Medical device patient information materials: a fact sheet for health professionals

In response to feedback from consumers about the lack of information available about medical devices, the Australian Government introduced the requirement for suppliers of implanted medical devices to provide more information for patients in the form of patient information leaflets (PILs) and patient implant cards (PICs). The PICs and PILs discuss the risks posed by medical devices and provide other important information about their implantable or active implantable medical devices. This fact sheet provides information for health professionals about who is responsible for providing the PILs and PICs to patients, and when they should be supplied.

Main sections:

· What are medical device patient information materials?

· Patient information leaflet (PIL)

· Patient implant card (PIC)

· Who is responsible for providing PILs and PICs to patients?

· What if I cannot find a PIL or PIC for my patient?