Patient implant cards and information leaflets

Since 1 December 2021 manufacturers of all new implantable medical devices (other than those exempted) have been required to provide patient implant cards and have a patient information leaflet in the TGA approved format.

Patient implant cards and patient information leaflets (collectively known as patient information materials) help patients have informed conversations with their health professional and understand their implantable medical device. They include important information about the device, such as risks, how to safely use and maintain it, and who to contact if patients are concerned.

Patient implant cards and patient information leaflets are required for a medical device that is:

• an implantable medical device or an active implantable medical device, and
• not a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article.

Information on the card and leaflet must be included in English (but may also be in other languages). The information may also include diagrams or drawings. Any number, letter, symbol, or letter or number in a symbol, used in a patient implant card or patient information leaflet must be legible and at least 1 millimetre high.

Patient implant cards for implantable devices

A patient implant card that meets the following requirements must be provided to the patient:

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

Patient information leaflets for implantable devices

A patient information leaflet that meets the following requirements must be provided to the patient:

The leaflet must include the following information:

• 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 about the device that the manufacture considers would be useful for patients.

In particular, the leaflet must include:

• the name and model of the device
• the intended purpose of the device and the kind of patient on whom the device is intended to be used
• any special operating instructions for the use of the device
• the intended performance of the device and any undesirable side effects that could be caused by use of the device
• any residual risks that could arise due to any shortcomings of the protection measures adopted
• warnings about risks that could arise from the interaction of the device with other equipment (eg risk of electrical interference from electro-surgical devices, or magnetic field interference from magnetic resonance imaging devices), and precautions and other measures that, because of those risks, should be taken by the patient or a health professional
• the nature and frequency of regular or preventative examination, monitoring or maintenance of the device that should be undertaken; symptoms that could indicate that the device is malfunctioning; precautions and other measures that should be taken by the patient if the performance of the device changes or the patient experiences any of the symptoms
• the expected device lifetime; anything that could shorten or lengthen the device lifetime; precautions and other measures that should be taken at, or near, the end of the expected device lifetime
• other circumstances in which the patient should contact a health professional in relation to the operation of the device
• the materials and substances included in the device, and any manufacturing residuals that could pose a risk to the patient, and
• a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and the address of the Therapeutic Goods Administration's website.

The information in the leaflet must be written in a way that is readily understood by patients.

Patient implant cards and information leaflets can be supplied in hard copy or electronic format, but must be readily accessible.

Adding information from the patient implant card to electronic health records

Patients or healthcare providers can add information from the patient implant card on My Health Record (MHR).

• Patients can add this information to MHR by creating a personal health note. A personal health note is a private health note about the patient’s health, which cannot be seen by healthcare providers.
• Healthcare providers can add an Event Summary to the patient’s MHR. The information on the patient implant card can be added to the ‘event details’ section, which can be viewed by other healthcare providers involved in the patient’s care, such as in the event of an emergency.

Patients can register for My Health Record online at any time, if they do not have one already.

Regulatory amendments available in full: Therapeutic Goods (Medical Devices) Amendment (Implantable Medical Devices) Regulations 2017.

For up-to-date information on this project, visit Medical devices reforms: Consumer information requirements.