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Ventilators permitted for supply under COVID-19 Emergency Exemption

31 January 2021

Update

The Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020 (the exemption) commenced on 8 April 2020 and remained in force until 31 January 2021. The exemption enabled ventilators manufactured in Australia to minimum technical requirements to be supplied to hospitals in Australia, without having to meet certain requirements under the Therapeutic Goods Act 1989 (the Act). Ventilators supplied to hospitals under the exemption were not TGA approved. The exemption was made to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to medical devices to treat patients requiring invasive ventilation. The exemption has now ceased. Ventilators manufactured under the exemption are no longer permitted to be supplied to Australian hospitals.

Hospitals may continue to use ventilators acquired under the exemption, noting it is the responsibility of hospital management to consider how and where to use these ventilators, considering their limitations.

Principally, only ventilators that have been included on the Australian Register of Therapeutic Goods (ARTG) are permitted to be supplied in Australia, in accordance with the Act and the Therapeutic Goods (Medical Devices) Regulations 2002. Manufacturers should also follow guidance for manufacturing medical devices for COVID-19.

For more information regarding the Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020 please see exemption to enable the domestic manufacture and supply of ventilators.

On 8 April 2020 the Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020 was made to support the Australian Government's rapid response to the COVID-19 emergency by facilitating access to medical devices to treat patients requiring invasive ventilation. The exemption instrument remains in force until 31 January 2021. Manufacturers may not supply new ventilators after this date, but healthcare facilities may continue to use ventilators they have acquired under the exemption.

The following list is comprised of ventilators that meet the minimum requirements, as set out in Ventilator for COVID-19 use in Australia and have received permission to be supplied under the exemption to enable the domestic manufacture and supply of ventilators.

Note

Ventilators supplied under this exemption have not had their safety and performance fully tested or reviewed by the TGA. Any ventilator manufactured using the exemption should only be used when ventilators that have regulatory approval by the TGA (i.e. included in the ARTG) are not available.

Ventilators supplied under this exemption have not received 'regulatory approval' by the TGA and manufacturers must not make any representation to this extent. The TGA strongly recommends that any healthcare facilities needing to use these devices conduct their own performance and usability validation.

List of ventilators permitted for supply under COVID-19 Emergency Exemption

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Ventilator: Ventasys-E

Manufacturer: Ampcontrol CSM Pty Ltd, 21 Old Punt Road, Tomago NSW Australia 2322

TGA observations

The Ventasys-E is a pressure controlled ventilator, which additionally incorporates PC-SIMV mode (validation data for which has not been provided to the TGA).

EMC testing in compliance with IEC 60601-1-2 (or other applicable standard) has not been performed; users must consider implications on placement of these devices. Documentation regarding software architecture and design specification has not been provided to the TGA, although risk analysis, testing and validation has been demonstrated.

Closed suction testing was failed, though it was noted pressure drops were of short duration and did not result in negative pressure.

Two ventilators were tested for the 14-day duty cycle and performed as intended.

Ventilator: GeVentor GEV019-100

Manufacturer: Gekko Medical Pty Ltd, 323 Learmonth Road, Ballarat VIC Australia 3350

TGA observations

The GeVentor GEV019-100, delivers ventilation in the following modes: volume controlled ventilation, pressure controlled ventilation, suction mode and CPAP. It does not offer synchronised or spontaneous breathing modes.

EMC testing has been performed and certified to IEC 60601-1-2:2014; electrical safety testing has not been performed to a recognised standard for medical devices - purchasers may wish to discuss with the manufacturer.

Accuracy of the ventilation delivered may be compromised in cases of high airway resistance and low compliance; PEEP is maintained under closed suctioning. Accuracy of the delivered ventilation parameters measured by the ventilator and displayed on the HMI has not been validated. Alarms were noted during the 14-day duty-cycle test, of one ventilator, whose cause was not known, but these were noted to be of short duration and self-correcting.

Utility as a transport ventilator or in field hospitals may be limited by compressed gas requirements and its operation has not been tested in circumstances simulating handling in transit.

Ventilator: CoVida FC100

Manufacturer: Vestech Medical Pty Ltd, 275 Alfred Street North, North Sydney NSW 2060

TGA observations

The CoVida FC100 is a volume controlled ventilator that requires medical oxygen and medical air gas supply. The design of the device is based on an emergency and transport ventilator and is therefore only suitable for short term respiratory support. The device should only be used in a highly supervised care environment.

  • Clinicians should consider the limitations of the device including those as outlined in the Instructions For Use:
    • The device failed the 3 second closed suction test: PEEP was not maintained during closed suctioning.
    • The IFU for the device states that it may take 5 minutes for the beneficial effects of PEEP to be restored after closed suctioning, and during this time the patient should be closely monitored.
    • The device has adjustability of FiO2 between 50%-100%.
    • Accuracy of delivered tidal volume may be compromised at low lung compliance.
  • Full compliance with IEC 60601-1-2 has not been demonstrated for Electromagnetic Compatibility (EMC) of the device. Section 8.3.4 of the Instructions For Use (IFU) provide guidance on EMC requirements for the device. Clinical staff and clinicians must consider the implications for placement and use of these devices, i.e. during defibrillation.
  • In regards to the software and control systems of the device, the manufacturer has provided limited evidence of verification and validation of the ventilator control system. The ventilator should therefore only be used in a highly supervised care environment.
  • The manufacturer completed the 14 day duty cycle test on a single device.