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.
- Find out about a software problem with the SmartDrive MX2+ App, for the PushTracker E2 and E3 wearable watches, causing safety issues for operating manual wheelchairs.
- Be alert to an issue affecting all units of the Scandinavian Total Ankle Replacement (STAR) Ankle Prosthesis supplied in the Australian market.
- Medtronic Australasia is informing customers about the serious risk of valve infolding for EvolutePRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.
- Check the labels of all medicines and medical devices, including those you buy without a doctor’s prescription.
- Essential principle 7 now mentions nanomaterials explicitly (see EP 7.7)
- Philips’ recall action for sleep apnoea and respiratory care machines – have you registered for a replacement?The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are affected by the recall action.
- 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.