The Australian Therapeutic Goods Administration (TGA) has posted a medical device safety alert concerning Breath-A-Tech (Standard and Hospital Grade) Spacers, manufactured by Medical Developments International Limited.

According to the TGA, the Instructions for Use (IFU) included with these devices has been updated with additional instructions for checking that the valve is sitting flat and for correct device assembly prior to use. There is a risk of valve deformity or dislodgement if the devices are assembled incorrectly.

The manufacturer is advising affected users that updated IFUs will be available with new devices distributed from January 2020. Existing users are advised to retain a copy of the Customer Letter with their device IFU and take note of the following specific instructions:

• Always take care to assemble the device correctly.
• Check for foreign objects and broken deteriorated parts.
• Replace the Breath-A-Tech Spacer immediately if any damaged or missing parts are evident.
• Never use a defective valve.
• Check that the valve is sitting flat and not twisted or deformed.
• When fitting in the valve, ensure the 4 pegs on the Chamber are lined up with the 4 holes in the valve.
• A deformed valve may indicate that the mouthpiece has been screwed on too tightly.
• Visually inspect the valve and the rest of the device before and after each use.
• There is a risk of the valve being dislodged if these steps are not always be followed.

For details, please refer to the following link:
https://apps.tga.gov.au/PROD/SARA/arn-detail.aspx?k=RC-2020-RN-00041-1

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 5 February 2020