Patient Implant Card

The Therapeutic Goods Administration (TGA) has introduced new regulations requiring patient information material to be provided for implantable medical devices. The new requirements came into effect from 1^st December 2021.

Patient Information Cards (PIC) and Patient Information Leaflets (PIL) provide patients with information about the implant and are intended to assist patients to:

– understand the medical device being implanted

– have informed consent conversations with their health care professional

– report any adverse events associated with their implanted medical device

It is the responsibility of the manufacturer/supplier (Teleflex) to provide the patient information materials to the hospital. The hospital/physician should then provide the materials to their patients. Suppliers of medical devices may provide the patient information materials in various formats over the next few years.

To comply with the regulation, Teleflex Medical Australia is providing electronic Patient Information Cards (PIC) and Patient Information Leaflets (PIL) online at this address: https://teleflex.com/anz/en/services/patient-info/

Please download, print, and issue the patient with the associated Patient Information Leaflet (PIL) and Patient Information Card (PIC).

To complete the card, information will need to be provided by the hospital:

– Patient name, surgery date, surgeon/doctor’s name, hospital/facility details

– Device details – model, batch/lot or serial number

Some of the above products may already have a sticky label with device details that can be affixed to the card. Otherwise, the details should be handwritten on the card.

Teleflex is working to include the patient implant card within the device packaging in the future. When these changes have been completed over the next few years, you will receive communication when you no longer need to use the electronic card.

Thank you for your support in providing important information to our patients. If you have any questions please contact your local sales representative or Customer Service at austCS@teleflex.com