This guideline provides:
- An overview of the requirements relating to implant cards and patient information brochures (commonly referred to as consumer information material) and,
- Advice on the way manufacturers can respond to requirements 13A.2 to 13A.4 of the TGA Regulation of 2002 on Therapeutic Products (Medical Devices),
The patient implant card is also known as the patient card or implant card, and the patient information brochures as consumer information brochures.
ANALYSIS
On 26 October 2017, the Australian government approved a regulation requiring that certain information material be provided with active implantable medical devices and implantable devices meeting the following definition:
“Any device, including those partially or totally absorbed, intended to:
- Be totally inserted into the human body, or
- Replace an epithelial surface or the surface of the eye,
by means of clinical intervention and remaining in place after the procedure.
Any device intended to be partially inserted into the human body by clinical intervention and remaining in place at least 30 days after the intervention is also generally considered as an implantable device.”
The definition is compliant with the EU Regulation on medical devices 2017/745 (EU MDR).
Both materials must be provided with medical devices.
When used correctly, these information documents will help patients to:
- Inform themselves about the medical device that has been implanted into them,
- Talk to their practitioner in advance and give their informed consent,
- Report any adverse effect associated with their implanted medical device.
What is an implant card?
Implant cards are small portable cards intended for patients after their operation, stating that they wear:
- A permanent implantable medical device (with the exception of certain devices, see below), or
- An active implantable medical device.
The card must contain the name, type and model of the implant received. It is important to note that manufacturers’ details (including details of the website) must be mentioned to enable patients to carry out additional research into their device.
What is a patient information brochure?
These are brochures provided with implantable medical devices intended for patients, containing important information on the device.
They can be used during patient-doctor discussions to understand:
- The type of medical device being considered, and
- The type of patient or pathology for which the medical device(s) are used.
They must be used alongside numerous other sources of information to help the patient reach a decision in relation to the implant.
They can also be used to provide patients with the device name and manufacturer, as well as information on what can happen after the operation, in particular adverse events and malfunctions.
They can also be used after the operation, for example to explain how to report adverse events and when to consult a doctor if the patient suspects a device malfunction. Information on precautions to take (if applicable) can be included in the discussion.
Implantable medical devices exempt from this requirement
- Sutures, staples, fillings, braces, crowns, screws, wedges, plates, wires, pins, clips, connecters.
Comments:
Dental implants for high-risk jaw operations, such as subperiosteal, transosseous, zygomatic and transcutaneous implants, are not covered by the exemption and must provide an implant card and information brochure.
Information contained on patient implant cards
Rule 13A.2 of the Regulation states that the following information must appear on patient implant cards:
- Device name,
- Model,
- Device batch number or serial number,
- Unique device identification (if applicable),
- Manufacturer’s name, address and website.
Do warnings need to be included on patient cards?
It is not necessary to include warnings on the implant card. However, in certain cases, device manufacturers can decide to include certain warnings intended for patients, if applicable (for example, on possible interactions with other electronic equipment, such as body scanners in airports or magnetic resonance imaging (MRI) equipment for pacemakers or ocular lenses).
Information contained in patient information brochures
Rule 13A.3 of the Regulation states that the following information must be included:
- Information to identify the device or type of device,
- Purpose of the device,
- Information explaining how to use the device safely,
- Other information on the device that the manufacturer deems useful for patients.
In particular, the brochure must include the information described below:
-1-
- Device name,
- Model.
-2-
- Purpose of the device,
- Type of patient for which the device is intended.
-3-
- Any specific instructions for use for the device.
-4-
- Expected performance of the device,
- Any adverse side effect that may result from using the device.
-5-
- Residual risks that may result from failure to adopt the protective measures.
-6-
- Warnings on the risks that may arise from interaction between the device and other equipment,
- Precautions and other measures that, as a result of these risks, should be taken by the patient or a healthcare professional.
-7-
- Nature and frequency of examinations, surveillance or regular or preventative maintenance to be carried out on the device,
- Symptoms or signs that may indicate a device malfunction,
- Precautions and other measures that the patient should take if the performance of the device changes or if one of the symptoms mentioned above presents,
- The expected service life of the device,
- Anything that can shorten or extend the service life of the device,
- Precautions and other measures to take at the latest at the end of the expected service life of the device,
- Other circumstances in which the patient should contact a healthcare professional in relation to the operation of the device.
-8-
- Materials and substances contained in the device,
- Any manufacturing residue that may present a risk to the patient.
-9-
- Notice indicating that any serious incident linked to the device must be reported to the manufacturer and the TGA,
- The TGA’s address and website.
Materials and substances included in the device
Materials and substances included the device, including any manufacturing residue that could present a risk to patients, must be included in the brochure.
How brochures must be provided
The Sponsors (or Authorised Officials) and manufacturers must ensure that patients and healthcare professionals have easy access to information brochures. Unless impossible or inappropriate to do so, brochures are to be provided with the medical device. Access must be free of charge.
Electronic brochures
Electronic brochures can be used if it is not practical to provide paper copies directly with the device. In this case, Sponsors must inform healthcare establishments of the availability of electronic brochures for communication with patients.
Brochures for a “type of device”
It is acceptable to have a patient information brochure for several devices if they:
- Are manufactured by the same manufacturer,
- Have the same Sponsor,
- Belong to the same class of device,
- Have the same purpose, and
- Share the same warnings, precautions and risks to users.
The devices covered by the brochure must be clearly identified and listed by name and model for each device.
Print date and version control
Paper and electronic version patient information brochures must indicate the publication date and, if applicable, the jurisdiction.
Presentation of information materials
Cards and brochures
Regulation 13A.3 (4) states that these materials:
- Must be provided in English and one other language,
- Can also include diagrams, pictures and symbols,
- Include a legible text with characters of at least 1 millimetre.
The information provided must be easy to understand.
Compliance with advertising regulations
The brochure is not intended for advertising or promotional purposes. To avoid the content being considered as promotional (and therefore an advertisement):
- Information must be presented in a factual and balanced manner,
- Information on various alternative therapeutic options must not be presented in such a way as to present the device as the best option.
- Coherent documentation on various therapeutic solutions can be provided, but no comparison must be made.
- Brochures without promotional content must not be used in a promotional context.
The regulatory directives of the TGA on advertising (https://www.tga.gov.au/publication/australian-regulatory-guidelines-advertising-therapeutic-goods-argatg) provide further information on the types of content likely to be considered promotional.
Use of simple language
Clear language must be used to ensure the information is easy to understand. Vague or unnecessarily complex language should be avoided.
User-focused label design
Recipients of the device and their specific requirements must be taken into account.
Use of images in the notice
It can be useful to use images, diagrams or pictures to describe the device.
Colour contrast
Colour contrast is an important tool in ensuring text legibility and facilitating a better understanding of the device and its functionalities.
Use of other elements in addition to colour
People perceive colours differently. Some people are colour-blind and colours can appear different depending on the light. It is recommended to use different types, sizes and fonts to distinguish the information provided.
Acceptable website addresses
A card or brochure can include the manufacturer’s website address, a QR code or another machine-readable code that will direct users to the manufacturer’s website.
Paper or electronic version patient cards
In their simplest form, patient cards are provided in the form of paper cards the size of standard bank or business cards. This enables patients to have “quick access to the information”.
TGA checks
Information brochures and patient cards will be checked by the TGA during the evaluation of medical device(s) as part of its regulatory activities. (Compliance evaluations, audits and post-market checks).
Reporting adverse events
These information materials will be useful to patients and healthcare professionals should an adverse event report need to be filed.