COVID-19 Pandemic

Test Kit Swabs

Problem

There is a shortage of the 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 own swabs as quickly and safely as possible.

NP swabs are flexible sticks with a bristled end that are inserted into the nose to the back of the nasal cavity and swept around to collect material that sticks to or wicks up the bristles. The swab is then placed into a vial that contains a culture medium. Swab sticks have an intentionally weak point 7-8cm from the bristled tip, which allows the stick to be broken to the correct length so that the vial can be capped before it is transported to a laboratory for testing.

Solution

Currently we are printing and optimizing swab designs co-created by doctors at USF Health and Northwell Health, as well evaluating designs from other leading hospitals.

Validation Status

Formlabs has printed samples of the test swab using the same material as our biocompatible, autoclavable Surgical Guide Resin. These samples have passed a variety of tests at USF Health, which has received an emergency IRB approval as well as authorization from regulatory, infectious disease, and virology, among others. These swabs are for US distribution only.

Visit our US website for the latest updates.

Conversion Kits

Problem

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 (N95 masks) and face shields. All are in short supply with people stockpiling these at home and stealing them from hospitals. In addition, 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.

Solution

Adapting a full face snorkel mask to fit a filter already in use for breathing circuits and in hospitals. Because this filter is reusable, and unavailable/unknown to the general public, it will be less at risk to be taken from providers treating ill patients.

Validation Status

Dr. Alex Stone and Dr. Jacqueline Boehme from a leading hospital in Boston are currently testing and validating designs for: seal, breathability, fogging, and ability to communicate with other physicians while wearing it.

Visit our US website for the latest updates.

Ventilator Splitter

Problem

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. 

Experimental Solution

Adding an adapter to one ventilation system to be used with more than one patient can help expand capacity. These adapters allow for two, three, or four patients with similar needs and conditions to potentially use one ventilator.

Several Formlabs customers are working on this problem, including Northwell Health and Southern Maine Community College.

The 3D Design and Innovation Lab at Northwell Health has provided Formlabs with STL files that fit standard tubing. These files allow for a HEPA filter to be placed at each end then connecting patient vent tubing.

Note

Ventilator splitters should only be considered as a last resort and with appropriate protections in place. Multiple medical associations have discouraged the use of ventilator splitters. Healthcare organizations need to assess and make decisions based on their own circumstances and judgement.

Validation Status

Northwell Health 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.

While there is the new capability to ventilate multiple patients for a short period of time without utilizing front line clinical staff, patients likely need to be similar in height, IBW (weight), lung dynamics, COVID-19 carrier status.  Also, heavy sedation / paralytics may be necessary to eliminate asynchrony, and tandem weaning.

Visit our US website for the latest updates.

Face Shields

Problem

Face shields are personal protective equipment (PPE) devices that are used for protection of the facial area and associated mucous membranes (eyes, nose, mouth) from splashes, sprays, and spatter of body fluids. Face shields are in short supply, with some hospitals reusing disposable units or improvising solutions from commercial products not intended for this use.

Solution

Formlabs is prototyping and evaluating several 3D printed and non-3D printed designs in parallel to determine effectiveness and near-term scalability. Current focus is on producing parts onto which a shield may be mounted and tightened, emulating existing designs such as from Halyard Health and McKesson. The shield itself is not being 3D printed.

Validation Status

Prototypes are being sent to Beth Israel Deaconess Medical Center for preliminary evaluation.

Visit our US website for the latest updates.