Medical devices safety
The safety and performance of medical devices is continuously monitored. Approved devices must continue to meet all the requirements of their approval.
- Testing indicates the presence of Ralstonia pickettii in saline products manufactured by Legency Remedies Private. As a precaution, Aerowash Eyewash and Wound Irrigation ampoules are being recalled in Australia.
- Safety alert and product recalls: updated advice following Ralstonia pickettii contamination of some saline productsWe're continuing to investigate and take action on the potential contamination of some saline products with Ralstonia pickettii. Read about the latest round of product recalls.
- Philips’ recall action for sleep apnoea and respiratory care machines – Final chance to register for a replacement deviceIf you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.
- It's #MedSafetyWeek, a global movement to encourage the reporting of medicine side effects (known as ‘adverse events’). You can join in and help spread the word.
- We have issued infringement notices totalling $82,632 to Ovira Pty Ltd, and an individual, for the alleged unlawful advertising of an analgesic TENS system.
- The TGA is working with the Australian Commission on Safety and Quality in Health Care and Australian hospitals, peak bodies, and state, and territory governments to improve and increase rapid information sharing about medical device safety and effectiveness
- In the past 12-18 months, the TGA has implemented a number of changes in an effort to increase and improve post-market monitoring and surveillance activities
- Final Report on the Australian Government Response to the Recommendations of the Senate Community Affairs References Committee ReportThe Australian Government remains committed to the safety, health and wellbeing of all Australians.