UCL-Ventura

UCL Ventura CPAP breathing aid set up for use
UCL Ventura CPAP breathing aid set up for use (James Tye / UCL)
The UCL-Ventura breathing aid is a Continuous Positive Airway Pressure (CPAP) device that supports patients with breathing difficulties.
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Introduction

The UCL-Ventura breathing aid is a Continuous Positive Airway Pressure (CPAP) device (“the CPAP”). The CPAP supports patients with breathing difficulties when oxygen via a face mask alone is insufficient.

It works by pushing an air-oxygen mix into the mouth and nose at a continuous pressure, keeping airways open and increasing the amount of oxygen entering the blood stream. This breathing aid can be used to help Covid-19 patients with serious respiratory problems to breathe more easily and has been shown to help prevent the need for invasive ventilation.

The design is based on an existing off-patent CPAP system that has been further modified to optimise oxygen consumption. The UCL-Ventura CPAP device is a reverse-engineered Resperonics WhisperFlow CPAP System.

The UCL-Ventura CPAP device has approval from the MHRA for use in the NHS in the UK under special conditions (see section on Initial Market and Regulatory Approvals), and has undergone patient evaluations across UCLH and sister London hospitals.

The UCL-Ventura designs and manufacturing instructions are being made available through UCL Business’ e-lucid express initiative and are available for download on UCLB’s dedicated site for technologies related to COVID19. The designs can be accessed on UCLB’s e-lucid platform.

Background

This breathing aid was produced within a rapid timeframe – it took fewer than 100 hours from the initial meeting to production of the first device.

Professor Tim Baker (UCL Mechanical Engineering) said: “Given the urgent need, we are thankful that we were able to reduce a process that could take years down to a matter of days.

“From being given the brief, we worked all hours of the day, disassembling and analysing an off-patent device. Using computer simulations, we improved the device further to create a state-of-the-art version suited to mass production.

“We were privileged to be able to call on the capability of Formula One – a collaboration made possible by the close links between UCL Mechanical Engineering and HPP.”

The collaboration, supported by the National Institute for Health Research UCLH Biomedical Research Centre, demonstrates the way that universities, the NHS and industry are coming together to help the national response to the Covid-19 coronavirus outbreak, by providing vital technologies to the NHS which can enable them to care for patients who require respiratory support.

Andy Cowell, Managing Director of Mercedes-AMG High Performance Powertrains, said: “The Formula One community has shown an impressive response to the call for support, coming together in the ‘Project Pitlane’ collective to support the national need at this time across a number of different projects. We have been proud to put our resources at the service of UCL to deliver the CPAP project to the highest standards and in the fastest possible timeframe.”

Professor David Lomas (UCL Vice Provost Health) said: “This breakthrough has the potential to save many lives and allow our frontline NHS staff to keep patients off ventilators. I would like to pay tribute to the incredible team of engineers and clinicians at UCL, HPP and UCLH, for working round-the-clock to develop this new prototype. It is, quite simply, a wonderful achievement to have gone from first meeting to regulator approval in just ten days. It shows what can be done when universities, industry and hospitals join forces for the national good.”

UCLH Chief Executive Marcel Levi said: “This is a real team effort and I am proud of colleagues at UCLH and our partners at UCL and HPP for their immense work to produce this device in such a short time. We hope this effort can be rolled out to hospitals across the UK to benefit all patients.

“Everyone involved in this project should know that their efforts will have a truly significant impact on patient care.”

Why we are releasing the designs and manufacturing instructions 

Our humanitarian intention is to distribute and share the UCL-Ventura device to help public health efforts during the Covid-19 pandemic emergency.

To help meet international need, we have released the designs and manufacturing instructions for free to governments, industry manufacturers, academics and health experts across the globe.

Our goal is to help the global response to the crisis by enabling healthcare systems around the world to provide respiratory support for patients with Covid-19.

The designs were released in a joint initiative between UCL Ventura and UCL Business. UCLB’s e-lucid platform has licensed the designs and manufacturing instructions for no cost. More information and updates can be found on UCLB’s dedicated UCL Ventura CPAP site

Team

This CPAP has been developed as a collaboration between  UCL Mechanical Engineering, UCL Institute of Healthcare EngineeringUniversity College London Hospital (UCLH) and Mercedes-AMG High Performance Powertrains. The designs are released in collaboration with UCL Business and their e-lucid platform.  

Innovation Method

Internal design sprint leveraging existing networks.

Technology Readiness

Commercial product.

Offering

What is being offered?

Design and manufacturing package.

What is available in the current release?

Packages 1, 2 and 3 of the design and manufacture instructions package for this CPAP are now available and include the following files:

Package 1 (now at version 3, released 11th April 2020)

  • Manufacturing drawings.
  • System schematics and characteristics.
  • Bill of materials and type of manufacturing machines used for CPAP production.

Package 2 (now at version 2, released 11th April 2020)

  • Development tests information.
  • Assembly procedures, including build tooling requirements.
  • Test procedure and pass-off protocol.

Package 3 (version 1, released 11th April 2020)

  • Frequently Asked Questions (FAQ)
  • Test Work instructions
  • CPAP – Assembly Process Flow and timing
  • User leaflet

This information is correct as at 21 April 2020.  Please check UCLB’s dedicated UCL Ventura CPAP website for details of any further releases and the most up-to-date information.

Are other releases planned and if so what will they contain?

Please check UCLB’s dedicated UCL Ventura CPAP website for details of any further releases.

Implementation

Manufacturing Requirements

Specialist manufacturing capability required.  See drop down list for what these codes mean.

F4, MM, MC, CNC, PR, MF, AS, MO, S4

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Ability to scale to other markets

Yes, however note the following regarding UK and local regulatory approvals in other markets:

This CPAP has been approved for manufacture by UCL by UK regulators, the Medicines and Healthcare products Regulatory Agency (MHRA) under special conditions. These conditions state that this is a non-CE marked CPAP, given approval for use in the NHS for the interest of public health protection under the Covid-19 pandemic emergency. Please note that UCL’s MHRA approval is time limited and ends on whichever of the following dates occurs soonest:

  1. 1st October 2020;
  2. The date when the device is CE marked; or
  3. There is no longer a need for the device in the treatment of COVID-19 patients.

Any manufacture and use of this CPAP by third parties must require the third party to have local regulatory approval in place, as required in the third party’s own country and must fully comply with any stipulated conditions, laws and regulations that ensure full patient safety.

The instructions for manufacture should be followed precisely to ensure quality and safety, with no deviations or substitutions.

All specifications and regulations are listed onUCLB’s dedicated UCL Ventura CPAP website and must be followed precisely.

Relevant resources:

World Health Organisation (WHO) guidance on resource planning for COVID-19, including critical items (PPE, diagnostic equipment, clinical care equipment).

UK National Health Service (NHS) guidance for the role and use of non-invasive respiratory support (including CPAP) in adult patients with COVID-19.

Further UK guidance on the use of personal protection equipment (PPE).

This information is correct as at 21 April 2020.  Please check UCLB’s dedicated UCL Ventura CPAP website for the most up-to-date information.

Downloadable documents / items included in the package

Packages 1, 2 and 3 of the design and manufacture instructions package for this CPAP are now available and include the following files:

Package 1 (now at version 3, released 11th April 2020)

  • Manufacturing drawings.
  • System schematics and characteristics.
  • Bill of materials and type of manufacturing machines used for CPAP production.

Package 2 (now at version 2, released 11th April 2020)

  • Development tests information.
  • Assembly procedures, including build tooling requirements.
  • Test procedure and pass-off protocol.

Package 3 (version 1, released 11th April 2020)

  • Frequently Asked Questions (FAQ)
  • Test Work instructions
  • CPAP – Assembly Process Flow and timing
  • User leaflet

This information is correct as at 21 April 2020.  Please check UCLB’s dedicated UCL Ventura CPAP website for details of any further releases and the most up-to-date information.

Specifications & Regulations

License

Type of license agreement
Restricted.
Full terms of license

License agreement T&Cs are available for preview on UCLB’s e-lucid platform which is licensing the UCL Ventura device at no cost.

 

Is there a license fee?
The technical specifications for this CPAP are being shared for humanitarian purposes, to help support the international community addressing pressing demands to care for Covid-19 patients. This is not a business venture. There is an expectation that those using these specifications to manufacture these devices follow the same guiding principles.

Initial Market and Regulatory Approvals

This CPAP has been approved for manufacture by UCL by UK regulators, the Medicines and Healthcare products Regulatory Agency (MHRA) under special conditions. These conditions state that this is a non-CE marked CPAP, given approval for use in the NHS for the interest of public health protection under the Covid-19 pandemic emergency. Please note that UCL’s MHRA approval is time limited and ends on whichever of the following dates occurs soonest:

  1. 1st October 2020;
  2. The date when the device is CE marked; or
  3. There is no longer a need for the device in the treatment of COVID-19 patients.

Any manufacture and use of this CPAP by third parties must require the third party to have local regulatory approval in place, as required in the third party’s own country and must fully comply with any stipulated conditions, laws and regulations that ensure full patient safety.

This information is correct as at 21 April 2020.  Please check UCLB’s dedicated UCL Ventura CPAP website for details of any further releases and the most up-to-date information.

Other conditions of use

The technical specifications for this CPAP are being shared for humanitarian purposes, to help support the international community addressing pressing demands to care for Covid-19 patients. This is not a business venture. There is an expectation that those using these specifications to manufacture these devices follow the same guiding principles.

The instructions for manufacture should be followed precisely to ensure quality and safety, with no deviations or substitutions.

All hospitals must work with their O2 engineering teams and ascertain their VIE outflow and downstream flows and pressures to specific ward areas before deploying these devices. Healthy patient evaluation data indicates O2 flow rates of 11, 14, 17 l/min for inhaled oxygen (FiO2) levels of 30, 40, 60%, respectively for calm breathing and O2 flow rates of 14, 25 and 46 l/min at FiO2 of 30, 40, 60%, respectively for heavy breathing.

Access

How to Access

Access to the design and manufacturing instructions package is by licence, which will be granted at no cost to governments, relevant industry manufacturers, academics and health experts. To help ensure relevance and legitimacy, users must make their requests for a licence using their work, university or institution email address.

All access must be made exclusively through UCLB’s e-lucid platform and dedicated UCL Ventura CPAP website.

 

Who can Request Access

We will only authorise requests from people representing the following organisations:

  1. Manufacturers
  2. Research Institutions
  3. Healthcare providers
  4. Non-profit sector

List of Information Required about the Applicant Applying for License

Name, job title, company, work email address, manufacturing capabilities.  Use link below to see codes to describe manufacturing capabilities.

(use codes which you can find here)

Who will be Rejected/not Granted a License?

Requests from people applying in a personal capacity will be rejected due to licensing restrictions.

Customer Service

How to Report Product Failures

n/a

Email Address for Queries

All requests to access the package must be made exclusively through UCLB’s e-lucid platform and dedicated UCL Ventura CPAP website.

Please email us with any other queries.

Additional notes

Please be aware that we have been inundated with requests so may be unable to respond immediately. We will work to respond to requests as soon as possible.

All access must be made exclusively through UCLB’s e-lucid platform and dedicated UCL Ventura CPAP website.

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