The Therapeutic Goods Administration (TGA) is aware of the recent report of a death of a child overseas. The death has been found to have been caused by a fire that occurred during the use of a hyperbaric chamber device.
No similar events have been reported in Australia for devices included in the Australian Register of Therapeutic Goods (ARTG). However, the TGA is issuing this advisory as a precaution.
Healthcare professionals are reminded of the critical importance of strictly following the Instructions for Use (IFU) provided with these devices, to ensure their safe operation. Consumers are strongly urged to seek treatment only from qualified healthcare professionals, appropriately trained in the use of hyperbaric chamber devices.
Hyperbaric oxygen therapy (HBOT) is a treatment where the air pressure in a special chamber is increased to create an environment with very high oxygen content. This can support healing and recovery and treat certain medical conditions, such as decompression sickness. It can also promote wound and tissue healing in certain circumstances.
These devices should only be used under the care of a trained healthcare professional.
The high concentrations of oxygen used in hyperbaric chambers can create highly flammable environments. The US FDA recently issued a statement urging healthcare providers to Follow Instructions for Safe Use of Hyperbaric Oxygen Therapy Devices.
The TGA will continue to monitor these devices through published literature, adverse event reporting and other emerging evidence.
As and when safety concerns or performance issues arise, the TGA may initiate further investigation.
Information for consumers
- Do not purchase a hyperbaric chamber for use at home.
- Hyperbaric chamber devices should only be used by qualified healthcare professionals in clinics that are properly equipped and authorised to deliver this specialised therapy. This helps to ensure that the equipment is used correctly, and that patients receive appropriate and safe care.
- If you have any concerns relating to HBOT or hyperbaric chamber devices, it is recommended that you seek further advice from your doctor.
Additional safety information for healthcare professionals
- Healthcare professionals are advised to read the manufacturer’s instructions for use carefully for any hyperbaric chamber devices being used. These devices should only be used in strict accordance with these instructions.
- Patients should be informed of the potential risks associated with hyperbaric chambers prior to commencing use of these devices.
- Patients should be closely monitored by a trained healthcare professional at all times whilst using a hyperbaric chamber device.
- All staff involved in the use of hyperbaric chamber devices should be adequately trained in their use, and maintain a full understanding of the associated risks, particularly around electrical safety and fire prevention and management.
- Appropriate safety measures should be in place, particularly around fire prevention. These may include:
- the use of proper grounding equipment to reduce the risk of static electricity build up, and
- Ensuring that patients are wearing clothing materials that are compatible with the use of hyperbaric chamber devices, as per manufacturer’s instructions. Cotton is generally preferred, as materials such as wool or polyester may produce more static electricity.
Reporting problems
We strongly encourage consumers and health professionals to report problems with medical devices. These reports will contribute to the TGA's monitoring of these products. See the TGA Incident Reporting and Investigation Scheme (IRIS).
The TGA cannot give advice about an individual's medical condition or treatment. You are strongly encouraged to talk with a health professional if you are concerned about a possible adverse event associated with a medical device.
If you have concerns about a product’s compliance with TGA’s requirements, you can report these concerns using the Report a perceived breach or questionable practices form.