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

2020 ◽  
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.

scholarly journals Potential risks of a widespread use of 3D printing for the manufacturing of face masks during the severe acute respiratory syndrome coronavirus 2 pandemic

2020 ◽  
Vol 4 (3) ◽  
pp. 135-147
Author(s):  
Sven Duda ◽  
Sascha Hartig ◽  
Karola Hagner ◽  
Lisa Meyer ◽  
Paula Wessling Intriago ◽  
...  
Keyword(s):  
3D Printing ◽  
Severe Acute Respiratory Syndrome ◽  
Face Mask ◽  
Protective Equipment ◽  
Technical Feasibility ◽  
Protective Gear ◽  
The Press ◽  
Fit Testing ◽  
3D Printed ◽  
Potential Risks

Background: In 2020, the severe acute respiratory syndrome coronavirus 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 & 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 with 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. Conclusion: In spite of their euphoric presentation in the press, none of the currently advertised 3D printed mask designs are suitable as reliable personal protective equipment.

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

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.

Feasibility study: Proposed alternative to N95 respirator during the personal protective equipment shortage from COVID-19 pandemic

2021 ◽  
Vol 19 (7) ◽  
pp. 192-202
Author(s):  
Ahel El Haj Chehade, MD ◽  
Jesintha Stephenson, MD ◽  
Evan Floyd, PhD ◽  
Jean Keddissi, MD, FCCP ◽  
Tony Abdo, MD ◽  
...  
Keyword(s):  
Pulse Oximetry ◽  
Feasibility Study ◽  
Personal Protective Equipment ◽  
Geometric Mean ◽  
Face Mask ◽  
The United States ◽  
Geometric Standard Deviation ◽  
Protective Equipment ◽  
Health Administration ◽  
Fit Testing

Introduction: Having an adequate supply of personal protective equipment during the COVID-19 pandemic has been a constant challenge for hospitals across the United States. In the event of shortages, our assembled mask might offer noninferior protection compared to an N95 respirator. Objective: To study the ability of an assembled mask to pass a quantitative fit testing.Methods: We conducted a feasibility study at the Oklahoma City Veteran Affairs Health Care System. Volunteers were fitted with an assembled mask made of either a Hans Rudolph half-face mask or a Respironics Performax full-face mask, attached to an Iso-Gard HEPA light Filter 28022 through a Performax SE elbow hinge. Quantitative fit testing was conducted using the Occupation Safety and Health Administration fit testing protocol. The primary outcome was the percentage of participants who pass the quantitative fit test. Secondary outcomes included the overall fit factor (FF), average FF for different exercises, changes in pulse oximetry and endtidal CO2 at 0 and 15 minutes, willingness to use the mask, and visibility assessment.Results: Twenty participants completed the study, and all (100 percent) passed the quantitative fit testing. The overall FF had a geometric mean of 2,317 (range: 208-16,613) and a geometric standard deviation of 3.8. The lowest FF was recorded while the subjects were talking. Between time 0 and 15 minutes, there was no clinically significant change in pulse oximetry and end-tidal CO2 levels. Most participants reported “very good” visibility and were “highly likely” to use the Hans Rudolph half-face mask in the case of shortage.Conclusion: Our assembled respirator offers noninferior protection to N95 respirators in the setting of hypothetical protective equipment shortage.

scholarly journals 3D Printing to Support the Shortage in Personal Protective Equipment Caused by COVID-19 Pandemic

Materials ◽  
2020 ◽  
Vol 13 (15) ◽  
pp. 3339 ◽  
Author(s):  
Mostapha Tarfaoui ◽  
Mourad Nachtane ◽  
Ibrahim Goda ◽  
Yumna Qureshi ◽  
Hamza Benyahia
Keyword(s):  
3D Printing ◽  
Medical Devices ◽  
Personal Protective Equipment ◽  
Health Concern ◽  
Protective Equipment ◽  
Global Public Health ◽  
Comprehensive Overview ◽  
3D Printed ◽  
Single Use ◽  
Tract Infections

Currently, the emergence of a novel human coronavirus disease, named COVID-19, has become a great global public health concern causing severe respiratory tract infections in humans. Yet, there is no specific vaccine or treatment for this COVID-19 where anti-disease measures rely on preventing or slowing the transmission of infection from one person to another. In particularly, there is a growing effort to prevent or reduce transmission to frontline healthcare professionals. However, it is becoming an increasingly international concern respecting the shortage in the supply chain of critical single-use personal protective equipment (PPE). To that scope, we aim in the present work to provide a comprehensive overview of the latest 3D printing efforts against COVID-19, including professional additive manufacturing (AM) providers, makers and designers in the 3D printing community. Through this review paper, the response to several questions and inquiries regarding the following issues are addressed: technical factors connected with AM processes; recommendations for testing and characterizing medical devices that additively manufactured; AM materials that can be used for medical devices; biological concerns of final 3D printed medical parts, comprising biocompatibility, cleaning and sterility; and limitations of AM technology.

scholarly journals Integrated 3D printing solution to mitigate shortages of airway consumables and personal protective equipment during the COVID-19 pandemic

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ferran Fillat-Gomà ◽  
Sergi Coderch-Navarro ◽  
Laia Martínez-Carreres ◽  
Núria Monill-Raya ◽  
Toni Nadal-Mir ◽  
...  
Keyword(s):  
Supply Chain ◽  
3D Printing ◽  
Medical Devices ◽  
Personal Protective Equipment ◽  
Medical Equipment ◽  
Quality Standard ◽  
Global Supply Chain ◽  
Protective Equipment ◽  
3D Printed ◽  
Online Catalogue

Abstract Background To cope with shortages of equipment during the COVID-19 pandemic, we established a nonprofit end-to-end system to identify, validate, regulate, manufacture, and distribute 3D-printed medical equipment. Here we describe the local and global impact of this system. Methods Together with critical care experts, we identified potentially lacking medical equipment and proposed solutions based on 3D printing. Validation was based on the ISO 13485 quality standard for the manufacturing of customized medical devices. We posted the design files for each device on our website together with their technical and printing specifications and created a supply chain so that hospitals from our region could request them. We analyzed the number/type of items, petitioners, manufacturers, and catalogue views. Results Among 33 devices analyzed, 26 (78·8%) were validated. Of these, 23 (88·5%) were airway consumables and 3 (11·5%) were personal protective equipment. Orders came from 19 (76%) hospitals and 6 (24%) other healthcare institutions. Peak production was reached 10 days after the catalogue was published. A total of 22,135 items were manufactured by 59 companies in 18 sectors; 19,212 items were distributed to requesting sites during the busiest days of the pandemic. Our online catalogue was also viewed by 27,861 individuals from 113 countries. Conclusions 3D printing helped mitigate shortages of medical devices due to problems in the global supply chain.

scholarly journals Integrated 3D Printing Solution to Mitigate Shortages of Airway Consumables and Personal Protective Equipment During the COVID-19 Pandemic

2020 ◽  
Author(s):  
Ferran Fillat-Gomà ◽  
Sergi Coderch-Navarro ◽  
Laia Martínez-Carreres ◽  
Núria Monill-Raya ◽  
Toni Nadal-Mir ◽  
...  
Keyword(s):  
Supply Chain ◽  
3D Printing ◽  
Medical Devices ◽  
Personal Protective Equipment ◽  
Medical Equipment ◽  
Quality Standard ◽  
Global Supply Chain ◽  
Protective Equipment ◽  
3D Printed ◽  
Online Catalogue

Abstract Background: To cope with shortages of equipment during the COVID-19 pandemic, we established a nonprofit end-to-end system to identify, validate, regulate, manufacture, and distribute 3D-printed medical equipment. Here we describe the local and global impact of this system. Methods: Together with critical care experts, we identified potentially lacking medical equipment and proposed solutions based on 3D printing. Validation was based on the ISO 13485 quality standard for the manufacturing of customized medical devices. We posted the design files for each device on our website together with their technical and printing specifications and created a supply chain so that hospitals from our region could request them. We analyzed the number/type of items, petitioners, manufacturers, and catalogue views.Results: Among 33 devices analyzed, 26 (78·8%) were validated. Of these, 23 (88·5%) were airway consumables and 3 (11·5%) were personal protective equipment. Orders came from 19 (76%) hospitals and 6 (24%) other healthcare institutions. Peak production was reached 10 days after the catalogue was published. A total of 22,135 items were manufactured by 59 companies in 18 sectors; 19,212 items were distributed to requesting sites during the busiest days of the pandemic. Our online catalogue was also viewed by 27,861 individuals from 113 countries.Conclutions: 3D printing helped mitigate shortages of medical devices due to problems in the global supply chain.

scholarly journals 3D Printing for Medical Applications: Current State of the Art and Perspectives during the COVID-19 Crisis

Surgeries ◽  
2021 ◽  
Vol 2 (3) ◽  
pp. 244-259
Author(s):  
Andrew Hagen ◽  
Megan Chisling ◽  
Kevin House ◽  
Tal Katz ◽  
Laila Abelseth ◽  
...  
Keyword(s):  
3D Printing ◽  
Personal Protective Equipment ◽  
Protective Equipment ◽  
Long Term Effects ◽  
Extreme Stress ◽  
Current State ◽  
Life Saving ◽  
3D Printed ◽  
Recent Trends

The coronavirus SARS-CoV-2 pandemic has affected over one hundred million people worldwide and has resulted in over two million deaths. In addition to the toll that coronavirus takes on the health of humans infected with the virus and the potential long term effects of infection, the repercussions of the pandemic on the economy as well as on the healthcare system have been enormous. The global supply of equipment necessary for dealing with the pandemic experienced extreme stress as healthcare systems around the world attempted to acquire personal protective equipment for their workers and medical devices for treating COVID-19. This review describes how 3D printing is currently being used in life saving surgeries such as heart and lung surgery and how 3D printing can address some of the worldwide shortage of personal protective equipment, by examining recent trends of the use of 3D printing and how these technologies can be applied during and after the pandemic. We review the use of 3D printed models for treating the long term effects of COVID-19. We then focus on methods for generating face shields and different types of respirators. We conclude with areas for future investigation and application of 3D printing technology.

scholarly journals 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

2021 ◽  
Vol 10 (3) ◽  
pp. 550 ◽  
Author(s):  
Eleni Amelia Felinska ◽  
Zi-Wei Chen ◽  
Thomas Ewald Fuchs ◽  
Benjamin Otto ◽  
Hannes Götz Kenngott ◽  
...  
Keyword(s):  
Personal Protective Equipment ◽  
Ad Hoc ◽  
Face Mask ◽  
Protective Equipment ◽  
Surgical Performance ◽  
Randomized Controlled ◽  
3D Printed ◽  
Group 2 ◽  
Full Face

(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.

scholarly journals Integrated 3D printing solution to mitigate shortages of airway consumables and personal protective equipment during the COVID-19 pandemic

2020 ◽  
Author(s):  
Ferran Fillat-Gomà ◽  
Sergi Coderch-Navarro ◽  
Laia Martínez-Carreres ◽  
Núria Monill-Raya ◽  
Toni Nadal-Mir ◽  
...  
Keyword(s):  
Supply Chain ◽  
3D Printing ◽  
Medical Devices ◽  
Personal Protective Equipment ◽  
Medical Equipment ◽  
Quality Standard ◽  
Global Supply Chain ◽  
Protective Equipment ◽  
3D Printed ◽  
Online Catalogue

Abstract Background: To cope with shortages of equipment during the COVID-19 pandemic, we established a nonprofit end-to-end system to identify, validate, regulate, manufacture, and distribute 3D-printed medical equipment. Here we describe the local and global impact of this system. Methods: Together with critical care experts, we identified potentially lacking medical equipment and proposed solutions based on 3D printing. Validation was based on the ISO 13485 quality standard for the manufacturing of customized medical devices. We posted the design files for each device on our website together with their technical and printing specifications and created a supply chain so that hospitals from our region could request them. We analyzed the number/type of items, petitioners, manufacturers, and catalogue views.Results: Among 33 devices analyzed, 26 (78·8%) were validated. Of these, 23 (88·5%) were airway consumables and 3 (11·5%) were personal protective equipment. Orders came from 19 (76%) hospitals and 6 (24%) other healthcare institutions. Peak production was reached 10 days after the catalogue was published. A total of 22,135 items were manufactured by 59 companies in 18 sectors; 19,212 items were distributed to requesting sites during the busiest days of the pandemic. Our online catalogue was also viewed by 27,861 individuals from 113 countries.Conclusions: 3D printing helped mitigate shortages of medical devices due to problems in the global supply chain.

scholarly journals 3D-printed N95 equivalent for personal protective equipment shortages: the Kansas City Mask

2020 ◽  
Vol 4 (4) ◽  
pp. 211-217
Author(s):  
Shiv Dalla ◽  
Brandon Bacon ◽  
Jack M Ayres ◽  
Stephen Holmstead ◽  
Alan J Ahlberg Elliot
Keyword(s):  
3D Printing ◽  
Personal Protective Equipment ◽  
Kansas City ◽  
Medical Center ◽  
Protective Equipment ◽  
Cdc Guidelines ◽  
Control And Prevention ◽  
3D Printed ◽  
Pandemic Response ◽  
Critical Challenge

Personal protective equipment (PPE) shortages represent a persistent and critical challenge during the COVID-19 pandemic. Communities of 3D printing hobbyists and experts responded by designing and producing homemade, 3D-printed PPE. This report discusses the design, manufacturing and validation of the Kansas City Mask (KC Mask). Once printed and assembled, masks were fit tested at Truman Medical Center in Kansas City, MO. The KC Mask was approved for use by pandemic response administration staff at the hospital. Fortunately, due to adequate PPE supply at the time of this publication, wide utilization of the KC mask has not been required. The authors endorse the KC Mask as a stopgap measure, proven to be effective in situations of critical PPE shortage based on Centers for Disease Control and Prevention (CDC) guidelines.

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