CPAP Helmet for COVID-19

A Mini-Moonshot

There’s an alternative for putting COVID-19 patients directly on a ventilator, but hospitals in the United States lack the necessary breathing device that could save thousands of lives. We’re asking you to make it, at scale.

Design Museum Everywhere is issuing a challenge to design and rapidly deploy a Continuous Positive Airway Pressure (CPAP) helmet to help save lives in the fight against the coronavirus COVID-19. We uncovered this urgent need in collaboration with administrators and doctors at Massachusetts General Hospital and Brigham & Women’s Hospital. We’re calling for design firms, engineering firms, corporations, makers, and innovators who have the necessary expertise and experience in developing and seeking approvals on medical devices to take up this challenge and produce CPAP breathing devices as quickly as possible to save lives. Any device created through this call to action must be approved by the FDA — we recommend through the Emergency Use Authorization program:

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

This isn’t a typical design competition. There is no Call for Entries, no cash prize. We’re not looking for you to submit conceptual designs to be evaluated by an expert jury. The deadline is yesterday, these devices are needed as soon as possible.

We’ve identified a need and we seek to spread the word so that the individuals and organizations with the needed expertise can hear the call and snap into action. Beyond the lifesaving nature of this device, this is a business opportunity as well for any firm that can execute on the need — the need likely extends beyond the COVID-19 pandemic — but regardless, the need is real and the need is now. If you’re able to take action, take action now. We’ll do what we can to help by answering questions and making connections.

Background

COVID-19 can cause serious health complications leading to hospitalization, frequently related to breathing issues. Many people hospitalized for COVID-19 require assistance breathing, eventually leading to being intubated and put on a ventilator. Being put on a ventilator is an invasive procedure that requires sedation and typically ICU-level care. There are not enough ventilators to deal with the increased demand because of COVID-19. While there is a large effort to build more ventilators, it may take too long for the current surge of patients.

There are other ways of providing breathing assistance to patients that can serve a majority of cases, so they do not have to escalate to intubation. One alternative is using a Continuous Positive Airway Pressure (CPAP) machine, of which hospitals often have more. CPAP machines and masks are also used by individuals at home when suffering from sleep apnea. When CPAP machines are used in this way — whether at home or in a hospital — it is referred to as noninvasive ventilation (NIV), and it can be very effective for COVID-19 patients.

The problem with using CPAP machines with masks for patients with COVID-19 is that as they exhale, the mask can leak, thereby aerosolizing the virus, greatly increasing the risk of transmitting the virus to others nearby — a dangerous situation for healthcare workers. For this reason, CPAP machines attached to masks cannot be used for COVID-19 patients.

There are other interfaces for delivering CPAP breathing assistance that could be helpful in the fight against COVID-19. Helmet-style CPAP interfaces have a much lower risk of aerosolizing the virus because the exhale is contained. CPAP helmets are not currently used in the United States, mainly because there are other interfaces that can be used with CPAP. Helmets are currently not FDA approved, however, CPAP helmets are widely used elsewhere around the world. In other countries dealing with COVID-19, CPAP helmets were widely cited as an essential tool in treating patients.

*No information discussed on this page should be considered medical advice.

Considerations & requirements

The device should have a clear PVC enclosure that surrounds the head and seals around the neck. The enclosure should be able to withstand the oscillating pressure of the CPAP machine without leaking. The device needs to held stationary and security around the patient’s head; this could be done with a rigid ring that sometimes connects to straps that go under the arms.

Two standard 22mm CPAP ports are needed, one for inlet from the machine and an outlet to a PEEP valve. The ports should be located in a manner that ensures fresh air is delivered near the nose and mouth for breathing. A backup vent port to prevent possible asphyxiation is likely required. Various access ports are typically included but may not be necessary. Our clinical contacts also recommend a device and alarm that can measure carbon dioxide build-up and pressure, so as to alert medical staff should a problem arise and then can take action to remove the helmet as soon as possible. Ideally, this alarm system connects to existing hospital equipment and could notify the nurses’ station. Any solution to this challenge must be FDA Approved, we recommend using the FDA’s Emergency Use Authorization program.

The Goal

We’re calling on those with the expertise, experience, and means to take up this challenge and produce a CPAP breathing device that meets these requirements and can be approved by the FDA’s Emergency Use Authorization as soon as possible.

Who should participate

Individuals and organizations with medical device design and development expertise, including experience working with the FDA. Joint ventures are encouraged — we recommend partnering as there are design, engineering, manufacturing, regulatory, and distribution elements to consider.

Resources

Frequently Asked Questions

How do I participate?

Launch your effort to design and develop a device as you would if developing any other medical product, but we do recommend speeding up the process as much as possible to meet the needs of the moment.

Can I donate?

You can support the Design Museum’s efforts to make this project a reality by making a tax-deductible gift.

I have technical questions about my design, who should I ask?

Find an expert, a medical professional or bio-mechanical engineer — if you can’t, submit your question here and we’ll do our best to connect with our contacts and find an answer.

How is this project funded, can we receive funding from the Design Museum?

There is no funding from the Design Museum for this project — like any medical product, this is a business opportunity if you can address the need, get FDA approval, and distribute it to customers (hospitals). If your product is ready and approved, and you need help connecting with hospitals, contact us, and we’ll do our best to connect you.

When and how should we submit ideas and prototypes?

You shouldn’t submit ideas and prototypes to the Design Museum, this isn’t a design competition. This is a call to action: develop your product, get it approved, and distribute it to save lives, and it’s likely a good business opportunity as well.

I work for a hospital or other medical provider, how can I contribute?

If you’re an expert or have real-world knowledge to share about CPAP, and are willing to answer questions from firms developing this product, please contact us and we’ll add you to the list of people we pose these questions to.

Get in touch

Have feedback or questions? Contact us and we will do our best to help