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Australia Will Introduce Patient Cards for Implantable Devices
Devices Regulatory Affairs
Australia’s Therapeutic Goods Administration is getting ready to introduce patient cards and consumer device information for all permanently implanted medical devices.
The TGA will introduce the cards in a staged approach beginning with urogynecological mesh devices on Dec. 1.
The move to require patient cards came in response to consumer concerns about the limited information provided with devices implanted during surgery. The agency said devicemakers must:
- Identify hazards and associated risks arising from the use of their device for its intended purpose and foreseeable misuse of the device;
- Eliminate or reduce risks as much as possible by adopting a policy of safe design and construction;
- If appropriate, ensure that adequate protection measures are taken, including alarms for risks that cannot be eliminated; and
- Inform users of any residual risks that may arise due to shortcomings of the protective measures adopted.