Valves & Adapters

The use of newly developed and non traditionally produced valves and adapters increases the availability and versatility of airway support options. A shortage of airway support devices has caused some hospitals to use them in non-traditional ways, such as the controversial ventilator splitters, requiring types of valves and adapters that did not previously exist [1].

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Requirements and Resources
Engineering Requirements
Must comply with standard, performance, safety, and sanitation requirements expected of commercial valves and adapters.
Additional Requirements
  • Facility Requirements:
    • All assembly surfaces must be cleaned and free of dust or oil.
    • Packaging facilities and surfaces must be well ventilated, single purpose, and sanitized immediately prior to packaging.
  • Pre/Post-Manufacturing:
    • All contact surfaces must be free of sharp edges and puncture hazards.
  • Shipping/Packaging:
    • Must wear gloves & PPE or disinfect during packaging for shipping.
  • Disclaimers/Labeling:
    • Labels must specify intended use: reusable/disposable.
    • Labels must specify recommended cleaning procedures.
    • Labels must include materials used (latex, PLA, PETG).
    • Must include directions for assembly if shipped unassembled.
Other Resources

Ventilators and Ventilator Accessories EUAs US-FDA List of specific ventilators, ventilator tubing connectors, and ventilator accessories given approval under the EUA.  Includes fact sheets, safety criteria, and labeling requirements.

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