Courault Pierre, Emery Stéphane, Boudour Sofia, Rochefort Françoise, Ruffion Alain, Dussart Claude, Corvaisier Stéphane
Hospices Civils de Lyon, Stérilisation Centrale, 1060 rue Nicéphore Niepce, 69800, Saint-Priest, France.
Hospices Civils de Lyon, Centre Hospitalier Lyon-Sud, Service d'urologie, 165 chemin du Grand-Revoyet, 69310, Pierre-Bénite, France.
Surg Endosc. 2021 Dec;35(12):6770-6776. doi: 10.1007/s00464-020-08181-4. Epub 2021 Jan 4.
In central sterile services departments (CSSD), the functionality of rigid endoscopes, which are complex and fragile reusable devices, is usually controlled visually and is considered a complex and subjective task. ScopeControl® was developed to provide an automated quality control of rigid endoscopes by measuring the value of six parameters: viewing angle (VA), field of view (FV), color correctness (CC), light transmission (LT), fibers transmission (FT), and focus (FC). The aim of the present study was to assess the ability of ScopeControl® to pre-emptively identify endoscope defects before the surgeon considers them as defective.
The same endoscope was evaluated by surgeons during surgery using a scoring scale as well as the CSSD staff using the ScopeControl® during reprocessing. The ScopeControl® categorized the endoscope into 3 groups: "passed," "in danger," and "failed." Correlations between the surgeon's evaluation and results of the ScopeControl® were calculated.
One hundred sixty-six controls were carried out concerning 51 different endoscopes. According to the surgeon's evaluation, 78.9% and 80.7% of controls were considered as satisfactory for image and brightness quality, respectively. Results obtained using ScopeControl® found that 13.3% of controls were considered as "passed," 31.3% "in danger," and 55.4% "failed," with poor correlation with the surgeons' evaluation. LT and FT parameters represented 95.2% of the reasons for failures. The ability of the ScopeControl® to detect endoscope defects earlier than surgeons was validated by tracking the results of endoscopes used and controlled several times.
The ScopeControl® achieved an objective and consistent quality control of endoscopes and showed poor correlation with the surgeon's opinion. In practice, the ScopeControl® could avoid the use of defective endoscopes in the surgery unit and thus improve the quality of the surgical procedure.
在中央消毒供应室（CSSD），硬质内镜是复杂且易碎的可重复使用设备，其功能通常通过目视检查来控制，这被认为是一项复杂且主观的任务。ScopeControl® 的开发目的是通过测量六个参数的值来对硬质内镜进行自动化质量控制，这六个参数分别为视角（VA）、视野（FV）、颜色正确性（CC）、光传输（LT）、纤维传输（FT）和焦点（FC）。本研究的目的是评估 ScopeControl® 在外科医生将内镜视为有缺陷之前预先识别内镜缺陷的能力。
同一条内镜在手术期间由外科医生使用评分量表进行评估，同时在再处理期间由CSSD工作人员使用ScopeControl® 进行评估。ScopeControl® 将内镜分为三组：“通过”、“有风险”和“失败”。计算外科医生的评估结果与ScopeControl® 的结果之间的相关性。
对51条不同的内镜进行了166次检查。根据外科医生的评估，分别有78.9%和80.7%的检查在图像和亮度质量方面被认为是令人满意的。使用ScopeControl® 获得的结果发现，13.3%的检查被认为“通过”，31.3%“有风险”，55.4%“失败”，与外科医生的评估相关性较差。LT和FT参数占失败原因的95.2%。通过跟踪多次使用和检查的内镜结果，验证了ScopeControl® 比外科医生更早检测到内镜缺陷的能力。
ScopeControl® 实现了对内镜的客观且一致的质量控制，并且与外科医生的意见相关性较差。在实际操作中，ScopeControl® 可以避免在手术科室使用有缺陷的内镜，从而提高手术质量。
