The Therapeutic Goods Administration (TGA) has recently published an updated guidance document providing an overview of patient information materials. The patient information materials consist of patient information leaflets (PIL) and patient implant cards (PIC), for implantable medical devices and active implantable devices. This latest guidance document provides an overview of the patient information leaflets and patient implant cards, the medical device when patient information must be supplied, how to meet the mandatory requirements for patient information, and best practice requirements for patient information. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.
Patient information materials assist patients to understand the medical device being implanted prior to and following surgery, have informed consent conversations with their health professional, and report any adverse events associated with their implanted medical device. On December 1st, 2018, the TGA required patient information materials to be supplied with implantable medical devices and active implantable devices. But according to the Therapeutic Goods (Medical Devices) Regulations 2002, there are medical devices excluded from this requirement, including suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, and connector. In addition, there are further examples of the medical devices that are or are not excluded from requirements, specified in Attachment 2 of the latest guidance document.
The patient information leaflet (PIL) should be one of many sources of information that inform a discussion on the decision regarding the implantation of a medical device. It is considered best practice to make leaflets available to doctors and potential patients prior to surgery so as to assist patient-doctor discussions regarding the type of medical device being considered, and the type of medical condition the medical device is used for. The patient information leaflet may also be used to provide patients with the name and manufacturer of the medical device, information about what may happen after the surgery, and information about possible adverse events and malfunctions. The TGA expects sponsors and manufacturers to ensure the patient information leaflet can be readily accessed by consumers and healthcare professionals, can be accessed free of charge, and is available as early as possible so that medical practitioners and patients can use it to inform their discussions on the proposed course of treatment.
On the other hand, a patient implant card (PIC) is a card intended to be provided to a patient following surgery when the patient has received an implantable medical device and an active implantable medical device. The purpose of patient implant cards is to ensure that patients are aware of the details of the device that they have been implanted with and that health practitioners can also identify particular devices. The cards should also better enable the traceability of the device and patient in order to more quickly and effectively alert patients and health practitioners to safety issues, such as precautions or recalls. Physical patient implant cards are the TGA’s preferred option. This will allow a health professional or patient rapid access to the information. Additional space on the card for healthcare professionals to insert the name of the surgeon and the name of the hospital where the procedure was undertaken may be provided. Bar codes on stickers with a device as a means of identifying the device may also be supplied. This is acceptable, provided the stickers are durable and contain the required information and are in the correct form.
For either patient information leaflet (PIL) or patient implant cards (PIC), the information must be contained according to the requirement specified in clause 13A.3 Patient information leaflets for implantable devices and 13A.4 Form of patient implant cards and patient information leaflets of the Therapeutic Goods (Medical Devices) Regulations 2002.
New medical devices that are not urogynaecological mesh devices must be accompanied by patient implant cards from December 1st, 2020. A graduated transition period applies for existing medical devices, which means one that is in the Australian Register of Therapeutic Goods (ARTG) because of an application made before December 1st, 2018, regardless of the date the device was included in the ARTG. From December 1st, 2021, all implantable or active implantable devices will require patient implant cards and patient information leaflets, unless they are specifically excluded from these requirements.