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Multi-Center Evaluation of Optical Degradation Patterns in Rigid Endoscopes: A Data-Driven Approach.

作者信息

Noordmans Herke Jan, de Braak Menno, Brakel Marco J, Onur Alexander R, De Geus Jeroen, Jaspers Joris E N

机构信息

Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, the Netherlands.

Research & Development, DOVIDEQ Medical, Hengelo, the Netherlands.

出版信息

Med Devices (Auckl). 2025 Oct 9;18:507-518. doi: 10.2147/MDER.S550187. eCollection 2025.

DOI:10.2147/MDER.S550187
PMID:41089934
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12517457/
Abstract

INTRODUCTION

The ScopeControl (Dovideq Medical, Hengelo, The Netherlands) measures the optical quality of rigid endoscopes in the sterilization department's cleanroom. Endoscopes with low quality are rejected for use and must be repaired or replaced.

METHODS

An analysis of 500,000 measurements from 95 ScopeControls worldwide was conducted to evaluate hospital strategies, such as endoscope replacement timing, repair versus replace decisions, brand selection, and the impact of operating room to central sterile department processes. For the UMC Utrecht, repair data and usage data from surgery were included in the analysis. Custom software was used to filter out inexplicable, deviating measurements and calculate trend parameters such as initial and average quality, average quality decrease, and time to failure.

RESULTS

The ScopeControl measurements are generally of good quality. Data exploration revealed significant variations between endoscopes. Lifespan ranged from 15 to 400 usages, with endoscopes often failing suddenly due to a broken lens, likely caused by mechanical or thermal shock. For specific endoscope types, comparisons between new and repaired endoscopes showed that repaired endoscopes have a median lifespan of 30% fewer usages and median light transmission that is 11% lower than new endoscopes. Entry measurements are highly recommended due to the large variation in the optical quality of both new and repaired endoscopes. Additionally, users appear to accept lower quality for vulnerable, long, thin pediatric endoscopes, possibly due to the high replacement cost, compared to endoscopes used for adult applications.

CONCLUSION

ScopeControl enables objective assessment of endoscope quality and supports data-driven decisions on repair and replacement. Our analysis suggests that repaired endoscopes generally do not match the optical quality of new ones, and we provide initial estimates of this difference. These findings highlight the need for further data collection and may encourage improvements in repair processes. Sudden failures underline the importance of regular checks, and linking ScopeControl data with repair and usage information remains essential for optimizing maintenance strategies and improving endoscope longevity.

摘要

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本文引用的文献

1
Quality control of rigid endoscopes: a comparative study between ScopeControl® and surgeons' evaluation.硬性内窥镜的质量控制:ScopeControl®与外科医生评估之间的比较研究
Surg Endosc. 2021 Dec;35(12):6770-6776. doi: 10.1007/s00464-020-08181-4. Epub 2021 Jan 4.
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An economic analysis of the benefits of sterilizing medical instruments in low-temperature systems instead of steam.对在低温系统而非蒸汽中对医疗器械进行消毒的益处的经济分析。
Am J Infect Control. 2017 Jul 1;45(7):756-760. doi: 10.1016/j.ajic.2017.02.026. Epub 2017 Mar 29.
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Evaluation of the ScopeControl endoscope test system in six hospitals in The Netherlands.荷兰六家医院对ScopeControl内窥镜测试系统的评估。
Phys Med. 2015 Mar;31(2):152-8. doi: 10.1016/j.ejmp.2014.12.006. Epub 2015 Jan 15.
4
Measures taken to reduce damage and repair costs of rigid endoscopes during their handling and processing in surgical practice.在外科手术实践中,为减少硬性内窥镜在处理和加工过程中的损坏及维修成本而采取的措施。
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