Healthcare facilities are currently seeking to expand their ventilator capacity in order to manage COVID-19 related patient care. Ideally, devices should be used for the purpose the manufacturer intended. Ventilators should be commercially available medical devices that are currently included in the Australian Register of Therapeutic Goods (ARTG) with an intended purpose of invasive ventilation of patients in an intensive care unit (ICU) environment.

The following information seeks to provide guidance to healthcare facilities that may assist with sourcing additional equipment to treat patients in the event of a shortage of ventilators and other respiratory support devices, and builds on COVID-19 information for clinicians on ventilators and alternative strategies when in short supply.

This guidance includes information about:

• Alternatives to purpose made ICU ventilators
• Other devices intended for respiratory support
• Domestically manufactured invasive ventilators for use during the COVID-19 pandemic.
• Other unapproved devices (and accessories) intended for respiratory support
• Advice for use of alternative devices for respiratory support

Alternatives to purpose made ICU ventilators

Purpose made ICU ventilators are invasive devices that require a tube to be inserted into the patient's airway and connected to a ventilator. These devices require:

• trained nursing staff to provide 24-hour care;
• personal protective equipment (PPE) for nursing staff;
• access to consumable products such as tubes and filters; and
• access to support infrastructure including ICU beds and oxygen delivery systems.

There are additional sources of purpose-made ICU ventilators other than new devices sold by sponsors (the person or company legally responsible for a device). Healthcare facilities may consider the following options:

• Recommissioning retired ventilators: provided ventilators were included in the ARTG when they were initially supplied, and the performance of the ventilator can be confirmed according to the manufacturer's instructions.
• Imported ventilators: ventilators which have not been included in the ARTG, but have been approved by comparable overseas regulators, may seek expedited processing by the TGA for ARTG inclusion and supply within Australia.
• Ventilators that have been used for alternative purposes: in some cases ventilators approved for use on humans which have been used for other purposes, such as in veterinary practice, may be used.

• Splitting existing ventilators between patients: The TGA is aware of reports in other countries of use of one ventilator for more than one patient in extreme circumstances when ventilators are in short supply.

Other devices intended for respiratory support

When a healthcare facility does not have enough ICU ventilators to treat all patients, alternative, similar devices may be used. When devices are used in a manner not intended by the manufacturer this is sometimes referred to as "off-label" use. Devices used in this manner require different monitoring, maintenance and calibration processes, which need to be clarified with the manufacturer where possible.

These other devices may include:

These devices can also be adapted or modified to enable invasive ventilation, although these kinds of changes would alter the manufacturer's intended purpose and therefore qualify as "off-label" use.

• Anaesthetic machines or transport ventilators intended for invasive ventilation: Although these types of devices have some significant differences to ICU ventilators, including the intended duration of their uninterrupted use, there are many mechanical similarities that mean these devices may be used instead of an ICU ventilator.

  The following will be required when using anaesthetic machines:

  • Monitoring of carbon dioxide levels in the breathing system: Anaesthesia machines have a carbon dioxide absorber which needs to be regularly replaced or replenished whereas ICU ventilators do not.
  • Regularly checking of condensate build-up: Most ICU ventilators include advanced condensate management, anaesthesia machines do not.
  • Monitoring for drops in pressure when suctioning: ICU ventilators have auto compensation when inline suction is used, as this can exacerbate atelectasis. Anaesthesia machines do not have this mechanism.
• Non-invasive ventilator devices including CPAP and Bi-level PAP (BPAP) machines: clinical evidence from the treatment of COVID-19 patients indicates that the use of non-invasive ventilation can be effective in forestalling the need for intubation, thereby reducing the need for invasive mechanical ventilation. CPAP and BPAP machines have been successfully utilised in some cases to treat patients with less severe symptoms. The advantage of using these devices are:
  • they require less support from trained healthcare practitioners than invasive ventilators;
  • they can be used in the home as well as the hospital; and
  • there are a number of these devices available in the community that may not currently be in use.

Domestically manufactured invasive ventilators for use during the COVID-19 pandemic

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.

Other unapproved devices (and accessories) to provide respiratory support

Additional, unapproved devices and/or accessories (including consumables and components) may be available to clinicians that can be used to provide respiratory support to patients, which are not subject to any specific exemption and cannot be included on the ARTG. The Therapeutic Goods (Medical Devices) Regulations 2002 permit clinicians to exercise discretion in using unapproved medical devices under the following exemptions:

• Clinical Trials. An unapproved medical device may be used in a clinical investigation study approved by a Human Research Ethics Committee (HREC) without review from the TGA through the Clinical Trial Notification scheme.
• Special Access Scheme. Health practitioners may use an unapproved medical device on any patient with a condition that is reasonably likely to lead to the person's death within less than a year under Category A of the Scheme. Health practitioners will need to submit a Category A notification form to the TGA within 28 days of using the device if their patient meets this criteria.
• Authorised Prescriber Scheme. The Scheme allows approved medical practitioners to prescribe unapproved therapeutic goods for a particular condition or class of patients in their immediate care without further TGA approval. Practitioners require approval of a HREC or a specialist college before the TGA can approve them as an authorised prescriber. Once approval is received, authorised prescribers are required to report the number of patients for whom the product is prescribed on a six-monthly basis to the TGA.

Advice for use of alternative devices and "off-label" use of devices for respiratory support

If you are intending to source and use alternative devices, or modify existing devices for an alternative purpose, in place of an ARTG-included device, we recommend the following:

• Undertake an appropriate risk evaluation and document the reason for utilising the alternative device.
• Undertake training and familiarise yourself with all aspects and unique performance characteristics of the device.
• Seek information from the manufacturer to determine:
  • whether they have information about the performance of the device when used in the manner you are intending; and
  • if there is any information relating to the maintenance/testing/calibration for the device when used in the manner you are intending.
• Report all adverse events to the TGA.

Further information

More information about the use of these devices in circumstances other than those outlined in the Instructions for Use for the device may be found:

• On the manufacturer's website.
• From appropriate professional societies including:
  • Australian Society of Anaesthetists
  • Safe Airway Society (SAS), Australia and New Zealand
  • Australian and New Zealand Intensive Care Society (ANZICS)
  • APSF/ASA Guidance on Purposing Anesthesia Machines as ICU Ventilators