Skip to main content
Log in

A risk-based maintenance approach for critical care medical devices: a case study application for a large hospital in a developing country

  • Case Studies
  • Published:
International Journal of System Assurance Engineering and Management Aims and scope Submit manuscript

Abstract

The availability of specialized medical equipment plays a critical role in the delivery of healthcare services. This becomes even more critical in developing countries where few medical devices are available in public hospitals, hence do not commensurate with demand, which leads to their overutilization. This often results in frequent failure of the medical devices and as a result, low availability. In turn, this leads to delayed treatment and consequently, access to affordable and quality healthcare by the disadvantaged in the society. This rather high unavailability of critical medical equipment in public hospitals in developing countries motivates this study, hence the necessitating the need to implement optimal maintenance strategies and operational protocols for maximizing equipment availability. However, selecting such optimal maintenance and operation strategies is not straightforward, and for this reason, a risk-based maintenance approach is proposed. The proposed approach addresses the aforementioned challenge through structured steps through which maintenance practitioners identify and prioritize prevalent failure modes. Based on the prioritized failure modes, operation and maintenance protocols may be derived. Moreover, the risk-based maintenance approach is useful for among other decisions, root cause analysis. The proposed risk-based maintenance approach consists of four steps; (1) data collection and standardization process, (2) modified failure mode and effect analysis step for prioritizing critical failure modes, (3) a root cause analysis step for analyzing the causes of recurrent failure modes, and (4) formulation of operation and maintenance strategies for mitigating equipment failure risks. The proposed approach is demonstrated in application in a case of large teaching and referral hospital in Kenya.

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

Access this article

Subscribe and save

Springer+ Basic
$34.99 /Month
  • Get 10 units per month
  • Download Article/Chapter or eBook
  • 1 Unit = 1 Article or 1 Chapter
  • Cancel anytime
Subscribe now

Buy Now

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3
Fig. 4
Fig. 5
Fig. 6
Fig. 7

Similar content being viewed by others

References

  • Better equipped to care? Follow-up report on managing medical equipment. www.audit-scotland.gov.uk. Accessed 8 Oct 2016

  • Carmignani Gionata (2009) An integrated structural framework to cost based FMCEA: the priority-cost FMCEA. Reliab Eng Syst Saf 94:861–871

    Article  Google Scholar 

  • Fechter RJ, Barba JJ (2004) Failure mode effect analysis applied to the use of infusion pumps. In: Proceeding of the 26th annual international conference of the IEEE EMBS. San Francisco, CA, pp 3496–3499

  • Fouad RH, Rawashdeh M, ALBashir A, AL-Sharif B (2012) Designing a computerized maintenance management system for medical devices in royal medical services. www.arpapress.com/Volumes/Vol10Issue1/IJRRAS_10_1_15.pdf

  • Jamshidi A, Rahimi SM, Ait-kadi D (2014) Medical devices inspection and maintenance; a literature review. In: Guan Y, Liao H (eds) Proceedings of the industrial and systems engineering research conference

  • Khalaf A, Djouani K, Hamam Y, Alayli Y (2014) Maintenance strategies and failure—cost model for medical equipment. Qual Reliab Eng Int 31:935–947

    Article  Google Scholar 

  • Liu L, Ma S, Wang Z, Li P (2012) Use related risk analysis for medical devices based on improved FMEA. Work 41:5860–5865

    Google Scholar 

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

    Article  Google Scholar 

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

    Article  Google Scholar 

  • Mahto D, Kumar A (2008) Application of root cause analysis in improvement of product quality and productivity. J Ind Eng Manag 1(2):16–53

    Google Scholar 

  • Mkalaf KA, Gibson P, Flanagan J (2013) A study of current maintenance strategies and the reliability of critical medical equipment in hospitals in relation to patient outcomes. Int J Soc Human Sci Eng 7(10):77–84

    Google Scholar 

  • Onofrio R, Piccagli F, Segato F (2015) Failure mode, effects and criticality (FMCEA) for medical devices: does standardization foster improvements in practice. Procedia Manufacturing 3:43–50

    Article  Google Scholar 

  • Performance Audit Report of the Auditor-General Specialized Healthcare Delivery at Kenyatta National Hospital Waiting-time for Cancer, Renal and Heart Patients. Office of the Auditor General November, 2012

  • Pun KF, Ching KS, Chow MF, Chow HCW (2002) An effective-centered approach to maintenance management, A case study. J Qual Maint Eng 8(4):346–368

    Article  Google Scholar 

  • Rahimi SA, Jamshidi A, Ait-Kadi D, Ruiz A (2013) 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

    Article  Google Scholar 

  • Rahimi SA, Jamshidi A, Ait-Kadi D, Ruiz A, Rebaiaia ML (2016) Prioritization of failures in radiation therapy delivery. IFAC -PapersOnline 49–12:1898–1903

    Article  Google Scholar 

  • Ridgway RM (2009a) Optimizing our PM program. J Biomed Instrum Technol 43:244–254

    Article  Google Scholar 

  • Ridgway MG (2009b) Manufacturer-recommended pm intervals: is it time for a change? Biomed Instrum Technol 43(6):498–500

    Article  Google Scholar 

  • Rosen MA, Lee BH, Sampson JB, Koka R, Chima AM, Ogbuagu OU, Marx MK, Kamara TB, Koroma M, Jackson EV Jr (2014) Failure mode and effects analysis applied to the maintenance and repair of anesthetic equipment in an austere medical environment. Int J Qual Healthcare 26(4):404–410

    Article  Google Scholar 

  • Sutrisno A, Lee T (2011) Service reliability assessment using failure mode and effect analysis (FMEA): survey and opportunity roadmap. Int J Eng Sci Technol 3(7):25–38

    Google Scholar 

  • Taghipour S, Banjevic D, Jardine AKS (2011) Reliability analysis of maintenance data for complex medical devices. Qual Reliab Eng Int 27:71–84

    Article  Google Scholar 

  • United States Environmental Protection Agency Guidance for Preparing Standard Operating Procedures (SOPs) EPA QA/G–‐6 [EPA/600/B–‐07/001 2007

  • Von Ahsen A (2008) Cost-oriented failure mode and effects analysis. Int J Qual Reliab Manag 25:466–479

    Article  Google Scholar 

  • Xiuxu Z, Xiaoli B (2010) The application of FMEA method in risk management of medical device during the lifecycle

Download references

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Stephen Vala.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Vala, S., Chemweno, P., Pintelon, L. et al. A risk-based maintenance approach for critical care medical devices: a case study application for a large hospital in a developing country. Int J Syst Assur Eng Manag 9, 1217–1233 (2018). https://doi.org/10.1007/s13198-018-0705-1

Download citation

  • Received:

  • Revised:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s13198-018-0705-1

Keywords