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

Herke Jan Noordmans,1 Menno de Braak,2 Marco J Brakel,1 Alexander R Onur,1 Jeroen De Geus,3 Joris E N Jaspers1 1Department of Medical Technology and Clinical Physics, University Medical Center Utrecht, Utrecht, the Netherlands; 2Research & Development, DOVIDEQ Medical, Hengelo, the Netherlands; 3Staff Division Laboratories, Pharmacy and Biomedical Genetics, University Medical Center Utrecht, Utrecht, the NetherlandsCorrespondence: Herke Jan Noordmans, Email [email protected]: 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.Keywords: rigid endoscopes, optical quality assessment, medical device quality control, predictive maintenance, repair versus replacement, data-driven healthcare