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TGA product safety review
Update - TGA product safety review
18 December 2018
The Therapeutic Goods Administration (TGA) convened an expert working group in September 2018, with representatives from State and Territory Health Departments and professional colleges and societies, relating to intensive care ventilators. The Group discussed:
- the level of clinical awareness about the disparity in the perceived and actual accuracy in volume-targeted ventilation and the impact this may have on patient outcomes,
- opinion on clinically acceptable ventilation parameters for neonatal and paediatric patients,
- how the design of these devices may impact on useability of the devices (and who uses/monitors the devices), and
- the existing ISO standard with the view of identifying the benefits and impacts that could be realised with the implementation of an Australian Standard.
The Working Group will reconvene next year to further discuss the accuracy of specialist neonatal/paediatric ventilators in comparison to universal ventilators. The working group also indicated their support for the implementation of an Australian Standard.
TGA product safety review
30 April 2018
In June 2017, the TGA issued a monitoring communication regarding ventilators following reports of a range of issues. Some of the issues listed in the monitoring communication were:
- unresponsive touch screens when trying to change or check settings, particularly in alarm situations e.g., screen blank or freezing, on-screen buttons not functioning
- spontaneous unexplained shut down
- increased service alerts
- auto-cycling or auto-triggering (unintended ventilation)
- power off or on difficulties
- oxygen sensor malfunction
- issues related to software, interface usability, and capture of data.
The TGA issues monitoring communications to raise awareness among health care providers about certain medical devices and encourages health care providers to monitor for these types of issues and report any adverse events.
Concurrently, the TGA has been sourcing information nationally and internationally regarding the safety and performance of ventilators included in the Australian Register of Therapeutic Goods (ARTG).
Based on the information collected since June 2017, a product safety review is being undertaken by the TGA to assess these kinds of devices being used in the intensive care or high-level care environments.
The TGA has requested that sponsors provide the following information:
- evidence that the ventilators meet the ventilation delivery and monitoring specifications published in the Instructions For Use, which should include evidence that the breathing circuits recommended for use with this ventilator are valid
- for ventilators that are intended for use with paediatric patients, a clear clinical justification and validation of why tidal volume delivery specifications are acceptable and safe
- post-market data
- which breathing circuits are suitable for use with the ventilator.
The information requested is undergoing review and any regulatory action resulting from the review will be published.
Products included in the review
The TGA's review covers ventilators that are used in high-care hospital settings for long-term therapy of intubated patients. Such long-term use will normally be associated with integral or separate humidifiers. It does not include ventilators used only for transport or in home settings.
The review will initially examine 18 of the more commonly used ventilators, but more may be added over time.
The table below lists the 18 ventilators included in the initial stage of the review. This table will be updated if additional ventilators are added.
|158739||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Infinity Evita V500|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Evita V300|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Evita XL|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Evita 4 Edition|
|140966||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Carina|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Evita 2 Dura|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Savina 300|
|92177||Draeger Medical Australia Pty Ltd||Dragenwerk AG & Co kGaA||Savina|
|108358||GE Healthcare Australia Pty Ltd||Datex-Ohmeda||Carescape R860|
|162468||Getinge Australia Pty Ltd (previously Maquet Australia Pty Ltd)||Maquet Critical Care AB||Servo-u|
|162468||Getinge Australia Pty Ltd (previously Maquet Australia Pty Ltd)||Maquet Critical Care AB||Servo-i|
|221416||Medtronic Australasia Pty Ltd||Covidien IIc||PB980|
|182309||Medtronic Australasia Pty Ltd (prevoiusly Covidien Pty Ltd)||Covidien IIc||PB840|
|230065||Philips Electronics Australia Ltd||Respironics California Inc||V680|
|159490||Philips Electronics Australia Ltd||Respironics Inc||Trilogy 100|
|159490||Philips Electronics Australia Ltd||Respironics Inc||Trilogy 202|
|120573||Resmed Limited||ResMed Paris||Elisee 350|
|120573||Resmed Limited||ResMed Paris||Elisee 150|
Information for consumers
These ventilators are used only in intensive care units and other high-level care wards within hospitals.
If you or someone you provide care for is hospitalised and needs mechanical ventilation, please be aware that the health professionals who work in these areas are highly trained and have protocols to deal with the potential issues that may affect these devices where they are being used in the absence of alternatives.
If you have any questions or concerns about this issue, speak to the hospital staff.
Information for hospitals and health professionals
The TGA advises that the devices can continue to be used while the product safety review is being conducted.
If information becomes available which indicates that the ventilators should not be used, the TGA will ensure that hospitals and health professionals are promptly notified.
Health professionals are encouraged to report any adverse events with these devices, especially those identified above.
In addition to adverse events involving ventilators, consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information see the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.