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Ventilators permitted for supply under COVID-19 Emergency Exemption

20 November 2020

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.