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.
One of the COVID-19 infection complications is acute respiratory distress syndrome (ARDS) which commonly requires ventilation support. Because of this, there is an increase in resource utilization and overseas outsourcing of supply production of ventilators and respiratory consumables leading to a market that is depleted of supplies that were previously made on a demand basis.
Existing Solutions
Penn State Milton S. Hershey Medical center maintains an adequate supply of respiratory consumables for normal hospital capacity use. With the onset of the SARS-COV-2 outbreak, there is an increased need for quantity of ventilators and their associated respiratory consumables, a few of which are included in the tables below with their associated suppliers and distributors.
| Consumable | Manufacturers |
| Vent Tubing including tubing for CPAP | Hamilton, Ambu, BCI, Tri-med, Teleflex, Medex, Flexicare, Smiths Medical, Fischer & Paykel, BD |
| Corrugated blue tubing | Hamillton, BD, Teleflex, Vitality Medical |
| HME filter | Ambu, BCI, Medex supply, Tri-med, Flexicare, Teleflex, Smiths Medical, Fischer and Paykel. BD, Vitality Medical |
| Y-connectors | Ambu, Tri-med, Teleflex (elbow connector), Smiths Medical, BD |
| HEPA filters | Ambu, BD, Teleflex, Smiths Medical, Fischer and Paykel |
| Heater wire | BD, Tri-med, Flexicare, Smiths Medical, Fischer and Paykel (adapters) |
| In line suction | Tri-med, BD, BCI, Medsource, Smiths Medical , Fischer and Paykel. Teleflex |
| ET CO2 sensors | Ambu, Hamilton, Flexicare, Smiths Medical, Fischer & Paykel Healthcare, Teleflex, BD |
| CO2 Absorbent Canister |
| RT 114 Circuits | McKesson, Vitality Medical, Fisher & Paykel, Active Forever, CNA Medical, Respiratory Care Store |
| RT 380 Circuits | McKesson, Medexsupply |
| MDI spacer (opti chamber) | direct home medical, philips, vitality medical |
| Humidifier chamber | the CPAP shop, direct home medical |
| 1L Water Bags | Vyaire Medical |
| ETCO2 cuvettes | draeger, pediatric home service, |
| V500 Expiratory Valves | Estate Medical, AAA Wholesale Company, Bees Medical, American Medical Depot |
| 15mm adapter | Vitality Medical, Angel Medical Supply, Bound Tree |
| 22mm adapter | Vitality Medical, Angel Medical Supply, Bound Tree |
| MAC 3 Disposable blade and Handle | The EMS store, Tiger Medical, 4MD Medical |
| MAC 4 Disposable blades and Handle | Tiger Medical, The EMS Store, 4MD Medical |
| Oxylog circuits | Draeger, Bound Tree |
| Simple circuit | |
| 3M micro pore tape 1/2 inch | Walmart, Amazon, Vitality, 3M, Brightlife Direct |
| 3M micro pore tape 2 inch | Walmart, Amazon, Vitality, 3M, Brightlife Direct |
| etCO2 adapter | MFI Medical Equipment, Philips, Cevi Med |
| LTV circuits Adult | Coast Biomedical, MBR medical, |
| RT 265 Circuits | Fisher & Paykel, Estate Medical |
| RT 266 circuits | Fisher & Paykel, Estate Medical, CNA medical, Respiratory Care Stores |
| Open suction catheters 14F | Vitality Medical, HealthcareSupply Pros, |
| Ambu bag / manual resuscitator bag | Medicaleshop, ambu, teleflex, tri-medical, vitality medical, mckesson, CNA medical, respiratory care store, fisher sci,bomimed, aaawholesalecompany, angel medical supply, american medical depot, bound tree, |
| Jet Circuits | |
| Aerogen neb cups | Pari, DME Supply USA |
| Peds HME | |
| T-pieces (T connector) | McKesson, Vitality Medical, Cascade Healthcare Solutions, Mar J-Medical Supply, PennCare.net, Bound Tree |
| Oxygen tubing | Vitality Medical, Amazon, Cascade Healthcare Solutions, Bound Tree, Angel Medical Supply |
| O2 Reducer | Draeger, Buyemp.com (emergency medical products) |
| Respironics Whisper Swivel Exhalation Adapter | Vitality Medical, CPAP Supply USA, The CPAP People |
| Heated Adult Respiratory Ventilator Circuit | Medicaleshop, draeger, teleflex, BOMImed, the CPAP people |
| Some sort of inlet that looks like it works with the T connector? | |
| HEPA Filter (in line) | Amazon, Thomas Scientific, Fischer Scientific |
| Double wall filter | |
| Video glidescope cover | Verathon (glidescope AVL) |
| Fisher & Paykel MR810 | MBR medical**, grayline medical, medicaleshop, ATC medical, Lake Superior Medical Equipment, McKesson, MedLine, Keene Medical Products |
| Fisher & Paykel MR850 | McKesson, Medical Monks, https://www.ebay.com/p/3011383593**, BemesOnline**, Outfront Medical**, MedEx Supply, TriMed Medical Supply, USMed Equip (for sale or rent), DRE Veterinary, MBR medical**, quality medical south |
Market Analysis
As the demand for ventilator use increased in late March/early April, so did the use and replacement of respiratory consumables. All current supply chains were notably overloaded and regulations on production limited the immediate replacement of stock.
One example of a respiratory consumable need that arose during the week of 4/2/2020 was a Fisher and Paykel MR810 and MR850 heated humidifier unit. All Fisher and Paykel supply and production was being provided to the US government. Seventeen DME companies were identified as selling these products through their online inventory. All companies were contacted and three had available stock of a total of 2 MR810s and 4 MR850s some of which were used or refurbished units. One company had available stock beginning April 13th if the supply chain was not disrupted before that time.
Alternative Solutions
- Operational
- Reuse consumables
- Sterilize used consumables
- Reuse consumables
- Re-engineering
- Modification/Production of consumables:
- Various 3D printed parts: https://www.3dsystems.com/material-finder?refinementList%5Bprinter_compatibility%5D%5B0%5D=Figure%204%20Standalone
- 3D printable “H” connector prototype for ventilators to reduce dead space volume & air leakage: H Connector – Copper 3D | Antibacterial 3D Printing
- Modification/Production of consumables:
- Novel Design
- Split Ventilators:
- “How to”: https://www.youtube.com/watch?reload=9&v=uClq978oohY
- Research article (2006): A single ventilator for multiple simulated patients to meet disaster surge
- Research article on experimental 3D Printed 4-Port Ventilator (2014): Experimental 3D Printed 4-Port Ventilator Manifold for Potential Use in Disaster Surges
- Split Ventilators:
Concept Screening
- Development of the solution should be tailored to the specific ventilator accessory in question. The function, sterility, durability, and intellectual property of the accessory and parts should be considered individually.
- Regulatory –
- On March 22, 2020, the FDA issued an immediately in effect guidance outlining a policy intended to help increase availability of ventilators and their accessories as well as other respiratory devices during the COVID-19 pandemic. For details, see Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease-2019 (COVID-19) Public Health Emergency. The policy fosters the continued availability of certain safe and effective medical devices while being flexible regarding manufacturer modifications made to ventilators, anesthesia gas machines and other respiratory devices, and their accessories, in response to the COVID-19 public health emergency.
- For consideration of 3D printing of parts as a solution, the FDA has previously issued guidance on the Technical Considerations for Additive Manufactured Medical Devices. This guidance outlines the FDA’s recommendations for 3D-printed devices from the device stage to process validation and acceptance activities of finished devices.
Strategic Development
- As an operational strategy, the respective institution should exhaust all existing channels to procure the respiratory consumables. Existing products are preferred due to regulatory requirements and potential need for testing.
- If inventory is minimal and existing products cannot be obtained, many of the consumables can be manufactured using 3D printing as discussed above. Should one desire to proceed with that route, the following guideline should be considered:
- Regulatory – As a class 1 device, disposable stethoscopes are exempt from 501(k) requirements. However, all medical devices are still subject to Quality System Regulation (21 CFR 820) (https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices) also known as “Good Manufacturing Practices”. Therefore, novel ways of manufacturing disposable stethoscopes are subject to the same quality system regulations.