Patient information materials are required to be supplied with implantable and active implantable medical devices in Australia.
These materials are part of the Essential Principles in the Therapeutic Goods (Medical Devices) Regulations 2002.
The Essential Principles are a set of mandatory requirements for medical devices in Australia, ensuring they are safe and perform as intended.
Patient information materials consist of:
- Patient Information Leaflet (PIL)
- Patient Implant Card (PIC)
Patient information materials assist patients to:
- understand the medical device being implanted
- have informed consent conversations with their health professional
- report any adverse events with their implanted medical device.
Abby's story highlights the practical importance of the patient information materials.
Abby's story
Abby's 16-year-old son Rory went into cardiac arrest while playing basketball.
Specialists couldn't pin-point the exact cause of the cardiac arrest. To safeguard against this life-threatening event happening again Rory had an implantable cardioverter defibrillator (ICD) fitted into his body.
An ICD is a small electrical implantable device. It is used to treat some types of abnormally fast heart rhythm which can be life-threatening.
Patient Information Leaflets (PIL)
Before the surgery to implant the device Rory and his parents were given a PIL.
PILs are essential documents that provide patients with clear, evidence-based information about their health, treatments, safe use, potential risks, interactions with other equipment and when to seek medical advice.
The PIL gave information about:
- The device
- Why it's needed
- The surgery to implant it
- Recovery
- What happens during surgery
- Living with an ICD and the kind of limitations it may put on life
- What safety precautions must be taken around electrical and magnetic fields
- What to do if he notices something isn't right with the device
This helped Rory and his parents make an informed choice about his healthcare and opened a dialogue between the patient and surgeon.
Patient Implant Card (PIC)
Rory, and his parents, carry the PIC they were given in their wallets.
The PIC includes information about:
- Name of the device
- Model of the device
- Batch code, lot number or serial number of the device
- Unique device identifier of the device (if any), and
- Manufacturer's name, address, and website.
Healthcare management
The card is helpful when Rory is seeing a new health professional or going for tests.
Some tests should not be performed as it can have an impact on how the ICD works. Carrying the card means Rory and his parents can make sure health professionals know exactly what he has implanted and determine if it's safe to proceed.
The card also helps in making sure any medications prescribed do not work against the ICDs purpose and cause an irregular heartbeat.
You can also add information from the implant card to My Health Record (MHR). This means the information is still there even if you don't have you PIC on you.
Safety precautions
Having an ICD means Rory must stay away from strong magnetic fields and electrical devices that could interfere with your ICD.
When travelling through airport security Rory must tell personnel about his device before going through security checks. The PIC can be used to confirm this.
Make an accurate adverse event report
Having the serial number and other information about the device helps Rory, his parents and doctors should they need to report an adverse event.
These details narrow down what investigators are looking at and can help other Australians with the same device.
Importance of knowing the details of your implantable device
Before patient information leaflets and cards became mandatory, patients weren't as informed about their implantable device. They often didn't know details like the model or serial number of their implantable.
For example, when TGA received adverse event reports into breast implant associated-anaplastic large cell lymphoma (BIA-ALCL), some patients struggled to know if their implant was being investigated.
In some cases, surgeries had taken place years earlier and the surgeon's practice, who had stored device records, had since closed.
Today, PILs and PICs ensure patients have clear, accessible, and device‑specific information.
What information should be on them
Information on the card and leaflet:
- must be in English (but may also be in other languages)
- may include diagrams or drawings
- be legible with characters at least 1 millimetre high
- must be in writing and language the patient understands.
Patient implant cards and information leaflets can be hard copies or electronic. They must be accessible.
Cards and leaflets are not needed for a suture, staple, dental filling, dental brace, tooth crown, screw, wedge, plate, wire, pin, clip, connector or similar article.
