Manufacturing and Sterilization for COVID-19

Design, development, prototyping, testing, and validation to help win the fight

Ventilators

Contents

Need Exploration and Identification

Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified in December 2019 in Wuhan, the capital of China’s Hubei province, and has since spread globally, resulting in the ongoing 2019–20 coronavirus pandemic. As of 14 April 2020, more than 1.94 million cases have been reported across 210 countries and territories, resulting in over 123,000 deaths (https://coronavirus.jhu.edu/map.html). The pandemic has resulted in travel restrictions and nationwide lockdowns in several countries.  With the sudden surges in patient volume during the COVID-19 outbreak, closing of borders and restrictions on international shipping, and temporary shutdown of manufacturers for medical supplies, personal protective equipment (PPE), ventilators and associated consumables, as well as many other medical supplies have become a scarce resource. 

Most hospitals in PA  maintain an adequate supply of ventilators for normal practice. However, with the onset of the SARS-COV-2 outbreak an increased need for ventilators demands that alternative supply chains be created. During this crisis, both public as well as private companies have offered solutions to the increased ventilator demand expected with the SARS-COV-2 pandemic. 

This document details strategies to optimize supplies of ventilators during this crisis:

Existing Solutions 

Mfg. Brands Country Location Contact information Stage Internal contact person Website
AutoMedX USA Not Contacted http://automedx.biz/automedx-home/about-automedx/
Siemens Not Contacted
Medtronic Puritan Bennett, Newport Not Contacted https://www.medtronic.com/covidien/en-us/products/mechanical-ventilation.html
Viasys Not Contacted
Phillips Respironics, Resmed Not Contacted
Drager Not Contacted
Hamilton Not Contacted https://www.hamilton-medical.com/en_US/
GE Medical Not Contacted
Pulmonetic Systems Inc Not Contacted
Percussionaire Bird Not Contacted https://percussionaire.com/about
Infrasonics Not Contacted
Getinge Marquet Sweden Gothenburg +46 10 335 0000 Not Contacted https://www.getinge.com/us/
Fisher & Paykel Healthcare US/NZ Not Contacted https://www.fphcare.com/us/
Vyaire Not Contacted https://www.vyaire.com/specialty/respiratory-therapy
Nippy Ventilator UK Stratford-upon-Avon +44 (0)1789 293460 Not Contacted http://www.nippyventilator.com/about/
oes-medical UK Witney, Oxfordshire +44 (0) 1865 301711 Not Contacted https://www.oes-medical.co.uk/
Löwenstein Medical UK Ltd. UK Bracknell Not Contacted https://hul.de/uk/produkt/prisma30st-5/
Meditec England UK +44 203 6423808 Not Contacted http://www.meditecengland.co.uk/
Diamedica UK Not Contacted http://www.diamedica.co.uk/english/product_details.cfm?id=1561
Aeroflow US Not Contacted https://aeroflowinc.com/respiratory/trilogy-ventilator/
Diagnosis Poland Warsaw “+48 22 331 05 03” Not Contacted https://www.diagnos.pl/category/wentylacja/
Air Liquide Medical Systems France Amtony https://www.device.airliquidehealthcare.com/
Resmed https://www.resmed.com

The federal government maintains a reported 12,700 unit stockpile of ventilators at the Strategic National Stockpile (SNS) which may be accessible upon request through state officials. This stockpile has been designed to allow allotment to areas with highest case burden as needed in 24-36hrs following request. Ventilator models include the LP10 (Covidien), LTV1200 (CareFusion), and the Uni-vent Eagle 754 (Impact Instrumentation).  – alternative solutions**

http://www.centerforhealthsecurity.org/resources/COVID-19/COVID-19-fact-sheets/200214-VentilatorAvailability-factsheet.pdf

Depletion of this stockpile under current pandemic conditions has required that the government order 30,000 new ventilators from General Electric. 6,700 of these ventilators are expected to be complete by June 1 of 2020 and the remainder by August of 2020. Pennsylvania has requested 1,000 ventilators from the SNS.

https://www.wsj.com/articles/gm-to-make-30-000-ventilators-for-national-stockpile-in-489-million-contract-11586347203

Additionally, at a state level Pennsylvania itself has approximately 4,000 ventilators available between hospitals, emergency medical services, and the state’s storage supply. Since the beginning of the SARS-COV-2 pandemic Pennsylvania reports having procured about 400 more ventilators and has also requested allotment from the SNS.

https://www.pennlive.com/coronavirus/2020/04/pa-needs-another-1000-to-1400-ventilators-its-governor-says-heres-how-the-state-is-trying-to-find-them.html

Options have included the ability to purchase or possibly rent ventilators. Companies including GE, Ventec, MedTronic, and Hamilton were contacted. These companies reported an unknown timeline from weeks to months for when orders would be filled due to supply chain disruption and overwhelming demand.

Market Analysis 

On April 1, 2020, IHME predicted that the United States would need a total of 32,517 ventilators (with predicted range between 15,180 and 51,180 ventilators) at the peak resource need of April 12th. On the same prediction date, IHME predicted that the peak resource use in Pennsylvania would hit on April 15th and PA would need a total of 936 ventilators (with predicted range between 513 and 1624 ventilators). These estimates reflected a larger demand than current supply at the local, state, and national level. At this time, Draeger, GE, Ventec, Medtronic, Hamilton, and Avante Renting Solutions (~25% of the invasive ventilator market share) were contacted about supply, production, and delivery estimates. Despite partnering with larger production companies, turnaround delivery times to meet the increased demand was not until June at the earliest which was at least 1.5 months after the expected surge in PA and the US. 

The federal government response to the ventilator shortage also included relaxing of FDA restrictions on home ventilator use. This new policy allowed hospitals to use ventilators outside of their previously cleared environments. This included at home and transport ventilators (https://www.fda.gov/media/136318/download). At this time, the same companies were contacted about travel/home ventilator availability. 

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Extrapolation data used for this estimate: 

7 biggest ventilator manufacturers: Becton Dickinson (through Vyaire Medical), Philips, Hamilton Medical,  Fisher & Paykel Healthcare, Draeger, Medtronic, GE Healthcare, Smiths, ResMed, Maquet

https://meticulousblog.org/top-10-companies-in-global-ventilators-market/

COVID-19 invasive ventilator projection: https://covid19.healthdata.org/united-states-of-america/pennsylvania

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Alternative Solutions 

Concept Screening 

  • Clinical
    • To respond effectively to the COVID-19 outbreak, appropriate clinical management and infection control and implementation of community mitigation efforts are critical.
    • The FDA is aware that patients suffering from respiratory complications as a result of COVID-19 may require ventilatory support. These patients may require assistance via mechanical ventilation through the controlled delivery of gases, including the delivery of oxygen during inhalation and/or the removal of carbon dioxide during exhalation.
    • Research paper on types of ventilation: The Mechanical Ventilator: Past, Present, and Future
    • CDC standards relating to ventilator use, operations and design:
Classification Regulation Device Type Product Code Device Classification

21 CFR 868.5895

 Ventilator, Continuous, Facility Use CBK II
Ventilator, Continuous, Minimal Ventilatory Support, Facility Use MNT II
Continuous, ventilator, home use NOU II
Ventilator, continuous, minimal ventilatory support, home use NQY II
Ventilator, continuous, non-life-supporting MNS II
Mechanical Ventilator ONZ II
21 CFR 868.5925 Ventilator, Emergency, Powered (Resuscitator) BTL II
21 CFR 868.5160 Gas-machine, anesthesia BSZ II

21 CFR 868.5905

 Ventilator, non-continuous (respirator) Including masks and interfaces under the same product code BZD II
Conserver, Oxygen NFB II
Device, Positive Pressure Breathing, Intermittent NHJ II
Resuscitator, Manual, Non Self-Inflating NHK II
21 CFR 868.5454 High flow/high velocity humidified oxygen delivery device QAV II
Category Part Current Activity Status In Clinical Use Next Steps
PPE – Face Shield Capacity High capacity frame without visor Manufacturing Active Yes Released
PPE – Face Shield w/ visor Frame with visor Optimization for SLS nylon Active Yes Verification

PPE – Face Mask

 Stopgap Face Mask Manufacturing Active Yes Released
Surgical Mask Approval Active No Manufacturing
Surgical N95 Respirator Prototyping Active No Bench Testing

Ventilator Solutions

 Various Support of ventilator OEMs Active Yes Continue collaborative efforts
Splitter HCP Evaluation Active Yes Contact to participate in clinical validation
Diagnostics Swabs HCP Evaluation Active Yes Contact to participate in clinical validation
Medical Education Lung Ultrasound COVID-19 Training Module Available Active Yes, for clinical training Contact to participate in clinical validation

Materials

All

 Material Technology Overview Chart created for download for Printer-material section

View

 The overview below may change based on continued results. The table will be updated regularly to reflect these changes

 

  • Regulatory

 

    • FDA Guidance on Ventilators
      • The FDA recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the COVID-19 pandemic. As a result, the FDA is recommending the following conservation strategies for use by health care organizations and personnel:
      •  FDA is permitting ventilator manufacturers to modify hardware and software without first submitting a premarket notification. ​
      • FDA is interested in interacting with manufacturers of ventilatory support devices that are not currently legally marketed in the U.S. as well as manufacturers who have not previously been engaged in medical device manufacturing with capabilities to increase supply of these devices. For current ventilator manufacturers whose product(s) are not currently marketed in the US, FDA recommends reaching out to CDRH-COVID19-Ventilators@fda.hhs.gov  and providing the following information:
        • General information such as your contact information, name and place of business, email address, and contact information for a U.S. agent (if any), in addition to general information about the device such as the proprietary or brand name, model number, and marketing authorization in your country (or region). 
        • A copy of the product labeling.
        • Whether the device currently has marketing authorization in another regulatory jurisdiction such as the European CE Mark, Australian Register of Therapeutic Goods Contains Nonbinding Recommendations 13 (ARTG) Certificate of Inclusion, Health Canada Licence, or Japan Pharmaceuticals and Medical Device (PMDA) approval (including certification number, if available).
        • Whether the device has been designed, evaluated, and validated in accordance with the applicable FDA recognized standards identified in Section IV.D above. e) Whether the device is manufactured in compliance with 21 CFR Part 820 or ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, or an equivalent quality system, and the manufacturer or importer has documentation of such. 
        • Whether the device is designed with a power supply that is compatible with United States voltage, frequency, and plug type standards or is accompanied by an appropriate power supply adapter for use in the United States.
      • FDA Expands use for home ventilators https://www.fda.gov/media/136318/download
    • The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with ventilators.
  • (IP)
    • FDA guidance to offer a streamlined path to market for automakers and other non-medtech manufacturers that want to repurpose their plants to supply ventilators (see FDA guidance above)
    • IP: existing Ventilator Patents should still be honored and respected.

Strategic Development  

 

  • Clinical:

 

    1. FDA Guidance on Ventilators
      1. The FDA recognizes that the need for ventilators, ventilator accessories, and other respiratory devices may outpace the supply available to health care facilities during the COVID-19 pandemic. As a result, the FDA is recommending the following conservation strategies for use by health care organizations and personnel:
        1. Ventilator Supply Mitigation Strategy 
    2. We fully support the FDA mitigation strategy as described above. In accordance with the above strategy, we propose the following steps:
  1. Sought to purchase new and used ventilators 
  2. Sought to rent ventilators 
  3. Repurposed OR anesthesia machines 
  4. Sought to repurpose/acquire transport and home ventilators
  5. Explore option to request ventilators from federal and state stockpiles
    1. DoD – Have not dispatched b/c agencies have not asked nor provided shipping location. Different from civilian vents so would probably need DoD personnel for training
    2. PEMA – contact Department of General Services at RA-procinternet@pa.gov 
  6. Explore option of private sector – 
    1. Tesla – To make an order, we are to call their customer service line 1888-518-3752 and use the pre-set options to get in touch with any representative. We will have to provide them with “all relevant information” (number of vents needed, where it would be used, priority of need, contact info, etc) and that information would be submitted to directly to Elon Musk’s secretary for rev
    2. Ford – will work with GE to increase production of simplified versions of GE’s ventilators. To get in the queue, will need to make an official quote (through GE rep). Shipments will most likely be staggered (~10 per week). Can cancel orders anytime and they will redistribute. 
  7. Back up plan to explore remanufacturing or design of de novo ventilator design using ready-made parts or 3D printing of parts

 

 

 

 

@CDCgov

@Surgeon_General

@PAHealthDept

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