[LIVE UPDATES] 3D printing in a time of coronavirus: the additive response to COVID-19

In the face of the COVID-19 pandemic, innovators are finding novel ways to apply 3D-printed solutions to assist the international response to coronavirus. Keep up with the latest news from the additive manufacturing community with our round-up of relevant updates.

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As the international response to the COVID-19 pandemic escalates, opportunities for intervention from additive manufacturing technologies present themselves. 

In this round-up, 3DMedNet aims to share the stories of innovators applying cross-industry additive knowledge and resources to address challenges associated with managing the response to the pandemic.

Do you have anything you would like to share about the stories included or have a story to share with the medical 3D printing community? Let us know in the comments or email the Editor, at g.makin@3dmednet.com 

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Collaboration announced to bioprint 3D lung models for coronavirus research

Allevi (PA, USA) and The Wistar Institute (PA, USA) have announced a collaboration to develop 3D bioprinted lung models for coronavirus research. The collaboration will include the provision of Allevi’s bioprinting capabilities to the Vaccine & Immunotherapy Center at The Wistar Institute.

We are accompanying the spectacular work from our peers in the scientific community and have identified tremendous potential for our platform to enable COVID-19 research in a much faster, yet physiologically relevant manner,” explained Taciana Pereira, Allevi Vice President of Life Sciences and a co-principal investigator on the project.

We have been advancing scientific investigations aimed at the treatment and prevention of COVID-19, and we believe that Allevi's innovative approach is an exciting modality to gain unique insights into the inner workings of the novel coronavirus,” explained David Weiner, Executive Vice President, Director of the Vaccine & Immunotherapy Center and W.W. Smith Charitable Trust Professor in Cancer Research, another co-principal investigator on the project.

This project has the potential to be a significant asset in the fight against COVID-19 and the scientific community will benefit greatly from this endeavour,” concluded Robert Langer, David H. Koch Institute Professor at the Massachusetts Institute of Technology (MA, USA) and Allevi Scientific Advisory Board member.

Source: https://wistar.org/news/press-releases/wistar-institute-allevi-inc-collaborate-3d-bioprinting-project-advance-covid-19


3dbio focuses bioprinting laboratory towards the search for drugs to treat COVID-19

3D Bioprinting Solutions (3dbio; Moscow, Russia) has announced a new focus for their bioprinting laboratories, as the team assumes an active role in the study of various antivirals.

The team is utilizing bioprinted tissues to model pathologies, predict toxicology and develop therapeutics for COVID-19-associated illnesses. By testing therapeutics on 3D spheroids, the team claims that they are able to better replicate the organization of native tissues and provide a better in vitro model than traditionally available.

Now we are especially clearly seeing and proud of the important role that our laboratory and its staff play in assisting virology and pharmacology specialists in the rapid and accurate development of antiviral drugs,” explained Yousef Hesuani, Co-Founder and Managing Partner of 3D Bioprinting Solutions.

Source: https://bioprinting.ru/press-center/publications/laboratory-3d-bioprinting-solutions-working-on-finding-cures-for-covid-19/


3D-printed robot performs zero-contact COVID-19 testing

A team of engineers from the University of Southern Denmark (Odense, Denmark) has developed a 3D-printed robot for performing throat swab testing with zero human contact.

Esben Østergaard (Co-Founder of Lifeline Robotics and Universal Robots, Odense, Denmark) takes a swab in the World's first automatic swab robot, developed with Thiusius Rajeeth Savarimuthu (Professor at the Maersk Mc-Kinney Moller Institute at The University of Southern Denmark)

The automated robot uses a 3D-printed, disposable tool to hold a swab and take a sample before placing the swab in a glass tube and fastening the lid.

I was surprised at how softly the robot managed to land the swab at the spot in the throat where it was supposed to hit, so it was a huge success,” explained Thiusius Rajeeth Savarimuthu, Professor at Maersk Mc-Kinney Moller Institute at The University of Southern Denmark.

There are prospects in developing a throat swab robot so that robots can take over the throat swabbing work both in relation to COVID-19, but also in all future viruses,” Savarimuthu continued.

As the message from the WHO continues to emphasize the importance of testing, the team hopes this robot could provide a solution to reduce the risk to healthcare professionals performing the tests.

Currently, healthcare professionals are carrying out throat swabs for Covid-19; but working conditions can be a challenge. The task entails long working days of monotonous work. At the same time, the employees are in great demand in other functions,” added Kim Brixen, Medical Director from Odense University Hospital (Denmark).

Large-scale testing is part of our community’s reopening strategy. The robot has great potential for mass screening for COVID-19 in the healthcare sector, but also in connection with border control or at airports. At the same time, we see that regular flu seems to have decreased during the lockdown. This may imply that we may need to rethink our strategy against the flu,” Brixen concluded.

Source: www.sdu.dk/en/nyheder/forskningsnyheder/robot-kan-pode-patienter-for-covid-19


UK government releases new guidance on the small-scale manufacture of PPE

The UK government’s Office for Product Safety & Standards has released new guidance on the small-scale manufacture of PPE. The guidance document provides clarity for businesses, organizations and individuals looking to manufacture PPE for local and national health systems, ensuring a regulated and safe approach.

Two key takeaways from the new guidance document include:

  • all PPE must be assessed for meeting ‘essential health and safety requirements’ by a notified body;
  • manufacturers have been advised not to contact their local health systems directly unless their PPE has been assured as ‘safe’.

Find out more in the full document, here.

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Automating the additive response to COVID-19: KUKA robots 3D print PPE for local hospitals

As concerns are voiced regarding the conditions in which some PPE and critical components have been manufactured, Caracol-AM (Lombardy, Italy) has announced the employment of KUKA (Augsburg, Bavaria) robots to 3D print face visors for local hospitals.

The team claims that the robots are capable of 3D printing over 1000 visors per day.

During the COVID-19 emergency, we want to make a contribution with our 3D printing processes. Thanks to our experience in this field, we were able to react quickly and convert our production," explained Francesco De Stefano, CEO of Caracol-AM.

Our robotic systems and industrial printers are running at full speed to produce protective equipment. The headgear printed by the KUKA robots is complemented by a plexiglas, which Caracol-AM purchases from a partner company, to protect against droplet infection,” De Stefano continued.

Our KUKA robots help us to produce quickly and meet the high demand for protective equipment. The robot systems are in operation around the clock," De Stefano concluded.

Source: www.kuka.com/en-us/press/news/2020/05/kuka-robots-print-protective-equipment-in-northern-italy

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US FDA answers frequently asked questions about 3D-printed devices, accessories, components and parts during COVID-19 pandemic

The US FDA has published an FAQ with resources for finding out more about specific regulatory guidance related to 3D-printed devices, including the optimization of PPE and the regulation of devices.

The FAQs further detail what healthcare providers should be checking for if using 3D-printed PPE and accessories, as well as where to find more information about the FDA’s plans for mitigating equipment shortages.

Source: www.fda.gov/medical-devices/3d-printing-medical-devices/faqs-3d-printing-medical-devices-accessories-components-and-parts-during-covid-19-pandemic

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3D-printed ventilator requires no electricity to function

A collaborative team of University of Central Florida (FL, USA) engineers and Oregon Health (OR, USA) medics has designed a ventilator from 3D-printed parts that does not require electricity to function.

With an emergency-use application now underway with the US FDA, the team has stopped initial durability testing of the first ventilator following 7 days of successful, continuous use.

Hearing the machine 'breathing' during testing was a really moving experience. The sound is such a reminder of why we continue to do everything we can to support our community in any way we can. It is an example of what teamwork can accomplish to change the world," explained Albert Manero, CEO and Co-Founder of Limbitless Solutions (OR, USA).

Engineers from UCF-based Limitless Solutions and trauma surgeon Albert Chi from OHSU have been collaborating on a clinical trial for over a year that relationship has led to a new 3D printed ventilator design. Credit: University of Central Florida.

Source: www.ucf.edu/news/ucf-trained-engineers-oregon-medical-team-design-3d-printed-ventilator-that-requires-no-electricity 

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Bioprinting company, CLECELL, bioprints lung tissue for COVID-19 vaccine testing

Bioprinting company, CLECELL (Gyeonggi-do, Republic of Korea), has announced the development of lung epithelium tissue for COVID-19 research and vaccine development.

According to the latest news from CLECELL, the company has been working with researchers at Harvard University (MA, USA) and plans to collaborate with researchers around the world to develop models for virus infection, drug delivery, toxicity and inflammation.

Despite the various existing methods of testing respiratory viruses in vitro, we require a more effective platform for testing,” explained Young-Jae Cho, Professor at the Department of Pulmonology at Seoul National University Bundang Hospital (Seongnam, South Korea).
The creation of precise artificial respiratory models through 3D bioprinting technology offers a potential alternative,” Cho concluded.

Source: http://clecell.co.kr/clecell-a-new-bioprinted-model-could-aid-covid-19-vaccine-testing/

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Open access hardware and 3D printing could help meet the demand for medical supplies during COVID-19

In a recent study published in PLoS Biology, Scientists from the University of Sussex (UK), University of Cambridge (UK) and Francis Crick Institute (London, UK) have recommended a community approach to tackling the shortage of medical supplies.

The team recommends considering the use of free open source hardware, providing an overview of blueprints and designs currently available, focussing on PPE, ventilators and test kits.

While some designs remain to be tested, others have reportedly already met suitable verification.

Professor of Neuroscience, Tom Baden (University of Sussex), explained:

Now is the time that Open Hardware could really shine and it’s so important that we get on board quickly. Previous studies and experiences have shown that free and open source hardware is a brilliant option in disaster situations. Designs can be shared globally, it has typically lower implementation costs than mass manufacturing and it can be easily adapted to meet local resources.”
But the real power – and the way this could really help to tackle COVID-19 - is that once a tool has been designed and tested, anyone can build it. This bypasses the traditional manufacturing and distribution routes and means that it can become a community-driven endeavour where anyone with the capacity to do so can help to produce much-needed equipment and supplies for the healthcare services,” Baden continued.
Anyone with the necessary knowhow, tools and time can build on this knowledge to meaningfully support their community. At a time when global health systems are facing immense pressure and becoming increasingly overburdened, we need a response not just from frontline workers such as medical staff and scientists, but from skilled members of the public who have the time, facilities and knowledge to meaningfully contribute,” Baden concluded.

Sources: Changas AM, Molloy JC, Prieto-Godino LL, Baden T. Leveraging open hardware to alleviate the burden of COVID-19 on global health systems. PLoS Biology. doi: 10.1371/journal.pbio.3000730 (2020) (Epub ahead of print); https://archive-stage.sussex.ac.uk/news/press-releases/id/51856

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ExOne and University of Pittsburgh collaboration produces reusable, metal respirator filters

ExOne (PA, USA) has announced a collaboration with the University of Pittsburgh (PA, USA) to develop reusable, metal respirator mask filters.

ExOne has reportedly 3D printed respirator filters in copper and 316L stainless steel at a range of porosity levels for use in a cartridge developed at the University of Pittsburgh’s Mechanical Engineering and Materials Science department at the Swanson School of Engineering.

Testing for airflow and filtration efficiency is now reportedly underway, as the filters are being optimized to be up to the standards of the N95 respirators.

The advantage of binder jet 3D printing over other additive manufacturing methods for this filter application is the ability to utilize the porosity of the printed part and then fine tune it during the high temperature densification or sintering process to achieve optimum filtering and airflow performance,” explained Markus Chmielus, Associate Professor of Mechanical Engineering and Materials Science at the Swanson School.

Source: www.exone.com/en-US/News/ExOne-Reusable-Metal-3D-Printed-Filter-Respirator

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Low-cost ventilators designed for emergency use do not require electricity to function

A team from the Oregon Health and Science University (OR, USA) has developed 3D-printable, low-cost ventilators.

The design is reportedly so simple that it does not function on electricity, only oxygen from standard tanks available at most hospitals. The ventilators can be replicated worldwide for under US $10.

The goal is to provide it for free to whoever needs it,” explained Albert Chi, an Associate Professor of Surgery (Oregon Health and Science University).
I wanted to have something we could print everywhere without the need for special equipment or custom manufacturing,” Chi continued.

The team has filed for emergency-use authorization from the US FDA as they continue to test and refine prototypes.

Source: https://news.ohsu.edu/2020/04/24/ventilators-available-with-the-flip-of-a-switch

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Electric stockings to prevent the loss of muscle mass in hospitalized patients with coronavirus

A team of doctors and engineers has developed a biocompatible electrode which can be integrated and 3D-printed onto textiles. The team, based at Aarhus University (Denmark) hopes this technology can be adapted for use with stockings, designed to prevent the loss of muscle mass in patients with COVID-19 at intensive care units.

One characteristic of COVID-19 patients is long-term intensive admissions and long periods on a respirator, often for up to 3 weeks. It may take months or years to recover from the treatment and some patients will never fully recover. The idea behind the project is to retain the muscle mass, so that patients are in approximately the same condition when they leave hospital as when they were admitted," explained Charlotte Suetta (University of Copenhagen, Denmark), who is leading the clinical trials for the project at Bispebjerg Hospital and Herlev Hospital (both Denmark).
We're already 3D printing electrodes and wires onto the first stockings. The electrodes have three ultra-thin layers, which make it possible to stimulate the muscles through the stocking with minimal irritation. We expect to have the first 50 prototypes ready for testing by patients in a month," added Shweta Agarwala, Assistant Professor and printed electronics specialist at the Department of Engineering at Aarhus University.

Source: https://ingenioer.au.dk/en/current/news/view/artikel/electric-stockings-to-help-intensive-care-patients-with-coronavirus/

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World Economic Forum launches ‘3D Printing COVID-19 Rapid Response Initiative’

The World Economic Forum has a published a directory of industry leaders capable of lending additive support to supply demands for a variety of critical parts, including ventilator valves, PPE and swabs.

The page also features links to companies with STL files available as well as information about each company’s distribution capability.

>> Find out more.

Source: www.weforum.org/projects/3d-printing-covid-19-rapid-response-initiative

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London surgeons team up with iMakr to print PPE in-house

In a recent tweet, Pankaj Chandak, Specialist Registrar in Transplant Surgery (Guy's, St Thomas', Evelina and Great Ormond Street Hospitals; London, UK) and Research Fellow (King's College London, UK), has described how mutli-discplinary teams at Guy’s and St Thomas’ hospital have been working to 3D print face shields in-house.

With support from iMakr (London, UK), the teams have so far printed over 100 visors for hospital staff.

Find out more about Chandak and how his team typically use 3D-printed models for surgery in our latest video series from the Science Museum (London, UK).

Source: https://twitter.com/pchandak1/status/1252657672593330176

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Four 3D-printed nasal swabs undergo clinical trials

Four 3D-printed nasal swabs have been identified following a clinical trial led by a multi-disciplinary team from Beth Israel Deaconess Medical Center (MA, USA).

Each swab was tested against a standard nasopharyngeal swab used to collect samples from 230 adults undergoing COVID-19 testing. According to the preprint of the team’s manuscript, the four swabs selected for review out of more than 100 designs showed excellent concordance with the standard swabs.

To develop novel, effective alternatives as quickly and safely as possible, we and our collaborators modeled our process on scientific studies that have shown that open and collaborative processes outperform closed or proprietary ones when it comes to time-sensitive innovation,” Ramy Arnaout, Associate Director of the Clinical Microbiology Laboratories (Beth Israel Deaconess Medical Center) explained.
We hope our collective experience can provide a useful roadmap to others working under the pressure of a public health emergency,” Arnaout added.

Sources: Callahan CJ, Lee R, Zulaf K et al. Rapid open development and clinical validation of multiple new 3D-printed nasopharyngeal swabs in response to the COVID-19 pandemic. doi: 10.1101/2020.04.14.20065094 (2020) (Preprint); www.bidmc.org/about-bidmc/news/2020/04/3d-printed-swabs

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European Commission releases guidance for 3D printing in the context of COVID-19

In a recent announcement, the European Commission has released guidance for manufacturers looking to 3D print solutions for PPE and critical equipment shortages.

The guidance released covers three areas, including the production of PPE, leave-on hand cleaners and hand disinfectants and 3D printing in the context of COVID-19. The European Commission has further promised more extensive guidance on medical devices, specifically, in the near future.

Thierry Breton, Commissioner for Internal Market (European Commission), commented:

We are acting swiftly and mobilising industry to increase and create new production lines for urgent health material and protective equipment across Europe. Many companies are already doing so and we are helping them to ensure not only that this is done quickly but also that their products comply with all necessary safety standards.”

Commissioner for Health and Food Safety, Stella Kyriakides (European Commission), added:

Stepping up the supply of medical and personal protective equipment is vital to address shortages and for our health care workers to continue saving lives. The guidance we issue today will support our industry in this effort. The fight against coronavirus requires all hands-on deck and our industry's contribution is essential.”

Source: https://ec.europa.eu/commission/presscorner/detail/en/ip_20_558

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Markforged announces validated, 3D-printed nasal swabs for higher accuracy COVID-19 testing

Markforged (MA, USA) has partnered with Neurophotometrics (CA, USA) to develop improved nasal swabs for COVID-19 testing.

The rayon-wrapped nasopharyngeal swabs are reportedly preferred by the US FDA and may be more effective for collecting samples for testing. Markforged has also claimed that they are capable of producing 10,000 of these swabs per day, with potential for scaling up to 100,000 if necessary.

In a recent update to the main page hosting the swabs information, Markforged has announced that:

The 3D-printed swabs completed clinical validation with the institutional review board at Rady Children’s Hospital San Diego (CA, USA) and the University of California San Diego (CA, USA) this week.”

The hospital has reportedly ordered 30,000 swabs from Neurophotometrics for COVID-19 testing.

Commenting on the Markforged response to COVID-19, Greg Mark, CEO and Founder (Markforged) explained:

Identifying COVID-19 infected patients is the best way to slow down the spread of the disease, but we’re seeing a lot of issues with wide-scale testing. There are massive shortages of nasal swabs and to make matters worse, hospitals are reporting false negatives with the current swabs on the market.”

Sources: https://markforged.com/covid-19/#swabs,  https://markforged.com/press-releases/markforged-neurophotometrics-nasal-swabs/

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[UPDATED] National additive consortium, 'SHIELD', announced in UK to meet PPE demand

A consortium of innovative 3D printing hubs has announced the launch of the Sustainable Hub for Innovation, Execution, Launch and Distribution (SHIELD) in the UK. The consortium brings together industry leaders and 3D printing experts in collaboration to meet the PPE demand, employing several 3D printing hubs in London (UK).

After forming a few weeks ago as a ‘best-practice’ collaboration of independent PPE campaigns, SHIELD now aims to support a ‘coordinated national effort’ in the challenge of protecting frontline NHS staff.

Within SHIELD we are collaborating to develop responsive supply streams for visors, gowns, ventilator consumables and other mission-critical medical devices,” explained Kate Hammer, Innovation Specialist at Hero Support.

As the first ‘hub’ prepares to go live this week based at Makerversity (London, UK), funded by HEREOS, HEROES Co-founder Dominic Pimenta added:

As we try to keep up with the effect of the virus on the UK, supplies are in demand and there is a need for sustainable solutions. Being an ICU doctor myself I am in a position to test our products on the ground giving us the opportunity to be agile and evolve with the virus each day. For HEROES, it was a no-brainer to be involved as supporting the NHS frontline with immediacy and impact is why we exist”.

Kadine James, Co-Founder of SHIELD and UK Lead of Women in 3D Printing concluded:

SHIELD brings together industry experts from across additive manufacturing who are all joining forces to support the NHS during these serious times, I am honoured to a part of the co-founding team." 

The SHIELD team advises that hubs can join the effort, find out more or enquire about funding via the dedicated website: www.shieldproject.org

Source: www.shieldproject.org/news/2020-04-12-shield-website-launched

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Face screens 3D-printed in Osaka, Japan

A team from Osaka University (Japan) in collaboration with Charmant, a global manufacturer of eyeglass frames (Sabae, Japan) has successfully 3D printed face screens for the protection of healthcare workers.

The team has also made their designs available for free online via a dedicated website, complete with instructional videos for putting the shields together once printed.

The collaborative development project between our university and Charmant was based on the idea that it would become easier to locally procure and produce face shields if it were possible to create frames with 3D printers, which have recently become more sophisticated and affordable, from locally-available, common materials," explained Professor Nakajima, project leader (Osaka University).
3D-printed face shield
Osaka University team member wearing a 3D-printed face shield. Credit: Osaka University.

Source: www.project-engine.org

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US universities continue commitment to the manufacture of PPE and critical equipment

As more US universities join the additive community in the 3D printing of PPE for local healthcare workers and innovative equipment for emergency use, find out more about each project in this brief round-up:

3D-printed swab
3D-printed swab. Credit: University of Louisville
  • A team from the University of Louisville (KY, USA) has 3D printed swabs (pictured above) to supplement the demand for COVID-19 testing kits. The team reports that the swabs are due to undergo clinical trials in the following week. Find out more >>
  • The University of Alabama (AL, USA) has announced a cross-college collaboration to 3D print PPE for local healthcare workers. Find out more >>
  • The University of New Mexico School of Engineering (NM, USA) announces the design and production of 3D-printed respirator masks and sanitizer. Find out more >>
  • West Virginia University (WV, USA) find inspiration from home furnaces in the development of 3D-printed N95 mask alternative. Find out more >>
  • Staff and students at Johns Hopkins University (MD, USA) have collaborated to develop 3D-printed ventilator splitter. Find out more >>

 

Is there anything else you would like to see in our round-up of additive activities at a time of COVID-19? Let us know in the comments or email the Editor directly: g.makin@3dmednet.com

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French hospital embeds 3D printing hub for emergency supplies production

A University Hospital Trust in Paris (AP-HP, France) has recruited a ‘fleet’ of 60 Stratasys (MN, USA) 3D printers to manufacture vital equipment amidst a critical shortage at AP-HP’s Paris Cochin Hospital.

Commenting on the installation, Andreas Langfeld, EMEA President (Stratasys), commented:

The sweeping and severe nature of COVID-19 continues to impact the supply chains of some of the world’s most critical medical equipment.”
Leveraging 3D printing technology on this scale gives AP-HP its own rapid-response supply chain in-house, placing production directly where it’s needed and ensuring essential equipment is quickly in the hands of frontline medical staff who are battling every day to save lives,” Langfeld continued.

In tandem with the new 3D printing hub at the hospital, AP-HP has developed a dedicated an online 3D printing platform (3dcovid.org) to fast-track requests from Paris as well as surrounding areas.

3D printing hub at AP-HP
The AP-HP’s 60 Stratasys 3D printers provide the hospital trust with a rapid-response supply chain in-house, ensuring essential equipment is quickly in the hands of frontline medical staff battling COVID-19. Credit: Stratasys

Source: Stratasys press release

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University of Birmingham and TU Graz announce production of medical shields for local frontline healthcare workers

A team comprised of students and staff from the University of Birmingham (UK) has 3D printed face visors for staff at Birmingham Children’s Hospital (UK).

The team aims to 3D print 60 visors in an initial batch, based on a design taken from blueprints of the tested PrusaPrinters (Prague, Czech Republic) shields previously covered in this column.

David Bassett from the School of Chemical Engineering at the University of Birmingham explained:

Rapid prototyping offers us a route to respond directly and quickly to the shortage of PPE needed for frontline workers in the NHS and beyond. Ramping up manufacture and distribution by traditional routes takes time and these face shields will provide much needed supplementary protection for frontline workers in the fight against COVID-19 in the interim.”

Also in Europe, a collaborative team from Graz University of Technology (TU Graz; Austria) has 3D printed 1,000 protective face shields for local hospital, KAGes (Graz, Austria). The team reports that the face shields have been tested by doctors and the relevant departments from KAGes for use and hygiene, are resusable and can be easily cleaned or disinfected.

The team further reports that a total of 10,000 face shields are due to be produced for KAGes over the next few weeks.

I am delighted that we have already been able to hand over the first 1,000 face shields to KAGes today. These were designed by my team at the Schumpeter Laboratory for Innovation at TU Graz and have been manufactured by us in shift operation since the weekend," explained Christian Ramsauer, Head of the Institute of Innovation and Industrial Management (TU Graz).

Sources: www.birmingham.ac.uk/news/latest/2020/04/birmingham-researchers-produce-3d-printed-visors-to-shield-against-coronavirus.aspx; www.tugraz.at/en/tu-graz/services/news-stories/tu-graz-news/singleview/article/kages-setzt-bei-schutzausruestung-auf-3d-druck-by-tu-graz0/

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First 3D-printed mask approved by US FDA

In a tweet from the Veteran’s Health Association Innovation Ecosystem (DC, USA), the group shares a photograph of the first 3D-printed mask to be approved by the US FDA.

Sources: https://twitter.com/VHAInnovation/status/1246164120992452612; https://twitter.com/VHAInnovation/status/1247212488736813057

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UK MHRA: 14 cases of ‘fake’ or unlicensed COVID-19 medications and devices investigated by UK regulator

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has stated that 14 fake or unlicensed COVID-19 medicinal products are subject to investigation.

The MHRA has stated that at this time, there are no medicines licensed specifically for the treatment or prevention of COVID-19, nor are there any CE marked self-testing kits available.

At present, nine domain names have already been disabled along with social media accounts claiming to sell fake or unauthorized COVID-19-related products.

Commenting on the investigation, MHRA Enforcement Official, Lynda Scammell explained:

The risk of buying medicines and medical devices from unregulated websites are that you just don’t know what you will receive and could be putting your health at risk. We are working alongside other law enforcement agencies to combat this type of criminal activity.”

Source: www.gov.uk/government/news/uk-medicines-and-medical-devices-regulator-investigating-14-cases-of-fake-or-unlicensed-covid-19-medical-products

Are you working to regulate your 3D-printed device for use in the response against COVID-19? We would like to speak to you about developing devices in an uncertain regulatory environment. Contact the Editor, via: g.makin@3dmednet.com

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Michigan State University, Duke University and Weil Cornell join additive response, 3D printing PPE for local healthcare workers

Michigan State University (MI, USA), Duke University (NC, USA) and Weil Cornell Medicine (NY, USA) have all announced initiatives for 3D printing protective face screens for healthcare workers in their respective areas.

Donna Crenshaw, Executive Director of Duke MEDx, the collaborative venture of the Duke School of Medicine and the Pratt School of Engineering, explained:

It is an extra level of safety for the person who is dealing with a COVID patient or somebody who may have COVID, so it’s an extra barrier. The other thing is, it’s a mechanism for helping to preserve the really important respirators, the N95 masks, that those providers are wearing. So, it really saves them from being contaminated.”

Aaron Walworth, Laboratory Manager at the School of Packaging at Michigan State University, commented on the collaborative effort of teams at the university:

None of us were PPE makers a few days ago and now, by pooling our talents, we’re able to do something that will hopefully make a difference. Many members of the team didn’t know each other prior to this and have still only met virtually due to social distancing. But there is this great sense of camaraderie as we’re all determined to do what we can to help.”

Kristen Petersen, Assistant Professor of Electrical and Computer Engineering at Weil Cornell Medicine concluded:

We’re in a city of designers and my biggest job right now is trying to keep people from redesigning these parts to optimize them – people at Weill Cornell Medicine do not have the capacity right now to test out different parts. The important thing is to just keep the printers going as fast as possible: 3D printing is probably the slowest possible method of making these parts, but we don’t have anything else set up right now.”

Sources: https://today.duke.edu/2020/04/solving-pressing-challenges-3d-printing-medical-grade-face-shields; https://msutoday.msu.edu/news/2020/msu-colleges-collaborate-to-create-3d-printed-medical-face-shields-in-response-to-covid-19-crisis/; https://news.cornell.edu/stories/2020/03/cross-campus-effort-rushes-3d-printed-gear-weill-cornell

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3D-printed ventilator splitters developed at Pennsylvania College of Technology

An Associate Professor of Automated Manufacturing and Machining at Pennsylvania College of Technology has utilized his own skills, filament and 3D printer to produce eight (non-FDA approved) ventilator splitters. 

I’m trying to get ahead of the curve,” explained Eric Albert (Pennsylvania College of Technology).
Hopefully, they won’t have to be used. If requested, I could make about 48 more in a couple days in our lab at the college. I can’t produce thousands, but I’m happy to do whatever I can,” Albert continued.
The beauty of additive manufacturing is its flexibility. I can shift from a face shield to a ventilator splitter just by changing the computer files,” Albert concluded.

Albert has also been busy 3D printing face shields for the college’s nursing home partners.

Source: https://pctoday.pct.edu/penn-college-professor-manufactures-ventilator-splitters/

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Viscient Biosciences to bioprint lung tissue for COVID-19 research

Viscient Biosciences (CA, USA) will be utilizing 3D bioprinting technologies to develop lung tissue models for COVID-19 research.

The bioptherapeutic company hopes to be able to accelerate the testing and development of COVID-19 therapies with efficient and highly biologically-accurate results.

Keith Murphy, Founder and CEO of Viscient Biosciences explained:

When you can remove diseased cells from the human body and reproduce that disease in a dish, you can see the true biology and quickly find a therapy that will work in clinical trials.  Drugs found in animal models so often fail because of the species gap, but as we proved with our non-alcoholic steatohepatitis liver work, important novel drug targets can be found using 3D bioprinting technology. We now are moving quickly to apply the same technology to create 3D human lung tissue to test potential COVID-19 therapies to accelerate development."

Source: www.prnewswire.com/news-releases/viscient-biosciences-will-bioprint-3d-lung-tissue-to-aid-pandemic-research-and-viscient-founder-calls-for-pause-in-organovo-merger-attempt-301032247.html

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Surgeons and clinicians return to NHS to help frontline healthcare response

As thousands of retired doctors, surgeons, nurses and healthcare workers volunteer to return to the NHS to aid the frontline response to COVID-19, Richard Kerr, Honorary Consultant Neurosurgeon (Oxford University Hospitals NHS Foundation Trust) and Council Member of the Royal College of Surgeons of England has announced that he is in discussions about returning to the NHS.

Kerr chaired the RCS Commission on the Future of Surgery in 2018 and more recently participated in a keynote panel discussion at 3DMedLIVE 2019.

Richard Kerr
Richard Kerr is currently in discussions about returning to a frontline healthcare role, pictured at 3DMedLIVE 2019: 3D printing in surgery.

>> Find out more about Richard Kerr and the future of surgery in this exclusive 3DMedNet interview from 3DMedLIVE 2019: 3D printing in surgery

On speaking to the BBC, Kerr explained that the pandemic:

has left everyone reeling.”
I think it’s pretty scary. There’s a degree of uncertainty. But being pragmatic, if we don’t do something about this, it’s only going to get worse,” Kerr continued.

Source: www.bbc.co.uk/news/uk-52115327

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Collaboration 3D prints and validates Formlabs nasal swab kits

A collaborative team formed between The University of South Florida (USF) Health (FL, USA), Tampa General Hospital (FL, USA), Northwell Health (NY, USA) and Formlabs (MA, USA) has announced success in the printing and validation of nasal swabs, fundamental to coronavirus testing kits.

According to the team, validation and rapid clinical testing demonstrated that the 3D-printed nasal swabs perform equally to standard swabs used for testing for COVID-19.

This is a prime example of the incredible impact we can have on human lives when teams of experts across academia, health care delivery and the tech industry come together,” explained Charles Lockwood, Senior Vice President for USF Health and dean of the USF Health Morsani College of Medicine.
During this current COVID-19 outbreak, there is little time for delay, and the swift, agile and adept action of everyone on this effort will greatly improve this nation’s ability to test patients,” Lockwood continued.

>> Find out more about the response from Formlabs in our earlier coverage

Source: https://hscweb3.hsc.usf.edu/blog/2020/03/28/usf-health-northwell-health-tampa-general-hospital-and-formlabs-join-forces-to-create-3d-printed-nasal-swabs-to-test-for-covid-19/

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Siemens launches forum for connecting 3D printing services

Siemens (Belin and Munich, Germany) has published an online forum for professionals and 3D printers to aid the additive response to COVID-19.

On the dedicated COVID-19 page, Siemens have published the details of their partners to enable medical professionals to reach designers and printers worldwide, connected via the Siemens network.

Source: https://additive-manufacturing-network.sws.siemens.com/fight-coronavirus/

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Staff, students and faculty team up to 3D print respirators at UC San Diego

A team of engineers and physicians have rallied at University of California San Diego (UC San Diego; CA, USA) to design and 3D print simple, easy-to-use ventilators.

One of the biggest things we heard was that there weren’t enough ventilators to treat all of the patients coming into the hospitals,” explained James Friend, Professor in the Department of Mechanical and Aerospace Engineering and the Department of Surgery at UC San Diego. “It’s clear that if we’re not careful, we might end up in the same situation.”

The team reports that the first step was to consult anesthetists and respiratory therapists about minimum requirements for a ventilator. Engineers and physicians were then able to design parts for developing their own ventilators.

As long as the correct materials are used, 3D printing can be used to produce a wide variety of tools in the fight against COVID-19,” added Shaochen Chen, Professor of Nanoengineering at the Jacobs School of Engineering (UC San Diego). “It’s not good for, say, entire N95 masks, but it can be used for producing testing swabs or even face shields for healthcare workers.”

Lonnie Petersen, Assistant Professor in the Department of Mechanical and Aerospace Engineering at UC San Diego, explained that the team are now awaiting parts to complete a design featuring an electric pump:

Our aim is to have functional devices as soon as possible. Once we’ve got the bare bones system up and running, we can start adding layers of sophistication and automation. Those additional layers will include advanced regulation of air pressure and flow to allow for a more disease-specific and patient-tailored respiratory support.”

The next steps will be to develop the design into a more sophisticated ventilator, potentially able to support multiple patients at any one time.

We are preparing for a shortage of both ventilators and specialized staff to run them,” added Petersen. “The questions quickly became ‘How can we tweak the ventilators that are available to support multiple patients? How can we create more ventilators that are easier for staff to use?’”
This is a team effort,” Petersen concluded. “And we can use the assistance of other engineers. We would love to hear from students, staff, and faculty with hands-on engineering experience who can help us with this project.”

Qualified volunteers should email: UCSDVentilatorEngHelp@gmail.com

Source: https://ucsdnews.ucsd.edu/feature/uc-san-diego-engineers-and-doctors-team-up-to-retrofit-and-build-ventilators-with-3d-printing

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Medical University of South Carolina releases plans for 3D-printable masks

As the threat of a shortage of face masks increases, a team of bioengineers from Medical University of South Carolina (SC, USA) has released plans for a 3D-printable protective mask.

The team is currently talking to manufacturers to ascertain whether mass production can commence following approval. The team claims, however, that the simple plans are available to anyone with a 3D printer.

High schools have a printer capable of making this," explained Michael Yost, Vice Chair of Research in the Department of Surgery (Medical University of South Carolina). 
Let's make this so simple that a high schooler could do it, yet effective to protect our people," Yost continued. 
Joshua Kim (Medical University of South Carolina) demonstrating how the filter cartridge can be adapted to fit onto existing masks.
Joshua Kim (Medical University of South Carolina) demonstrating how the filter cartridge can be adapted to fit onto existing masks. Credit: Sarah Pack (Medical University of South Carolina)

Source: https://web.musc.edu/about/news-center/2020/03/26/3d-printed-masks-developed-at-medical-university-of-south-carolina

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US FDA grants emergency-use authorization for 3D-printed ventilator component

Prisma Health (SC, USA) has announced that their 3D-printed ventilator components have received US FDA authorization for emergency use.

The device, called ‘VESper™’, is described as a ‘unique’ ventilator adaptor that can allow for up to four patients to use a single ventilator. As the demand for ventilators increases as the COVID-19 pandemic develops, the splitters could be instrumental in managing a shortage of equipment.

When we see rapid increases in patients who require machine-assisted breathing, an acute shortage of necessary equipment can happen overnight,” explained Peter Tilkemeier, Chair of the Department of Medicine at Prisma Health-Upstate.
The VESper™ device can be lifesaving when the number of critically ill patients requiring breathing support is greater than the number of available ventilators. A number of US hospitals are likely to begin experiencing this with COVID-19,” Tilkemeier continued.
Immediately, we realized we had an opportunity to impact patient outcomes all over the country, and potentially beyond the US,” added Marjorie Jenkins, Chief Academic Officer for Prisma Health–Upstate and dean of the University of South Carolina School of Medicine Greenville (SC, USA).
What we needed was a collaborative team to put the plan in motion and close the loop between design, production, FDA approval and distribution to hospitals with critical need,” Jenkins continued.
VESper device
VESper device, available via: www.multivu.com/players/Englis... 
This is an exemplary demonstration of rapid innovation and collaboration,” commented Mark O’Halla, President and CEO of Prisma Health.
I am so proud of the creativity and perseverance of our clinical team who came together to develop a potentially life-saving solution at a critical time for our country, our communities and our patients. We are anxiously awaiting the results of the prototype field tests,” O’Halla concluded.

Hospitals can begin to apply to receive the free source code and printing specifications for the device today by registering on Prisma Health’s website: www.prismahealth.org/VESper

Source: www.multivu.com/players/English/8708651-prisma-health-vesper-ventilator-expansion-device-covid-19/

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MHRA allows special exemptions from device regulations during COVID-19 outbreak

The UK MHRA has announced that non-CE marked medical devices may be approved for use under special measures from the regulatory agency.

In a statement outlined on the MHRA website, the MHRA claims that it may authorize the supply of a non-CE marked device in the ‘interest of the protection of health’, under regulations 12(5), 26(3) and 39(2) of the Medical Devices Regulations 2002.

Applications are currently being accepted for ventilators through the Department of Health and Social Care, as well as for other devices including surgical (medical) face masks, examination or surgical gloves, directly through the MHRA.

Find out more via the website at: www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak

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HP utilizes global community for 3D printing critical parts

HP Inc (CA, USA) and its global partners have announced the mobilization of digital manufactures around the world to deliver crucial parts in the battle against COVID-19.

More than 1000 3D-printed parts have reportedly already been delivered to hospitals in Barcelona (Spain), Corvallis (OR, USA), San Diego (CA, USA) and Vancouver (WA, USA).

Initially, HP Inc focuses on validating face masks, face shield, mask adjusters, nasal swabs, hands-free door openers and respirator parts.

HP and our digital manufacturing partners are working non-stop in the battle against this unprecedented virus. We are collaborating across borders and industries to identify the parts most in need, validate the designs and begin 3D printing them,” explained Enrique Lores, President and CEO of HP Inc.
Our deepest appreciation goes to our employees, partners, customers and members of our community for their tireless efforts to support the medical professionals making a difference on the front lines,” Lores added.

 

FFP3 mask
Example of FFP3 mask developed by Czech Technical University (Prague, Czech Republic), with HP Mutli Jet Fusion 3D printing technology. This mask is still undergoing validation for production. Credit: Czech Technical University, available via HP Inc website

Source: https://press.ext.hp.com/us/en/press-releases/2020/hp-inc--and-partners-mobilize-3d-printing-solutions--to-battle-c.html

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Axial3D publishes open letter to encourage network and community response to COVID-19

In an open letter published on the Axial3D (Belfast, UK) website, Roger Johnston, CEO, invites the medical community to contact Axial3D and its founders directly to share information about any COVID-19 related initiatives requiring 3D-printed parts, or if anyone has access to 3D printers who may be able to help Axial3D in their response.

At present, the Axial3D team are validating designs and prototyping 3D-printed test kits, swabs, masks and ventilators.

Axial3D 3D-printed parts
Axial3D are 3D printing prototypes, validating critical parts for production. Photos courtesy of Axial3D.

Source: www.axial3d.com/blog/axial3ds-response-to-the-covid-19-pandemic/

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3D LifePrints releases 3D-printable ‘distancer’ to reduce in-hospital contamination

In an effort to prevent contamination in hospitals, 3D LifePrints (Liverpool, UK) has developed and released the designs for a 3D-printable ‘distancer’ for hospital workers, in collaboration with Alder Hey Children’s Hospital (Liverpool, UK).

Innovation can be simple yet effective. A hospital-based medical professional in their daily movements can pass through over 100 doors. Each door or ID access point can be a potential source of viral or bacterial contamination,” Paul Fotheringham, Founder and CTO of 3D LifePrints explained.
3D LifePrints in conjunction with Alder Hey NHS Foundation have designed and made 3D printable a low-cost device that has the following features: can hang off a keychain or lanyard, slide insert for the user's electronic ID card, visible for staff identification, handle to enable the user to not touch the actual card or reader, hook to enable the user to open a door, flat end for pushing with recess for protruding buttons,” Fotheringham concluded.
‘The Distancer’ from 3D LifePrints
‘The Distancer’ from 3D LifePrints. Photo courtesy of 3D LifePrints.

Source: www.3dlifeprints.com

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Prusa prints face screens amidst respirator regulation debate

While there remains a little uncertainty around the responsible, regulated 3D printing of respirator and ventilator parts, Josef Průša of Prusa Research (Prague, Czech Republic) has described the process of designing, printing and verifying face shields in a recent blog post.

As Prusa describes the designs for the face screen and other projects that are currently in progress, he also highlights the safety, sterilization and verification of the shields, reminding the community to check professional standards before 3D printing parts for clinical use.

The designs for the face screen and other objects are available via the full blog post.

Source: https://blog.prusaprinters.org/from-design-to-mass-3d-printing-of-medical-shields-in-three-days/

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Formlabs publishes online form to convene 3D printing community with medical supplies demand

In a new online form on the Formlabs (MA, USA) website, the company is calling for anyone working on coronavirus-related projects or willing to volunteer themselves and their Formlabs equipment to join the 750+ volunteers who have already registered via the Formlabs website.

In a statement preceding the form, Formlabs has announced four main focus areas, including test kit swabs, snorkel mask conversion kits, ventilator splitters and face shields.

Find out more and register your interest in collaboration via the Formlabs website.

Source: https://formlabs.com/uk/covid-19-response/

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3D-printed face screen production ramped up by Stratasys

[UPDATE] After publishing the initial story, Stratasys has since announced the launch of a collaboration with over 150 partners to 3D print 11,000 and then 16,000 face masks per week. Find out more, here.

Stratasys (MN, USA) has announced a ‘global mobilization’ of the company’s resources and expertise to 3D print face shields and PPE for healthcare workers.

Stratasys aims to have 3D printed 5,000 face shields by Friday 27 March at no cost to the recipients.

Should any 3D printing shop in the USA want to be involved in this initiative, Stratasys have included more information and an online form for finding out more. Full instructions for printing and assembling the shields are available via the website.

Stratasys 3D-printed face screen
Stratasys and its partners are producing several thousand face shields with 3D-printed plastic frames. (Photo: Business Wire)
We are humbled by the opportunity to help. We see additive manufacturing as an essential part of the response to the COVID-19 global epidemic,” explained Stratasys CEO Yoav Zeif.
The strengths of 3D printing – be anywhere, print virtually anything, adapt on the fly – make it a capability for helping address shortages of parts related to shields, masks, and ventilators, among other things. Our workforce and partners are prepared to work around the clock to meet the need for 3D printers, materials, including biocompatible materials, and 3D-printed parts,” Zeif concluded.

Sources: https://investors.stratasys.com/news-events/press-releases/detail/524/stratasys-responds-to-covid-19-pandemic-by-ramping-uphttps://investors.stratasys.com/news-events/press-releases/detail/526/correcting-and-replacingstratasys-coalition-for-face

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3D-printed valves supply unmanageable demand for essential ventilator equipment

In one story gracing international headlines, a small team from Northern Italy has assisted health workers struggling with limited supplies of ventilator valves by quickly designing and 3D printing replacement parts.

Posting about this success on Facebook (translated from Italian), Massimo Temporelli (The FabLab; Milan, Italy) explained how supplies of the valve were depleting in a local hospital managing many COVID-19 cases, at a rate faster than what the manufacturer could feasibly supply.

Temporelli was reportedly initially contacted by a reporter, asking if it would be technically possible to 3D print the valve to keep up with the increasing demand at the local hospital.

After a few hours and many phone calls later, Cristian Fracassi of Isinonnova arrived at the hospital with a 3D printer and a design for a substitute valve, ready to print as many valves as required to meet the demand.

Since this relatively small but immediate intervention, another local additive manufacturing company, Lonati SpA, has reported that based on Fracassi’s design, team members Michele Faini and Marco Gavazzi have been able to amplify production efforts to further meet increasing demand and pressure, confirming that ‘many’ patients are now using the 3D-printed devices.

3D-printed valves from Lonati SpA.
3D-printed valves from Lonati SpA.

Since this story broke, there have been calls from the Government in the UK for manufacturers to switch focus on the development of more ventilators – could the 3D printing community be in a prime position to help industry deliver in the rapid production of essential medical equipment in response to the COVID-19 pandemic?

As the UK Government calls upon engineering firms to switch some of their manufacturing output to the production of new ventilators to help tackle the coronavirus health crisis, I have brought together a consortium of industry leaders and academics from across the UK who are all looking into ways that we can support the production of parts for ventilators during these unprecedented times. 3D printing technologies can allow us to produce parts very quickly,” explained Kadine James, Creative Tech Lead at Hobs 3D (London, UK)
We will also be hosting a Global Call with University College London (UK) on 19 March 2020,” James continued.

However, there is still some uncertainty surrounding the capability and safety of sharing STL files with hospitals and independent ‘printers’ for mass production. Outside of conflicts relating to copyright and patent law, the regulatory burden for in situ emergency 3D printing for devices use in life-critical scenarios is certainly questionable.

Sources: www.facebook.com/massimo.temporelli/posts/10219716100146800www.lonati.com/en/news-e-eventi/3D-printed-valves-Lonati-printer

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A unique solution for ‘containment’: Materialise releases minimum-contact door handle

As experts believe that corona virus can survive on surfaces for an extended time, Materialise (Leuven, Belgium) has announced the release of a freely-downloadable file for a 3D-printed door handle extension which minimizes direct contact with potentially contaminated surfaces.

The power of 3D printing in combination with Materialise’s 3 decades of 3D printing expertise made it possible to turn an idea into an innovative product in less than 24 hours,” explained Fried Vancraen, CEO of Materialise.

By making the design available digitally, it can be produced on 3D printers everywhere and become available around the world in a matter of hours. In this case, we designed the product in Belgium and people in China, Europe or the US can now 3D print the door opener locally,” Vancraen concluded.

 

Materialise door handle
Materialise door handle, available via: www.materialise.com/en/press-r... 

The file can be downloaded at www.materialise.com/en/hands-free-door-opener

Source: www.materialise.com/en/press-releases/3d-printing-technology-supports-coronavirus-containment-efforts

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Collaborative team solves PPE shortage issue: 3D-printed facemasks and PPE for healthcare workers in Hong Kong

A collaborative team from The Hong Kong Polytechnic University, Queen Elizabeth Hospital and the Hospital Authority (all Hong Kong) has reported success in developing effective, 3D-printed eye shields and face shields.

During the coronavirus outbreak, solidarity is one of the essential elements to battle the disease. The partnership between The Hong Kong Polytechnic University, Queen Elizabeth Hospital/Hospital Authority and the industry is a good example that embodies the spirit of 'when one place suffers, aid comes from all sides'. We join hands to overcome these difficult times together," explained Professor Alexander WAI Ping-kong, Vice President (Research Development), Deputy President and Provost designate at The Hong Kong Polytechnic University.

In a statement released from The Hong Kong Polytechnic University, the team reports that it took only a fortnight to design and develop the masks, of which they hope to 3D print over 30,000 per day by the end of March.

3D-printed face screens
(from left) Prof HC Man, Prof. Alexander WAI Ping-kong and Ms YUEN Woon Wah of Hospital Authority reveal the new 3D-printed face shield. Available via: www.polyu.edu.hk/media/media-r... 

Source: www.polyu.edu.hk/media/media-releases/2020/0225_polyu-designs-a-new-3d-printed-face-shield-for-ha/

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When industries unite: how 3D-printed ‘huts’ serve as emergency quarantine wards

At the beginning of the COVID-19 outbreak in February, architectural company Yingchuang Building Technique (Winsun; Shanghai, China), reported that several 3D-printed huts were printed, loaded and sent to various hospitals needing fast solutions in response to increasing pressure for quarantine facilities. 

According to reports hosted on the Winsun website, 20 3D printers could produce a 10x10 ward each within 2 hours from recycled construction materials, offering a fast and sustainable solution to expanding quarantine capabilities in high-incidence areas.

Winsun further explains that following the use of these small hut-like buildings for the immediate quarantine pressure, the buildings could be further used for news kiosks, small shops or mobile offices.

3D-printed quarantine wards in transit
3D-printed quarantine wards in transit, available via: www.winsun3d.com/En/News/news_...

Sources: www.winsun3d.com/En/News/news_inner/id/541; www.winsun3d.com/En/News/news_inner/id/542

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Go to the profile of Georgi Makin

Georgi Makin

Senior Editor, 3DMedNet, Future Science Group

I am the Senior Editor of 3DMedNet, so please do not hesitate to get in touch should you have any queries or comments. You can also follow me on Twitter for the latest updates: @GeorgiMakin

1 Comments

Go to the profile of Kiran
Kiran 3 months ago

This is a great idea! We at zeal 3d would also like to do our bit to the society, currently, we have printed some masks and face shields as per requirement, if anyone needs our help especially from Australia, please feel free to contact us at info@zeal3dprinting.com.au We are giving free assistance also a free mask or face shield with each order.