Wipe Disinfection of Reusable Elastomeric Half-Mask Respirators for Health Care Use

Probably not a substantial claim: may not pass S3 (load-bearing).

Disinfecting filtering facepiece respirators is difficult.

“FFR disinfection is challenging (Cheng et al., 2020);”

• cites Cheng et al., 2020 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

The laboratory methods in this study were adapted from Lawrence et al. (2017).

“There is variation in methods for respirator disinfection testing across studies; methods in this study were adapted from Lawrence et al. (Lawrence et al., 2017).”

• cites Lawrence et al., 2017 sourceSupported

Classified as probably not a substantial claim. May combine two claims.

A test of filtering facepiece respirator disinfection must show that microbes are reduced while filtration efficiency is not reduced.

“testing must demonstrate a reduction in microbes without a reduction in filtration efficiency (Centers for Disease Control and Prevention, 2020; Lindsley et al., 2015; National Personal Protective Equipment Technology Laboratory, 2019).”

• cites Centers for Disease Control and Prevention, 2020Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites Lindsley et al., 2015 sourcePartly supported

  The Introduction identifies microbial inactivation and preservation of filtration as considerations in respirator decontamination. But the Discussion reports that UVGI increased particle penetration in some tests and recommends testing each respirator model against acceptable performance limits; it does not require filtration efficiency to remain entirely unchanged. The paper reports microbial-reduction results from earlier studies rather than testing that outcome itself (page numbers unavailable in our copy). (LLM, conf=0.86)

  Experimental — accuracy not yet measured
• cites National Personal Protective Equipment Technology Laboratory, 2019Not matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

Probably not a substantial claim: may not pass S3 (load-bearing).

Other investigators found that hydrogen peroxide activity against non-enveloped viruses was similar to its activity against MS2 in this study.

“Other investigators also found that HP activity against non-enveloped viruses was similar to activity against MS2 in our study (Omidbakhsh & Sattar, 2006).”

• cites Omidbakhsh & Sattar, 2006 sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Hydrogen peroxide has good virucidal, bactericidal, and sporicidal properties.

“After disinfection with HP, which has good virucidal, bactericidal, and sporicidal properties (Lin et al., 2020; Omidbakhsh & Sattar, 2006; Rutala & Weber, 2019), Φ6 and P. aeruginosa were undetectable on all sampled areas, with a greater than 8 log10 reduction overall for both.”

• cites Lin et al., 2020 sourceFetching the cited paper…
• cites Omidbakhsh & Sattar, 2006 sourcePartly supported

  The Abstract Results report that the full-strength accelerated hydrogen peroxide product was bactericidal and virucidal in one minute. The paper does not report sporicidal activity, and its Discussion distinguishes the tested formulation from hydrogen peroxide used on its own. Thus it supports two of the three properties for the tested product, but not the full claim about hydrogen peroxide. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites Rutala & Weber, 2019 sourceNot checked — no full text of the source

May combine two claims.

The instructions given and the number of wipes used did not significantly affect microbial reduction.

“Instructions and the number of wipes used did not significantly affect reduction.”

May combine two claims.

Bacillus atrophaeus was the least susceptible organism to all disinfectants, and viable spores were recovered from 72.92% of surfaces.

“B. atrophaeus was least susceptible to all disinfectants, with viable spores recovered on 72.92% of surfaces.”

May combine two claims.

Pseudomonas aeruginosa was highly susceptible to hydrogen peroxide and to the quaternary ammonium compound and alcohol combination.

“P. aeruginosa was highly susceptible to HP and QAC/alcohol.”

May combine two claims.

Hydrogen peroxide produced the largest log10 reductions among the tested disinfectants, but its reductions were not significantly greater than those of the quaternary ammonium compound and alcohol combination.

“HP had the greatest reductions, but these were not significantly higher than QAC/alcohol, X2(1)=0.04, p=.8.”

May combine two claims.

In the volunteer study, log10 reductions varied both within individual subjects and between subjects.

“Log10 reductions varied within and between subjects (Figure 2).”

May combine two claims.

Bacteriophage Φ6 was highly susceptible to every tested disinfectant, with an overall median log10 reduction greater than 8.62.

“Φ6 was highly susceptible to all disinfectants (overall median log10 reduction >8.62) (Table 1).”

May combine two claims.

MS2 reduction was highest with hydrogen peroxide and lowest with the quaternary ammonium compound and saline combination.

“Median reduction for MS2 was highest using HP and lowest using QAC+saline.”

May combine two claims.

Disinfection duration differed by site but not by cohort.

“Duration of disinfection differed by site but not by cohort, and subjects spent more time disinfecting straps and noses than covers.”

May combine two claims. The quote only partly states this claim.

The study used Pseudomonas aeruginosa, Bacillus atrophaeus, MS2, and bacteriophage Φ6 as surrogates for gram-negative bacteria, spore-forming bacteria, non-enveloped viruses, and enveloped viruses, respectively.

“Sets of three EHMRs (Honeywell model RU8500) were inoculated with organisms chosen as surrogates representative of different classes of health care-acquired infections (HAIs), including gram-negative bacteria, spore-forming bacteria, and viruses.”

• Also stated in: § Laboratory Study · plain

  “Φ6 was a surrogate for enveloped respiratory viruses such as SARS-CoV-2 and MS2, a non-enveloped virus, was chosen as a conservative surrogate to represent human viruses that are more resistant to disinfection and environmental stressors.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The Emory University Institutional Review Board reviewed and approved the study.

“This study was reviewed and approved by the Emory University Institutional Review Board (STUDY00002519; See 45 C.F.R. part 46.114; 21 C.F.R. part 56.114).”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

A facilitator watched whether subjects in the two-wipe and five-wipe groups followed the instructions, recorded any departures on a checklist, and told them immediately when they missed a step.

“A facilitator observed whether two- and five-wipe subjects followed instructions, noted departures on a checklist, and informed them in real time if they missed a step.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The written instructions were tested and revised repeatedly with five people who did not know the project, in order to make them clear.

“Instructions were piloted iteratively for clarity with five people unfamiliar with the project.”

Classified as probably not a substantial claim.

Volunteer subjects were randomly assigned to one of three groups: a naive group, a two-wipe group, and a five-wipe group.

“Subjects were randomized into three cohorts: naive, two-wipe, and five-wipe.”

Probably not a substantial claim: may not pass S3 (load-bearing).

One investigator performed all of the sampling in the volunteer study.

“All sampling was done by the same investigator.”

Probably not a substantial claim: may not pass S3 (load-bearing). May combine two claims.

Participants were not told where contamination was on the respirator, but they may have seen small dried spots and this may have drawn their attention to some sites while disinfecting.

“Although participants were not told where contamination was located on the respirator surface, they may have been able to see some small residual dried spots, possibly drawing attention to some sites when disinfecting.”

May combine two claims.

Because every wipe contained disinfectant, the study could not separate the effect of mechanical wiping alone on microbial removal or determine whether wiping moved microbes between sites on the respirator surface.

“all wipes contained disinfectant, so it was not possible to separate the effects of mechanical wiping alone on microbial removal or determine if wiping transferred microbes between sites on the surface.”