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.

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 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.

scholarly journals Evaluation of the Mechanical Properties of Porous Thermoplastic Polyurethane Obtained by 3D Printing for Protective Gear

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Hyojeong Lee ◽  
Ran-i Eom ◽  
Yejin Lee
Keyword(s):  
Tensile Strength ◽  
3D Printing ◽  
Thermoplastic Polyurethane ◽  
Three Dimensional ◽  
Protective Equipment ◽  
Shock Absorption ◽  
Protective Gear ◽  
Compression Properties ◽  
Impact Deformation ◽  
3D Printed

Three-dimensional (3D) printing is an efficient and sustainable technology useful in various manufacturing fields. The aim of this study was to investigate the applicability of thermoplastic polyurethane (TPU) as a 3D printing material and the conditions related to the use of TPU as personal protective equipment. The tensile strength, shock absorption, and compressibility were evaluated for different infill and thickness conditions. An increase in the infill rate led to an increase in the tensile strength, regardless of the sample thickness. Similarly, the compression energy increased as the infill increased. Both the shock absorption and compression properties increased as the thickness decreased under identical infill conditions. The actual shock absorption test data were compared to the results of structural analyses, which confirmed the potential for predicting impact deformation through the analysis of the tensile characteristics and the basic properties of a 3D printed material.

scholarly journals 3D Printed Snorkel Mask Adapter for Failed N95 Fit Tests and PPE Shortages

2020 ◽  
Author(s):  
Shiv Dalla ◽  
Rohit Shinde ◽  
Jack M Ayres ◽  
Stephen Waller ◽  
Jay Nachtigal
Keyword(s):  
3D Printing ◽  
Kansas City ◽  
Protective Equipment ◽  
Proof Of Concept ◽  
University Of Kansas ◽  
Fit Testing ◽  
3D Printed ◽  
Full Face ◽  
The University ◽  
N95 Respirators

Introduction The shortage of personal protective equipment (PPE) across the country has been widely discussed throughout the COVID-19 pandemic. Unfortunately, recent reports indicate that PPE shortages persist amidst continually increasing caseloads nationwide. Additionally, there have been reports of poor-fitting masks, a problem which is magnified by shortages. The lack of adequate access to conventional N95 masks pushed for some to pursue 3D printing and locally distributing their own manufactured masks as substitutes when PPE, including N95 masks, were not readily available. The design presented, the snorkel mask adapter, is one such design born from the local maker community in partnership with local physicians and hospitals. This article discusses the design, manufacturing, and validation of the snorkel mask adapter and its immediate use in the COVID-19 pandemic as well as future use as stopgap PPE. Methods The design presented is an adapter which can be used with a commercially available snorkel mask in order to serve as a full face respirator in either the case of a PPE shortage or more pertinently for those who are unable to pass fit testing with the available N95 respirators at their respective facilities. Mask components were 3D printed, assembled, and then fit tested by qualitative fit testing (QLFT) at The University of Kansas Health System (TUKHS) in Kansas City, KS as a proof of concept.   Results At TUKHS, the mask was fit tested on 22 individuals who required an N95 mask but were not able to pass qualitative fit testing with the masks available to them at the time. Of the 22 tested, all 22 of them were able to pass QLFT with the snorkel mask, adapter, and viral/bacterial filter combination. Conclusion The results of the fit testing at TUKHS is promising for this N95 alternative. More extensive testing can and should be done, including quantitative fit testing. Persistently increasing caseloads and PPE shortages necessitates an urgent dissemination of these preliminary results. The authors do not advocate for this design as a replacement of traditional N95 masks or other PPE but do 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 Printed frames to enable reuse and improve the fit of N95 and KN95 respirators

2020 ◽  
Author(s):  
Malia McAvoy ◽  
Ai-Tram N. Bui ◽  
Christopher Hansen ◽  
Deborah Plana ◽  
Jordan T. Said ◽  
...  
Keyword(s):  
3D Printing ◽  
Design Process ◽  
Clinical Settings ◽  
Short Supply ◽  
Iterative Design ◽  
Healthcare Settings ◽  
Fit Testing ◽  
3D Printed ◽  
Single Use ◽  
Repeated Use

Background: In response to supply shortages during the COVID-19 pandemic, N95 filtering facepiece respirators (FFRs or "masks"), which are typically single-use devices in healthcare settings, are routinely being used for prolonged periods and in some cases decontaminated under "reuse" and "extended use" policies. However, the reusability of N95 masks is often limited by degradation or breakage of elastic head bands and issues with mask fit after repeated use. The purpose of this study was to develop a frame for N95 masks, using readily available materials and 3D printing, which could replace defective or broken bands and improve fit. Results: An iterative design process yielded a mask frame consisting of two 3D-printed side pieces, malleable wire links that users press against their face, and cut lengths of elastic material that go around the head to hold the frame and mask in place. Volunteers (n= 41; average BMI= 25.5), of whom 31 were women, underwent qualitative fit with and without mask frames and one or more of four different brands of FFRs conforming to US N95 or Chinese KN95 standards. Masks passed qualitative fit testing in the absence of a frame at rates varying from 48-92% (depending on mask model and tester). For individuals for whom a mask passed testing, 75-100% (average = 86%) also passed testing with a frame holding the mask in place. Among users for whom a mask failed in initial fit testing, 41% passed using a frame. Success varied with mask model and across individuals. Conclusions: The use of mask frames can prolong the lifespan of N95 and KN95 masks by serving as a substitute for broken or defective bands without adversely affecting fit. Frames also have the potential to improve fit for some individuals who cannot fit existing masks. Frames therefore represent a simple and inexpensive way of extending the life and utility of PPE in short supply. For clinicians and institutions interested in mask frames, designs and specifications are provided without restriction for use or modification. To ensure adequate performance in clinical settings, qualitative fit testing with user-specific masks and frames is required.

scholarly journals Leveraging 3D Printing Capacity in Times of Crisis: Recommendations for COVID-19 Distributed Manufacturing for Medical Equipment Rapid Response

2020 ◽  
Vol 17 (13) ◽  
pp. 4634 ◽  
Author(s):  
Albert Manero ◽  
Peter Smith ◽  
Amanda Koontz ◽  
Matt Dombrowski ◽  
John Sparkman ◽  
...  
Keyword(s):  
3D Printing ◽  
Hospital Staff ◽  
Global Supply Chain ◽  
Protective Equipment ◽  
High Demand ◽  
Global Demand ◽  
Short Run ◽  
3D Printed ◽  
Traditional Manufacturing ◽  
Rule Out

The SARS-CoV-2 (COVID-19) pandemic has provided a unique set of global supply chain limitations with an exponentially growing surge of patients requiring care. The needs for Personal Protective Equipment (PPE) for hospital staff and doctors have been overwhelming, even just to rule out patients not infected. High demand for traditionally manufactured devices, challenged by global demand and limited production, has resulted in a call for additive manufactured (3D printed) equipment to fill the gap between traditional manufacturing cycles. This method has the unique ability to pivot in real time, while traditional manufacturing may take months to change production runs. 3D printing has been used to produce a variety of equipment for hospitals including face shields, masks, and even ventilator components to handle the surge. This type of rapid, crowd sourced, design and production resulted in new challenges for regulation, liability, and distribution. This manuscript reviews these challenges and successes of additive manufacturing and provides a forward plan for hospitals to consider for future surge events. Recommendations: To accommodate future surges, hospitals and municipalities should develop capacity for short-run custom production, enabling them to validate new designs. This will rapidly increase access to vetted equipment and critical network sharing with community distributed manufacturers and partners. Clear guidance and reviewed design repositories by regulatory authorities will streamline efforts to combat future pandemic waives or other surge events.

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.

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