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.
- EvolutTM PRO+34mm Transcatheter Aortic Valve (TAV)Medtronic Australasia is informing customers about the serious risk of valve infolding for EvolutePRO+ 34mm Transcatheter Aortic Valve (TAV), item code - EVPROPLUS-34US.
- FreeStyle LibreLink Android AppUsers may experience extended periods of signal loss and during this time they won’t receive high or low glucose alarms.
- Updated information for repaired Philips Respironics Trilogy 100 devicesPhilips Respironics (the manufacturer) detected two problems with corrected Trilogy 100 ventilators
- Changes to medical device essential principles for nanomaterialsEssential 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.
- Acellular dermal matrix products used in breast reconstructionAcellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.
- Progress update: Improving post-market monitoring and surveillance of medical devicesIn 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.
- Progress report: Australian Government response to the Senate Community Affairs References Committee reportOn Monday, 2 December 2019, a TGA Progress Report to the Senate Mesh Inquiry was tabled in the Senate