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The paper studied adoption of the Failure Mode, Effects, and Criticality Analysis (FMECA) technique to build a risk profile for public procurement of medical devices in Tunisia’s largest university hospital. Over six months, a multidisciplinary team in the pharmacy unit reviewed the procurement process from need assessment to contract signing, using process mapping, brainstorming, and Fishbone diagrams to identify 34 failure modes across 10 steps and 18 sub-steps, then scoring each by likelihood, damage, and detectability on a 5-point scale to derive criticality indices and rank modes above a mean threshold of 38. The requirement identification step had the highest cumulative criticality, and tender publication had the highest mean criticality; 55% of failure modes were deemed critical, and the action plans targeted measures covering 70% of overall criticality. Limitations explicitly noted include that this is a preprint not peer reviewed and the data may be preliminary, and the analysis was confined to a single hospital over a defined six-month period. The paper does not explicitly discuss endometriosis or adenomyosis; it was included in the corpus via a keyword match in the upstream search index.
Abstract
Objectives : This study focuses on the adoption of the Failure Mode, Effects, and Criticality Analysis (FMECA) technique in the medical device procurement framework risk profile at Tunisia’s largest university hospital. Methods: : The analytical study was conducted for six months in the pharmacy unit. The multidisciplinary working team, reviewed the entire procurement process from need assessment to contract signing. Failure modes were analyzed through process mapping, brainstorming, and Fishbone diagrams. Each was evaluated for its likelihood of occurrence, the damage that could be done, and the chances of being noticed, grading it out of 5. Criticality Indices (CIs) were derived and subsequently ranked beyond the mean CI threshold of 38. Action plans were created for the critical failure modes. Results: : A total of 34 failure modes were identified. The process included 10 steps with 18 sub-steps. The cumulative criticality was 1277, with a mean CI of 38 ± 22. The requirement identification step had the highest cumulative criticality (256 points). The publication of tenders showed the highest mean CI (64 ± 22). Nineteen failure modes (55%) were considered critical. The action plan addressed 70% of the overall criticality and included structural, organizational and strategic measures. Conclusion: The FMECA process has been useful with regard to pinpointing procurement risks and defining mitigating actions at the Tunisian university hospital. Tools upgrades and AI-tools integration seem to be a radical solution to ease the process without forgetting the easing and updating of the regulatory framework.
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Risk analysis applied to the process of public procurement of medical devices in a university hospital Running: Risk analysis applied to procurement of medical devices | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 21 January 2026 V1 Latest version Share on Risk analysis applied to the process of public procurement of medical devices in a university hospital Running: Risk analysis applied to procurement of medical devices Authors : Ahlem Ben Cheikh Brahim , Nour El Houda Ben Fatma , Fatma Sellami [email protected] , Wadie Belhadj , Khawla Rhayem , and Aimen Abbassi Authors Info & Affiliations https://doi.org/10.22541/au.176899168.86972163/v1 116 views 42 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Objectives : This study focuses on the adoption of the Failure Mode, Effects, and Criticality Analysis (FMECA) technique in the medical device procurement framework risk profile at Tunisia’s largest university hospital. Methods: The analytical study was conducted for six months in the pharmacy unit. The multidisciplinary working team, reviewed the entire procurement process from need assessment to contract signing. Failure modes were analyzed through process mapping, brainstorming, and Fishbone diagrams. Each was evaluated for its likelihood of occurrence, the damage that could be done, and the chances of being noticed, grading it out of 5. Criticality Indices (CIs) were derived and subsequently ranked beyond the mean CI threshold of 38. Action plans were created for the critical failure modes. Results: A total of 34 failure modes were identified. The process included 10 steps with 18 sub-steps. The cumulative criticality was 1277, with a mean CI of 38 ± 22. The requirement identification step had the highest cumulative criticality (256 points). The publication of tenders showed the highest mean CI (64 ± 22). Nineteen failure modes (55%) were considered critical. The action plan addressed 70% of the overall criticality and included structural, organizational and strategic measures. Conclusion: The FMECA process has been useful with regard to pinpointing procurement risks and defining mitigating actions at the Tunisian university hospital. Tools upgrades and AI-tools integration seem to be a radical solution to ease the process without forgetting the easing and updating of the regulatory framework. Supplementary Material File (figure.docx) Download 480.51 KB File (main doc final.docx) Download 502.28 KB File (table finish.docx) Download 16.83 KB Information & Authors Information Version history V1 Version 1 21 January 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords fmeca hospital pharmacy medical device procurement process risk Authors Affiliations Ahlem Ben Cheikh Brahim University of Monastir View all articles by this author Nour El Houda Ben Fatma University of Monastir View all articles by this author Fatma Sellami [email protected] University of Monastir View all articles by this author Wadie Belhadj Charles Nicolle Hospital Finance Department View all articles by this author Khawla Rhayem Procurement Department View all articles by this author Aimen Abbassi University of Monastir View all articles by this author Metrics & Citations Metrics Article Usage 116 views 42 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Ahlem Ben Cheikh Brahim, Nour El Houda Ben Fatma, Fatma Sellami, et al. Risk analysis applied to the process of public procurement of medical devices in a university hospital Running: Risk analysis applied to procurement of medical devices. Authorea . 21 January 2026. DOI: https://doi.org/10.22541/au.176899168.86972163/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! Copying failed. 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