FAQs – Patient Implant Cards & Leaflets

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.

What LifeHealthcare products require PIC and PIL?

To find what products require PIC and PIL, please visit this link

What products are exempt?

The below items are the list of excluded products in the regulations. The exact exemptions are expanded on in TGA guidelines and some items that fit in to these categories may not be considered exempt.
sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors

How is LifeHealthcare supplying the manufacturer PICs?

LHC will be providing PICs in a variety of methods. Initially, as the manufacturers are preparing these requirements as part of their upcoming MDR transition, most products will not have the PIC included in the packaging. Manufacturer Cards Manufacturers will be providing cards in the boxes over the coming months. Once these cards are in the product packaging, this will be the card intended to be used and the LHC card can stop being used

How will LHC be managing PICs while the manufacturer’s cards are not available?

To allow devices to be provided with cards LHC will be providing a generic PIC to hospitals. We will be conducting an initial mailout to allow for immediate commencement of implant card supply. Once hospitals begin using the cards they will need to order new ones to ensure they have supply.

How long will we need to order generic cards?

This is an interim measure and will only be required until the manufacturer of a device is providing cards in the packaging. The latest date that this will be occurring is May 2024, however, most manufacturers are intending to include the cards well before that time.

What does the PIC look like and how/when do I use it?

The generic LHC card is available through this link.

The PIC has fields to complete by hand, such as the Patients name, Surgeon name, Implant date, and an area to adhere the patient implant stickers to. The patient implant stickers can be found inside the packaging of implantable medical devices. These PIC fields can be completed following surgery and supplied to the patient at a convenient time, such as during the post-operative conversation or during hospital discharge.

I have looked for the PIL on the website and cannot find it.

As the manufacturers are working to multiple dates, not all PILs are finalised. Any products that are missing PILs have been allowed to continue supply during this transition. In this case an alternate document may be available, or the IFU can be used in its place. If you have any concerns, please contact your LHC representative.

I do not have enough space on the implant card for all of the products used in surgery. What do I do?

If you use up all the available space on one PIC, please proceed to complete a second PIC. Provide the patient with both PICs following surgery.

I have lost or damaged the patient implant stickers; how do I complete the PIC?

Replacement Implant stickers cannot be obtained. Please review the patient records to find the relevant information and handwrite on to the PIC. If you have the booking details, LHC customer care may be able to assist in obtaining the implanted devices and their details.