Every patient getting an implantable medical device or an active implant must be provided with a patient information leaflet and implant card.
These materials help patients:
- have informed conversations with their healthcare practitioner
- understand their implantable medical device
- keep a record of the medical device that has been implanted.
These materials can also help when reporting an adverse event or responding to a recall or safety update.
Information on the leaflet and card:
- must be in English, but may also be in other languages
- may include diagrams or drawings
- must be legible, with characters at least one millimetre high
- must be in writing and language the patient understands.
Patient information leaflets and implant cards may be provided in hard copy or electronic format. They must be accessible.
Leaflets and cards are not needed for a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article.
Patient information leaflets
Patient information leaflets must meet the following requirements.
The leaflet must include:
- information identifying the device, or the kind of device
- the intended purpose of the device
- information explaining how to use the device safely, and
- other information the manufacture considers helpful for patients.
In particular, the leaflet must include:
- the name and model of the device
- its purpose and the kind of patient it's intended for
- any special operating instructions for the use of the device
- the intended performance of the device and any side effects that could occur
- residual risks from any shortcomings in the protection measures
- warnings about risks that could arise from the interaction of the device with other equipment (for example risk of electrical interference from electro-surgical devices, or magnetic field interference from magnetic resonance imaging devices),
- precautions and other measures that, because of those risks, should be taken by the patient or a health professional
- how often the device and patient should be examined, monitored, or maintained
- device's expected lifetime: anything that could shorten or lengthen it; precautions and other measures to take at, or near, the end of its expected lifetime
- when the patient should see a health professional about the device
- list of the materials and substances in the device, and any manufacturing residuals that could be harmful, and
- a notice that any serious incident involving the device should be reported to the manufacturer and to the TGA (the TGA's website address).
Patient implant cards
Patient implant card must meet the following requirements.
The implant card must include:
- the name of the device
- the model of the device
- the batch code, lot number or serial number of the device
- the manufacturer’s name, address, and website.
For devices that are subject to Unique Device Identification (UDI) requirements, the patient implant card must also include:
- the full UDI, including both the UDI-Device Identifier (UDI-DI) and the UDI-Production Identifier (UDI-PI) in a machine-readable format such as a barcode or other Automatic Identification and Data Capture (AIDC) format
- the UDI-DI in Human Readable Interpretation (HRI) format so it can be read without any scanning equipment.
For more information on UDI, see: 'Patient Implant Cards' on our UDI and other TGA processes or activities page.
My Health Record (MHR)
My Health Record (MHR) allows patients or healthcare providers to record information about implanted devices. Patients can register for My Health Record online at the Australian Digital Health Agency (the Agency) website at any time, if they do not have one already.
State-based Digital Health Records
Many Australian states and territories have implemented state-based Digital Health Records. Some of these systems can also record information about implanted devices.
Instructions for healthcare providers
Healthcare providers can add an Event Summary to the patient’s MHR, detailed on the Agency's website.
All healthcare providers involved in the patient's care can see this information, including in emergency situations.
It is expected that the healthcare provider will work with the medical device’s Australian representative (the sponsor) to ensure patients have access to patient information materials. Patients can be provided with PILs and PICs by health professionals, hospitals, or they can be direct to the sponsor of the medical device to access these materials.
If a patient loses their patient implant card and the information has not been added to their state-based Digital Health Record or MHR, the healthcare provider may be able to help retrieve the implant details or arrange a replacement card. This may be done using the healthcare provider’s records or by assisting the patient to obtain the information from the sponsor.
Instructions for patients
Patients should keep their patient implant card somewhere safe and easy to access. We also recommend taking a photo of your patient implant card in case the original is lost or misplaced.
Patients can add implant information to MHR by creating a personal health note, as outlined on the Agency's website. Personal health notes can only be viewed by the patient and cannot be accessed by healthcare providers.
If a patient loses their patient implant card, they should check whether the implant information has been added to their state-based Digital Health Record or MHR. If the information is not available, patients can contact their healthcare provider or healthcare facility where the device was implanted. They may be able to provide the implant details or help obtain a replacement card.