The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device regulation, issued guidance highlighting the performance requirements applicable to ventilators used in Australia during the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” The outbreak has resulted in increased demand for ventilators due to the respiratory illnesses and complications caused by the virus. The scope of the document covers the ventilators used for adult patients except those having complex responses when special devices should be used. It is also important to mention that rules and requirements set forth by the present specification should not be applied to devices already approved to be marketed and used in Australia. The administration also emphasizes the importance of using any complex medical equipment, such as ventilators, by experienced and properly trained healthcare professionals.
TGA Requirements on Features of Ventilators
The TGA describes the minimal requirements that the device should meet in order to be allowed for marketing and use in Australia. First of all, the guidance outlines the features of the ventilator that should be approved in order to be used for its intended purpose. The list of the features the document contains includes, inter alia, the following ones:
- Mandatory ventilation. The device should allow healthcare professionals to set a respiratory rate and a tidal volume. The ventilator should also provide the possibility to switch between pressure-controlled ventilation (PCV) and volume-controlled ventilation (VCV).
- Positive and expiratory pressure (PEEP) should be adjustable in steps of 2cm H2O or smaller, provided the general range is 5 – 25 cm H2O.
- Respiratory rate should be adjustable in steps of 2 or less with a general range of 5 – 30 breaths per minute.
- Tidal volume should be adjustable in steps of 50 ml or less, with the time-varying from 0.5 to 2 seconds.
- Displays should provide information on settings of inspiratory time, frequency, Vt (tidal volume), PEEP, and ventilation mode. It is also allowed to use mechanical displays on control devices.
- Alarms. The ventilator should generate alarms in case of failure of electricity or gas supply, switching off the machine when connected to a patient, and in other cases prescribed by specification.
Besides technical and operational requirements described by the TGA, the device should also meet the following additional requirements:
- The labeling of the devices should contain information about all functions and controls provided in generally accepted terms and pictograms,
- The device should be supplied with the detailed instructions for use providing healthcare professionals using it with the exhaustive information necessary to ensure the safety and performance of the device as intended by the manufacturer, and also the recommendations on fixing possible errors and malfunctions,
- The design of the device, its manufacturing process, and supply chain should be transparent enough for the regulating authority to access its reliability,
- The construction of the device should provide the possibility to move it,
- It should be possible to perform general cleaning and disinfection procedures applicable to the devices of this type,
- All disposable elements and spare parts should be available in Australia (this requirement is especially important due to the freight movement restrictions imposed nowadays).
The guidance issued by the TGA also provides detailed requirements on raw materials to be used, the manufacturing process and the hazard mitigation measures to be applied by the manufacturer to reduce the identified potential risks. These requirements include the following ones:
- The materials used should be simple and pure when reasonably possible.
- It is recommended to use polyethylene and polypropylene as materials for flexible components.
- The use of additives should be avoided to the maximum extent possible.
- The use of polyvinyl chloride (PVC) should be avoided, especially for the patient gas pathway.
- Ventilators should be manufactured in a reasonably clean room while it is not required to comply with the cleanroom specifications.
- The design of the device should provide HME filters placed between the ventilator and breathing system to avoid contacting with the chemicals removed from the device during its use.
It is also stated that ventilators should meet the requirements set forth in the applicable guidelines issued by the Medicines and Healthcare products Regulatory Agency (MHRA), the UK regulating authority. In particular, the guidelines on testing protocols for final validation of safety and performance of RVMS should be applied, including the appropriate appendix thereto concerning the software that could be determined as a medical device.
Ventilators’ Desirable Features
Besides the mandatory features and requirements described by the TGA, the guidance also provides a list of additional features the authority recommends implementing. The list of recommended features includes the following ones:
- Spontaneous ventilation. Depending on whether the patient starts to breathe in or breathe out, the device should automatically switch between the inspiratory pressure and expiratory pressure. At the same time, if the patient stops breathing in pressure support mode, the device should automatically switch to mandatory ventilation mode.
- Synchronized mandatory ventilation – special mode providing that the device synchronizes the mandatory ventilation to the efforts made by the patient. The device should also provide support for patients attempting to breathe themselves.
- Exhalation filters. It is advised to use removable elements to simplify cleaning and disinfection procedures.
- Batteries should allow the device to be used for 2 hours.
- Displays. The device should display the confirmation of each patient breath when operating in pressure support mode, and also notify healthcare professionals when it becomes below the acceptable range.
The TGA guidance also outlines the applicable international harmonized standards the device should meet, including the following ones:
- ISO 10651-3:1997 Lung Ventilators for Medical Use – Emergency and Transport.
- ISO 80601-2-84:2018 Medical electrical equipment.
- ISO 19223:2019 Lund ventilators and related equipment.
- AS 2896-2011 Medical gas systems – Installation and testing of non-flammable medical gas pipeline systems.
- IEC 60601-1-11:2015 Medical electrical equipment – General requirements for basic safety and essential performance.
- IEC 62353:2014 Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment.
Summarizing the information provided, the guidance issued by the Australian TGA describes the minimum requirements ventilators should meet in order to be allowed to be placed on the market, and also the additional features and functions the authority recommends implementing to improve the safety and performance of the devices. The document also provides a list of applicable standards medical device manufacturers could refer to with regard to the design and composition of the devices. By issuing the present specification, the authority intends to find a balance between ensuring the highest level of patients` health protection and making ventilators available in Australia in the amount sufficient to meet the increased demand these devices face nowadays due to the respiratory illnesses and complications caused by the COVID-19.
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