Exploring options for reprocessing of N95 Filtering Facepiece Respirators (N95-FFRs) amidst COVID-19 pandemic: A systematic review

Diptanu Paul; Ayush Gupta; Anand Kumar Maurya

doi:10.1371/journal.pone.0242474

Peer Review History

Original SubmissionJuly 31, 2020
14 Sep 2020 Decision Letter - Amitava Mukherjee, Editor PONE-D-20-23922 Exploring options for reprocessing of N95 Filtering Facepiece Respirators (N95-FFRs) amidst COVID-19 pandemic: a systematic review PLOS ONE Dear Dr. Gupta, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. Please submit your revised manuscript by Oct 29 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Amitava Mukherjee, ME, Ph.D. Academic Editor PLOS ONE Journal Requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf [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: Partly ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: 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 ****** 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 ****** 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: Thank you for the opportunity to review this manuscript. The authors have performed an extensive literature search and review on N95 make re-processing. The topic is pertinent in the current setting, although rapidly changing. The authors have mostly stuck to peer-reviewed content, which is not always the case for studies at this time, but is beneficial to their work. The manuscript is very comprehensive, perhaps a little too much for a topic that they comment on as inadequate and sparse. My concerns are: • The comments “full set of personal protective equipment (PPE) including gowns, gloves, facemasks, face-shields or goggles and respirators for their protection during patient care” and “HCWs need to be protected against bioaerosols at all costs, which at minimum, is offered by use of N95 Filtering Facepiece Respirator (N95-FFR)” are misleading. In fact, citation (4) by the authors states that N95s are only needed during aerosol generating procedures. The authors should clarify this in the introduction. • “removes > 95% particles of around 300 nm” – there is an official definition of what an N95 filters, the authors should use that • The statement “No independent study prior to 2020 has evaluated microbicidal efficacy of H2O2 on FFRs” is not correct, see Fischer et. al 2020, among others • The discussion is far too long, essentially putting the tables into text. As such: • Paragraph 1 of the discussion is off topic and tangential opinion, it should be removed • The paragraph that starts “A typical N95-FFR consists of facepiece…” was not material analysed by the literature search and should be removed • The statement “N95-FFRs are difficult to decontaminate owing to the porous nature of the main body and electrostatically charged nature of electret media” needs a reference, this is debatable • The discussion needs to be reduced to key points and synthesis, with a cohesive analysis of the literature. At least two pages could be removed. • The conclusion doesn’t provide any conclusion regarding the review, but comments on the need for the review and then, again, summarizes the general concepts. There is no analysis here. There is also a dichotomy here, with one sentence stating a need for solution for low income countries (which I agree with), to the very next sentence stating an urgent need to study UV and HPV (not low income country solutions, by the authors own admission). • My biggest concern here is that this really isn’t a systematic review. It attempts to be, and provides the needed supplementary info (i.e. PRISMA diagram) but doesn’t provide any significant analysis. This is really a narrative review with an extensive literature search. Minor • The virus name is actually “SARS-CoV-2” not “SARS-COV-2” • Figure 2 legend “plotted against the reprocessing method” – not sure what the authors mean, it is a table, nothing is “plotted” ****** 6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. 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Revision 1
13 Oct 2020 Author Response Comment 1: Section: Introduction The comments “full set of personal protective equipment (PPE) including gowns, gloves, facemasks, face-shields or goggles and respirators for their protection during patient care” and “HCWs need to be protected against bioaerosols at all costs, which at minimum, is offered by use of N95 Filtering Facepiece Respirator (N95-FFR)” are misleading. In fact, citation (4) by the authors states that N95s are only needed during aerosol generating procedures. The authors should clarify this in the introduction. Author’s Reply: The authors have suitably modified the sentence as suggested by the reviewers in the Introduction section (Page 4, Paragraph 1). Comment 2: Section: Introduction removes > 95% particles of around 300 nm” – there is an official definition of what an N95 filters, the authors should use that Author’s Reply: The authors have modified the sentence and provided the reference of the official definition (Reference 7). In previously submitted manuscript, reference 5 & 7 were duplicated, now the new reference is given in place of Reference 7 (Page 4, Paragraph 1). Comment 3: Section: Discussion The statement “No independent study prior to 2020 has evaluated microbicidal efficacy of H2O2 on FFRs” is not correct, see Fischer et. al 2020, among others. Author’s Reply: Fischer et al (2020) have referenced Batelle report which evaluated microbicidal efficacy of Hydrogen peroxide for decontamination of N95-FFRs. It was a third party “commercial” evaluation of Clarus C Hydrogen Peroxide vapor generator done by Batelle Institute on behalf of FDA. This wasn’t an independent study published in scientific domain. Hence, we are of the opinion that the statement is correct. Furthermore, we have referenced findings of Batelle report in the Discussion section of the manuscript, where deemed suitable (Page 42, Paragraph 1). Comment 4: Section: Discussion The discussion is far too long, essentially putting the tables into text. As such: i. Paragraph 1 of the discussion is off topic and tangential opinion, it should be removed Author’s Reply: In our opinion, this paragraph is important as it highlights the chronology of the scientific progress made in finding a suitable reprocessing method for enabling reuse of FFRs. We humbly opine that had such a method been found in the previous decade, the crises of FFRs wouldn’t have been of this humongous proportions during COVID-19 pandemic. In late to 2000s to late 2010s, there was scientific thrust in finding such a reprocessing method which got derailed in the mid to late 2010s contributing partly to the current crises of shortage of FFRs. ii. The paragraph that starts “A typical N95-FFR consists of facepiece…” was not material analysed by the literature search and should be removed. Author’s Reply: The paragraph has been removed as suggested by the reviewers (Omitted). iii. The statement “N95-FFRs are difficult to decontaminate owing to the porous nature of the main body and electrostatically charged nature of electret media” needs a reference, this is debatable Author’s Reply: The statement & paragraph containing it has been removed in the revised Discussion (Omitted). iv. The discussion needs to be reduced to key points and synthesis, with a cohesive analysis of the literature. At least two pages could be removed. Author’s Reply: Discussion has been extensively modified as suggested by the reviewers. Comment 5: Section: Conclusion The conclusion doesn’t provide any conclusion regarding the review, but comments on the need for the review and then, again, summarizes the general concepts. There is no analysis here. There is also a dichotomy here, with one sentence stating a need for solution for low income countries (which I agree with), to the very next sentence stating an urgent need to study UV and HPV (not low income country solutions, by the authors own admission). Author’s Reply: The conclusions are now modified, hopefully to the reviewer’s satisfaction. The first 2 paragraphs summarize the findings of the study whereas the last paragraph gives general concepts and way for the future (Pages 45-46). Comment 6: Section: My biggest concern here is that this really isn’t a systematic review. It attempts to be, and provides the needed supplementary info (i.e. PRISMA diagram) but doesn’t provide any significant analysis. This is really a narrative review with an extensive literature search. Author’s Reply: We wholeheartedly accept the criticism of the reviewer. However, we will like to counter on the following points: 1. Systematic reviews address a specific research question using explicit methodology of collecting, selecting and appraising studies and synthesizing the results qualitatively or quantitatively, as appropriate. 2. Our review appears as a narrative review because it addresses a broad research question and the outcome of the included studies is discussed more in “Qualitative terms” rather than quantitatively. 3. We are of the opinion that the included studies varied extensively in terms of heterogeneity hence discussion in quantitative terms will not do justice to the essence of the article. Hence, qualitative results of included studies were taken into account in discussion and Quantitative details are provided in the Tables. 4. Overall the studies have not shown conflicting results between themselves for a particular reprocessing method despite being extremely heterogeneous. Hence the findings appear as General concepts, when in fact they are qualitative synthesis of the published literature on the topic. Wherever, conflicting results for a particular reprocessing method have been observed amongst studies, we have made an attempt to discuss. 5. Hence, as suggested by the reviewer, we have revised the Discussion & Conclusion sections extensively focusing now more on the qualitative findings pertaining to the review, hopefully to the reviewer’s satisfaction. Minor Comment 7: The virus name is actually “SARS-CoV-2” not “SARS-COV-2” Author’s Reply: This has been corrected in all the relevant places Comment 8: Figure 2 legend “plotted against the reprocessing method” – not sure what the authors mean, it is a table, nothing is “plotted” Author’s Reply: The legend has been suitably modified Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0242474.r002
27 Oct 2020 Decision Letter - Amitava Mukherjee, Editor PONE-D-20-23922R1 Exploring options for reprocessing of N95 Filtering Facepiece Respirators (N95-FFRs) amidst COVID-19 pandemic: A systematic review PLOS ONE Dear Dr. Gupta, Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process. ============================== Your manuscript can be accepted subject to minor revisions as detailed by the reviewer. Please check the term "systematic" in the title, and consider whether it may be changed to "Narrative" review. ============================== Please submit your revised manuscript by Dec 11 2020 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file. Please include the following items when submitting your revised manuscript: A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'. A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'. An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'. If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter. If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols We look forward to receiving your revised manuscript. Kind regards, Amitava Mukherjee, ME, Ph.D. Academic Editor PLOS ONE [Note: HTML markup is below. Please do not edit.] Reviewers' comments: Reviewer's Responses to Questions Comments to the Author 1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation. Reviewer #1: (No Response) ******** 2. 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 ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: Yes ****** 4. 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 ****** 5. 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 ****** 6. 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: >> The statement “No independent study prior to 2020 has evaluated microbicidal efficacy of H2O2 on FFRs” is not correct, see Fischer et. al 2020, among others. Author’s Reply: Fischer et al (2020) have referenced Batelle report which evaluated The authors must have the wrong Fischer et al. (2020) – I am referring to 1. Fischer, R. J., (2020) Effectiveness of N95 Respirator Decontamination and Reuse against SARS-CoV-2 Virus. Emerging Infect. Dis. 10.3201/eid2609.201524. This article does not reference any other article, but does the experiments themselves. This is but one example. It is actually very important to the manuscript, as this is now the most common method for commercial decontamination. The discussion is still too long and re-states the results. I encourage the authors to think of how to discuss the results, not re-state them. ****** 7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files. If you choose “no”, your identity will remain anonymous but your review may still be made public. Do you want your identity to be public for this peer review?** For information about this choice, including consent withdrawal, please see our Privacy Policy. Reviewer #1: No [NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.] While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step. https://doi.org/10.1371/journal.pone.0242474.r003
Revision 2
1 Nov 2020 Author Response To The Editor PLOSONE Sir At the outset we would like to thank the Reviewer(s) for critically reviewing our manuscript. Here is our point by point rebuttal to the suggestions/ concerns raised by the Reviewer: COMMENT 1: SECTION: TITLE Please check the term “systematic” in the title, and consider whether it may be changed to “Narrative review. Author’s Reply: In our humble opinion, a “Systematic review” differs from a “Narrative review” in the following points: a. The research question is well defined. b. There is clearly defined criteria for selection for articles published in literature c. Methods of extraction of and synthesis of data are explicit d. The critical appraisal of the quality of included studies is explicitly done In summary, systematic reviews differ from narrative reviews in their “Methodology” rather than the “Results”. We are of the opinion that our review ticks all the boxes in this regard. Furthermore the protocol of the article is also registered with the International prospective register of systematic reviews (PROSPERO) beforehand. We have already explained that the results of our article are synthesized and discussed more in the qualitative terms rather than quantitative terms due to the heterogeneity in the methodologies of various articles who have researched this topic. Hence, we humbly request that we should persist with the word “Systematic” in the title. COMMENT 2: SECTION: DISCUSSION The authors must have the wrong Fischer et al. (2020)- I am referring to 1. Fischer R.J., (2020) Effectiveness of N95 Respirator Decontamination and Reuse against SARS-CoV-2 Virus. Emerging Infect Dis 10.3201/eid2609.201524. This article doesn’t reference any other article , but does the experiments themselves. This is but one example. It is actually very important to the manuscript, as this is now the most common method for commercial decontamination. Author’s Reply: We had cited the same study which the reviewer is referring to but it was a preprint version which we cited (Reference 43). Our statement in previous rebuttal “Fischer et al (2020) have referenced Batelle report which evaluated microbicidal efficacy of Hydrogen peroxide for decontamination of N95-FFRs”was based on this pre-print version but their comment about Batelle report are now removed from the final print when this article is published as “Letter” in Emerging Infectious Disease, which the reviewer is referring to, hence the confusion. Thus, we have now modified the reference of this article (No. 43) in our manuscript to final print version from the originally given pre-print version. In the first cycle of peer review, the reviewer had commented “The statement- No independent study prior to 2020 has evaluated microbicidal efficacy of H2O2 on FFRs - is not correct, see Fischer et al 2020, among others.” We modified it in our article as “Prior to 2020, no study, in published literature, had evaluated microbicidal efficacy of H2O2 on FFRs, but recently, Fisher et al[43] found it effective in removing SARS-CoV-2 from N95-FFRs”. Our statement in the manuscript is correct probably the phrase “Prior to 2020” is ignored. This study by Fischer et al is published online in June 2020 (preprint version) & final version in September 2020. They evaluated the efficacy of VHP (Vaporized Hydrogen Peroxide) on N95 respirators contaminated with SARS-CoV-2 virus, a virus which was non-existent prior to 2020, so how can our statement be deemed as incorrect as we are specifically talking about research done Prior to 2020. Furthermore, it is said that such inaccuracies are an example. We humbly request the reviewer to provide specific statements which are inaccurate and require correction. Comment 3: Section: Discussion The discussion is still too long and re-states the results. I encourage the authors to think of how to discuss the results, not re-state them. Author’s Reply: We humbly request the reviewer’s criticism in terms of 2 things: length of discussion and re-stating the results in discussion, but kindly consider this: a. The discussion appears lengthy because there are multiple methods which have been evaluated in the published literature for reprocessing of FFRs. We believe that all these methods needs to be discussed individually in terms of their variables, pros, and cons so that their suitability in reprocessing of FFRs in a particular setting can be assessed. b. Regarding, the re-stating of results in discussion section, we believe that some form of re-stating of the result is required to initiate discussion of a particular issue. Hence, taking the criticism in our stride, we have once again attempted to reduce the length of the discussion, hopefully to the reviewer’s satisfaction. Overall word count of our manuscript text (without abstract, tables/ figures and their legends, references) is 4633, which in our opinion is usual for such articles. Dr. Ayush Gupta Assistant Professor Department of Microbiology AIIMS Bhopal Attachments Attachment Submitted filename: Response to Reviewers.docx https://doi.org/10.1371/journal.pone.0242474.r004
4 Nov 2020 Decision Letter - Amitava Mukherjee, Editor Exploring options for reprocessing of N95 Filtering Facepiece Respirators (N95-FFRs) amidst COVID-19 pandemic: A systematic review PONE-D-20-23922R2 Dear Dr. Gupta, 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. Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication. An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Amitava Mukherjee, ME, Ph.D. Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0242474.r005
Formally Accepted
9 Nov 2020 Acceptance Letter - Amitava Mukherjee, Editor PONE-D-20-23922R2 Exploring options for reprocessing of N95 filtering facepiece respirators (N95-FFRs) amidst COVID-19 pandemic: A systematic review Dear Dr. Gupta: I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department. If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org. If we can help with anything else, please email us at plosone@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Professor Dr. Amitava Mukherjee Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0242474.r006

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