Eligibility criteria for the acquisition of mechanical ventilators in the context of COVID-19
An affidavit and/or technical documents must be attached to verify the following:
- Does the supplier have technical service (own or subcontracted) to carry out training and maintenance work?
- The technical service must be proportional to the number of types of equipment offered
- Does the supplier have a stock of accessories and spare parts?
- The quantities of the stock must be consistent with the offer presented.
- Also, indicate if the supplier has the feasibility to deliver consumables.
- Does the offer include a product guarantee of at least 24 months?
- Does the equipment have a Free Sales Certificate (FSC) in any of the following countries or jurisdictions: Australia, Canada, Japan, the United States, or the European Union? For example, the CFS from the US FDA and/or CE mark must be granted by a certified body and must be specific to the equipment offered (not only include a declaration of conformity).
- In the event that the equipment has a FSC from another regulatory authority, it must be supported by the quality and performance standards indicated in items 2 and 3. It may indicate equivalent national standards.
Provide the technical documentation to verify conformity to:
5. Proof of compliance of each manufacturer site involved in the manufacturing process with ISO 13485: Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes, an equivalent quality system standard; or a certificate of Good Manufacturing Practice (GMP).
Provide the technical documentation to verify conformity to:
6. ISO 18562-1 Biocompatibility evaluation of breathing gas pathways in healthcare applications
7. ISO 20789:2018 Anaesthetic and respiratory equipment
8. ISO 80601-2-12 Medical Electrical Equipment - Part 2-12: Particular Requirements for the Safety of Lung Ventilators - Critical Care Ventilators.
9. IEC 60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Basic Safety and Essential Performance – Collateral Standard: Electromagnetic
10. National standards that are equivalent to the standards listed above
Select the type of ventilator and complete the information as appropriate:
12. Type of ventilator
Item 4: Technical information
- Brand and model
Requested Specifications:
- Ventilation modes
- Pressure regulated volume control (PRVC), or similar.
- Pressure control ventilation (PCV)
- Volume control ventilation (VCV)
- Synchronized intermittent mandatory ventilation (SIMV)
- Pressure support ventilation (PSV)
- Non-Invasive ventilation capability
- Monitored and controlled parameters (by user)
- FiO2: 21% - 100%
- Tidal volume: 20 - 2000 mL
- Inspiratory flow: 1 -160 L/min
- Inspiratory pressure: 0 - 40 cmH2O
- I:E ratio; I:E inverse ratio;
- RR: 10 to 60 [breaths/min]
- Inspiratory pause manoeuvre capability to measure plateau pressure;
- Peak pressure limitation/pressure-cycling mechanism adjustable range of 5 - 20 cmH2O above measured peak pressure
- PEEP: 0 to 20 [cmH2O], minimum.
- Displayed parameters (colour and graphic are preferable)
- Display easily readable in low ambient light and sunlight.
- 3 scalar waveforms: pressure, volume and flow.
- 3 loop (axis) displays: pressure-volume, flow-volume and pressure-flow, preferable.
- Status indicators for ventilator mode, battery status, patient data, alarm settings
- FiO2.
- Airway pressures (peak, plateau mean and PEEP).
- Tidal volume (inspired and expired).
- Minute volume (inspired and expired).
- I:E ratio
- RR (spontaneous and mechanical)
- Alarms, related to gas delivered
- High/low FiO2;
- High/low inspiratory pressure and PEEP;
- High/low tidal volume (not achieved or exceeded);
- Apnoea, adjustable from 10-30 sec;
- High/low respiratory rate;
- Continuously high pressure/occlusion;
- Breathing circuit disconnect.
- Alarms, related to equipment operation
- Gas supply failure;
- Power failure;
- Low battery;
- Self-diagnostics failure alarm.
- Consumables labeled “single-use”
- Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of outside diameter.
- Bacterial/Viral filters.
- Exhaled gas filter
- Accessories, reusable
- Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of outside diameter. Expiratory housing with in-built bacteria filters; as well as the possibility to accommodate heat moisture exchangers (HMEs).
- Flex adapters for placement between the circuit way-adapter and the ETT (protects from unnecessary trauma from eve small circuit repositioning.
- Exhalation valve.
- CO2 sensors.
- Servo-controlled heated humidifier; alternatively access to HMEs.
- Internal air compressor capacity (or high-performance turbines).
- Connector 30 mm, if required for the gas exhaust port.
- Standard connectors to air and oxygen wall pipelines.
- Portability
- Mounting tray and support stand (cart for transport with at least 2 castors fitted with breaks).
- Power supply and battery
- Operates from AC power electric line: 100 to 240 V~ / 50 to 60 Hz.
- Built-in rechargeable battery.
- Automatic switch from AC power electric-line mode to battery operating mode and vice versa.
- Continuous in battery operating mode with standard ventilation not less than 1 hour.
- Total re-charging time not greater than 6 hours.
Item5: Labeling and user manuals
Complete the information about the equipment according to the following structure:
- The supplier must provide information on labeling, including:
- a) Instructions for use
- b) Training material
- c) Service manual
- d) Technical description of the equipment
- e) Intended use
- f) Any other material with instructions for the clinical user and technical personnel.
- Present documentation that identifies at least:
- a) Brand and commercial name of the ventilator
- b) Product model or reference
- c) Catalog number
- f) Manufacturer contact information
- g) Recommendations for risk minimization
- h) Recommendations for transportation
- g) Warnings and precautions
- i) Any other particular condition of the equipment
- Preferably, the instructions for use should be following the labeling principles for medical devices indicated in IMDRF / GRRP WG / N52 FINAL: 2019
- All supporting documentation, operation, service, and user manuals must be presented in the official language of the country in which the equipment will be used.
Item 4: Technical information
- Brand and model
Requested Specifications:
- Ventilation modes
- Pressure regulated volume control (PRVC), or similar.
- Pressure control ventilation (PCV)
- Volume control ventilation (VCV)
- Synchronized intermittent mandatory ventilation (SIMV)
- Pressure support ventilation (PSV)
- Non-Invasive ventilation capability
- Monitored and controlled parameters (by user)
- FiO2: 21% - 100%
- Tidal Volume: 20 - 1000 mL, ideally
- Air and externally supplied oxygen mixture ratios fully controllable.
- Inspiratory pressure: 0 – 40 [cmH2O];
- I:E ratio;
- RR: 10 to 60 [breaths/min], minimum
- Displayed parameters (colour and graphic are preferable)
- Display easily readable in low ambient light and sunlight
- Real-time scalar waveforms for flow, volume and pressure at least 2 simultaneously.
- Inspiration and expiration times.
- Status indicators for ventilator mode, battery status, patient data, alarm settings.
- FiO2.
- Airway pressures (Peak, Mean and PEEP).
- Tidal volume (Expired).
- Minute volume (expired, spontaneous).
- Air and oxygen pressure;
- Occlusion pressure detection;
- I:E ratio. RR.
- Spontaneous ventilation
- Leak percentage.
- Alarms, related to gas delivered
- High/Low FiO2;
- High/Low Inspiratory pressure;
- High/Low Flow;
- Apnoea;
- Breathing circuit disconnect.
- Alarms, related to equipment operation
- Gas supply failure;
- Power failure;
- Low battery.
- Self-diagnostics failure alarm.
- Consumables labeled “single-use”
- Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of the outside diameter.
- Bacterial/Viral filters.
- Exhaled gas filter
- Accessories, reusable
- Breathing circuits: double-limb with standard outlet/inlet connectors with 22 mm of outside diameter. Expiratory housing with in-built bacteria filters.
- Exhalation valve.
- CO2 sensors, preferable
- Internal air compressor capacity (or high-performance turbines).
- Standard connectors to air and oxygen wall pipelines.
- Portability
- Portable equipment with mechanical strength to lever rough handling.
- Power supply and battery
- Able to operate from AC power electric line: 100 to 240 V~ / 50 to 60 Hz.
- In-built rechargeable battery.
- Automatic switch from AC power electric-line mode to the battery operating mode and vice versa.
- Continuous in battery operating mode with standard ventilation, not less than 4 hours.
- Total re-charging time not greater than 6 hours.
Item 5: Labeling and user manuals
Complete the information of the equipment according to the following structure:
- The supplier must provide information on labeling, including:
- a) Instructions for use
- b) Training material
- c) Service manual
- d) Technical description of the equipment
- e) Intended use
- f) Any other material with instructions for the clinical user and technical personnel."
- Present documentation that identifies at least:
- a) Brand and commercial name of the ventilator
- b) Product model or reference
- c) Catalog number
- f) Manufacturer contact information
- g) Recommendations for risk minimization
- h) Recommendations for transportation
- g) Warnings and precautions
- i) Any other particular condition of the equipment
- Preferably, the instructions for use should be following the labeling principles for medical devices indicated in IMDRF / GRRP WG / N52 FINAL: 2019
- All supporting documentation, operation, service, and user manuals must be presented in the official language of the country in which the equipment will be used.
Right to share information with PAHO Member States
PAHO, at its sole discretion, may share with the corresponding National Regulatory Authorities from the recipient country, documents from the technical proposal or other documents and data requested for clarification or to resolve any potential claims or inquiries.