With the global Covid-19 pandemic showing no signs of slowing down, 3D printing companies have taken it upon themselves to use their rapid customization capabilities to manufacture cheaper but medically-approved alternatives to existing medical devices.
Formlabs, the market-leading manufacturer in desktop SLA 3D printers, is also helping the medical community to address the medical device shortages through its technical expertise and vast customer network. The company released a statement where it mentioned, “We have many customers in the healthcare space already using Formlabs’ products to test applications for COVID-19 related projects, and recently launched the Formlabs Support Network for COVID-19 Response. This is an initiative to match healthcare organizations and providers with Formlabs customers who are willing to use their printers and volunteer their time to help address critical supply chain shortages and other healthcare needs. We are working closely with health systems, government agencies, and our network of over 1,500 volunteers to help design, prototype, and produce parts to be tested and potentially adopted by clinicians.”
Formlabs is working on multiple products with reputed partners and the products are currently at various stages of approval. Below is a list of the products:
|CATEGORY||COMPONENT||CLINICAL PARTNER/ TESTER||CLINICAL STEPS COMPLETED||CURRENT STATUS||WHAT’S NEXT|
|Test Kits||Nasal swabs||USF Health and Northwell Health (NY)||Emergency IRB approval, PCR test pass, ID sign off and pathology||FDA Class I Exempt status||Awaiting clinical protocol and final printable files|
|Ventilators||Tubing splitter (1 to 2, 3, and 4 patients)||Northwell Health||Passed lab testing with standard tubing (2)||Awaiting final files and clinical protocols||Files and instructions made available later this week|
|Facial Shield||Adjustment strap||Several hospitals // Budmen (3)||Awaiting initial feedback||Prototypes printed||Awaiting clinical input|
|Respiratory mask (adapter)||Scuba mask conversion to PPE||Two leading hospitals in the US (4)||Lab testing||Lab testing||Next round of lab testing|
|Surgical Masks and Respirators||N95 respirators and masks||Several hospitals||Successful printing. Clinical fit failure||Temporarily on hold||N/A (5)|
Formlabs is currently focussing on the hundreds of requests it has received, evaluated dozens of requests for potential applications of 3D printed products, and is now supporting a handful of projects with high-impact potential. The current priority areas were selected based on clinical demand, technical feasibility, and regulatory implications. Priority areas for focus include test kit swabs, ventilator splitters, and face shields. Once designs have been tested and validated by the medical community, Formlabs has the resources available to scale production to tens of thousands of parts per week. We are ready to engage our internal resources and community of skilled volunteers to produce parts for healthcare providers all over the world.
Below are the key projects that Formlabs is spearheading, with guidance from medical thought leaders and physician innovators.
Nasal Testing Swabs
There is a worldwide shortage of nasopharyngeal (NP) swabs needed to collect samples for COVID-19 testing. These swabs are typically used for testing for influenza and other respiratory infections. The current and impending supply chain shortages are serious enough that clinicians are beginning to design and test their swabs as quickly and safely as possible.
These swabs are printed from its biocompatible, autoclavable material as Surgical Guide Resin. It has printed hundreds of samples that have passed multiple tests at UDF Health and has received an Emergency IRB approval as well as authorization from regulatory, infectious disease, and virology, among others.
These swabs are Class I medical devices exempted from premarket notification requirements and require manufacturers to register and list the products. Formlabs will produce swabs in its FDA-registered, ISO 13485 certified facility in the United States.
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Front-line providers are running out of personal protective equipment (PPE). At many hospitals, there is a very limited supply of PPE remaining. PPE includes face masks and/or respirators (e.g. N95 masks) and face shields. Besides, the typical forms of PPE are disposable and more durable solutions are needed given the limited supply. Moreover, most PPE is designed to be used for minutes at a time, not for an entire day.
Dr. Alex Stone and Dr. Jacqueline Boehme from a leading Boston hospital are currently testing and validating designs for seal, breathability, fogging, and the ability to communicate with other physicians while wearing it.
As the number of patients in critical condition grows, mechanical ventilation is required to provide sufficient oxygen into the lungs and body. Ventilator machines are limited in supply, and hospitals can run out of machines faster than they can order new devices.
Formlabs has partnered with Northwell Health and has conducted lab testing and states that while this would allow one to split a ventilator in a life or death situation, there are certain caveats one needs to be aware of.
Northwell is currently writing clinical protocols. Neither Northwell Health nor the CDC, have studied ventilation splitting on human patients.
A respiratory therapist at Maine Medical Center in Portland, Maine conducted a 36-hour test using the Southern Maine Community College device and reported no issues. Maine Medical Center is assessing how this resource can be utilized to best support current or future patient needs.
Above: Dr. Charlene Babcock explains how to modify a ventilator and the risks involved/Video Credit: Formlabs/YouTube
While there is the new capability to ventilate multiple patients for a short period without utilizing front line clinical staff, patients likely need to be similar in height, IBW (weight), lung dynamics, and COVID-19 carrier status. Also, heavy sedation/paralytics may be necessary to eliminate asynchrony and tandem weaning.
With other projects still in the evaluation and testing phase, Formlabs hopes to achieve a multiple medically-approved solution-line that can be useful to the hospitals treat the Covid-19 patients.
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