An organization working towards crowd-sourced medical manufacturing, PPEDash aims to help you make, sterilize, and handoff crowdsourced 3D printed medical devices to healthcare workers in need.
One of our group members was inspired after they saw a spreadsheet of 4,503 people with access to 3D printers on a Facebook group called "Open Source COVID Medical Supplies" a group that spanned up to 59,129 makers globally; all with a desire to use their 3D printers to help healthcare workers but not knowing how. Since then, PPEDash was born and the dash to get healthcare workers medical equipment as fast as possible began.
As of 3/25/2020, the European Centre for Disease Prevention and Control and World Health Organization (WHO) announced that more than 575,444 cases of COVID-19 were reported worldwide by more than 202 countries along with 26,654 confirmed deaths.
If infections proceed at their current pace across the globe, we will not have enough medical supplies to prevent the higher mortality rates (>8%) that Italy is seeing as of 4/17/2020.
While patients are hospitalized but in non-critical condition, healthcare workers typically wear N95 masks, gowns, and gloves and face shields to prevent undue airborne and droplet-based virus contact.
Shortage of Personal Protective Equipment (PPE):
Due to the growing urgency of this pandemic, healthcare workers have been forced to work long shifts that average 12-16 hours, above the estimated usage time that all FDA-cleared N95 respirators and surgical masks were designed for. Most of these masks were designed to be single-use and disposable devices, as respirators can easily be damaged or soiled. With the pandemic forcing healthcare workers to work longer hours on end and the increasing influx of patients, the quantity of masks is slowly becoming scarce among healthcare workers who lack the proper protection to go to work safely.
Shortage of Ventilators and Ventilator Parts:
On average, a hospital will have 5-15 different ventilators. With the surging number of patients, hospitals are desperate for ventilators because they expect the need to far outstrip their supply in the coming weeks. Even after a shipment of 4,000 of the complex machines from the federal government and other emergency efforts, New York is expecting a shortage in the thousands. Currently, they are on track to be short of 15,000 ventilators for the estimated patients they foresee requiring respiratory support. We aim to help hospitals crowdsource non-invasive ventilator valves that are FDA and WHO approved for patients of COVID-19.
After guiding makers through the 3D printing process, we guide them through sterilization with heat as an accessible variable for consumer sterilization prior to hospital handoff in the following forms:
- Oven Baking
- Boiling Water
Stanford University released a study about adhoc sterilization, stating that medical devices and equipment can be sterilized with minimal reduction of efficiency by baking at 70oC for 30 minutes. Larry Chu, a Professor of Anesthesiology, Perioperative and Pain Medicine and Director of the Stanford Anesthesia Informatics found that boiling N95 masks in water for 5 minutes was sufficient for sterilizing the masks. If baked in an oven, masks and other medical devices must be properly suspended so that they are not in direct contact with metal surfaces, which can damage or melt the equipment. If masks are boiled, they must have 10 min to air dry.
For crowdsourced PPE, oven baking and boiling in water are also sufficient sterilization methods. For larger PPE, such as face shields, boiling in water may not be convenient. PETG face shields may be sterilized with isopropyl alcohol or hydrogen peroxide, both common household materials. Face masks 3D printed with PLA may be sterilized with hydrogen peroxide if boiling or oven baking are inaccessible to the maker.
Dr. Peter P. Tsai, an inventor of the electrostatic charging technology that makes the filter media of face masks including medical and N95, also released a research article on March 25, 2020 stating that masks can also be sterilized using boiling water without significant reduction in filtration ability. The use of alcohol or chlorine based solutions removes the static charge, causing a significant reduction in the filtration capability of the masks.
Makers around the world want to help hospitals around the world but they don’t have FDA approved medical instructions on how to do so. We created documentation and a user platform that crowdsources the proper resources to use, the making process, and how to facilitate a contact-free handoff to a local hospital that requires the medical equipment.
What it does
Our mission is to provide the 3D printing community with the online-based resources necessary to create, sterilize, and deliver PPE and medical devices to their local medical facilities. We want to help makers create a positive impact through crowdsourcing. We provide an open-source marketplace of potential 3D equipment to print and a list of nearby hospitals or pharmacies to donate based on their location.
How we built it
Our marketplace models were all created with SolidWorks or AutoCAD to ensure a seamless printing process for makers. We combed through up to 200+ different potential designs that ranged different 3D printing styles and the following 8 models were selected based upon the research maker guidelines released by Stanford University, and Dr. Peter P. Tsai (the creator of the n95 mask).
Our website platform was created in React using Firebase (to store the 3D files) and we used STL files (Solid Works + AutoCAD) to provide download ready files for users to 3D print. We also used Balsamiq, Cinema4D, and Sketch for our design/illustration elements.
On the front end, we used the Chakra UI Components to style our website.
The packages required for this project are as follows:
- RxJS + RxFire
- Chakra UI Components
- Sketch + Balsamiq (UX)
- AutoCAD + Solid Works (3D printing models)
Demo: The working demo of our model can be seen at our website link. In our website, we provided 6 different 3D prototypes for makers to select from based on their selective printer and available printing resources. The website provides both printing instructions, 3D files for free download and sterilization instructions prior to handoff.
We also created the following 3D printing guidelines for our users based on our research findings and medical consultancy of two of our members with a medical background:
Our 3D printer material guidelines:
- Polylactic Acid Plastic (PLA) Bio-based and biodegradable. Solubility in water: 0mg/mL Melting point: 150 C
- Acrylonitrile Butadiene Styrene (ABS) Solubility in water: 0mg/mL Melting point: No true melting point. Glass transition temp of 105C
- Polyamide (PA)
- PA (Nylon) requires printing temperatures higher than many FDM extruders can manage. High Impact Polystyrene (HIPS) Solubility in water: 0mg/mL Melting point: 240C HIPS filament is generally printed with a nozzle temperature between 220°C and 240°C, and a bed temperature between 90°C and 110°C. This means some machines will have trouble with bed adhesion, as the high bed temperatures are harder to reach and maintain.
Given the above material properties, we recommend masks be printed with PLA.
Challenges we ran into
When creating this platform one of the biggest challenges we ran into was determining what 3D prototypes were most feasible for makers to print and how best to facilitate the sterilization process for PETG face shields, airborne masks, and ventilator devices to ensure limited liability challenges.
Medical device manufacturing continues to be heavily regulated and because this pandemic is ongoing, the regulations that use to heavily regulate the making process were lifted because of the “emergency innovation capacity” stated by the FDA and World Health Organization as a means for the unprecendented time. Due to this, we collaborated with the research findings released with Stanford University and Dr. Peter P. Tsai, creating a marketplace that provided options that follow their research guidelines for safe medical manufacturing practices.
Accomplishments that we're proud of
We manage to finish the project in such a limited time of 5 days in our free time from school and work. The project first came to mind after our team members all met online, passionate about creating a project that will help arm frontline workers with equipment against the war on COVID-19. We also enjoyed collaborating and reaching out in research to organizations like Path.org and Last Mile Health, to better understand how PPE crowdsourcing and management is at the heart of this pandemic.
What we learned
Through this project, we learnt the process of sterilization can be incredibly daunting for the typical consumer. With medical consultancy and hours of research, we formulated a maker friendly safe process for makers to sterilize products prior to hospital handoff. This project couldn't have be done without the efforts and collaboration from a team with such diverse backgrounds in technical skills.
Our team consisted of Sasha Eslami (Product Manager), Rishi Kothari (Developer), Timothy Do (Medical Consultant), Diana Zhong (MD - Medical Consultant), Layla Masri (Developer), 3D Designer (Guilherme Scheider) and Tina (Developer - Designer).
What's next for PPEDash
- In the future, we’d love to expand the PPEDash platform to have a direct healthcare-to-maker messaging system, where communication is seamless between healthcare workers and makers.
- We plan to add a larger variety of airborne N95 respirators, as we are currently limited to Ventilator Adapters, 4 outlets (For Puritan Bennett™ 980 and 840 ventilators), Prusa RC3 model (recently WHO approved), HP Face Shield, Safe Catridge Mask System (ABS, PETG, PLA), HP Mask Adjuster (PA, TPU) and Filitration Mask (PLA, ABS).
- We’d also love to expand the making process to utilize printing materials that are more consumer accessible with more testing research available on the chemical compatibility of common consumer items and 3D printing (Heikkinen, Ismo & Kauppinen 2020).
- We also want to expand our sterilization methods and options with more research becoming available about how makers can pursue methods like UV Light or sterilization at home (Price, A. & Chu, L.)
Safety and Liability of 3D Printing Medical Devices and Equipment:
While ideating different solutions, our research and the medical background of our team members helped illuminate the many engineering and manufacturing risks around medical devices. Though the FDA has issued Emergency Use Authorizations (EUA) (Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices, FDA), to avoid doing more harm than good, it is recommended to attempt to the best of your ability and circumstances to follow regulations which exist for the safety of patients and liability of healthcare institutions and workers.
The following regulatory standards apply to the supplies and devices in our product:
- eCFR: QUALITY SYSTEM REGULATION (especially Identification and Traceability, Production and Process Controls, and Labeling) https://www.ecfr.gov/cgi-bin/text-idx?SID=4a139a0c2e75564b0dd819dc12940dc5&mc=true&node=pt21.8.820&rgn=div5
- eCFR: GENERAL HOSPITAL AND PERSONAL USE DEVICES https://www.ecfr.gov/cgi-bin/text-idx?SID=354d8b0fcc9bacaf08ef6e9d25250208&mc=true&node=pt21.8.880&rgn=div5
Protecting our users:
In the United States, Good Samaritan laws offer legal protection from civil lawsuits to people who voluntarily provide reasonable aid to those who are injured, ill, in danger, or otherwise incapacitated. A claim of negligent care can also be raised if the injuries or illness were made worse by the volunteer's negligence. Laws generally do not exempt a Good Samaritan who acts in a willful, wanton or reckless manner in providing care, advice, or assistance. We are providing you with the specifications you will need to manufacture items which are much-needed during this pandemic; however, you are responsible for your creations, so please practice due diligence (the care that a reasonable person exercises to avoid harm to other persons or their property). We want your contributions to help, not harm!
References: Good Samaritans (US Legal) https://definitions.uslegal.com/g/good-samaritans/
If you are familiar with similar laws in other countries, please reach out to us with relevant references as we expand globally!
Have any other questions? Email us at email@example.com
Medical Practitioner Research Interview References:
U.S. Food and Drug Administration, “Technical Considerations for Additive Manufactured Medical Devices.” Guidance for Industry and Food and Drug Administration Staff, U.S. Department of Health and Human Services, 20 Dec. 2017, www.fda.gov/media/97633/download?fbclid=IwAR2KaL1WoiluQ5eDxRwXWCAPzRD7rZ4UOsYGZeAo1wgWUKk8pGiJEaXxOOM
National Commission of Health. “Coronavirus.” World Health Organization, World Health Organization, 28 Mar. 2020, www.who.int/emergencies/diseases/novel-coronavirus-2019
Infection prevention and control of epidemic-and pandemic-prone acute respiratory infections in health care. World Health Organization (2014). .https://apps.who.int/iris/handle/10665/112656
Yang X, Yu Y, Xu J, et al. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med 2020; published online Feb 24. https://doi.org/10.1016/S2213-2600(20)30079-5
World Health Organization. “Advice on the use of masks the community, during home care and in health care settings in the context of the novel coronavirus (2019-nCoV) outbreak.” World Health Organization. World Health Organization. 29 Jan. 2020, https://www.who.int/docs/default-source/documents/advice-on-the-use-of-masks-2019-ncov.pdf
Food and Drug Administration. “N95 Respirators and Surgical Masks (Face Masks).” Food and Drug Administration. Food and Drug Administration. 11 Mar. 2020, https://www.fda.gov/medical-devices/personal-protective-equipment-infection-control/n95-respirators-and-surgical-masks-face-masks
Zhou, F. et al. Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. The Lancet 395, 1054–1062 (2020).
Price, A. & Chu, L. Addressing COVID-19 Face Mask Shortages [v1.2]. (2020). Available at: https://stanfordmedicine.app.box.com/v/covid19-PPE-1-1. (Accessed: 29th March 2020)
“Ventilators, Transport.” World Health Organization, United Nations, 10 2017, www.who.int/medical_devices/innovation/hospt_equip_37.pdf?ua=1.
Tsai, Peter P. “Information and FAQs on Performance, Protection, and Sterilization of Masks Against COVID-19.” University of Tennessee Research Foundation, University of Tennessee, 25 Mar. 2020, utrf.tennessee.edu/information-faqs-performance-protection-sterilization-of-masks-against-covid-19. “3D Printer Crowdsourcing for COVID-19 (Responses).” Google Drive, Google, docs.google.com/spreadsheets/u/1/d/1QE1vzezYdf6QJwxaMMLrWIks5AYAPUeSRWXxaYd3yK8/htmlview#gid=587452832
“COVID-19 Response.” National Institutes of Health, U.S. Department of Health and Human Services, 25 Mar. 2020, 3dprint.nih.gov/collections/covid-19-response.
Heikkinen, Ismo & Kauppinen, Christoffer & Liu, Zhengjun & Asikainen, Sanja & Spoljaric, Steve & Seppälä, Jukka & Savin, Hele & Pearce, Joshua. (2018). Chemical Compatibility of Fused Filament Fabrication-based 3-D Printed Components with Solutions Commonly Used in Semiconductor Wet Processing. Additive Manufacturing. 23. 99-107. 10.1016/j.addma.2018.07.015.
“Chemical Disinfectants.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 18 Sept. 2016, www.cdc.gov/infectioncontrol/guidelines/disinfection/disinfection-methods/chemical.html.
“Billings Clinic Foundation.” Billings Clinic, www.billingsclinic.com/foundation/.
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3dprinting, autocad, balsamiq, chakralibrary, cinema4d, drift, firebase, google-maps, react, sketch, solidworks