Patient Information Requirements for Implantable Medical Devices
From 1 December 2021, suppliers of implantable medical devices are required to have patient information materials available in the form of Patient Information Cards (PIC) and Patient Information Leaflets (PIL). These information materials provide patients and medical practitioners with important information about specific implantable medical devices.
The PIC is used to record the details of the specific device that a patient has implanted – including the name of the device, the manufacturer, the model and batch number, and who to contact if they experience any issues. The details on the card can be recorded in patient electronic records, discharge summaries, or if a physical card, be carried by the patient in their wallet. The information recorded on the card enables improved traceability of the device if there are any issues or recalls. Many suppliers of medical devices already provide these cards (e.g. pacemakers and spinal rods) that patients display when having MRIs or going through airport security screening.
The PIL offers a source of information that can be used to inform discussions on the decision to implant a type of medical device. Leaflets should be available prior to surgery to assist patient-doctor discussions regarding the type of medical device being considered and the type of medical condition the device is used for. The leaflet may also be used to provide patients with the name and manufacturer of the device, information about what may happen after the surgery, and information about possible adverse events and malfunctions.
More information regarding the patient information materials is available on the TGA website.
Suppliers of medical devices may provide the patient information materials in various formats over the next few years. It is important that suppliers discuss with hospitals and surgeons, how they plan to provide these materials, in what format and how to access them.
The TGA has published advice on their website to advise healthcare facilities of the requirements and that suppliers may have a range of ways to provide the information, including to patients.
If you are a patient or healthcare professional and have not received patient information materials with an implantable medical device supplied after 1 December 2021, your first point of contact should be the supplier of the device.
For further information please email the TGA directly.