What are the patient information materials?
Patient Information Leaflets (PIL) The patient information leaflet should be one of many sources of information that inform a discussion on the decision regarding the implantation of a device. It is considered best practice to make leaflets available to doctors and potential patients 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.
Patient Implant Cards (PIC)
A patient implant card 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.