A prospective, quasi-experimental study on the efficacy of a novel double-headed endoscope cleaning brush for cleaning flexible endoscopes | BMC Gastroenterology | Full Text

Feb 19, 2025

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The most important step in endoscope retreatment is careful manual cleaning before disinfection. Selecting the proper brushes is critical to disinfection. The study investigated the effectiveness of a novel double-headed disposable brush for cleaning flexible gastrointestinal endoscopes.

This prospective, quasi-experimental study included endoscopes used in a first-class hospital between January 2020 and August 2021. The primary outcome was the change in the amount of bacteria determined using the relative light unit (RLU) value of adenosine triphosphate (ATP) fluorescence.

A total of 267 endoscopes (131 double-headed brushes and 136 conventional ones) were included. The changes in RLU values of the ATP detection before and after brushing in the double-headed group were significantly higher than in the conventional group (ΔRLU, 116 (55, 251) vs. 76 (26, 181), P = 0.001). Similar results were observed in the subgroup analysis of colonoscopes, especially those with a 3.8-mm channel (ΔRLU, 115 (34, 265) vs. 52 (19, 199), P = 0.007), but not for gastroscopes (P = 0.363). Positive bacterial culture rates were higher in the double-headed/nylon brush end and double-headed/non-woven fabric end than in the single-headed brush (40.5% and 70.2% vs. 33.1%, P < 0.001).

The results indicated the advantage of the novel double-headed disposable brush for flexible endoscope cleaning, and the nylon brush end may explain the advantage.

The cleaning effect of the novel double-headed disposable brush for the flexible endoscope was better than the conventional one.

Not applicable.

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Digestive endoscopy is one of the greatest medical innovations of the 20th century and an important means of diagnosing and treating digestive tract diseases [1, 2, 3]. Its minimal invasiveness makes digestive endoscopy the procedure of choice for visualizing the digestive mucosa and treating various benign and malignant lesions [1, 2, 3]. Digestive endoscopy is the most frequent procedure performed by gastroenterologists, with > 10 million procedures each year in the United States of America [4].

The digestive tract contains many bacteria; many of them are potentially pathogenic but are kept in check by the microbial ecosystem in healthy individuals [5, 6]. Endoscopes are susceptible to forming biofilms because of their fine and complex structure and because the internal surface is prone to scratches after long-term use [7, 8, 9]. Such biofilms are notoriously difficult to clean and disinfect [8, 10, 11]. Failure to clean and disinfect digestive endoscopes can lead to the spread of infectious diseases, bringing serious consequences to patient safety and medical institutions [12, 13, 14]. Biofilms can also play a role in antibiotic resistance [15] and the spread of dangerous intestinal bacteria such as Clostridium difficile [16].

The most important step in endoscope retreatment is careful manual cleaning before disinfection, and such manual cleaning is a key factor in determining the success of disinfection; if cleaning is not thorough, disinfection will be ineffective because of the intrinsic resistance of biofilms to disinfection [17]. The “WS507-2016 Flexible Endoscope Cleaning and Disinfection Technical Specification” issued by the Chinese government in 2016 emphasizes that medical institutions must pay the utmost importance to endoscope cleaning and disinfection and include it in medical quality management [18]. Other authoritative organizations worldwide also emphasized this requirement [12, 13, 19, 20, 21]. Brushing all openings and channels is critical in endoscope retreatment, and selecting the proper brushes is critical to cleaning [22].

The innovation tested in the present study is the design and use of a double-headed disposable brush for optimal endoscope retreatment. Hence, this study aimed to investigate the efficacy of the novel double-headed endoscope cleaning brush for endoscope cleaning compared with the usual single-headed endoscope brush.

This prospective, quasi-experimental trial was undertaken at the digestive endoscopy center of a first-class hospital in our city between June 2020 and October 2021. The study was approved by the Ethics Review Committee of the hospital.

The endoscopes were included by convenience sampling. The main gastroscope used for examination was the GIF-H290 (Olympus, Japan; channel diameter, 2.8 mm). The main colonoscopes used for examination were the CF-H290I (Olympus, Japan; channel diameter, 3.2 mm), CF-HQ290I (Olympus, Japan; channel diameter, 3.7 mm), and EC-601WM (Fujifilm, Japan; channel diameter, 3.8 mm). The inclusion criteria were (1) one of the endoscope models listed above, (2) the endoscope was used on an actual patient in the outpatient setting, and (3) met the clinical standards before and after the examination [18]. Endoscopes with records of damage or repair were excluded.

The endoscopes were divided into the conventional and double-headed groups according to even and odd numbers of their cleaning orders after use. The even-numbered endoscopes were in the conventional group, and the odd-numbered ones were in the double-headed group. The dedicated endoscopy staff collected and cleaned the used endoscopes together in the cleaning area. The infection control personnel were blind to the cleaning methods and sampled and analyzed the instruments.

The endoscopes were uniformly pre-treated in accordance with the “WS507-2016 Flexible Endoscope Cleaning and Disinfection Technical Specification” [18, 19] and sent to the cleaning and disinfection room after treatment. Running water was used to clean the outer and mirror surfaces of the endoscope. A high-pressure water gun was used to flush the forceps channel for > 10 s until no material was visible to the naked eye. Two endoscope cleaning brushes were used to clean the endoscope forceps channel according to grouping (single-headed vs. double-headed brush) and cleaning standards [18, 19]. The endoscopes in the double-headed group were cleaned using a new double-headed disposable endoscope cleaning brush (Supplementary Figure S1) to complete the one-way cleaning by inserting the nylon brush head through the endoscope forceps channel from the inlet to the outlet, then pulling out the wire until the non-woven brush head protruded from the outlet of the forceps channel. The new type of double-headed endoscope cleaning brush (Supplementary Figure S1, patent number: ZL 20180200321764.4), produced by Shanghai Futang Biotechnology Co., Ltd., is divided into three parts: the head end, the metal spiral bourdon tube, and the tail end. For gastroscopes, the nylon brush head was 4.0 mm in diameter and 15.0 mm in length, and the non-woven brush head was 4.0 mm in diameter and 13.0 mm in length. For colonoscopes, the nylon brush head was 5.0 mm in diameter and 15.0 mm in length, and the non-woven brush head was 5.0 mm in diameter and 20.0 mm in length. The total length of the double-headed brush was 2400 mm. The new double-headed brush is disposable, eliminating the need for brush retreatment.

In the single-headed group, the usual single-headed endoscope cleaning brush was used to complete the two-way cleaning by inserting the nylon brush head through the endoscope forceps channel from the inlet to the outlet until the nylon brush exited the outlet, then by retracting back the nylon brush and pulling it out of the inlet. The single-headed brush had a head of 6.0 mm in diameter and 15 mm in length, with a total length of 2400 mm.

Apart from the different brushes and the number of passes (one pass for the two-headed brush and two passes for the single-headed brush), all procedures were the same in the two groups. All endoscopes were processed by two technicians with professional qualifications in sanitation, disinfection, and sterilization and with 5 years of experience. Both technicians used the two brushes.

The primary outcome was the change in the amount of bacteria according to the relative light unit (RLU) value of adenosine-triphosphate (ATP) detection before and after the brush cleaning process (ΔATP), as determined by on-site test strips and ATP tests [23, 24]. The secondary outcomes were the ATP pass rate and the positive rate of bacterial cultures after brushing. The cleaning time, defined as the duration from when the brush was inserted into the endoscope to when it was pulled out, was also recorded.

The ATP fluorescence detection method was used to measure the RLU of the flexible endoscope forceps channel. Samples were taken before and after brushing using special sampling swabs (ATP Quickswab A017, Xian Tianlong Science and Technology). The Quickswab was taken out of the refrigerator and was left to return to room temperature for about 10–20 min. The reaction tube was unscrewed at the lower part of the swab. The Quickswab was used to take a sample from the test area, swabbing back and forth twice within 5 cm from the front end of the endoscope lumen. The swab was rotated during the sampling process to ensure that the cotton tip made full contact with the endoscope. One sampling was done before retreatment, and another was taken after retreatment. The Quickswab was reassembled in the reaction tube. The protective cap was removed from the upper end of the swab. The swab was held vertically, and the spring cap was pressed down firmly. It was repeated several times to ensure that all the reagent was injected into the reaction tube. The reaction tube was mixed by inclining left and right by 30° for 5 s. The tube was inserted into the test compartment of the ATP measurement instrument, and the ATP was determined (BioLum, Xian Tianlong Science and Technology). The results were expressed as RLUs. The ΔATP was calculated as ATPbefore-ATPafter.

After brushing, the brush heads were cut off with sterile scissors and put into the sterilization neutralizer. After full shaking, 1 ml was taken out for bacterial culture. The presence of at least one bacterial colony in a dish was considered positive. A higher positive rate of the bacteria culture of the brush head after brushing indicated that the brush head could clean more bacteria and have a better cleaning effect. The ATP pass rate was defined as ≤ 15 RLUs, according to the manufacturer’s standards.

Statistical analysis was performed according to the statistical analysis plan prespecified in the protocol. The primary and secondary outcome data were collected and recorded in Microsoft Excel 2016 (Microsoft, Redmond, WA, USA) by two people independently. The two entries were compared to detect entry errors. The statistical analyses were performed using SPSS 18.0 (IBM, Armonk, NY, USA).

Continuous data (ATP levels) were tested for normal distribution using the Kolmogorov-Smirnov test. Data were non-normally distributed and were presented as median (P25, P75) and compared using the Wilcoxon rank-sum test. Categorical data were presented as n (%) and compared using the chi-squared test. Subgroup analyses were performed based on the type of endoscope. A two-sided P < 0.05 was considered statistically significant.

A total of 267 endoscopes were included in the study. All endoscopes met the clinical requirement criteria before use [18]. Among the 267 endoscopes, 131 (30 gastroscopes and 101 colonoscopes) were cleaned using the double-headed brush, and 136 (30 gastroscopes and 106 colonoscopes) were cleaned using the single-headed brush. All endoscopes were Fujinon 450, with different instrument channel diameters. The instrument channel diameter of the gastroscopes was 2.8 mm, while the colonoscopes had channels of 3.2, 3.7, or 3.8 mm (Table 1). There were no significant differences in the ratio of gastroscopes to colonoscopes or the proportion of the endoscopes with different channel diameters (all P > 0.05). The cleaning time in the double-headed brush group was 15.4 (15.0, 16.1) seconds, while it was 15.6 (15.2, 16.0) seconds in the single-headed group.

The changes in RLU values of ATP detection before and after brushing in the double-headed group were significantly higher than in the conventional group (116 [55, 251] vs. 76 [26, 181] RLU, P = 0.001) (Table 2). Similar results were observed for colonoscopes (115 [39, 275] vs. 52 [18, 175] RLU, P = 0.001), especially those with a 3.8-mm channel (115 [34, 365] vs. 52 [19, 199], P = 0.007). There were no significant differences between the two groups for the gastroscopes (129 [91, 187] vs. 122 [67, 183], P = 0.363) (Table 3). In the double-headed group, there were no significant differences between the two types of endoscopes (Z = 1331.000, P = 0.313) and among colonoscopes with different channel diameters (Z = 2.769, P = 0.250) (Table 4).

The ATP pass rate (87.97% vs. 61.03%, P < 0.001) and positive bacterial culture rates (78.63 vs. 33.09, P < 0.001) were significantly higher in the double-headed group compared with the conventional group (Table 2). There were no significant differences in the positive bacterial culture rates among different channel diameters (P = 0.358) (Supplementary Table S1). In the double-headed group, the positive bacterial culture rates were higher in the double-headed/nylon brush end (40.46%) and double-headed/non-woven fabric end (70.23%) than in the single-headed brush (33.09%) (P < 0.001) (Table 4).

The retreatment of a flexible endoscope is a high-risk process. Although various countries and institutions have issued several guidelines or regulations emphasizing the significance and necessity of standardized endoscope retreatment and standardizing the retreatment process of a digestive endoscope [20, 21], there are still great differences in the level of disinfection among medical facilities [25]. In 2018, a study by the Society for Healthcare Epidemiology of America (SHEA) showed that almost all gastrointestinal endoscope-related iatrogenic infections were due to substandard endoscope retreatment [26]. Due to its special and precise structure, flexible digestive endoscopes are difficult to clean and disinfect. Clinical evidence showed that even after rigorous and standardized retreatment, endoscopes still have microbial contamination [27, 28, 29]. It can be because contaminants on the smooth surface of the endoscope can be easily removed by routine digestive endoscope retreatment, but for special structures, such as channels or lifter structures, biofilms often accumulate because such structures are difficult to clean [30].

In this study, the endoscopes washed with a double-headed disposable brush had a significantly greater change in ATP fluorescence detection before and after cleaning than in the conventional group, indicating that the cleaning effect of the new-type double-headed brush was better than the usual single-headed brush. In terms of the bacterial culture rates, the positive rates of the two heads of the double-headed brush were significantly higher than for the single-headed brush, indicating that the cleaning effect of the new double-headed endoscope cleaning brush was higher than the usual single-headed cleaning brush.

The two heads of the new double-headed brush are made of two different materials: a nylon brush head (the same as the conventional brush) and a novel brush made of non-woven fabric. Even though the double-headed brush uses a one-way cleaning method, it is equivalent to cleaning twice. On the other hand, the single-headed brush uses a two-way cleaning method, and the second cleaning reuses the same brush head that has already been used and can carry microorganisms back into the endoscope. Using two brushes could help with cleaning, but the two brushes are of two different types and materials, potentiating the cleaning effect.

This study also showed that there were no significant differences between different types of endoscopes and colonoscopes with different channel diameters. It means that the double-headed brushes can be used to clean different kinds of endoscopes.

This study showed that the non-woven fabric brush head was superior to nylon brush heads in terms of cleaning effect, which is similar to the findings of Ditommaso et al. [31] and Chung et al. [32], whose studies explored the effect of different materials on the monitoring of culture surfaces with flexible fiber laryngoscopes, and showed that TNT wet tissues were significantly better than cellulose and hydrated sponges in terms of efficiency in extracting Bacillus spores, suggesting that the cleaning brushes of different materials have different effects on the cleaning of bacteria, secretions, and other substances from the endoscope channel. A novel ball brush made of a silicon ball wrapped in microfibers also had a better cleaning effect than conventional brushes [33]. Previous research showed that scrubbing with hard bristles and wire can also damage the lumen of the endoscope channel [20]. The nylon brush head was kept because the conventional brush is made of nylon, as stipulated in the retreatment guidelines [18, 19]. The performance of a retreatment brush without a nylon brush head should be explored in future studies.

This study has several limitations. First, the study used a convenient sampling method to sample the endoscopes over a certain period. Second, only the endoscopes were studied, not the patients. The characteristics of the patients could influence the results, but they were not collected. Third, the study was a single-center study with a relatively small sample size, and the selection of the endoscopes may have some bias. Fourth, the subgroup analysis is provided for indicative purposes only. Indeed, the 3.8-mm subgroup was the most important subgroup, and it is possible that the other subgroups had a number of endoscopes too small to reach statistically significant results. Moreover, indicators for evaluating the difficulty of using the double-headed brush were not collected, which warrants further study. Multicenter and multi-period studies with larger sample size are needed to improve the credibility and generalizability of the results.

In conclusion, the cleaning effect of the novel double-headed disposable endoscope cleaning brush for flexible endoscopes was better than with the usual single-headed endoscope brush. The effect of the non-woven brush head on bacteria removal was significantly better than that of the nylon brush head. The new double-headed disposable endoscope cleaning brush is easy to use and may be worthy of clinical application.

All data generated or analyzed during this study are included in this article and supplementary information files.

Relative light unit

Adenosine triphosphate

Society for Healthcare Epidemiology of America

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This study was funded by the Shanghai Nursing Society (No. 2018MS-B14).

Rui Shen, Yaping Wu these two authors contribute equally to the work.

Center of Endoscopy, Ruijin Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, 200000, China

Rui Shen, Qukai Liu & Weiyan Yao

Department of Gastroenterology, School of Medicine, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, 200000, China

Yaping Wu, Jiajun Lv, Weiyan Yao & Shu Chen

Department of Nursing, School of Medicine, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, 200000, China

Rui Shen & Yaping Wu

Medical Department, Changhai Hospital, Naval Medical University, Shanghai, 200000, China

Dandan Liu & Huijun Xi

Department of Hospital Infection Management, School of Medicine, Ruijin Hospital, Shanghai Jiaotong University, Shanghai, 200000, China

Yibo Zhang

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Jiajun Lv, Dandan Liu and Yaping Wu carried out the studies, participated in collecting data, and drafted the manuscript. Qukai Liu, Shu Chen, Huijun Xi and Weiyan Yao performed the statistical analysis and participated in its design. Rui Shen and Yibo Zhang participated in acquisition, analysis, or interpretation of data and draft the manuscript. All authors read and approved the final manuscript.

Correspondence to Huijun Xi or Yibo Zhang.

This study has been approved by the Ethics Review Committee of Ruijin Hospital, School of Medicine, Shanghai Jiaotong University. The samples collected in this study were endoscopes used in our hospital from January 2020 to August 2021, and no human data was collected and analyzed, so the consent to participate was not required.

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Shen, R., Wu, Y., Lv, J. et al. A prospective, quasi-experimental study on the efficacy of a novel double-headed endoscope cleaning brush for cleaning flexible endoscopes. BMC Gastroenterol 25, 90 (2025). https://doi.org/10.1186/s12876-025-03680-x

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Received: 29 August 2024

Accepted: 11 February 2025

Published: 18 February 2025

DOI: https://doi.org/10.1186/s12876-025-03680-x

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