Patient implant cards and information leaflets

Every patient getting an implantable medical device or an active implant needs a patient implant card and information leaflet. These materials help patients have informed conversations with their healthcare practitioner and understand their implantable medical device. It is also a record of the medical device that has been implanted.

Information on the card and leaflet:

• must be in English (but may also be in other languages),
• may include diagrams or drawings,
• be legible with characters at least 1 millimetre high,
• must be in writing and language the patient understands.

Patient implant cards and information leaflets can be hard copies or electronic. They must be accessible.

Cards and leaflets are not needed for a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article.

Patient implant cards

The patient must have a patient implant card that meets these requirements:

• name of the device
• model of the device
• batch code, lot number or serial number of the device
• unique device identifier of the device (if any), and
• manufacturer’s name, address, and website.

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 thinks patients will find helpful.

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).

My Health Record (MHR)

My Health Record (MHR) lets patients or providers add information from an implant card. 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.

Instructions for patients

Patients can add this information to MHR by creating a personal health note, as detailed on the Agency's website. Healthcare providers can't see a personal health note.

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. For example, such as in the event of an emergency.

Resources