On April 6, 2020 Mexico’s Cofepris released provisions on the minimum requirements for ventilators to receive approval during the COVID-19 pandemic. The provisions will remain in force only for the duration of the public health emergency related to COVID-19, decreed by the General Health Council. This Blog will summarize the ventilation parameters and modes for adults and newborns. The full English translated provision can be accessed here.
Cofepris Minimum requirements required for Intensive Care Ventilators:
The following are the minimum requirements necessary to be clinically acceptable in ventilators that are used in patients with acute respiratory insufficiency due to COVID-19 infection, thus expecting a therapeutic benefit to patients requiring invasive ventilation. The guidance specifies monitored parameters and specification,ventilation modes in adults and newborns, pollution control, alarms, gas and electricity supply, biological safety, software safety, portable backup battery, and instruction manual requirements.
The equipment must have at least one of the following ventilation modes:
- Controlled ventilation, for those patients who are deeply sedated or paralyzed.
- Optional support mode for patients breathing to a certain extent.
Monitored Parameters and Specifications:
Current or tidal volume:
- 2 mL to 2000 mL mayor, for adult-pediatric-neonatal ventilator.
- At least 25 to 50 mL at the lower limit and 2000 mL or higher at the upper limit adult-pediatric
- 2 mL to 2000 mL for neonatal ventilators.
- Range from 0 to 150 breaths per minute.
Continuous positive air pressure (CPAP/PEEP):
- Range from 0 to 20 cm H20.
- Range from 0 to 45 cm H20.
Inspired Oxygen Fraction (FiO2):
- Between 21 and 100%.
Inspirational and expiratory times:
- At least 0.1 sec and 10 sec. respectively.
Relationship between inspiring time and expiratory time:
- 1:1 to 1:3
- From 0 to 150 L/min.
- Range from 0 to 80 cm of H20.
- Controlled Assisted Ventilation
- Volume-Controlled Synchronized Intermittent Mandatory Ventilation (SIMV).
- Controlled Assisted Ventilation and Mandatory Intermittent Ventilation Pressure-controlled SIMV.
- Support pressure (PSV) or Assisted Pressure.
- CPAP or spontaneous with raised baseline.
- Backrest in case of apnea according to ventilatory mode, by volume and by pressure.
- Pressure regulated ventilation with guarantee in manual or automatic volume assisted/controlled and SIMV (Guaranteed volume, Autoflow, PRVC, Volume ventilation plus, APV or Vsync or adaptive ventilation mode).
- Non-invasive ventilation (NIV).
- Spontaneous breathing at two pressure levels (BiLevel or Biphasic or DuOPAP or Bi-VentVent or BiPAP) orairway pressure release (APRV) or Belevel).
- With warranty orvolume limit for CPAP or spontaneous ventilation or support pressure or ASV or self-volume or volume control
- Support volume (VS) or with ventilation with spontaneous and controlled minute volume.
- Controlled by volume and pressure
- SIMV by volume and pressure
- Measures capnography.
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- ISO 80601-2-12:2020. Medical electrical equipment — Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators.
- IEC: 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2, Medical electrical equipment – Part 1-2: General requirements for safety –Collateral standard: Electromagnetic compatibility – Requirements and tests.
- List of Priority Medical Devices in the context of COVID-19 Pan American Health Organization – WHO. 2a. Version, March 27
- Rapidly manufactured ventilator system specification United Kingdom Government. March 20, 2020.
- CPAP: Positive Air Continuous Pressure.
- PEEP: Positive Pressure at the End of Inspiration.
- SIMV: Intermittently Synchronized Mandatory Ventilation.
- NIV: Non-invasive ventilation.
- HEPA: High Air Particle Efficiency.
- VS: Volume Support.
- FIO2: Oxygen Inspired Fraction.
- H2o: Water.
- PSV: Support pressure.
- APRV: Airway Pressure Release.
- PRVC: Controlled Volume and Pressure Regulation.
- APV: Adaptive Pressure Volume.
- ASV: Adaptive Assisted Ventilation.