Magnetic resonance imaging respirators: a randomized crossover trial to assess respiratory protection, usability, and comfort.

Objective: Many available facepiece filtering respirators contain ferromagnetic components, which may cause significant problems in the magnetic resonance imaging (MRI) environment. We conducted a randomized crossover trial to assess the effectiveness, usability, and comfort of 3 types of respirators, judged to be "conditionally MRI safe" with an aluminum nosepiece (Halyard 46727 duckbill-type respirators and Care Essentials MSK-002 bifold cup-type respirators) or "MRI safe" completely metal free (Eagle AG2200 semirigid cup-type respirators). Design and setting: We recruited 120 participants to undergo a quantitative fit test (QNFT) on each of the 3 respirators in a randomized order. Participants then completed a usability and comfort assessment of each respirator. Results: There were significant differences in the QNFT pass rates (51% for Halyard 46727, 73% for Care Essentials MSK-002, and 86% for Eagle AG2200, P < .001). The first-time fit test pass rate and overall fit factor were significantly higher for Eagle AG2200 compared with the other 2 respirators. Eagle AG2200 scored the lowest ratings in the ease of use and overall comfort. There were no significant differences in other modalities, including the seal rating, breathability, firmness, and overall assessment. Conclusions: Our study supports the utility of the Eagle AG2200 and Care Essentials MSK-002 respirators for healthcare professionals working in an MRI environment, based on their high QNFT pass rates and reasonably good overall usability and comfort scores. Eagle AG2200 is unique because of its metal-free construction. However, its comparatively lower usability and comfort ratings raise questions about practicality, which may be improved by greater user training.

Development of a rapid, multi-organisational, multi-modal assessment of a newly available disposable respirator.

BACKGROUND: A rapid large-scale evaluation of a newly available duckbill style P2/N95 respirator, the Care Essentials (CE) MSK-003, was required to determine its suitability for deployment into the Victorian healthcare service. The aims of this study were to assess the feasibility of establishing a rapid, multi-organisational and multi-modal evaluation of the respirator, and to investigate whether this respirator would meet the needs of healthcare workers. METHODS: The evaluation was a collaboration among three healthcare organisations - two tertiary hospitals in metropolitan Melbourne and a rural-based hospital. Participants were healthcare workers undertaking their routine fit tests. They were required to complete quantitative fit testing and a usability assessment survey on the CE MSK-003 respirator. The a priori performance criteria were set as fit test pass rate of >70%, plus satisfactory subjective overall comfort and performance assessments, defined as a rating of adequate, good, or very good in >90% of the cohort. RESULTS: A total of 1070 participants completed the multi-modal assessment within a month. Seventy-eight percent of participants passed their quantitative fit test. Over 90% of survey respondents reported that the CE MSK-003 was adequate, good or very good in terms of its overall comfort and performance assessments. CONCLUSION: We demonstrated that a multi-modal evaluation of a new respirator can be rapidly conducted with a high level of participation in a controlled, consistent manner across multiple organisations. The evaluation results of the CE MSK-003 respirator exceeded our predetermined (a priori) minimal criteria, making it suitable for broad distribution to healthcare organisations.

Prospective comprehensive evaluation of an elastic-band beard cover for filtering facepiece respirators in healthcare workers.

OBJECTIVE: To undertake a healthcare-based multimodal evaluation of the combination of filtering facepiece respirator (FFR) with the elastic-band beard cover technique, including quantitative fit test (QNFT) results, skills assessment, and usability assessment. DESIGN AND SETTING: We conducted a prospective study through the Respiratory Protection Program at the Royal Melbourne Hospital from May 2022 to January 2023. PARTICIPANTS: Healthcare workers who required respiratory protection and could not shave for religious, cultural, or medical reasons. INTERVENTION: Online education and personal face-to-face training on the use of FFR with the elastic-band beard cover technique. RESULTS: Among 87 participants (median beard length 38 mm; interquartile range [IQR], 20-80), 86 (99%) passed 3 QNFTs consecutively with the elastic-band beard cover under a Trident P2 respirator and 68 (78%) passed 3 QNFTs consecutively with a 3M 1870+ Aura respirator. The first QNFT pass rate and the overall fit factors were significantly higher when using the technique than without the elastic-band beard cover. Most participants displayed a high skill level in their donning, doffing, and user seal-check techniques. Of 87 participants, 83 (95%) completed the usability assessment. The overall ease of use, comfort, and overall assessment were rated highly. CONCLUSIONS: The elastic-band beard cover technique can provide safe and effective respiratory protection for bearded healthcare workers. The technique was easily taught, comfortable, well tolerated and accepted by healthcare workers, potentially allowing them full participation in the workforce during pandemics with airborne transmission. We recommend further research and evaluation of this technique in a broader health workforce.

Protocol of a prospective comprehensive evaluation of an elastic band beard cover for filtering facepiece respirators in healthcare.

Individuals who are unable to be clean shaven for religious, medical or cultural reasons are unable to wear a filtering facepiece respirator (FFR), as the respirator cannot provide adequate protection against aerosol-transmissible diseases. There is currently a paucity of validated techniques to ensure the safe inclusion of bearded healthcare workers in the pandemic workforce. We propose to undertake a healthcare-based multi-modal evaluation study on the elastic band beard cover for FFR technique, examining the quantitative fit test (QNFT) results, usability and skill level of participants with repeated assessments over time. This is a prospective study conducted through the Respiratory Protection Program at the Royal Melbourne Hospital. Healthcare workers are invited to participate if they require respiratory protection and cannot shave for religious, cultural or medical reasons. An online education package on the use of respiratory protective equipment and the elastic band beard cover for FFR technique is provided. This is followed by a face-to-face session, where the participant will receive: one-on-one training; undergo a skill assessment on their donning, doffing and user seal check techniques; complete QNFTs and a usability survey. Participants will be invited to repeat the assessment within 3 months of the first session and at 12 months. This study involves multimodal and repeated assessments of an elastic band beard cover for FFRs. The findings of this study will provide information on: whether this simple technique can provide safe, consistent and effective respiratory protection; whether it will interfere with occupational activities; and whether it is comfortable and tolerable for the duration of wear. This is of significant importance to the health workforce around the world, who cannot shave but require access to respiratory protective equipment during the COVID-19 pandemic.

Quantitative fit-test concordance of a pair of similar-fit 3M Aura respirator models, 3M 9320A+ and 3M 1870+: A randomized crossover study.

OBJECTIVE: Some manufacturers provide information on similar-fit model pairings of filtering facepiece respirators (FFRs), suggesting that fit-test outcome of one model helps predict the other. This guidance may be useful during crisis capacity when FFR supplies and/or fit tests are constrained. The purpose of this study was to compare quantitative fit-test (QNFT) results and concordance between a pair of similar-fit 3M Aura FFRs: the 3M 9320A+ and 3M 1870+. METHODS: All participants completed online training and a QNFT with both respirators. The order of the respirator being examined first was randomly allocated. The outcomes included QNFT pass rate, concordance between the 2 models, overall and individual fit factors, and percentage of male and female participants who passed or failed the QNFT. RESULTS: We recruited 1,000 participants (668 females and 332 males). The QNFT pass rate, overall fit factors, and individual fit factors were significantly higher for the 3M 9320A+ than the 3M 1870+ FFR. The concordance between the models was "fair" (κ coefficient, 0.38). Male participants who passed a QNFT with either of the FFRs had 96% chance of passing the QNFT for the alternate model. Female participants who passed the 3M 1870+ had 97% chance of passing the QNFT for the 3M 9320A+ model. However, ∼1 in 12 females who passed the QNFT for the 3M 9320A+ failed the QNFT for the 3M 1870+ FFR. CONCLUSIONS: Similar-fit paired FFR models may provide a consequentially different level of respiratory protection, especially for women. Our findings are important for FFR stockpiling and fit-testing strategies, especially during crisis capacity.

A randomised crossover trial of two flat-fold cup respirators: BYD DE2322 N95 versus Care Essentials MSK-002 P2.

BACKGROUND: The use of respiratory protection remains important in protecting health care workers from airborne pathogens such as viruses. Respirator supply is constantly changing with new models regularly becoming available. Health services should consider a broad range of factors when procuring respirators, including the results of quantitative fit testing in a representative sample of the workforce. Subjective comfort factors and compatibility with a variety of workplace tasks, such as suitability for staff use near magnetic resonance imaging (MRI) environments where relevant, should also be considered. This article compares the quantitative fit factors and user assessments for two styles of flat-fold cup respirators, Care Essentials (CE) MSK-002 P2 and BYD DE2322 N95. METHODS: Quantitative fit tests (QNFT) were performed on 300 participants on each model of respirator in this randomised crossover trial. Participants then completed a questionnaire on their assessments of each respirator. RESULTS: The Care Essentials MSK-002 had a significantly higher quantitative fit test pass rate than the BYD DE2322 (57% vs 18%, p < 0.001). There was no concordance between fit test pass rates for each model. Additionally, the Care Essentials MSK-002 achieved significantly higher scores on each of the responses in the subjective usability survey. CONCLUSION: It is recommended that the Care Essentials MSK-002 be made available for health care use due to higher QNFT pass rates, higher subjective usability assessment scores, plus its potential for use in MRI environments when compared to the BYD DE2322.

Optimizing twin sampling tube stabilization improves quantitative fit test results for flat-fold duckbill filtering facepiece respirators.

INTRODUCTION: When performing quantitative fit testing (QNFT) on filtering facepiece respirators using an ambient aerosol technique, a twin sampling tube is connected between the condensation nuclei count machine and the probed respirator. To achieve high quality and repeatable QNFT results, robust sampling tube stabilization is required. METHODS: In this prospective randomized crossover study, conducted in December 2021 to February 2022, we compared the commonly used hand-hold technique with the manufacturer-recommended lanyard technique in stabilizing the sampling tube during QNFT on a Halyard N95 respirator. Outcomes included QNFT pass rates, overall and individual fit factors, and concordance between the two techniques. RESULTS: A total of 228 out of 316 participants (72.2%) passed the QNFT with the hand-hold technique, compared to the lanyard technique (166/316, 52%, P < .001). The most significant drop in the fit factors with the lanyard technique occurred during head movement side-to-side and up-and-down. The concordance between the 2 techniques was fair (Kappa coefficient = 0.39). CONCLUSION: Our study demonstrates that the method of sampling tube stabilization during QNFT has a significant impact on fit test pass rates, with a potential for false negative fit tests due to inadequate tube stabilization. Further research is required to examine the generalizability of these results to other respirators and fit testing apparatuses.

N95 respirators: quantitative fit test pass rates and usability and comfort assessment by health care workers.

OBJECTIVES: To compare the performance of four N95 respirator types with respect to quantitative fit test pass rate and health care worker-rated usability and comfort. DESIGN, SETTING, PARTICIPANTS: Health care workers who participated in the respiratory protection program at the Royal Melbourne Hospital, 1 October 2020 - 31 May 2021. Participants underwent quantitative N95 respirator fit testing (at least three of four types: semi-rigid cup, flat-fold cup, duckbill, and three-panel flat-fold types), and were invited to complete an online usability and comfort assessment for respirators for which their fit test results were passes. MAIN OUTCOME MEASURES: Fit test pass rate, and user-rated overall comfort and assessment ratings (five-point Likert scales), by N95 respirator type. RESULTS: A total of 2161 health care workers underwent quantitative fit testing (women, 1586 [73.4%]; nurses, 1271 [58.8%]). The overall fit test pass rates were 65.0% for the semi-rigid cup respirators (1029/1583 tests), 32.4% for the flat-fold respirator (660/2035 tests), 59.2% for the duckbill respirators (2005/3387 tests), and 96.4% for the three-panel flat-fold respirator (1876/1946 tests). 378 health care workers completed the comfort and usability survey. Overall comfort and assessment ratings each differed by respirator group (P < 0.001); the median overall comfort (4; IQR, 3-4) and overall assessment values (4; IQR, 3-5) were highest for the three-panel flat-fold respirator and lowest for the semi-rigid cup respirators (comfort: 2 [IQR, 1-3]; assessment: 2 [IQR, 2-3]). CONCLUSIONS: The three-panel flat-fold N95 respirator outperformed the three alternative types with regard to fit test pass rate and user-rated comfort and usability. To maximise respiratory protection for health care workers, these factors should be considered when making respirator procurement decisions.

Respiratory protection preparedness in critical care healthcare workers: An observational audit of facial hair at a major tertiary hospital in Australia.

BACKGROUND: Facial hair under a tight fitting P2/N95 respirator diminishes respiratory protection. There is limited guidance with respect to the threshold to be clean shaven in readiness to wear N95 respirators. METHODS: We performed a cross sectional audit in late August 2021 to observe whether staff had facial hair that could decrease respiratory protection of tight fitting respirators. The audit was conducted in three critical care areas at a major tertiary public hospital in Australia during a period of moderate-to-high community prevalence of COVID-19. All staff observed had previously successfully completed quantitative fit testing with a clean shaven face in the preceding 12 months. RESULTS: 110 consecutive male critical care staff were observed including thirty staff who were required to wear a N95/P2 respirator at the time. Forty - five percent of male staff observed were not clean shaven in the face seal zone of their respirators. CONCLUSIONS: The readiness to wear a tight-fitting respirator and hence the need to be clean shaven, should be guided by both state and local COVID-19 risk ratings, as well as the specific respiratory biohazard risks present in the clinical area at that time. During periods of significant community transmission of COVID-19, critical care clinical staff should be clean shaven, so they are fit-for-purpose and ready to wear a tight fitting respirator at short notice. Respiratory protection preparedness in critical care healthcare workers: An observational audit of facial hair at a major tertiary hospital in Australia.