Risk management in the sterilization process for reusable medical devices: Moroccan Hospital experience

Abstract

In the hospital environment, risk mapping aims to identify and assess the criticality of potential risks associated with each stage in the sterilization process for reusable medical devices (RMDs). Our approach aims to develop preventive and corrective measures to better control these risks. From September to December 2023, an a priori risk analysis was carried out in the central sterilization unit of Rabat's specialized hospital. The methodology used will be based on the FMEA method (Failure Modes, Effects and Criticality Analysis), enabling a qualitative and quantitative analysis of risks. A total of 37 failure modes were identified during the sterilization process, including 20 minor criticality risks, 13 medium criticality risks and 4 major criticality risks. The highest number of failures occurred in the cleaning/disinfection and packaging stages, while the riskiest process was recomposition, with two unacceptable risks identified. Once the criticality had been assessed, corrective measures were proposed for all unacceptable risks likely to have a significant impact on the safety of patients and hospital staff. In light of the results, the working group was able to implement a number of preventive and curative measures, and communication remains a crucial element in ensuring compliance with the DMR and the safety of patients and medical staff.

Keywords

• Risk management
• Sterilization
• FMEA
• Reusable medical device
• Quality assurance system

References

1. [1] Ssekitoleko RT, Oshabaheebwa S, Munabi IG, Tusabe MS, Namayega C, Ngabirano BA, et al. The role of medical equipment in the spread of nosocomial infections: A cross-sectional study in four tertiary public health facilities in Uganda. BMC Public Health. 2020;20(1):1561 https://doi.org/10.1186/s12889-020-09662-w
2. [2] Garvey M. Medical device-associated healthcare ınfections: sterilization and the potential of novel biological approaches to ensure patient safety. Int J Mol Sci. 2023;25(1):201.https://doi.org/10.3390/ijms25010201
3. [3] Rutala WA, Weber DJ. Disinfection, Sterilization, and Control of Hospital Waste. Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases. 2015. p. 3294-3309.e4 https://doi.org/10.1016/B978-1-4557-4801- 3.00301-5
4. [4] Josephs-Spaulding J, Singh O V. Medical device sterilization and reprocessing in the era of Multidrug-Resistant (MDR) Bacteria: Issues and regulatory concepts. Front Med Technol. 2020;2:587352 https://doi.org/10.3389/fmedt.2020.587352
5. [5] Cheikh MHB, Teka M, Fhal M, Zribi K, Majdoub A. Mise en place d´un système de management de la qualité dans une unité de stérilisation centralisée: expérience de l´Hôpital Tahar Sfar de Mahdia en Tunisie [Implementation of a quality management system in a central sterilization unit: experience in the Hospital Tahar Sfar, Mahdia, Tunisia]. Pan Afr Med J. 2021;39:287. https://doi.org/10.11604/pamj.2021.39.287.25653.
6. [6] Panta G, Richardson AK, Shaw IC, Coope PA. Compliance of primary and secondary care public hospitals with standard practices for reprocessing and steam sterilization of reusable medical devices in Nepal: Findings from nation-wide multicenter clustered audits. BMC Health Serv Res. 2020;20(1):923 https://doi.org/10.1186/s12913-020- 05788-0.
7. [7] Maurin A, Petit A, Tilleul P, Combeau D. Certification ISO 9001 d’un service de stérilisation : passage à la version 2015 [ISO 9001 certification of a sterilization unit: Transition to the 2015 version]. Ann Pharm Fr. 2019;77(5):363-373. French. https://doi.org/10.1016/j.pharma.2019.05.002
8. [8] Trouillard A, Gillois A, Tournayre V, Barrans MA, Boix S, Vidal JR. [ISO 9001 quality approach in Sterilization Unit and developing the skills of agents: Contribution of a multi-support, transdisciplinary and multi-professional training plan]. Ann Pharm Fr. 2022;80(1):67–75 https://doi.org/10.1016/j.pharma.2021.04.004

9. [9] Mustapha L, Lebel C, Boddaert S, Castelain S, Duverlie G, Ganry O, Herpe YÉ, Lebreton S, Marolleau JP, Sevestre H, Soriot-Thomas S, Tebbakha R, Yzet T, Sautier A, Schmit JL. Certification ISO 9001 : 2015 de l’ensemble des activités de recherche d’un centre hospitalier universitaire [ISO 9001: 2015 certification of all research activities of a university hospital center]. Therapie. 2023;78(6):721-732. French.
10. [10] Kammoun A, Hachicha W, Aljuaid AM. Integrating Quality Tools and Methods to Analyze and Improve a Hospital Sterilization Process. Healthcare (Basel). 2021;9(5):544. https://doi.org/10.3390/healthcare9050544
11. [11] Poli M, Quaglierini M, Zega A, Pardini S, Telleschi M, Iervasi G, Guiducci L. Risk Management in Good Manufacturing Practice (GMP) Radiopharmaceutical Preparations. Appl Sci. 2024;14(4) : 1584. https://doi.org/10.3390/app14041584
12. [12] Wyss UP. Improving the Quality of Life of Patients With Medical Devices by a Timely Analysis of Adverse Events. Front Med. 2019;6:56 https://doi.org/10.3389/fmed.2019.00056
13. [13] Chen YJ, Chiou CM, Huang YW, Tu PW, Lee YC, Chien CH. A Comparative Study of Medical Device Regulations:: US, Europe, Canada, and Taiwan. Ther Innov Regul Sci. 2018;52(1):62–69 https://doi.org/10.1177/2168479017716712
14. [14] McEvoy B, Rowan NJ. Terminal sterilization of medical devices using vaporized hydrogen peroxide: a review of current methods and emerging opportunities. J Appl Microbiol. 2019;127(5):1403–1420 https://doi.org/10.1111/jam.14412
15. [15] Ashley L, Armitage G, Neary M, Hollingsworth G. A Practical Guide to Failure Mode and Effects Analysis in Health Care: Making the Most of the Team and Its Meetings. Jt Comm J Qual Patient Saf. 2010;36:351–358 https://doi.org/10.1016/S1553-7250(10)36053-3
16. [16] Rath F. Tools for developing a quality management program: proactive tools (process mapping, value stream mapping, fault tree analysis, and failure mode and effects analysis). Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S187-190 https://doi.org/10.1016/j.ijrobp.2007.07.2385
17. [17] Caldwell BS. Tools for developing a quality management program: human factors and systems engineering tools. Int J Radiat Oncol Biol Phys. 2008;71(1 Suppl):S191-194 https://doi.org/10.1016/j.ijrobp.2007.06.083
18. [18] Liu HC, You XY, Tsung F, Ji P. An improved approach for failure mode and effect analysis involving large group of experts: An application to the healthcare field. Qual Eng. 2018;30:1–44 https://doi.org/10.1080/08982112.2018.1448089
19. [19] Sobral J, Teixeira D, Morais H, Neves M. Methodology to assess medical processes based on a Failure Mode and Effects Analysis (FMEA). In: 2017 IEEE 5th Portuguese Meeting on Bioengineering (ENBENG), pp. 1–4 https://doi.org/10.1016/j.heliyon.2022.e08944
20. [20] El-Awady SMM. Overview of Failure Mode and Effects Analysis (FMEA): A Patient Safety Tool. Glob J Qual Saf Healthc. 2023;6(1):24–26 https://doi.org/10.36401/JQSH-23-X2
21. [21] Harris S, Nino V, Claudio D. Simulating a sterilization processing department to evaluate block schedules and tray configurations. Syst Eng. 2024;27(1):54–73 https://doi.org/10.1016/j.heliyon.2022.e08944
22. [22] Jildeh ZB, Wagner PH, Schöning MJ. Sterilization of objects, products, and packaging surfaces and their characterization in different fields of ındustry: The Status in 2020. Phys status solidi. 2021;218(13):2000732 https://doi.org/10.1002/pssa.202000732
23. [23] Mascia A, Cirafici AM, Bongiovanni A, Colotti G, Lacerra G, Di Carlo M, et al. A failure mode and effect analysis (FMEA)-based approach for risk assessment of scientific processes in non-regulated research laboratories. Accredit Qual Assur. 2020;25(5):311–321 https://doi.org/10.1007/s00769-020-01441-9
24. [24] Subriadi AP, Najwa NF. The consistency analysis of failure mode and effect analysis (FMEA) in information technology risk assessment. Heliyon. 2020;6(1):e03161 https://doi.org/10.1016/j.heliyon.2020.e03161
25. [25] Mardani Shahri M, Eshraghniaye Jahromi A, Houshmand M. Failure Mode and Effect Analysis using an integrated approach of clustering and MCDM under pythagorean fuzzy environment. J Loss Prev Process Ind. 2021;72:104591 https://doi.org/10.1016/j.jlp.2021.104591
26. [26] Panta G, Richardson AK, Shaw IC, Chambers S, Coope PA. Effectiveness of steam sterilization of reusable medical devices in primary and secondary care public hospitals in Nepal and factors associated with ineffective sterilization: A nation-wide cross-sectional study. PLoS One. 2019;14(11):e0225595 https://doi.org/10.1371/journal.pone.0225595
27. [27] Selvik JT, Signoret JP. How to interpret safety critical failures in risk and reliability assessments. Reliab Eng Syst Saf. 2017;161:61–68 https://doi.org/10.1016/j.ress.2017.01.003
28. [28] Bowles J. An Assessment of RPN Prioritization in a Failure Modes Effects and Criticality Analysis. J IEST. 2003; 47: 380–386 . https://doi.org/10.17764/jiet.47.1.y576m26127157313.