Additive Manufacturing Strategies

3D Printing and COVID-19, April 6, 2020 Update

ST Medical Devices

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Companies, organizations, and individuals continue to attempt to lend support to the COVID-19 pandemic supply effort. We will be providing regular updates about these initiatives where necessary in an attempt to ensure that the 3D printing community is aware of what is being done, what can be done, and what shouldn’t be done to provide coronavirus aid.

Individuals globally are lending their 3D printing support to produce the face shields we are now all familiar with. Made up of a 3D printed headband and piece of transparent plastic film, doctors from hospitals are requesting these wherever possible according to users in online 3D printing communities, such as the Facebook groups “3D Printing” and “3D Printing Club”.

Hospitals in Michigan, Ohio and the U.K. are relying on some of these club members to print an endless supply of shields for their staff. Some users have been printing so many face shields that they are quickly running out of filament, while in South Africa, one user was unable to donate their face shields because they weren’t a licensed medical device manufacturer, which would require about $1,300 for a license application.

Based on regulatory classification and the guidance of the U.S. Food and Drug Administration, some products must be limited to facilities with a Quality Management System in place. However, because face shields do not meet this threshold, they are deemed acceptable for hobbyists to print. If hobbyists, small business owners, and educational institutions are hoping to print face shields, there are designs that have been approved by the National Institute of Health (NIH) available on the NIH 3D Print Exchange. Please note that just because a file is available on that website, it doesn’t automatically mean that this file has been approved. Read the comments below the file to find out the status and method of approval.

Outside of hobbyists, large companies continue to support supply efforts. Materialise has already developed a hands-free door opener for medical staff, a hands-free shopping cart handle and a connector to adapt Scuba masks to allow for air filtration and oxygen supply. Now, the Belgian firm has developed a device for converting standard positive end expiratory pressure (PEEP) machines into breathing masks that can be connected to oxygen supply. This frees up mechanical ventilators for other patients in critical need.

The company, which has a long history of making certified medical devices, is obtaining fast track approval in Europe and the U.S. and aims to have the device widely available by mid-April. Materialise is also supporting a clinical trial to test the clinical efficacy of the device with results expected within two weeks. Anticipating its approval, the firm is now 3D printing the parts in its ISO 13485 certified facilities in Belgium and Michigan.

Since Medtronic put out the design documents for its respirator, engineers are presumably working on building their own versions. Medical professionals who have seen some of the first attempts at creating ventilator devices may be appalled at their operation, which often don’t include methods for regulating airflow in response to patient breathing but instead regularly pump oxygen in a brute force manner. Real Engineering has put out a video (embedded below) describing how dangerous some of these machines would be if used in a medical setting, while also discussing some guidelines that make respirators function properly.

MIT has also published documentation related to the fabrication and sterilization of Covid-19 personal protection equipment (PPE). MIT is continuing to maintain a list of resources to learn more about respirators, their decontamination, and reuse. Because the institution is expecting PPE supplies to be replenished in the coming weeks, it is focusing primarily on organizing and distributing donations.

The school also believes that the focus of the 3D printing community on 3D printing masks is diverting energy and attention away from other issues such as the need for more filter media for existing, medically approved respirators and surgical masks. For that reason, MIT staff conclude “3D printing at MIT is best applied in the way it always has been, to rapidly convert good ideas into proof of concepts.”

We are continuing to compile information about what the 3D printing industry and community can do and should not do in response to the coronavirus pandemic and will have input from medical professionals shortly.

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