Surgical Performance Is Not Negatively Impacted by Wearing a Commercial Full-Face Mask with Ad Hoc 3D-Printed Filter Connection as a Substitute for Personal Protective Equipment during the COVID-19 Pandemic: A Randomized Controlled Cross-Over Trial

(1) Background: During the COVID-19 pandemic, shortages in the supply of personal protective equipment (PPE) have become apparent. The idea of using commonly available full-face diving (FFD) masks as a temporary solution was quickly spread across social media. However, it was unknown whether an FFD mask would considerably impair complex surgical tasks. Thus, we aimed to assess laparoscopic surgical performance while wearing an FFD mask as PPE. (2) Methods: In a randomized-controlled cross-over trial, 40 laparoscopically naive medical students performed laparoscopic procedures while wearing an FFD mask with ad hoc 3D-printed connections to heat and moisture exchange (HME) filters vs. wearing a common surgical face mask. The performance was evaluated using global and specific Objective Structured Assessment of Technical Skills (OSATS) checklists for suturing and cholecystectomy. (3) Results: For the laparoscopic cholecystectomy, both global OSATS scores and specific OSATS scores for the quality of procedure were similar (Group 1: 25 ± 4.3 and 45.7 ± 12.9, p = 0.485, vs. Group 2: 24.1 ± 3.7 and 43.3 ± 7.6, p = 0.485). For the laparoscopic suturing task, the FFD mask group needed similar times to the surgical mask group (3009 ± 1694 s vs. 2443 ± 949 s; p = 0.200). Some participants reported impaired verbal communication while wearing the FFD mask, as it muffled the sound of speech, as well as discomfort in breathing. (4) Conclusions: FFD masks do not affect the quality of laparoscopic surgical performance, despite being uncomfortable, and may therefore be used as a substitute for conventional PPE in times of shortage—i.e., the global COVID-19 pandemic.

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Protection Level and Reusability of a Modified Full-Face Snorkel Mask as Alternative Personal Protective Equipment for Healthcare Workers During the COVID-19 Pandemic

10.1101/2020.08.16.20176081 ◽

2020 ◽

Author(s):

Jean Schmitt ◽

Lewis S. Jones ◽

Elise A. Aeby ◽

Christian Gloor ◽

Berthold Moser ◽

...

Keyword(s):

Personal Protective Equipment ◽

Healthcare Workers ◽

Large Scale ◽

Low Cost ◽

Face Mask ◽

Protective Equipment ◽

Additional Protection ◽

Small Virus ◽

3D Printed ◽

Full Face

The worldwide outbreak of the COVID-19 drastically increased pressure on medical resources and highlighted the need for rapidly available, large-scale and low-cost personal protective equipment (PPE). In this work, an alternative full-face mask is adapted from a modified snorkel mask to be used as PPE with two medical grade filters and a 3D-printed adapter. As the mask covers the eyes, mouth and nose, it acts as a full-face shield, providing additional protection to healthcare workers. The filtration efficiency of different medical filters is measured for particles below 300 nm to cover the size of the SARS-CoV-2 and small virus-laden droplets. The filtration performance of the adapted full-face mask is characterized using NaCl particles below 500 nm and different fitting scenarios. The mask is compared to a commercial respirator and characterized according to the EN 149 standard, demonstrating that the protection fulfills the requirements for the FFP2 level (filtering face-piece 2, stopping at least 94% of airborne particles). The device shows a good resistance to several cycles of decontamination (autoclaving and ethanol immersion), is easy to be produced locally at low cost and helps addressing the shortage in FFP2 masks and face shields by providing adequate protection to healthcare workers against particles below 500 nm.

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Full-face mask adapter as COVID-19 Personal Protective Equipment: design, tests and validation

IEEE Latin America Transactions ◽

10.1109/tla.2021.9451244 ◽

2021 ◽

Vol 19 (6) ◽

pp. 986-993

Author(s):

Ruben Fuentes-Alvarez ◽

Mariel Alfaro-Ponce ◽

Fanny Alvarado ◽

Jessica Aidee Mora-Galvan ◽

Rita Q. Fuentes-Aguilar ◽

...

Keyword(s):

Personal Protective Equipment ◽

Face Mask ◽

Equipment Design ◽

Protective Equipment ◽

Full Face

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3D-printed snorkel mask adapter for failed N95 fit tests and personal protective equipment shortages

Journal of 3D Printing in Medicine ◽

10.2217/3dp-2020-0018 ◽

2020 ◽

Vol 4 (4) ◽

pp. 203-209

Author(s):

Shiv Dalla ◽

Rohit Shinde ◽

Jack Ayres ◽

Stephen Waller ◽

Jay Nachtigal

Keyword(s):

3D Printing ◽

Health System ◽

Personal Protective Equipment ◽

Kansas City ◽

Protective Equipment ◽

University Of Kansas ◽

Fit Testing ◽

3D Printed ◽

Full Face ◽

The University

Personal protective equipment (PPE) shortages persist amidst increasing COVID-19 caseloads. These shortages encouraged some to pursue 3D printing to produce stopgap N95 alternatives. The design presented is an adapter for a commercially available snorkel mask to serve as a full-face respirator, used in dire PPE shortages or in individuals who failed fit testing. Masks were fit tested at The University of Kansas Health System in Kansas City, KS. The mask was fit tested on 22 individuals who previously failed fit testing, and all passed qualitative fit testing with the snorkel mask, adapter and viral filter apparatus. The authors endorse this design as a stopgap measure, proven to be effective in situations of dire PPE shortage or for individuals who have failed fit testing with conventional PPE.

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Modified full-face snorkel masks as reusable personal protective equipment for hospital personnel

PLoS ONE ◽

10.1371/journal.pone.0244422 ◽

2021 ◽

Vol 16 (1) ◽

pp. e0244422

Author(s):

Laurel Kroo ◽

Anesta Kothari ◽

Melanie Hannebelle ◽

George Herring ◽

Thibaut Pollina ◽

...

Keyword(s):

Personal Protective Equipment ◽

Medical Personnel ◽

Protective Equipment ◽

Noisy Environments ◽

Filter Performance ◽

Usability Tests ◽

Care Workers ◽

Full Face ◽

N95 Respirators

Here we adapt and evaluate a full-face snorkel mask for use as personal protective equipment (PPE) for health care workers, who lack appropriate alternatives during the COVID-19 crisis in the spring of 2020. The design (referred to as Pneumask) consists of a custom snorkel-specific adapter that couples the snorkel-port of the mask to a rated filter (either a medical-grade ventilator inline filter or an industrial filter). This design has been tested for the sealing capability of the mask, filter performance, CO2 buildup and clinical usability. These tests found the Pneumask capable of forming a seal that exceeds the standards required for half-face respirators or N95 respirators. Filter testing indicates a range of options with varying performance depending on the quality of filter selected, but with typical filter performance exceeding or comparable to the N95 standard. CO2 buildup was found to be roughly equivalent to levels found in half-face elastomeric respirators in literature. Clinical usability tests indicate sufficient visibility and, while speaking is somewhat muffled, this can be addressed via amplification (Bluetooth voice relay to cell phone speakers through an app) in noisy environments. We present guidance on the assembly, usage (donning and doffing) and decontamination protocols. The benefit of the Pneumask as PPE is that it is reusable for longer periods than typical disposable N95 respirators, as the snorkel mask can withstand rigorous decontamination protocols (that are standard to regular elastomeric respirators). With the dire worldwide shortage of PPE for medical personnel, our conclusions on the performance and efficacy of Pneumask as an N95-alternative technology are cautiously optimistic.

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Potential Risks of a Widespread Use of 3D Printing for the Manufacturing of Face Masks during the SARS-CoV-2 Pandemic

10.31224/osf.io/n57ar ◽

2020 ◽

Cited By ~ 1

Author(s):

Sven Duda ◽

Sascha Hartig ◽

Karola Hagner ◽

Lisa Meyer ◽

Paula Wessling Intriago ◽

...

Keyword(s):

3D Printing ◽

Personal Protective Equipment ◽

Face Mask ◽

Protective Equipment ◽

Technical Feasibility ◽

The Press ◽

Fit Testing ◽

3D Printed ◽

Potential Risks

Background In 2020 the SARS-CoV-2 pandemic caused serious concerns about the availability of face masks. This paper studies the technical feasibility of user specific face mask production by 3D printing and the effectiveness of these masks. Material and Methods Six different face mask designs were produced by 3D printing and tested by subjective experimenter evaluation and using a respirator fit testing kit. Results were compared to the requirements as given for standard protective face masks. Results None of the printed masks came anywhere near the required standards for personal protective gear.ConclusionIn spite of their euphoric presentation in the press, none of the currently advertised 3D printed mask designs are suitable as reliable personal protective equipment.

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Influence of Personal Protective Equipment on the Quality of Chest Compressions: A Meta-Analysis of Randomized Controlled Trials

Frontiers in Medicine ◽

10.3389/fmed.2021.733724 ◽

2021 ◽

Vol 8 ◽

Author(s):

Ying Cui ◽

Siyi Jiang

Keyword(s):

Personal Protective Equipment ◽

Meta Analysis ◽

Controlled Trials ◽

Protective Equipment ◽

Chest Compressions ◽

Randomized Controlled ◽

Significant Difference ◽

Simulation Based ◽

Reduced Rate

Background: Randomized controlled trials (RCTs) evaluating the influence of personal protective equipment (PPE) on quality of chest compressions during cardiopulmonary resuscitation (CPR) showed inconsistent results. Accordingly, a meta-analysis was performed to provide an overview.Methods: Relevant studies were obtained by search of Medline, Embase, and Cochrane's Library databases. A random-effect model incorporating the potential heterogeneity was used to pool the results.Results: Six simulation-based RCTs were included. Overall, pooled results showed that there was no statistically significant difference between the rate [mean difference (MD): −1.70 time/min, 95% confidence interval (CI): −5.77 to 2.36, P = 0.41, I2 = 80%] or the depth [MD: −1.84 mm, 95% CI: −3.93 to 0.24, P = 0.11, I2 = 73%] of chest compressions performed by medical personnel with and without PPE. Subgroup analyses showed that use of PPE was associated with reduced rate of chest compressions in studies before COVID-19 (MD: −7.02 time/min, 95% CI: −10.46 to −3.57, P < 0.001), but not in studies after COVID-19 (MD: 0.14 time/min, 95% CI: −5.77 to 2.36, P = 0.95). In addition, PPE was not associated with significantly reduced depth of chest compressions in studies before (MD: −3.34 mm, 95% CI: −10.29 to −3.62, P = 0.35) or after (MD: −0.97 mm, 95% CI: −2.62 to 0.68, P = 0.25) COVID-19. No significant difference was found between parallel-group and crossover RCTs (P for subgroup difference both > 0.05).Conclusions: Evidence from simulation-based RCTs showed that use of PPE was not associated with reduced rate or depth of chest compressions in CPR.

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An Overview on Personal Protective Equipment (PPE) Fabricated with Additive Manufacturing Technologies in the Era of COVID-19 Pandemic

Polymers ◽

10.3390/polym12112703 ◽

2020 ◽

Vol 12 (11) ◽

pp. 2703 ◽

Cited By ~ 1

Author(s):

Szilard Rendeki ◽

Balint Nagy ◽

Matyas Bene ◽

Attila Pentek ◽

Luca Toth ◽

...

Keyword(s):

Additive Manufacturing ◽

Open Source ◽

Personal Protective Equipment ◽

Face Mask ◽

Protective Equipment ◽

Fused Filament Fabrication ◽

Small Series ◽

Source Models ◽

3D Printed ◽

Manufacturing Technologies

Different additive manufacturing technologies have proven effective and useful in remote medicine and emergency or disaster situations. The coronavirus disease 2019 (COVID-19) disease, caused by the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus, has had a huge impact on our society, including in relation to the continuous supply of personal protective equipment (PPE). The aim of the study is to give a detailed overview of 3D-printed PPE devices and provide practical information regarding the manufacturing and further design process, as well as describing the potential risks of using them. Open-source models of a half-face mask, safety goggles, and a face-protecting shield are evaluated, considering production time, material usage, and cost. Estimations have been performed with fused filament fabrication (FFF) and selective laser sintering (SLS) technology, highlighting the material characteristics of polylactic acid (PLA), polyamide, and a two-compound silicone. Spectrophotometry measurements of transparent PMMA samples were performed to determine their functionality as goggles or face mask parts. All the tests were carried out before and after the tetra-acetyl-ethylene-diamine (TAED)-based disinfection process. The results show that the disinfection has no significant effect on the mechanical and structural stability of the used polymers; therefore, 3D-printed PPE is reusable. For each device, recommendations and possible means of development are explained. The files of the modified models are provided. SLS and FFF additive manufacturing technology can be useful tools in PPE development and small-series production, but open-source models must be used with special care.

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Safe On-Boat Resuscitation by Lifeguards in COVID-19 Era: A Pilot Study Comparing Three Sets of Personal Protective Equipment

Prehospital and Disaster Medicine ◽

10.1017/s1049023x2100011x ◽

2021 ◽

pp. 1-7

Author(s):

Roberto Barcala-Furelos ◽

Cristian Abelairas-Gómez ◽

Alejandra Alonso-Calvete ◽

Francisco Cano-Noguera ◽

Aida Carballo-Fazanes ◽

...

Keyword(s):

Pilot Study ◽

Cardiopulmonary Resuscitation ◽

Severe Acute Respiratory Syndrome ◽

Personal Protective Equipment ◽

High Efficiency ◽

Prehospital Care ◽

Protective Equipment ◽

Preparation Time

Abstract Introduction: On-boat resuscitation can be applied by lifeguards in an inflatable rescue boat (IRB). Due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-COV-2) and recommendations for the use of personal protective equipment (PPE), prehospital care procedures need to be re-evaluated. The objective of this study was to determine how the use of PPE influences the amount of preparation time needed before beginning actual resuscitation and the quality of cardiopulmonary resuscitation (CPR; QCPR) on an IRB. Methods: Three CPR tests were performed by 14 lifeguards, in teams of two, wearing different PPE: (1) Basic PPE (B-PPE): gloves, a mask, and protective glasses; (2) Full PPE (F-PPE): B-PPE + a waterproof apron; and (3) Basic PPE + plastic blanket (B+PPE). On-boat resuscitation using a bag-valve-mask (BVM) and high efficiency particulate air (HEPA) filter was performed sailing at 20km/hour. Results: Using B-PPE takes less time and is significantly faster than F-PPE (B-PPE 17 [SD = 2] seconds versus F-PPE 69 [SD = 17] seconds; P = .001), and the use of B+PPE is slightly higher (B-PPE 17 [SD = 2] seconds versus B+PPE 34 [SD = 6] seconds; P = .002). The QCPR remained similar in all three scenarios (P >.05), reaching values over 79%. Conclusion: The use of PPE during on-board resuscitation is feasible and does not interfere with quality when performed by trained lifeguards. The use of a plastic blanket could be a quick and easy alternative to offer extra protection to lifeguards during CPR on an IRB.

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Fit Testing Retrofitted Full-Face Snorkel Masks as a Form of Novel Personal Protective Equipment During the COVID-19 Pandemic

Disaster Medicine and Public Health Preparedness ◽

10.1017/dmp.2021.133 ◽

2021 ◽

pp. 1-16

Author(s):

Stephanie Toigo ◽

Michel Jacques ◽

Tarek Razek ◽

Ewa Rajda ◽

Sidney Omelon ◽

...

Keyword(s):

Personal Protective Equipment ◽

Healthcare Workers ◽

Health Centre ◽

Disease Outbreaks ◽

Protective Equipment ◽

Test Results ◽

Passing Rate ◽

Fit Testing ◽

Full Face ◽

Medical Grade

ABSTRACT Objective: Bottlenecks in the personal protective equipment (PPE) supply chain have contributed to shortages of PPE during the COVID-19 pandemic, resulting in fractures in the functionality of healthcare systems. This study was conducted with the aim of determining the effectiveness of retrofitted commercial snorkel masks as an alternative respirator for healthcare workers during infectious disease outbreaks. Methods: A retrospective analysis was performed, analyzing qualitative and quantitative fit test results of the retrofitted Aria Ocean Reef® full-face snorkeling mask on healthcare workers at the McGill University Health Centre between April-June 2020. Historical fit test results, using medical-grade respirators, for healthcare workers were also analyzed. Results: During the study period, 71 participants volunteered for fit testing, 60.6% of which were nurses. The overall fit test passing rate using the snorkel mask was 83.1%. Of the participants who did not previously pass fit testing with medical-grade respirators, 80% achieved a passing fit test with the snorkel respirator. Conclusions: The results suggest that this novel respirator may be an effective and feasible alternative solution to address PPE shortages, while still providing healthcare workers with ample protection. Additional robust testing will be required to ensure that respirator fit is maintained, after numerous rounds of disinfection.

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