FDA Ventilator Guidance

The FDA has just released specific guidance around an Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID-19).


76 Replies to “FDA Ventilator Guidance”

  1. Diego Rivera
    Diego Rivera

    I’m from Guatemala. We are deeply concerned on the exponential growth of this pandemic and want to recieve as much information as posible to start prototyping the ventilator, and possibly provide an option for the people affected.

  2. ANTONIO CAMPANARI
    ANTONIO CAMPANARI

    We are part of a group of entrepreneurs in the Amazon Region in Brazil who are endevouring what is possibles to bring ideas and new low-cost technology for assembling or producing ventilator to help hospitals and ambulances during the coronvirus fight. We need your help and ideas so we can stay put and firm during this illness.

  3. Guna Govind
    Guna Govind

    Dear Researchers,

    I live in San Diego, CA and basically from India. I’m very interested in building this product as soon as the working prototype is available. My interest is to build and make it available on emergency situation. I can get the respective Government permissions and connect with manufacturing units on not-for-profit basis. All the best with your research.

    Thanks,
    Guna Govind

  4. Dan Hariton
    Dan Hariton

    Hi All: Just registered today here, as this E-Vent web site was recommended to me. I have designed a number of ICs and integrated SOCs. In process of becoming familiar with all the specifications for ventilators.
    I have an immediate comment/question on the power supply. It is specified as 12V and 5A nominal (typ). Later, the description mentions 15A spikes/surges. If the 15A “events” are occurring, are observable, or are expected during this ventilator’s normal operation do please upgrade the power supply requirement from [12V and 5A nominal] to [12V and 15A nominal].

    From the reliability point of view it also makes sense to have a single 12V & 15A typ power supply (one component) than having a 12V & 5A typ supply plus an added capacitor to handle 15A spikes (two components) / or a 12V additional battery.

    For redundancy purposes, yes, an additional 12V battery makes sense as a stand-by power-failure backup. I would recommend that the single main power supply be capable to handle well the 15A load spikes in a repetitive manner.

    • Mohit Bhartiya
      Mohit Bhartiya

      spikes are not power drawn but the surge due to the motor being stopped suddenly. hence it would be a reverse power surge that needs to be suppressed. Also for starting toque few capacitors can provide the necessary boost. no point in increasing the cost of the power supply. also as per the power calculations given we only require around 26w of power. 60w power input is already over compensated.

      • Dan Hariton
        Dan Hariton

        Hi Mohit: in common practice, to suppress the 15A spike generated each time the motor turns off, would like to mention that “Flyback diodes are commonly used when inductive loads are switched off by semiconductor devices: in relay drivers, H-bridge motor drivers, and so on” (Wikipedia). A capacitor is not necessarily needed in conjunction with the power supply when the motor turns off.
        Understood that these 15A spikes are not drawn from the power supply, so the power supply itself can be defined as 12V and 5A typical/max (we are not doing any fancy inductor-stored energy-recovery).
        Still this means 60W. Where can I find info on the “around 26W power calculation given” please?

        Capacitors are used at times for motor startup. So if my updated understanding is correct, we have
        A) no added capacitors are used in conjunction with the power supply, and
        B) capacitors are used in conjunction with the motor turning ON
        C) motor turning OFF generates 15A spikes that need to be suppressed

  5. Moses Msiza
    Moses Msiza

    Dear Researchers
    Iam from South Africa,in the past have worked with Prof Neil from MIT collabotating with CSIR rapid deployment of fablabs,would like to know is the package going to be available on Open Source..as the is infrastructure for mass production in place for such ventilators as they are about to be medical focal point in South Africa

  6. antonio selem
    antonio selem

    hello, I am from Mexico and worry as you about the critical issue of ventilators with no previous experience in this field but capable of organizing a task to set up a production line. Please tell me what is necessary to do it. ¿wherecan look for specifications, drawings, guidance for assembly? thank you very much and many thanks to the people have done this possible. My email is aselem@gmail.com and cel and WhatsApp is +52 1 55 15 574577

    • Sergio Rivera
      Sergio Rivera

      Que tal, Sergio aquí, estamos evaluando la adaptación de este diseño a la cadena de suministro mexicana. Unir manos esfuerzos nos ayudara. Ya estamos en contacto con la cámara de comercio de Sinaloa y organizando revisiones con especialistas. Si alguien está trabajando en entre proyecto o tiene información favor de contactarme sergio@aquaexploracion.mx

  7. Alexander Parker
    Alexander Parker

    Greetings my name is Alexander Parker, I am a Systems Engineer working for Google in Cambridge, MA. I have coding as well as tech writing experience, and I am interested in producing video documentation simplifying the build process for those with no engineering experience. Please contact me by email at parkera@google.com, or mobile at (617) 851-5194. Thanks much.

  8. Felix Yepez
    Felix Yepez

    Greetings, my name is Félix Yepez, I am a Electronic Engineer and maker developer. I have experience in coding as well. I would like to get the whole documentation about this project, including the code source. I want to contribute with my country. Please contact me by email at fyepezsalazar@gmail.com. Thanks much.

  9. James Lin
    James Lin

    Hello, I am a regulatory affairs professional specializing in the medical devices field: getting a device approved by health authorities globally. I would be glad to volunteer my time to help propel this project forward.

    • Yueh Lee
      Yueh Lee

      James – based on the latest guidance from the FDA – what exactly is needed for approval in the US? What testing, documentation, etc? I think we would all appreciate expertise in understanding this, especially from an engineering, then subsequently manufacturing perspective. Clearly there will be no “1” device. Thanks. Feel free to reach out directly, also, I’ve asked our regulatory team the same question.

  10. Maianh Nguyen
    Maianh Nguyen

    Hello, I am a Vietnamese living in Japan and I am currently staying home isolated to prevent the plague. I believe I can try and successfully make the ventilator with the amount of resources available here. Please help me.

  11. RONALD GUEVARA
    RONALD GUEVARA

    Hello, I would like to receive information on the design plans. I am from HONDURAS and my country is very poor. I would like to help my city. There are more than half a million people and there are only two mechanical fans. I hope your help.

    • Galel Fajardo
      Galel Fajardo

      Please contact UNAH. Now they have designs for ventilators and students are frantically working to get them done.
      Por favor contáctate con la UNAH. Ya ellos tienen diseños de ventiladores clínicos. Si puedes ayudar, es de unirse con ellos.
      Los estudiantes han estado trabajando en eso ya. Unámonos todos en esta lucha.

  12. Dan Hariton
    Dan Hariton

    Medtronic Shares Ventilation Design Specifications to Accelerate Efforts to Increase Global Ventilator Production
    PB560
    DUBLIN, March 30, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced it is publicly sharing the design specifications for the Puritan Bennett™ 560 (PB 560) to enable participants across industries to evaluate options for rapid ventilator manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally.
    NB
    {i.e. operating & service manuals, specs and schematics,etc}

  13. Dan Hariton
    Dan Hariton

    Medtronic PB560 design, manuals, and specifications info (WEB site) can be accessed (after a simple and free on-line registration) at:
    https://www.medtronic.com/us-en/e/open-files.html?cmpid=vanity_url_medtronic_com_openventilator_Corp_US_Covid19_FY20

    “Medtronic is mobilizing to fight the COVID-19 pandemic — and we’re inviting innovators everywhere to join us. Currently, there is a shortage of respirators and ventilators around the world. As recently announced, Medtronic is responding to this crisis by making the design files for the PB560 ventilator system available to the public. Our hope is that manufacturers and engineers will use this intellectual property to inspire their own potentially lifesaving innovations.”

  14. Gabriel Alejandro Hernández
    Gabriel Alejandro Hernández

    Saludos desde Chile, necesito saber si puedo realizar este proyecto, con fines de ayuda a mis compatriotas ya que en algún momento serán de much utilidad, y si no en otro lugar del mundo, entonces necesito saber ver, estudiar este proyecto juntarme con la gente y los recursos y desarrollarlo. en nombre de la humanidad y los seres que amo. He desarrollado una impresora 3d con Arduinos y esto parece relativamente realizable. así que ayuda por favor los planos videos tuturiales, si me otorgan eso juro lo realizo

  15. Alex Maldonado
    Alex Maldonado

    I need information, how built a vent because in my country, we dont have nothing.
    Necesito planos de fabricación con fines de ayuda, en mi país solo hay alrededor de 100 ventiladores en los hospitales y quisiera poder fabricar para ver como puedo ayudar

  16. Jose Ormeno
    Jose Ormeno

    Dear MIT Responsibles and researchers,

    I am interested in getting complete informartion in order to manufacture Medical Ventilators to my country (Peru) in order to help facing this terrible pandemic in our country. We are specialized in thermal equipments and ventilators for industrial purposes but we will be able to help developing this critical equipment.
    Looking forward to hearing from you.

  17. Allan Morel
    Allan Morel

    I´m Autodesk Inventor Expert, trying to get sketches, blueprints or any kind of information usefull, I offer my services for free or in exchange for information to help my people and country.
    Soy experto en Autodesk Inventor, busco esquemas, planos o lo que sea de información a cerca de los ventiladores, ofrezco mis servicios de forma gratuita a cambio de información que pueda ser útil para mi pueblo.

  18. Desire Hamza
    Desire Hamza

    I am a student of mechanical engineer from Nigeria. The current cases of the covid-19 is fast rising and the country needs more ventilator. I would like to get more information about the E-vent so that I can help the people of my country in my own little way.

  19. Doug Solomon
    Doug Solomon

    I read in MIT review that the MIT team is having conversations with the FDA on getting an emergency approval for this design. Can you please tell us what the status is of this discussion? Any advice for others in the US who want to make these devices? Thanks.

  20. Segundo Vargas
    Segundo Vargas

    My company is interested in putting together a prototype of the most current design available of this e-ventilator for evaluation, testing, improvements as needed and setting up a production line of these units. How do we go about getting drawings and parts lists to start the process. I would appreciate a prompt reply.
    svargas@csi-instruments.com (the company is in lockdown at this time unless an opportunity to help opens).
    973-303-3781 mobile

  21. viviana badilla
    viviana badilla

    Hi I live in Chile, in extreme zone ( Patagonia) in this zone there is a one hospital and
    there are not enough mechanical fans in my area. My husband is mechanical enginering, he wants to built a ventilator to help the people. I you may send me the plans to build it ?

    Kind regards

    Viviana Badilla morales
    Coyhaique – Chile

  22. Fernando Ramírez
    Fernando Ramírez

    Hola, desde Colombia
    Israel, me gustaría colaborar a mi pueblo con la construcción de un ventilador, soy ingeniero mecánico y trabajo de profesor en un pueblo que se llama Oiba y trabajo en la escuela industrial de Oiba, colegio público
    Si gustas puede verificar.
    Muchas gracias
    Atentamente
    Fernando Ramírez González
    Whatsapp
    +57 3213723993

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