper Res 36(6):1768–1779

    MATH  Google Scholar 

  • Chou IC, Hsueh HC, Lee RG (2009) Example for mobile ECG holter design using FMEA model. Biomed Eng Appl Basis Commun 21(1):61–70

    Google Scholar 

  • Chu KC, Hung LP (2014) Adaptive failure identification for healthcare risk analysis and its application on e-healthcare. J Appl Math 2014

    Google Scholar 

  • Cimadomo D, Ubaldi FM, Capalbo A, Maggiulli R, Scarica C, Romano S, Poggiana C, Zuccarello D, Giancani A, Vaiarelli A, Rienzi L (2016) Failure mode and effects analysis of witnessing protocols for ensuring traceability during PGD/PGS cycles. Reprod BioMed Online 33(3):360–369

    Google Scholar 

  • Ciocca M, Cantone MC, Veronese I, Cattani F, Pedroli G, Molinelli S, Vitolo V, Orecchia R (2012) Application of failure mode and effects analysis to intraoperative radiation therapy using mobile electron linear accelerators. Int J Radiat Oncol Biol Phys 82(2):e305–e311

    Google Scholar 

  • Claxton K, Campbell-Allen NM (2017) Failure modes effects analysis (FMEA) for review of a diagnostic genetic laboratory process. Int J Qual Reliab Manage 34(2):265–277

    Google Scholar 

  • Coles G, Fuller B, Nordquist K, Kongslie A (2005) Using failure mode effects and criticality analysis for high-risk processes at three community hospitals. Joint Comm J Qual Patient Saf 31(3):132–140

    Google Scholar 

  • Collins CM, Elsaid KA (2011) Using an enhanced oral chemotherapy computerized provider order entry system to reduce prescribing errors and improve safety. Int J Qual Health Care 23(1):36–43

    Google Scholar 

  • Dağsuyu C, Göçmen E, Narlı M, Kokangül A (2016) Classical and fuzzy FMEA risk analysis in a sterilization unit. Comput Ind Eng 101:286–294

    Google Scholar 

  • Daniels LM, Barreto JN, Kuth JC, Anderson JR, Zhang B, Majka AJ, Morgenthaler TI, Tosh PK (2015) Failure mode and effects analysis to reduce risk of anticoagulation levels above the target range during concurrent antimicrobial therapy. Am Soc Health-Syst Pharmacists 72(14):1195–1203

    Google Scholar 

  • Day S, Dalto J, Fox J, Turpin M (2006) Failure mode and effects analysis as a performance improvement tool in trauma. J Trauma Nurs 13(3):111–117

    Google Scholar 

  • Day S, Dalto J, Fox J, Allen A, Ilstrup S (2007) Utilization of failure mode effects analysis in trauma patient registration. Qual Manage Healthc 16(4):342–348

    Google Scholar 

  • de Giorgi I, Fonzo-Christe C, Cingria L, Caredda B, Meyer V, Pfister RE, Bonnabry P (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):170–178

    Google Scholar 

  • Deandrea S, Tidone E, Bellini A, Bisanti L, Leonardo NG, Silvestri AR, Consonni D (2018) Implementation of failure mode and effects analysis to the specimens flow in a population-based colorectal cancer screening programme using immunochemical faecal occult blood tests: a quality improvement project in the Milan colorectal cancer screening programme. BMJ Open Qual 7(1):e000299

    Google Scholar 

  • Denny DS, Allen DK, Worthington N, Gupta D (2014) The use of failure mode and effect analysis in a radiation oncology setting: the cancer treatment centers of America experience. J Healthc Qual 36(1):18–28

    Google Scholar 

  • Flegar-Meštrić Z, Perkov S, Radeljak A, Kardum Paro MM, Prkačin I, Devčić-Jeras A (2017) Risk analysis of the preanalytical process based on quality indicators data. Clin Chem Lab Med 55(3):368–377

    Google Scholar 

  • Ford EC, Gaudette R, Myers L, Vanderver B, Engineer L, Zellars R, Song DY, Wong J, DeWeese TL (2009) Evaluation of safety in a radiation oncology setting using failure mode and effects analysis. Int J Radiat Oncol Biol Phys 74(3):852–858

    Google Scholar 

  • Ford EC, Smith K, Terezakis S, Croog V, Gollamudi S, Gage I, Keck J, DeWeese T, Sibley G (2014) A streamlined failure mode and effects analysis. Med Phys 41(6):061709

    Google Scholar 

  • Frewen H, Brown E, Jenkins M, O’Donovan A (2018) Failure mode and effects analysis in a paperless radiotherapy department. J Med Imaging Radiat Oncol 22(5):707–715

    Google Scholar 

  • Frosini F, Miniati R, Grillone S, Dori F, Gentili GB, Belardinelli A (2016) Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery. Technol Health Care 24(6):873–887

    Google Scholar 

  • Geum Y, Cho Y, Park Y (2011a) A systematic approach for diagnosing service failure: service-specific FMEA and grey relational analysis approach. Math Comput Model 54(11–12):3126–3142

    MATH  Google Scholar 

  • Geum Y, Shin J, Park Y (2011b) FMEA-based portfolio approach to service productivity improvement. Serv Ind J 31(11):1825–1847

    Google Scholar 

  • Giardina M, Castiglia F, Tomarchio E (2014) Risk assessment of component failure modes and human errors using a new FMECA approach: application in the safety analysis of HDR brachytherapy. J Radiol Prot 34(4):891–914

    Google Scholar 

  • Han TH, Kim MJ, Kim S, Kim HO, Lee MA, Choi JS, Hur M, St John A (2013) The role of failure modes and effects analysis in showing the benefits of automation in the blood bank. Transfusion 53(5):1077–1082

    Google Scholar 

  • Ho CC, Liao CJ (2011) The use of failure mode and effects analysis to construct an effective disposal and prevention mechanism for infectious hospital waste. Waste Manage 31(12):2631–2637

    Google Scholar 

  • Hosoya K, Mochinaga S, Emoto A, Yokoo H, Tokushima H, Egoshi M, Sueoka-Aragane N, Kimura S (2015) Failure mode and effects analysis of medication adherence in patients with chronic myeloid leukemia. Int J Clin Oncol 20(6):1203–1210

    Google Scholar 

  • Hu YP, You XY, Wang L, Liu HC (2018) An integrated approach for failure mode and effect analysis based on uncertain linguistic GRA–TOPSIS method. Soft Comput. https://doi.org/10.1007/s00500-018-3480-7

  • Ibanez-Rosello B, Bautista-Ballesteros JA, Bonaque J, Celada F, Lliso F, Carmona V, Gimeno-Olmos J, Ouhib Z, Rosello J, Perez-Calatayud J (2016) Failure mode and effects analysis of skin electronic brachytherapy using Esteya((R)) unit. J Contemp Brachytherapy 8(6):518–524

    Google Scholar 

  • Ibanez-Rosello B, Bautista JA, Bonaque J, Perez-Calatayud J, Gonzalez-Sanchis A, Lopez-Torrecilla J, Brualla-Gonzalez L, Garcia-Hernandez T, Vicedo-Gonzalez A, Granero D, Serrano A, Borderia B, Solera C, Rosello J (2018) Failure modes and effects analysis of total skin electron irradiation technique. Clin Transl Oncol 20(3):330–365

    Google Scholar 

  • Inoue H, Yamada S (2010) Failure mode and effects analysis in pharmaceutical research. Int J Qual Serv Sci 2(3):369–382

    Google Scholar 

  • Intra G, Alteri A, Corti L, Rabellotti E, Papaleo E, Restelli L, Biondo S, Garancini MP, Candiani M, Viganò P (2016) Application of failure mode and effect analysis in an assisted reproduction technology laboratory. Reprod BioMed Online 33(2):132–139

    Google Scholar 

  • Jain K (2017) Use of failure mode effect analysis (FMEA) to improve medication management process. Int J Health Care Qual Assur 30(2):175–186

    Google Scholar 

  • Jamshidi A, Rahimi SA, Ait-Kadi D, Ruiz A (2015) A comprehensive fuzzy risk-based maintenance framework for prioritization of medical devices. Appl Soft Comput 32:322–334

    Google Scholar 

  • Jiang Y, Jiang H, Ding S, Liu Q (2015) Application of failure mode and effects analysis in a clinical chemistry laboratory. Clin Chim Acta 48:80–85

    Google Scholar 

  • Jones RT, Handsfield L, Read PW, Wilson DD, Van Ausdal R, Schlesinger DJ, Siebers JV, Chen Q (2015) Safety and feasibility of STAT RAD: improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis. Pract Radiat Oncol 5(2):106–112

    Google Scholar 

  • Kaestli LZ, Cingria L, Fonzo-Christe C, Bonnabry P (2014) Prospective risk analysis and incident reporting for better pharmaceutical care at paediatric hospital discharge. Int J Clin Pharm 36(5):953–962

    Google Scholar 

  • Kahraman C, Kaya İ, Şenvar Ö (2013) Healthcare failure mode and effects analysis under fuzziness. Hum Ecol Risk Assess 19(2):538–552

    Google Scholar 

  • Khare RK, Nannicelli AP, Powell ES, Seivert NP, Adams JG, Holl JL (2013) Use of risk assessment analysis by failure mode, effects, and criticality to reduce door-to-balloon time. Ann Emerg Med 62(4):388–398

    Google Scholar 

  • Kirkire MS, Rane SB, Jadhav JR (2015) Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study. J Ind Eng Int 11(4):595–611

    Google Scholar 

  • Kumru M, Kumru PY (2013) Fuzzy FMEA application to improve purchasing process in a public hospital. Appl Soft Comput 13(1):721–733

    Google Scholar 

  • Kunac DL, Reith DM (2005) Identification of priorities for medication safety in neonatal intensive care. Drug Saf 28(3):251–261

    Google Scholar 

  • Kuo FY, Huang WC, Chiou KR, Mar GY, Cheng CC, Chung CC, Tsai HL, Jiang CH, Wann SR, Lin SL, Liu CP (2013) The effect of failure mode and effect analysis on reducing percutaneous coronary intervention hospital door-to-balloon time and mortality in ST segment elevation myocardial infarction. BMJ Qual Saf 22(8):626–638

    Google Scholar 

  • Lago P, Bizzarri G, Scalzotto F, Parpaiola A, Amigoni A, Putoto G, Perilongo G (2012) Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report. BMJ Open 2(6):e001249

    Google Scholar 

  • Lee H, Lee H, Baik J, Kim HJ, Kim R (2017a) Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct. Drug Des Dev Ther 11:3035–3043

    Google Scholar 

  • Lee YC, Kim Y, Huynh JWY, Hamilton RJ (2017b) Failure modes and effects analysis for ocular brachytherapy. Brachytherapy 16(6):1265–1279

    Google Scholar 

  • Lelong AS, Martelli N, Bonan B, Prognon P, Pineau J (2014) Use of a risk assessment method to improve the safety of negative pressure wound therapy. Int Wound J 11(3):253–258

    Google Scholar 

  • Lepage B, Robert R, Lebeau M, Aubeneau C, Silvain C, Migeot V (2009) Use of a risk analysis method to improve care management for outlying inpatients in a university hospital. Qual Saf Health Care 18(6):441–445

    Google Scholar 

  • 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 96(51):e9339

    Google Scholar 

  • Liao CJ, Ho CC (2014) Risk management for outsourcing biomedical waste disposal—using the failure mode and effects analysis. Waste Manage 34(7):1324–1329

    Google Scholar 

  • Lin QL, Wang DJ, Lin WG, Liu HC (2014) Human reliability assessment for medical devices based on failure mode and effects analysis and fuzzy linguistic theory. Saf Sci 62:248–256

    Google Scholar 

  • Liu HC (2016) FMEA using uncertainty theories and MCDM methods. Springer, Singapore

    Google Scholar 

  • Liu HC, Liu L, Liu N (2013) Risk evaluation approaches in failure mode and effects analysis: a literature review. Expert Syst Appl 40(2):828–838

    Google Scholar 

  • Liu HC, Fan XJ, Li P, Chen YZ (2014a) Evaluating the risk of failure modes with extended MULTIMOORA method under fuzzy environment. Eng Appl Artif Intell 34:168–177

    Google Scholar 

  • Liu HC, You JX, You XY (2014b) Evaluating the risk of healthcare failure modes using interval 2-tuple hybrid weighted distance measure. Comput Ind Eng 78:249–258

    Google Scholar 

  • Liu HC, Li P, You JX, Chen YZ (2015a) A novel approach for FMEA: combination of interval 2-tuple linguistic variables and gray relational analysis. Qual Reliab Eng Int 31(5):761–772

    Google Scholar 

  • Liu HC, You JX, You XY, Shan MM (2015b) A novel approach for failure mode and effects analysis using combination weighting and fuzzy VIKOR method. Appl Soft Comput 28:579–588

    Google Scholar 

  • Liu HC, You JX, Chen S, Chen YZ (2016a) An integrated failure mode and effect analysis approach for accurate risk assessment under uncertainty. IIE Trans 48(11):1027–1042

    Google Scholar 

  • Liu HC, You JX, Li P, Su Q (2016b) Failure mode and effect analysis under uncertainty: an integrated multiple criteria decision making approach. IEEE Trans Reliab 65(3):1380–1392

    Google Scholar 

  • Liu HC, Li Z, Song W, Su Q (2017) Failure mode and effect analysis using cloud model theory and PROMETHEE method. IEEE Trans Reliab 66(4):1058–1072

    Google Scholar 

  • Liu HC, You JX, Duan CY (2019) An integrated approach for failure mode and effect analysis under interval-valued intuitionistic fuzzy environment. Int J Prod Econ 207:163–172

    Google Scholar 

  • López-Tarjuelo J, Bouché-Babiloni A, Santos-Serra A, Morillo-Macías V, Calvo FA, Kubyshin Y, Ferrer-Albiach C (2014) Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability. Radiother Oncol 113(2):283–289

    Google Scholar 

  • Lu Y, Teng F, Zhou J, Wen A, Bi Y (2013) Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks. Transfusion 53(12):3080–3087

    Google Scholar 

  • MacDonald E, Fox E, Tyler L (2011) Drug shortages: process for evaluating impact on patient safety. Hosp Pharm 46(12):943–951

    Google Scholar 

  • Magnezi R, Hemi A, Hemi R (2016) Using the failure mode and effects analysis model to improve parathyroid hormone and adrenocorticotropic hormone testing. Risk Manage Healthc Policy 9:271–274

    Google Scholar 

  • Malfará M, Pernassi M, Aragon D, Carlotti A (2018) Impact of the clinical pharmacist interventions on prevention of pharmacotherapy related problems in the paediatric intensive care unit. Int J Clin Pharm 40(3):513–519

    Google Scholar 

  • Manger RP, Paxton AB, Pawlicki T, Kim GY (2015) Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery. Med Phys 42(5):2449–2461

    Google Scholar 

  • Manger R, Rahn D, Hoisak J, Dragojević I (2018) Improving the treatment planning and delivery process of Xoft electronic skin brachytherapy. Brachytherapy 17(4):702–708

    Google Scholar 

  • Manrique-Rodríguez S, Sánchez-Galindo AC, López-Herce J, Calleja-Hernández MÁ, Iglesias-Peinado I, Carrillo-Álvarez Á, Sáez MS, Fernández-Llamazares CM (2014) Risks in the implementation and use of smart pumps in a pediatric intensive care unit: application of the failure mode and effects analysis. Int J Technol Assess Health Care 30(2):210–217

    Google Scholar 

  • Mardani A, Zavadskas EK, Khalifah Z, Jusoh A, Nor KMD (2016) Multiple criteria decision-making techniques in transportation systems: a systematic review of the state of the art literature. Transport 31(3):359–385

    Google Scholar 

  • Marx DA, Slonim AD (2003) Assessing patient safety risk before the injury occurs: an introduction to sociotechnical probabilistic risk modelling in health care. Qual Saf Health Care 12(suppl 2):ii33–ii38

    Google Scholar 

  • Mayadev J, Dieterich S, Harse R, Lentz S, Mathai M, Boddu S, Kern M, Courquin J, Stern RL (2015) A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy. Brachytherapy 14(6):866–875

    Google Scholar 

  • McElroy LM, Collins KM, Koller FL, Khorzad R, Abecassis MM, Holl JL, Ladner DP (2015) Operating room to intensive care unit handoffs and the risks of patient harm. Surgery 158(3):588–594

    Google Scholar 

  • McElroy LM, Khorzad R, Nannicelli AP, Brown AR, Ladner DP, Holl JL (2016) Failure mode and effects analysis: a comparison of two common risk prioritisation methods. BMJ Qual Saf 25(5):329–336

    Google Scholar 

  • Mendes ME, De Almeida Rezende Ebner P, Romano P, Neto MP, Sant’anna A, Sumita NM (2013) Practical aspects of the use of FMEA tool in clinical laboratory risk management. Jornal Brasileiro de Patologia e Medicina Laboratorial 49(3):174–181

    Google Scholar 

  • Mila L, Valdes R, Tamayo A, Padilla S, Ferro W (2012) Application of a risk analysis method to different technologies for producing a monoclonal antibody employed in hepatitis B vaccine manufacturing. Biologicals 40(2):118–128

    Google Scholar 

  • Moraes CDS, Rabin EG, Viegas K (2018) Assessment of the care process with orthotics, prosthetics and special materials. Revista Brasileira de Enfermagem 71(3):1099–1105

    Google Scholar 

  • Morelli P, Vinci A, Galetto L, Magon G, Maniaci V, Banfi G (2007) FMECA methodology applied to two pathways in an orthopaedic hospital in Milan. J Prev Med Hyg 48(2):54–59

    Google Scholar 

  • Moss J (2010) Reducing errors during patient-controlled analgesia therapy through failure mode and effects analysis. Jt Comm J Qual Patient Saf 36(8):359–364

    Google Scholar 

  • Najafpour Z, Hasoumi M, Behzadi F, Mohamadi E, Jafary M, Saeedi M (2017) Preventing blood transfusion failures: FMEA, an effective assessment method. BMC Health Serv Res 17(1):453

    Google Scholar 

  • Nasim F, Poterucha JT, Daniels LM, Park JG, Seelhammer TG, Bohman JK, Friedrich TP, Blau CL, Elmer JL, Schears GJ (2018) Practical implementation of failure mode and effects analysis for extracorporeal membrane oxygenation activation. Am J Med Qual. https://doi.org/10.1177/1062860618754703

  • Nguyen C, Côté J, Lebel D, Caron E, Genest C, Mallet M, Phan V, Bussières JF (2013) The AMÉLIE project: failure mode, effects and criticality analysis: a model to evaluate the nurse medication administration process on the floor. J Eval Clin Pract 19(1):192–199

    Google Scholar 

  • Nickerson T, Jenkins M, Greenall J (2008) Using ISMP Canada’s framework for failure mode and effects analysis: a tale of two FMEAs. Healthc Q 11(3):40–46

    Google Scholar 

  • Niv Y, Itskoviz D, Cohen M, Hendel H, Bar-Giora Y, Berkov E, Weisbord I, Leviron Y, Isasschar A, Ganor A (2018) The utility of failure modes and effects analysis of consultations in a tertiary, academic, medical center. Qual Manage Health Care 27(2):69–73

    Google Scholar 

  • Noel CE, Santanam L, Parikh PJ, Mutic S (2014) Process-based quality management for clinical implementation of adaptive radiotherapy. Med Phys 41(8):081717

    Google Scholar 

  • Novak P, Moros EG, Straube WL, Myerson RJ (2005) Treatment delivery software for a new clinical grade ultrasound system for thermoradiotherapy. Med Phys 32(11):3246–3256

    Google Scholar 

  • Ofek F, Magnezi R, Kurzweil Y, Gazit I, Berkovitch S, Tal O (2016) Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards. Israel J Health Policy Res 5(1):30

    Google Scholar 

  • Ookalkar A, Joshi AG, Ookalkar DS (2009) Quality improvement in haemodialysis process using FMEA. Int J Qual Reliab Manage 26(8):817–830

    Google Scholar 

  • Perks JR, Stanic S, Stern RL, Henk B, Nelson MS, Harse RD, Mathai M, Purdy JA, Valicenti RK, Siefkin AD, Chen AM (2012) Failure mode and effect analysis for delivery of lung stereotactic body radiation therapy. Int J Radiat Oncol Biol Phys 83(4):1324–1329

    Google Scholar 

  • Poder J, Brown R, Howie A, Yuen J, Ralston A, Schreiber K, Bece A, Bucci J (2018) A risk-based approach to development of ultrasound-based high-dose-rate prostate brachytherapy quality management. Brachytherapy 17(5):788–793

    Google Scholar 

  • Pollack TA, Illuri V, Khorzad R, Aleppo G, Johnson Oakes D, Holl JL, Wallia A (2018) Risk assessment of the hospital discharge process of high-risk patients with diabetes. BMJ Open Qual 7(2):e000224

    Google Scholar 

  • Rafter N, Hickey A, Condell S, Conroy R, O’Connor P, Vaughan D, Williams D (2015) Adverse events in healthcare: learning from mistakes. Q J Med 108(4):273–277

    Google Scholar 

  • Rah JE, Manger RP, Yock AD, Kim GY (2016) A comparison of two prospective risk analysis methods: traditional FMEA and a modified healthcare FMEA. Med Phys 43(12):6347–6353

    Google Scholar 

  • Redfern E, Brown R, Vincent CA (2009) Identifying vulnerabilities in communication in the emergency department. Emergency Med J 26(9):653–657

    Google Scholar 

  • Reece KM, Lozano MA, Roux R, Spivey SM (2016) Implementation and evaluation of a gravimetric i.v. workflow software system in an oncology ambulatory care pharmacy. Am J Health-Syst Pharm 73(3):165–173

    Google Scholar 

  • Riehle MA, Bergeron D, Hyrkas K (2008) Improving process while changing practice: FMEA and medication administration. Nurs Manage 39(2):28–33

    Google Scholar 

  • Rienzi L, Bariani F, Dalla Zorza M, Romano S, Scarica C, Maggiulli R, Nanni Costa A, Ubaldi FM (2015) Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF. Reprod BioMed Online 31(4):516–522

    Google Scholar 

  • Rienzi L, Bariani F, Dalla Zorza M, Albani E, Benini F, Chamayou S, Minasi MG, Parmegiani L, Restelli L, Vizziello G, Costa AN (2017) Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis. Hum Reprod 32(8):1612–1620

    Google Scholar 

  • Robinson DL, Heigham M, Clark J (2006) Using failure mode and effects analysis for safe administration of chemotherapy to hospitalized children with cancer. Jt Comm J Qual Patient Saf 32(3):161–166

    Google Scholar 

  • Rodriguez-Gonzalez CG, Martin-Barbero ML, Herranz-Alonso A, Durango-Limarquez MI, Hernandez-Sampelayo P, Sanjurjo-Saez M (2015) Use of failure mode, effect and criticality analysis to improve safety in the medication administration process. J Eval Clin Pract 21(4):549–559

    Google Scholar 

  • Sadeghi M, Karbasiyan M, Navabakhsh M (2014) Designing a model for reliability improvement with FTA and FMEA techniques on medical gas outlet. Int J Logistics Syst Manage 18(3):322–342

    Google Scholar 

  • Saizy-Callaert S, Causse R, Thébault A, Chouaïd C (2002) Failure mode, effects and criticality analysis (FMECA) as a means of improving the hospital drug prescribing process. Int J Risk Saf Med 15(4/3):193–202

    Google Scholar 

  • Sanchez-Izquierdo-Riera JA, Molano-Alvarez E, La Fuente ISD, Maynar-Moliner J, Marín-Mateos H, Chacón-Alves S (2016) Safety management of a clinical process using failure mode and effect analysis: continuous renal replacement therapies in intensive care unit patients. Am Soc Artif Intern Organs J 62(1):74–79

    Google Scholar 

  • Saulino MF, Patel T, Fisher SP (2017) The application of failure modes and effects analysis methodology to intrathecal drug delivery for pain management. Neuromodulation 20(2):177–186

    Google Scholar 

  • Sawant A, Dieterich S, Svatos M, Keall P (2010) Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems. Med Phys 37(12):6466–6479

    Google Scholar 

  • Sayler E, Eldredge-Hindy H, Dinome J, Lockamy V, Harrison AS (2015) Clinical implementation and failure mode and effects analysis of HDR skin brachytherapy using Valencia and Leipzig surface applicators. Brachytherapy 14(2):293–299

    Google Scholar 

  • Schuller BW, Burns A, Ceilley EA, King A, Letourneau J, Markovic A, Sterkel L, Taplin B, Wanner J, Albert JM (2017) Failure mode and effects analysis: a community practice perspective. J Appl Clin Med Phys 18(6):258–267

    Google Scholar 

  • Scorsetti M, Signori C, Lattuada P, Urso G, Bignardi M, Navarria P, Castiglioni S, Mancosu P, Trucco P (2010) Applying failure mode effects and criticality analysis in radiotherapy: lessons learned and perspectives of enhancement. Radiother Oncol 94(3):367–374

    Google Scholar 

  • Serafini A, Troiano G, Franceschini E, Calzoni P, Nante N, Scapellato C (2016) Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure. Ann Ig 28(4):288–295

    Google Scholar 

  • Sofronia RE, Knott T, Davidescu A, Savii GG, Kuhlen T, Gerressen M (2013) Failure mode and effects analysis in designing a virtual reality-based training simulator for bilateral sagittal split osteotomy. Int J Med Robot Comput Assist Surg 9(1):e1–e9

    Google Scholar 

  • Sorrentino P (2016) Use of failure mode and effects analysis to improve emergency department handoff processes. Clin Nurse Spec 30(1):28–37

    Google Scholar 

  • Southard PB, Kumar S, Southard CA (2011) A modified delphi methodology to conduct a failure modes effects analysis: a patient-centric effort in a clinical medical laboratory. Qual Manage Health Care 20(2):131–151

    Google Scholar 

  • Stamatis DH (2003) Failure mode and effect analysis: FMEA from theory to execution, 2nd edn. ASQ Quality Press, New York

    Google Scholar 

  • Terezakis SA, Pronovost P, Harris K, De Weese T, Ford E (2011) Safety strategies in an academic radiation oncology department and recommendations for action. Jt Comm J Qual Patient Saf 37(7):291–299

    Google Scholar 

  • Thornton E, Brook OR, Mendiratta-Lala M, Hallett DT, Kruskal JB (2011) Application of failure mode and effect analysis in a radiology department. Radiographics 31(1):281–293

    Google Scholar 

  • Van Der Eijk AC, Rook D, Dankelman J, Smit BJ (2013) Defining hazards of supplemental oxygen therapy in neonatology using the FMEA tool. Am J Matern/Child Nurs 38(4):221–228

    Google Scholar 

  • van Leeuwen JF, Nauta MJ, de Kaste D, Odekerken-Rombouts YM, Oldenhof MT, Vredenbregt MJ, Barends DM (2009) Risk analysis by FMEA as an element of analytical validation. J Pharm Biomed Anal 50(5):1085–1087

    Google Scholar 

  • Vazquez-Valencia A, Santiago-Saez A, Perea-Perez B, Labajo-Gonzalez E, Albarran-Juan ME (2017) Utility of failure mode and effect analysis to improve safety in suctioning by orotracheal tube. J PeriAnesthesia Nurs 32(1):28–37

    Google Scholar 

  • Veronese I, De Martin E, Martinotti AS, Fumagalli ML, Vite C, Redaelli I, Malatesta T, Mancosu P, Beltramo G, Fariselli L, Cantone MC (2015) Multi-institutional application of failure mode and effects analysis (FMEA) to cyberknife stereotactic body radiation therapy (SBRT). Radiat Oncol 10:132

    Google Scholar 

  • Vidali C, Severgnini M, Urbani M, Toscano L, Perulli A, Bortul M (2017) FMECA application to intraoperative electron beam radiotherapy procedure as a quality method to prevent and reduce patient’s risk in conservative surgery for breast cancer. Front Med 4:138

    Google Scholar 

  • Vora C, Patadia R, Mittal K, Mashru R (2013) Risk based approach for design and optimization of stomach specific delivery of rifampicin. Int J Pharm 455(1–2):169–181

    Google Scholar 

  • Wang LE, Liu HC, Quan MY (2016) Evaluating the risk of failure modes with a hybrid MCDM model under interval-valued intuitionistic fuzzy environments. Comput Ind Eng 102:175–185

    Google Scholar 

  • Weingart SN, Spencer J, Buia S, Duncombe D, Singh P, Gadkari M, Connor M (2011) Medication safety of five oral chemotherapies: a proactive risk assessment. J Oncol Pract 7(1):2–6

    Google Scholar 

  • Wetterneck TB, Skibinski KA, Roberts TL, Kleppin SM, Schroeder ME, Enloe M, Rough SS, Hundt AS, Carayon P (2006) Using failure mode and effects analysis to plan implementation of smart iv pump technology. Am J Health-Syst Pharm 63(16):1528–1538

    Google Scholar 

  • Whiteley GS, Derry C, Glasbey T (2015) Failure analysis in the identification of synergies between cleaning monitoring methods. Am J Infect Control 43(2):147–153

    Google Scholar 

  • Win KT, Phung H, Young L, Tran M, Alcock C, Hillman K (2004) Electronic health record system risk assessment: a case study from the MINET. Health Inf Manage 33(2):43–48

    Google Scholar 

  • Xu AY, Bhatnagar J, Bednarz G, Flickinger J, Arai Y, Vacsulka J, Feng W, Monaco E, Niranjan A, Lunsford LD, Huq MS (2017) Failure modes and effects analysis (FMEA) for gamma knife radiosurgery. J Appl Clin Med Phys 18(6):152–168

    Google Scholar 

  • Yang F, Cao N, Young L, Howard J, Logan W, Arbuckle T, Sponseller P, Korssjoen T, Meyer J, Ford E (2015) Validating FMEA output against incident learning data: a study in stereotactic body radiation therapy. Med Phys 42(6):2777–2785

    Google Scholar 

  • Younge KC, Wang Y, Thompson J, Giovinazzo J, Finlay M, Sankreacha R (2015) Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery. Int J Radiat Oncol Biol Phys 91(5):1003–1008

    Google Scholar 

  • Younge KC, Lee C, Moran JM, Feng M, Novelli P, Prisciandaro JI (2016) Failure mode and effects analysis in a dual-product microsphere brachytherapy environment. Pract Radiat Oncol 6(6):e299–e306

    Google Scholar 

  • Yousefinezhadi T, Jannesar Nobari FA, Behzadi Goodari F, Arab M (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):207–223

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. School of Economics and Management, Tongji University, Shanghai, China

    Hu-Chen Liu

  2. College of Economics and Management, China Jiliang University, Zhejiang, China

    Hu-Chen Liu

Authors
  1. Hu-Chen Liu
    View author publications

    You can also search for this author in PubMed Google Scholar

Rights and permissions

Reprints and permissions

Copyright information

© 2019 Springer Nature Singapore Pte Ltd.

About this chapter

Check for updates. Verify currency and authenticity via CrossMark

Cite this chapter

Liu, HC. (2019). FMEA for Proactive Healthcare Risk Analysis: A Systematic Literature Review. In: Improved FMEA Methods for Proactive Healthcare Risk Analysis. Springer, Singapore. https://doi.org/10.1007/978-981-13-6366-5_2

Download citation

  • DOI: https://doi.org/10.1007/978-981-13-6366-5_2

  • Published:

  • Publisher Name: Springer, Singapore

  • Print ISBN: 978-981-13-6365-8

  • Online ISBN: 978-981-13-6366-5

  • eBook Packages: EngineeringEngineering (R0)

Publish with us

Policies and ethics

Search

Navigation