Update: 8 April 2020 'Commonwealth Government taskforce' with addition of the Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020

The COVID-19 pandemic has caused disruption in health systems all over the world. It is anticipated that there will be a surge in the number of patients requiring respiratory support, and there may be a shortfall in the number of devices available, that are intended to ventilate these patients.

There are significant concerns regarding the availability of intensive care unit (ICU) ventilators to meet potential needs and the Therapeutic Goods Administration (TGA) has been involved in exploring ways to further increase supply of ventilators when and where they are needed. This has included the recent expedited premarket approval of new ventilator devices. This information is provided in response to anticipated requests regarding what other options may be available for use, to supplement available ventilator capacity.

Off-label use and modifications may be applied to ventilators, anaesthesia gas machines and other devices intended for respiratory support, in response to the COVID-19 pandemic. Although inclusion on the Australian Register of Therapeutic Goods (ARTG) is required for a medical device to be lawfully supplied, the TGA takes a proactive stance with respect to repurposing of alternative devices (such as veterinary devices) and rapid establishment of new manufacturing capability.

Additionally, a Commonwealth Government taskforce has been working to identify domestic manufacturing capability of these devices. Australia's Chief Scientist, Dr Alan Finkel, has led these efforts and, with support from an expert panel of ICU clinicians from across Australia, has compiled Ventilator for COVID-19 use in Australia. This document details minimum technical requirements for invasive ventilators that would be suitable for supply to and use in Australian hospitals when approved devices are not available during the COVID-19 emergency. The specification was prepared in consultation with the TGA and serves as a guide to domestic manufacturers seeking to support Australia's efforts in managing the COVID-19 emergency. The specification is referenced in the Therapeutic Goods (Medical Devices - Ventilators) (COVID-19 Emergency) Exemption 2020 to enable the lawful manufacture and supply of ventilators manufactured in accordance with the specification in Australia. This requires written permission from the TGA, following review of testing and risk management documentation. Additional information for manufacturers on the exemption instrument, together with testing and other requirements have been published. It remains preferable that when it is possible, health care facilities should use approved conventional full-featured ventilators when necessary to support patients with respiratory failure.

The TGA believes that modifications would not create undue risks in the following scenarios:

• The use of emergency ventilators and anaesthesia gas machines for patients needing mechanical ventilation:
  • While an anaesthesia device has a ventilator within it, the overall device is not the same as an ICU ventilator, and it is critical to understand the differences in order to minimise risks to patients.
  • The risks of an anaesthesia device used for ICU ventilation may be significantly greater for paediatric or neonatal patients. Such use is strongly discouraged.
• The use of ventilators outside their intended situation of use (for example, use of a ventilator in a health care facility when it is only intended for use at home or during transport);
• The use of devices indicated for sleep apnoea (including non-continuous ventilators delivering continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP)) to treat patients with respiratory insufficiency, provided that appropriate mitigations are in place to minimise aerosolization;
• The use of oxygen concentrators for primary supply when medically necessary and clinically appropriate.

In such scenarios it is recommended suppliers / manufacturers are contacted for information on how best to use these devices, so that clinicians may make informed decisions about which patients they provide a suitable alternative for.

The proposed use of ventilator alternatives would be for short-term stabilisation (hours to days). Ideally, these would be able to function as a broader function ventilator which could support a patient for a number of days, when more advanced ventilatory support becomes necessary.

Important facts to consider when using any device for respiratory support:

• Evidence suggests that NIV (non-invasive ventilation) and HFNO (high flow nasal oxygen) should not be used when the patient has severe respiratory failure suggesting that invasive ventilation is inevitable. In these circumstances, patients should be transitioned to intubation and invasive ventilation without delay.
• The potential advantages of using HFNO and NIV need to be balanced against the risk of virus aerosolization. It should be assumed that NIV and HFNO are aerosol generating. Patients receiving these therapies should be cared for in airborne isolation rooms and staff should wear full personal protective equipment (PPE) (including N95/P2 masks) while in the patient's room.
• Clinicians considering use of the above alternative strategies during the pandemic must weigh the risks and benefits, ensuring proper training and safe handling of the devices. Manufacturers and suppliers should be contacted to obtain best information to support this.

Should components and breathing circuit supplies related to ventilators and anaesthesia gas machines be in short supply, strategies such as extension of the shelf life and duration of use should be considered. The duration of use of passive humidifiers (heat-moisture exchangers) may be considered to be extended for up to one week based on patient condition and available resources. The TGA strongly advises caution when considering alternatives or undertaking modifications to manufacturer approved breathing circuit supplies and components.

Note of caution on use of universal ventilators

Health professionals are advised to exercise caution when using universal ventilators for the following reasons:

• Universal ventilators may not be suitable for all patient groups, particularly newborns (neonates). Health professionals should exercise caution when ventilating neonates with a universal ventilator. These devices should not be the first choice of ventilator if a specialised ventilator is available.
• Instructions for Use for universal ventilators may not contain critical information, such as:
  • the delivery or setting range the ventilator was tested at during verification of the device.
  • the intended patient cohort for the device based on the range that was tested during verification of the device.
  • information regarding validation of accessories.
  • information regarding the lifespan of reusable accessories.

For further information

• Contact the device manufacturer or review the manufacturer website for guidance regarding labelling and usage.
• Contact the appropriate professional societies for up-to-date information:
  • Australian Society of Anaesthetists - www.asa.org.au
  • Safe Airway Society (SAS), Australia and New Zealand - www.safeairwaysociety.org
  • Australian and New Zealand Intensive Care Society (ANZICS) - www.anzics.com.au

Reporting adverse events

• The TGA encourages health care providers to report any adverse events or suspected adverse events experienced with ventilators.

  https://www.tga.gov.au/reporting-problems

• Prompt reporting of adverse events can help the TGA identify and better understand the risks associated with medical devices.

References

https://www.tga.gov.au/ventilator-covid-19-use-australia

https://www.fda.gov/medical-devices/letters-health-care-providers/ventilator-supply-mitigation-strategies-letter-health-care-providers

https://www.mja.com.au/journal/2020/212/10/consensus-statement-safe-airway-society-principles-airway-management-and

https://www.gov.uk/government/publications/coronavirus-covid-19-ventilator-supply-specification/rapidly-manufactured-ventilator-system-specification