Open-source ventilator

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The Open-Source Ventilator's OpenLung project, an open-source, low-resource, quick-deployment mechanical ventilator design utilizes a bag valve mask (BVM or Ambu-bag) as a core component. Open source ventilator-OpenLung-01-design.png
The Open-Source Ventilator's OpenLung project, an open-source, low-resource, quick-deployment mechanical ventilator design utilizes a bag valve mask (BVM or Ambu-bag) as a core component.
Mechanics of the OpenLung ventilator Open source ventilator-OpenLung-02-mechanics resp cycling.png
Mechanics of the OpenLung ventilator

An open-source ventilator is a disaster-situation ventilator made using a freely licensed (open-source) design, and ideally, freely available components and parts (open-source hardware). Designs, components, and parts may be anywhere from completely reverse-engineered or completely new creations, components may be adaptations of various inexpensive existing products, and special hard-to-find and/or expensive parts may be 3D-printed instead of purchased. [2] [3] As of early 2020, the levels of documentation and testing of open-source ventilators was well below scientific and medical-grade standards. [4]

Contents

One small, early prototype effort was the Pandemic Ventilator created in 2008 during the resurgence of H5N1 avian influenza that began in 2003, so named "because it is meant to be used as a ventilator of last resort during a possible avian (bird) flu pandemic." [5]

Quality assessment

The policy of using both free and open-source software (FOSS) and open-source hardware theoretically allows community-wide peer-review and correction of bugs and faults in open-source ventilators, which is not available in closed-source hardware development. In early 2020 during the COVID-19 pandemic, a review of open-source ventilators stated that "the tested and peer-reviewed systems lacked complete documentation and the open systems that were documented were either at the very early stages of design ... and were essentially only basically tested ..." The author speculated that the pandemic would motivate development that would significantly improve the open-source ventilators, and that much work, policies, regulations, and funding would be needed for the open-source ventilators to achieve medical-grade standards. [4]

Design requirements

A number of features are required for an invasive mechanical ventilator to be safely used on a patient: [6]

The requirements for non-invasive ventilation are less strict.

COVID-19 pandemic

The FOSS Initiative OpenVentilator.io project began on March 19, after two weeks of research. [10] Jeremias Almadas [11] had posted some drafts he made on the Open Source COVID-19 Medical Supplies forum. [12] [13] Marcos Mendez contacted him to join efforts to develop a solution that could be reproduced on a very high scale. [14] This project later became the "OpenVentilator Spartan Model". [ citation needed ]

With the COVID-19 pandemic a new challenge had just arisen, this was no longer to manufacture ventilator, after all, these are manufactured since biblical times, [15] including since the 1960s models like the Bird MK VII [16] were already consolidated with an enviable engineering that is very simple.

The challenge now was to design an item that solves a problem on a global scale. Manufactured on a very large scale and with parts found in small towns and villages. These were the premises assumed by some projects like OpenVentilator.io. [10]

On March 18, Medtronics had opened its code and files for manufacturing its main pulmonary ventilation equipment. [17] ] The issue was on a scale that Medtronics would not be able to fulfill at the global level, nor at the regional level. The same was already happening with Philips and G&E and Draguer, world leaders in the manufacture of this type of equipment. It would not make sense to reinvent something that had already been studying for 100 years. The problem was also not an engineering problem, but a logistical and scale problem so that these projects that were to emerge were applicable and achievable. Manufacturing should be decentralized, focused on the regional resources of each individual on planet earth. Nine out of ten Brazilian cities do not even have an ICU bed, let alone an electronics store and or an Ambu factory. The African situation had already been proclaimed a catastrophe. [18]

Several projects are beginning to emerge in this area, many of them with an engineering approach, many others following strict validations with the regulations.[ citation needed ]

There are few projects that have an [analysis of complex thinking [19] [ circular reference ] within the global economic-political stagnation. [20]

A major worldwide design effort began during the COVID-19 pandemic after a Hackaday project was started, in order to respond to expected ventilator shortages causing higher mortality among severe patients. This project aims to build a continuous positive airway pressure device. [21] [ non-primary source needed ]

On March 19, the MakAir open-source ventilator project [22] was started by a team of software engineers in France, using 3D printing to quickly iterate on a prototype, with the goal of letting an established manufacturer produce the final ventilators for a cost nearing €2,000. The team built a working prototype in one month, [23] at the end of which a successful 12 hour ventilation test on a pig was performed. The project received official support [24] from the French Army's investment branch, Agence Innovation Défense of Direction générale de l'armement, granting the project €426,000 to help fund clinical trials. Groupe SEB agreed [25] to manufacture the MakAir ventilator in their facilities in Vernon, France. As of December 2020, the MakAir ventilator project is still active on the engineering side, with full support for both pressure and volume controlled ventilation modes, and on the medical side with ongoing clinical trials at CHU Nantes [26] on human patients.

On March 20, 2020, Irish Health Services [27] began reviewing designs. [28] A prototype is being designed and tested in Colombia. [29]

MIT E-Vent Unit 002 Setup, design by MIT MIT E-Vent Unit 002 Setup Image by MD.jpg
MIT E-Vent Unit 002 Setup, design by MIT

The University of Minnesota Bakken Medical Device Center initiated a collaboration with various companies to bring a ventilator alternative to the market that works as a one-armed robot and replaces the need for manual ventilation in emergency situations. The Coventor device was developed in a very short time and approved on April 15, 2020, by the FDA, only 30 days after conception. The mechanical ventilator is designed for use by trained medical professionals in intensive care units and easy to operate. It has a compact design and is relatively inexpensive to manufacture and distribute. The cost is only about 4% of a normal ventilator. In addition, this device does not require pressurized oxygen or air supply, as is normally the case. A first series is manufactured by Boston Scientific. The plans are to be freely available online to the general public without royalties. [31] [32]

The Polish company Urbicum reports successful testing [33] of a 3D-printed, open-source prototype device called VentilAid. The makers describe it as a last resort device when professional equipment is missing. The design is publicly available. [34] The first Ventilaid prototype requires compressed air to run.[ citation needed ]

On March 21, 2020, the New England Complex Systems Institute (NECSI) began maintaining a strategic list of open source designs being worked on. [35] [36] The NECSI project considers manufacturing capability, medical safety and need for treating patients in various conditions, speed dealing with legal and political issues, logistics and supply. [37] NECSI is staffed with scientists from Harvard, MIT, and others who have an understanding of pandemics, medicine, systems, risk, and data collection. [37]

Massachusetts Institute of Technology began an emergency project to design a low-cost ventilator that uses a bag valve mask as the main component. [30] Other groups and companies, such as Monolithic Power Systems, also developed designs based on this concept. [38]

The Oxysphere project develops open blueprints for a positive pressure ventilation hood. [39]

On April 23, 2020, NASA reported building, in 37 days, a successful COVID-19 ventilator (named VITAL ("Ventilator Intervention Technology Accessible Locally") which is currently undergoing further testing. NASA is seeking fast-track approval by the United States Food and Drug Administration for the new ventilator. [40] [41]

On May 29, 2020, NASA revealed the "Eight US Manufacturers Selected to Make NASA COVID-19 Ventilator." [42]

The U.S. companies selected for licenses are:

Israeli engineers created an open-source ventilator [43]

NASA VITAL Ventilator
PIA23891-NASA-VITAL-Team-20200430.jpg
Engineering team
PIA23775-NASA-VITAL-Ventilator-20200430.jpg
Front view
DSC 0509-Edit-cr.jpg
Side view

Disaster-relief provisions

On March 24, 2020, the U.S. Secretary of Health and Human Services (HHS) enacted Emergency Use Authorizations [44] to allow the use of additional devices, including: "Ventilators, positive pressure breathing devices modified for use as ventilators (collectively referred to as 'ventilators'), ventilator tubing connectors, and ventilator accessories." This was done in accordance with its February 4 declaration [45] for medical countermeasures against the coronavirus disease 2019, and the equipment is subject to the FDA's "criteria for safety, performance and labeling."

See also

Related Research Articles

Ventilator Device that provides mechanical ventilation to the lungs

A ventilator is a machine that provides mechanical ventilation by moving breathable air into and out of the lungs, to deliver breaths to a patient who is physically unable to breathe, or breathing insufficiently. Ventilators are computerized microprocessor-controlled machines, but patients can also be ventilated with a simple, hand-operated bag valve mask. Ventilators are chiefly used in intensive-care medicine, home care, and emergency medicine and in anesthesiology.

Mechanical ventilation, assisted ventilation or intermittent mandatory ventilation (IMV), is the medical term for using a machine called a ventilator to fully or partially provide artificial ventilation. Mechanical ventilation helps move air into and out of the lungs, with the main goal of helping the delivery of oxygen and removal of carbon dioxide. Mechanical ventilation is used for many reasons, including to protect the airway due to mechanical or neurologic cause, to ensure adequate oxygenation, or to remove excess carbon dioxide from the lungs. Various healthcare providers are involved with the use of mechanical ventilation and people who require ventilators are typically monitored in an intensive care unit.

Iron lung Type of negative pressure mechanical respirator

An iron lung, also known as a tank ventilator or Drinker tank, is a type of negative pressure ventilator (NPV); a mechanical respirator which encloses most of a person's body, and varies the air pressure in the enclosed space, to stimulate breathing. It assists breathing when muscle control is lost, or the work of breathing exceeds the person's ability. Need for this treatment may result from diseases including polio and botulism and certain poisons.

Artificial ventilation Assisted breathing to support life

Artificial ventilation is a means of assisting or stimulating respiration, a metabolic process referring to the overall exchange of gases in the body by pulmonary ventilation, external respiration, and internal respiration. It may take the form of manually providing air for a person who is not breathing or is not making sufficient respiratory effort, or it may be mechanical ventilation involving the use of a mechanical ventilator to move air in and out of the lungs when an individual is unable to breathe on their own, for example during surgery with general anesthesia or when an individual is in a coma or trauma.

An oxygen concentrator is a device that concentrates the oxygen from a gas supply by selectively removing nitrogen to supply an oxygen-enriched product gas stream. They are used industrially and as medical devices for oxygen therapy.

Bag valve mask Hand-held device to provide positive pressure ventilation

A bag valve mask (BVM), sometimes known by the proprietary name Ambu bag or generically as a manual resuscitator or "self-inflating bag", is a hand-held device commonly used to provide positive pressure ventilation to patients who are not breathing or not breathing adequately. The device is a required part of resuscitation kits for trained professionals in out-of-hospital settings (such as ambulance crews) and is also frequently used in hospitals as part of standard equipment found on a crash cart, in emergency rooms or other critical care settings. Underscoring the frequency and prominence of BVM use in the United States, the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiac Care recommend that "all healthcare providers should be familiar with the use of the bag-mask device." Manual resuscitators are also used within the hospital for temporary ventilation of patients dependent on mechanical ventilators when the mechanical ventilator needs to be examined for possible malfunction or when ventilator-dependent patients are transported within the hospital. Two principal types of manual resuscitators exist; one version is self-filling with air, although additional oxygen (O2) can be added but is not necessary for the device to function. The other principal type of manual resuscitator (flow-inflation) is heavily used in non-emergency applications in the operating room to ventilate patients during anesthesia induction and recovery.

Continuous positive airway pressure Form of ventilator which applies mild air pressure continuously to keep airways open

Continuous positive airway pressure (CPAP) is a form of positive airway pressure (PAP) ventilation in which a constant level of pressure greater than atmospheric pressure is continuously applied to the upper respiratory tract of a person. The application of positive pressure may be intended to prevent upper airway collapse, as occurs in obstructive sleep apnea, or to reduce the work of breathing in conditions such as acute decompensated heart failure. CPAP therapy is highly effective for managing obstructive sleep apnea. Compliance and acceptance of use of CPAP therapy can be a limiting factor, with 8% of people stopping use after the first night and 50% within the first year. Reliable storage solutions are essential for the effective working of CPAP machines, as they are used in the life-critical industry of medicine and healthcare.

An Emergency Use Authorization (EUA) in the United States is an authorization granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), as codified by 21 U.S.C. § 360bbb-3, to allow the use of a drug prior to approval. It does not constitute approval of the drug in the full statutory meaning of the term, but instead authorizes the FDA to facilitate availability of an unapproved product, or an unapproved use of an approved product, during a declared state of emergency from one of several agencies or of a "material threat" by the Secretary of Homeland Security.

InBios International, Inc. is a medical diagnostic company based in Seattle that specializes in the design, development, and manufacture of immunodiagnostic devices for infectious diseases. The company was founded in 1996 and, since its inception, has developed several technologies useful in designing rapid and ELISA based immunodiagnostic assays. InBios offers a number of life science reagents, along with a portfolio of more than 25 diagnostic products, including FDA Emergency Use Authorization for COVID-19 products and FDA-cleared ELISA kits for Zika, dengue, and West Nile and rapid test kits for Chagas and leishmaniasis. InBios is GMP compliant, FDA registered, USDA licensed and ISO 13485:2016 certified.

A negative pressure ventilator (NPV) is a type of mechanical ventilator that stimulates an ill person's breathing by periodically applying negative air pressure to their body to expand and contract the chest cavity.

Remdesivir Antiviral drug

Remdesivir, sold under the brand name Veklury, is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein. During the COVID-19 pandemic, remdesivir was approved or authorized for emergency use to treat COVID‑19 in around 50 countries. Updated guidelines from the World Health Organization in November 2020 include a conditional recommendation against the use of remdesivir for the treatment of COVID-19.

Virgin Orbit A private launcher services provider

Virgin Orbit is a company within the Virgin Group which provides launch services for small satellites. On January 17, 2021, their LauncherOne successfully reached orbit, and successfully deployed 10 cubesats.

Empatica Inc. is an MIT Media Lab spinoff company born in Cambridge, MA operating in Healthcare, providing AI-enabled tools to advance forecasting, monitoring, research, and treatment. Empatica produces medical-grade wearables, software and algorithms for the collection and interpretation of physiological data. Empatica’s wearables, Embrace2 and E4, track physiological signals such as Heart Rate Variability, electrodermal activity, acceleration and movement, skin temperature, and autonomic arousal. Embrace2 has been cleared by the FDA as a seizure alerting solution for epilepsy patients suffering from generalized tonic-clonic seizures. The E4 is used by researchers for real-time physiological data capture. The company is headquartered in Boston, MA with offices in Milan, Italy, and Seoul, South Korea.

Shortages related to the COVID-19 pandemic Medical material and other goods shortages that are a major issue

Shortages of medical materials, manufacturing and consumer goods caused by the COVID-19 pandemic quickly became a major issue worldwide, as did interruptions to the global supply chain, which has challenged supply chain resilience across the globe. Shortages of personal protective equipment, such as medical masks and gloves, face shields, and sanitizing products, along with hospital beds, ICU beds, oxygen therapy equipment, ventilators, and ECMO devices were reported in most countries.

Medical gown Type of personal protective equipment worn by medical professionals

Medical gowns are hospital gowns worn by medical professionals as personal protective equipment (PPE) in order to provide a barrier between patient and professional. Whereas patient gowns are flimsy often with exposed backs and arms, PPE gowns, as seen below in the cardiac surgeon photograph, cover most of the exposed skin surfaces of the professional medics.

There is no specific, effective treatment or cure for coronavirus disease 2019 (COVID-19), the disease caused by the SARS-CoV-2 virus. One year into the pandemic, highly effective vaccines have now been introduced and are beginning to slow the spread of SARS-CoV-2; however, for those awaiting vaccination, as well as for the estimated millions of immunocompromised persons who are unlikely to respond robustly to vaccination, treatment remains important. Thus, the lack of progress developing effective treatments means that the cornerstone of management of COVID-19 has been supportive care, which includes treatment to relieve symptoms, fluid therapy, oxygen support and prone positioning as needed, and medications or devices to support other affected vital organs.

Public health mitigation of COVID-19 Measures to halt the spread of the respiratory disease among populations

Speed and scale are key to mitigation of COVID-19, due to the fat-tailed nature of pandemic risk and the exponential growth of COVID-19 infections. For mitigation to be effective, (a) chains of transmission must be broken as quickly as possible through screening and containment, (b) health care must be available to provide for the needs of those infected, and (c) contingencies must be in place to allow for effective rollout of (a) and (b).

United States responses to the COVID-19 pandemic Actions by the United States regarding the COVID-19 pandemic

The United States' response to the COVID-19 pandemic with consists of various measures by the medical community; the federal, state, and local governments; the military; and the private sector. The public response has been highly polarized, with partisan divides being observed and a number of concurrent protests and unrest complicating the response.

United Kingdom responses to the COVID-19 pandemic Actions by the United Kingdom regarding the COVID-19 pandemic

The United Kingdom's response to the COVID-19 pandemic with consists of various measures by the national health services community; the British and devolved governments; the military; and the research sector.

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