This article is about disaster-situation machines that assist breathing. For standard ventilators used in the medical industry, see ventilator.
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
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]
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]
On March 16, 2020,[10] the Open Source Ventilator Ireland (OSV) group was formed[11][12][13] initially with the goal of building a focus team in Ireland to begin development on what was termed the “Field Emergency Ventilator (FEV)”. Inspired by the initial efforts of the Open Source Medical Supplies (OSCMS),[14] which initially focused on developing open ventilators but quickly refocusing mainly on the local production of Personal Protective Experiment (PPE).[15] OSV Ireland partnered with the OpenLung team[16][17] in Canada, who were developing and publishing open source designs via GitLab.[18] The group quickly grew amassing volunteer engineers, designers and medical professionals with the goal of developing new, low resource medical interventions to support a perceived lack of mechanical ventilation equipment globally. The well-known Bag Valve Mask (BVM) quickly became the core functional component of their design,[19] with the goal of utilizing 3D printed and traditionally manufactured components for localized assembly of the systems to maximise potential manufacturing capabilities around the globe. The Open Source Ventilator Ireland (OSV) group evolved into TeamOSV, to fully incorporate both ventilator and other covid related medical equipment.
The FOSS Initiative OpenVentilator.io project began on March 19, after two weeks of research.[20] Jeremias Almadas [21] had posted some drafts he made on the Open Source COVID-19 Medical Supplies forum.[22] Marcos Mendez contacted him to join efforts to develop a solution that could be reproduced on a very high scale.[23] 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,[24] including since the 1960s models like the Bird MK VII [25] 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.[20]
On March 18, Medtronic had opened its code and files for manufacturing its main pulmonary ventilation equipment.[26] The issue was on a scale that Medtronic would not be able to fulfill at the global level, nor at the regional level. The same was already happening with Philips, GE and Drager, world leaders in the manufacture of this type of equipment. It would not make sense to reinvent something that had already been studied 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.[27]
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[28][circular reference] within the global economic-political stagnation.[29]
On March 19, the MakAir open source ventilator project[31] 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,[32] at the end of which a successful 12 hour ventilation test on a pig was performed. The project received official support[33] 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[34] 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[35] on human patients.
On March 20, 2020, Irish Health Services[36] began reviewing the designs from the Open Source Ventilator Ireland project.[37] A prototype is being designed and tested in Colombia.[38]
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.[40][41]
The Polish company Urbicum reports successful testing[42] 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.[43] 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.[44][45] 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.[46] NECSI is staffed with scientists from Harvard, MIT, and others who have an understanding of pandemics, medicine, systems, risk, and data collection.[46]
The Oxysphere project develops open blueprints for a positive pressure ventilation hood.[48]
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.[49][50]
On May 29, 2020, NASA revealed the "Eight US Manufacturers Selected to Make NASA COVID-19 Ventilator."[51]
The U.S. companies selected for licenses are:
Vacumed, a division of Vacumetrics, Inc. in Ventura, California
Stark Industries, LLC in Columbus, Ohio
MVent, LLC, a division of Minnetronix Medical, in St. Paul, Minnesota
iButtonLink, LLC in Whitewater, Wisconsin
Evo Design, LLC in Watertown, Connecticut
DesignPlex Biomedical, LLC in Fort Worth, Texas
ATRON Group LLC in Dallas
Pro-Dex, Inc. in Irvine, California
Israeli engineers created an open source ventilator [52]
NASA VITAL Ventilator
Engineering team
Front view
Side view
Disaster-relief provisions
On March 24, 2020, the U.S. Secretary of Health and Human Services (HHS) enacted Emergency Use Authorizations[53] 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[54] for medical countermeasures against the coronavirus disease 2019, and the equipment is subject to the FDA's "criteria for safety, performance and labeling."
Respironics is an American medical supply company owned by Philips that specializes in products that improve respiratory functions. It is based in the Pittsburgh suburb of Murrysville in Pennsylvania, United States.
A ventilator is a type of breathing apparatus, a class of medical technology 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 may be 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 or assisted ventilation is the medical term for using a ventilator machine 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.
An iron lung 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 or respiration is when a machine assists in a metabolic process to exchange gases in the body by pulmonary ventilation, external respiration, and internal respiration. A machine called a ventilator provides the person air manually by moving air in and out of the lungs when an individual is unable to breathe on their own. The ventilator prevents the accumulation of carbon dioxide so that the lungs don't collapse due to the low pressure. The use of artificial ventilation can be traced back to the seventeenth century. There are three ways of exchanging gases in the body: manual methods, mechanical ventilation, and neurostimulation.
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep them oxygenated and alive. There are three basic types: a manual version consisting of a mask and a large hand-squeezed plastic bulb using ambient air, or with supplemental oxygen from a high-pressure tank. The second type is the expired air or breath powered resuscitator. The third type is an oxygen powered resuscitator. These are driven by pressurized gas delivered by a regulator, and can either be automatic or manually controlled. The most popular type of gas powered resuscitator are time cycled, volume constant ventilators. In the early days of pre-hospital emergency services, pressure cycled devices like the Pulmotor were popular but yielded less than satisfactory results. Most modern resuscitators are designed to allow the patient to breathe on his own should he recover the ability to do so. All resuscitation devices should be able to deliver more than 85% oxygen when a gas source is available.
A breathing apparatus or breathing set is equipment which allows a person to breathe in a hostile environment where breathing would otherwise be impossible, difficult, harmful, or hazardous, or assists a person to breathe. A respirator, medical ventilator, or resuscitator may also be considered to be breathing apparatus. Equipment that supplies or recycles breathing gas other than ambient air in a space used by several people is usually referred to as being part of a life-support system, and a life-support system for one person may include breathing apparatus, when the breathing gas is specifically supplied to the user rather than to the enclosure in which the user is the occupant.
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 (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.
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.
Modes of mechanical ventilation are one of the most important aspects of the usage of mechanical ventilation. The mode refers to the method of inspiratory support. In general, mode selection is based on clinician familiarity and institutional preferences, since there is a paucity of evidence indicating that the mode affects clinical outcome. The most frequently used forms of volume-limited mechanical ventilation are intermittent mandatory ventilation (IMV) and continuous mandatory ventilation (CMV). There have been substantial changes in the nomenclature of mechanical ventilation over the years, but more recently it has become standardized by many respirology and pulmonology groups. Writing a mode is most proper in all capital letters with a dash between the control variable and the strategy.
The SensorMedics High-Frequency Oscillatory Ventilator is a patented high-frequency mechanical ventilator designed and manufactured by SensorMedics Corp. of Yorba Linda, California. After a series of acquisitions, Vyaire Medical, Inc. marketed the product as 3100A/B HFOV Ventilators. Model 3100 received premarket approval from the United States Food and Drug Administration (FDA) in 1991 for treatment of all forms of respiratory failure in neonatal patients. In 1995, it received pre-market approved for Pediatric Application with no upper weight limit for treating selected patients failing on conventional ventilation.
Prone ventilation, sometimes called prone positioning or proning, is a method of mechanical ventilation with the patient lying face-down (prone). It improves oxygenation in most patients with acute respiratory distress syndrome (ARDS) and reduces mortality. The earliest trial investigating the benefits of prone ventilation occurred in 1976. Since that time, many meta-analyses and one randomized control trial, the PROSEVA trial, have shown an increase in patients' survival with the more severe versions of ARDS. There are many proposed mechanisms, but they are not fully delineated. The proposed utility of prone ventilation is that this position will improve lung mechanics, improve oxygenation, and increase survival. Although improved oxygenation has been shown in multiple studies, this position change's survival benefit is not as clear. Similar to the slow adoption of low tidal volume ventilation utilized in ARDS, many believe that the investigation into the benefits of prone ventilation will likely be ongoing in the future.
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, 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 numerous countries.
Shortages related to the COVID-19 pandemic are pandemic-related disruptions to goods production and distribution, insufficient inventories, and disruptions to workplaces caused by infections and public policy.
The treatment and management of COVID-19 combines both supportive care, which includes treatment to relieve symptoms, fluid therapy, oxygen support as needed, and a growing list of approved medications. Highly effective vaccines have reduced mortality related to 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. Some people may experience persistent symptoms or disability after recovery from the infection, known as long COVID, but there is still limited information on the best management and rehabilitation for this condition.
Part of managing an infectious disease outbreak is trying to delay and decrease the epidemic peak, known as flattening the epidemic curve. This decreases the risk of health services being overwhelmed and provides more time for vaccines and treatments to be developed. Non-pharmaceutical interventions that may manage the outbreak include personal preventive measures such as hand hygiene, wearing face masks, and self-quarantine; community measures aimed at physical distancing such as closing schools and cancelling mass gathering events; community engagement to encourage acceptance and participation in such interventions; as well as environmental measures such surface cleaning. It has also been suggested that improving ventilation and managing exposure duration can reduce transmission.
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.
The United Kingdom's response to the COVID-19 pandemic consists of various measures by the healthcare community, the British and devolved governments, the military and the research sector.
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