PONE-D-22-18329Disinfection of otorhinolaryngological endoscopes with electrolysed acid water: a cross-sectional and multicentre studyPLOS ONE

Dear Dr. Omori,

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Academic Editor

PLOS ONE

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2. Thank you for stating the following in the Competing Interests section: 

"I have read the journal's policy and the authors of this manuscript have the following competing interests: Protein Clean Sheets and a CLEANTOP KD-1 automatic washer and disinfector used in the present study were provided by Kaigen Pharma, Co., Ltd. and one of the authors, Hideki Hayashi, is an employee of Kaigen Pharma, Co., Ltd."

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Additional Editor Comments:

Reviewer 1:

1- Significant differences between A-1, A-2, and A-3 . sampling sites should be mentioned.

2- There are some typos and grammatical errors which should be revised.

3- This sentence is not correct "The verbal

210 informed consent for participation was obtained form patients visiting the outpatient facility of the

211 Department of Otorhinolaryngology using an opt-out methodology because this study does not

212 harm the patients in any way including direct microbiological sampling or blood sampling"

4- I couldn't find any of the references from the 21, 22 and 23

Reference correction is necessary

Reviewer 2:

Authors have reported effective use of Electrolyte acid water (EAW) in disinfecting otorhinolaryngological endoscopes, which is of clinical significance. Authors have presented sufficient data in support of research question keeping limitation of study in account. Manuscript can be accepted for publication after making amendments as suggested.

Some specific comments/reviews to incorporate/amend are as follows:

1- Abstract: Authors have summarized key findings appropriately. However, in vitro inactivation of bacteria and SARS-CoV-2 need to be presented consistently in number/percentage or CFU to enhance reader's understanding.

2-Introduction: Significance of using EAW for disinfection of otorhinolaryngological endoscopes for bacteria has been presented appropriately. however, authors need to include significance of using EAW for SARS-CoV-2 as well briefly.

2- Methods: Authors used appropriate methodology to address the research question. However, following amendments 13are suggested:

Page 8, lines 138-139: Authors either need to include time/concentration for disinfection using Cleantop-KD-1 or reference

for the procedure.

Page 11, lines 190-191: "Overnight" incubation time need to be rephrased in terms of "Hours" for clarity.

3- Results: Authors have presented results appropriately using tables facilitating reader's understanding. Suggested amendment:

Page 13, lines 220-221: "29 patients had nasal disease....." needs correction as breakdown adds up to 30.

Page 14, lines 234- 235: " ...only in 1 of 75 patients...." needs to be corrected as " ...only in 1 of 75 endoscopes...."

4-Discussion: Overall needs to be rephrased. Few amendments suggested are:

Page 18-19, line 286- 301, "Because otorhinolaryngology ........high-level disinfection." is a repeat from introduction

need to be deleted.

Page 19-20, para 2, line 309-320: Needs rephrasing for clarity. Also, reference of table needs to be removed from

discussion.

5- Conclusion: It is vague and needs rephrasing keeping context of study in view to highlight the significance of study.

Reviewer 3:

1. Lines 90 - 93: Despite there is no study that presents the disinfection efficacy of EAW in clinically used otorhinolaryngological endoscopes, authors have mentioned about the effectiveness of using EAW in disinfecting clinically for gastrointestinal endoscopes. Authors should highlight their significant findings and contributions.

2. Introduction can be improved by adding a few sentences about the hypochlorous acid since it is the primary antibacterial agent in the study.

3. Line 95: "Fig 1. Schematic of generation of electrolysed acid water" is not necessary to be included in the manuscript, as it is well known.

4. Lines 116 –148: it is helpful to provide an image (as supporting Information file) of the endoscopy instruments with two sites (A-1 to A-3, B-1 to B-3) to aid the understanding of this part.

5. Line 149 and line 340: this a study designed to culture aerobic and anaerobic bacteria as well as fungi but there is limited discussion about fungi being observed or detected or fungicidal effect, please explain more.

6. Line 171: the subheading "bacteria and culture" is more generic while the paragraph discusses EAW treatment; please edit the subheading to reflect all the aspects of the method on bacterial culture and bactericidal effects of EAW.

7. Lines 216- 226: A table is preferred here given the amount of data being presented.

8. Line 270: What is the control sample for the data presented in the Table 3?

9. Full name of bacterial strains should be mentioned in the (Table 3) as mentioned in from line 172-175 have to be.

10. Lines 258 – 301: Discussion can be improved to avoid repetition with introduction section.

11. The conclusion is supported by the results for EAW treatment of SARS-CoV-2 but not for bacteria. Therefore, this section must be improved and highlight why EAW can be an ideal disinfectant (bactericidal and virucidal effects) and use it at present as regarded to be safe and environmentally friendly to overcome supply crisis during pandemic emergency and enable the safe continuity.

12. Line 183: influenzae, make the last letter (e) italic as well.

13. Line 210: form or from

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Partly

Reviewer #3: Partly

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: I Don't Know

Reviewer #2: N/A

Reviewer #3: N/A

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: No

Reviewer #3: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Please see the following published research:

1- https://www.researchgate.net/profile/Raad-Hasan/publication/357303354_Detection_of_fimH_kpsMTII_hlyA_and_traT_genes_in_Escherichia_coli_isolated_from_Iraqi_patients_with_cystitis/links/61c5a20bb8305f7c4bf970a1/Detection-of-fimH-kpsMTII-hlyA-and-traT-genes-in-Escherichia-coli-isolated-from-Iraqi-patients-with-cystitis.pdf

2- https://www.researchgate.net/deref/https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F35096341%2F

3- https://www.researchgate.net/deref/https%3A%2F%2Fwww.cabdirect.org%2Fglobalhealth%2Fabstract%2F20193498480

4- https://www.researchgate.net/deref/https%3A%2F%2Fworldresearchersassociations.com%2FBiotechSpecialIssueMarch2019%2F7.pdf

Reviewer #2: Authors have reported effective use of Electrolyte acid water (EAW) in disinfecting otorhinolaryngological endoscopes, which is of clinical significance. Authors have presented sufficient data in support of research question keeping limitation of study in account. Manuscript can be accepted for publication after making amendments as suggested.

Some specific comments/reviews to incorporate/amend are as follows:

1- Abstract: Authors have summarized key findings appropriately. However, in vitro inactivation of bacteria and SARS-CoV-2 need to be presented consistently in number/percentage or CFU to enhance reader's understanding.

2-Introduction: Significance of using EAW for disinfection of otorhinolaryngological endoscopes for bacteria has been presented appropriately. however, authors need to include significance of using EAW for SARS-CoV-2 as well briefly.

2- Methods: Authors used appropriate methodology to address the research question. However, following amendments 13are suggested:

Page 8, lines 138-139: Authors either need to include time/concentration for disinfection using Cleantop-KD-1 or reference

for the procedure.

Page 11, lines 190-191: "Overnight" incubation time need to be rephrased in terms of "Hours" for clarity.

3- Results: Authors have presented results appropriately using tables facilitating reader's understanding. Suggested amendment:

Page 13, lines 220-221: "29 patients had nasal disease....." needs correction as breakdown adds up to 30.

Page 14, lines 234- 235: " ...only in 1 of 75 patients...." needs to be corrected as " ...only in 1 of 75 endoscopes...."

4-Discussion: Overall needs to be rephrased. Few amendments suggested are:

Page 18-19, line 286- 301, "Because otorhinolaryngology ........high-level disinfection." is a repeat from introduction

need to be deleted.

Page 19-20, para 2, line 309-320: Needs rephrasing for clarity. Also, reference of table needs to be removed from

discussion.

5- Conclusion: It is vague and needs rephrasing keeping context of study in view to highlight the significance of study.

Reviewer #3: Manuscript Number: PONE-D-22-18329

Type: Research Article Title: Disinfection of otorhinolaryngological endoscopes with electrolysed acid water: a cross-sectional and multicentre study

Authors: Takayuki Okano1, Tatsunori Sakamoto2, Seiji Ishikawa3, Susumu Sakamoto4, Masanobu Mizuta1, Yuji Kitada1, Keisuke Mizuno1, Hideki Hayashi5,6, Youichi Suzuki7, Takashi Nakano6,7, Koichi Omori1*

Summary: The article describes the practical steps involved in preparing and evaluating electrolyzed acidic water for the disinfection of otorhinolaryngological endoscopes in clinical settings, and an in vitro study of the efficacy of EAW at removing possible pathogenic bacteria related to otorhinolaryngology and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).

Overall, the research design is appropriate, the methods adequately described, the results clearly presented and all cited references relevant to the research.

Comments to authors:

1. Lines 90 - 93: Despite there is no study that presents the disinfection efficacy of EAW in clinically used otorhinolaryngological endoscopes, authors have mentioned about the effectiveness of using EAW in disinfecting clinically for gastrointestinal endoscopes. Authors should highlight their significant findings and contributions.

2. Introduction can be improved by adding a few sentences about the hypochlorous acid since it is the primary antibacterial agent in the study.

3. Line 95: "Fig 1. Schematic of generation of electrolysed acid water" is not necessary to be included in the manuscript, as it is well known.

4. Lines 116 –148: it is helpful to provide an image (as supporting Information file) of the endoscopy instruments with two sites (A-1 to A-3, B-1 to B-3) to aid the understanding of this part.

5. Line 149 and line 340: this a study designed to culture aerobic and anaerobic bacteria as well as fungi but there is limited discussion about fungi being observed or detected or fungicidal effect, please explain more.

6. Line 171: the subheading "bacteria and culture" is more generic while the paragraph discusses EAW treatment; please edit the subheading to reflect all the aspects of the method on bacterial culture and bactericidal effects of EAW.

7. Lines 216- 226: A table is preferred here given the amount of data being presented.

8. Line 270: What is the control sample for the data presented in the Table 3?

9. Full name of bacterial strains should be mentioned in the (Table 3) as mentioned in from line 172-175 have to be.

10. Lines 258 – 301: Discussion can be improved to avoid repetition with introduction section.

11. The conclusion is supported by the results for EAW treatment of SARS-CoV-2 but not for bacteria. Therefore, this section must be improved and highlight why EAW can be an ideal disinfectant (bactericidal and virucidal effects) and use it at present as regarded to be safe and environmentally friendly to overcome supply crisis during pandemic emergency and enable the safe continuity.

12. Line 183: influenzae, make the last letter (e) italic as well.

13. Line 210: form or from?

With regards,

**********

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Reviewer #1: Yes: Raad N Hasan

Reviewer #2: No

Reviewer #3: No

**********

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Disinfection of otorhinolaryngological endoscopes with electrolyzed acid water: a cross-sectional and multicenter study

PONE-D-22-18329R1

Dear Dr. Koichi Omori,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

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Kind regards,

Awatif Abid Al-Judaibi, PhD

Academic Editor

PLOS ONE