TGA Introduces Patient Implant Cards…and the dates are approaching fast!
In October 2017, the Australian government approved regulations introducing requirements for manufacturers to provide consumer information with all new permanently implantable devices (other than those exempted) supplied in Australia. As the date approaches, it’s important that manufacturers fully understand these new requirements. In most instances, they align with requirements in the EU and the US. So the implementation should not be too challenging, but manufacturers always need to ensure they understand the detail.
In September, TGA published a clear guidance around the implementation dates and specifically called out the content requirements. Implementation dates stagger base on the product type. (See table below)
From Therapeutic Goods Administration publication dated 19 September 2018: https://www.tga.gov.au/community-qa/patient-implant-cards-and-information-leaflets
Patient Device Information Leaflet
Effective December 2018, any newly introduced Implantable product approved on the Australian market (those approved on or after December 1), will be required to meet the first stage of the requirements, which is to include a leaflet containing the following information:
- information identifying the device, or the kind of device;
- the intended purpose of the device;
- information explaining how to use the device safely;
- other information about the device that the manufacturer considers would be useful for patients.
More specifically, TGA has advised that the leaflet must include:
- the name and model of the device
- the purpose of the device and the kind of patient on we intend to use the device on
- any special operating instructions for the use of the device
- the intended performance of the device and any undesirable side effects that could be caused by use of the device
- any residual risks that could arise due to any shortcomings of the protection measures adopted
- warnings about risks that could arise from the interaction of the device with other equipment (eg risk of electrical interference from electro-surgical devices, or magnetic field interference from magnetic resonance imaging devices), and precautions and other measures that, because of those risks, should be taken by the patient or a health professional
- the nature and frequency of regular or preventative examination, monitoring or maintenance of the device that should be undertaken; symptoms that could indicate that the device is malfunctioning; precautions and other measures that should be taken by the patient if the performance of the device changes or the patient experiences any of the symptoms
- the expected device lifetime; anything that could shorten or lengthen the device lifetime; precautions and other measures that should be taken at, or near, the end of the expected device lifetime
- other circumstances in which the patient should contact a health professional in relation to the operation of the device
- the materials and substances included in the device, and any manufacturing residuals that could pose a risk to the patient
- lastly, a notice that any serious incident that occurs in relation to the device should be reported to the manufacturer and to the Therapeutic Goods Administration; and the address of the Therapeutic Goods Administration’s website.
Patient Implant Cards
Manufacturers will also need to begin preparing for the additional requirements around patient cards. Although this has been a hot topic between industry and the regulatory agency over the last several months, the implementation is moving ahead.
The second phase for manufacturers to consider is the Patient Card. The TGA defines the patient implant card as a small, portable card intended to be provided to patients (after surgery) who have received either:
- a permanent implantable medical device (except devices that are excluded from this requirement), or
- an active implantable medical device.
In addition to the information provided in the leaflet, the card must contain the name, type and model of the implant they have received. Importantly, the patient card must contain the manufacturer’s contact details (including website details) that will enable patients to seek further information or updates on their implanted device.
Medical Devices Excluded from patient card and leaflet requirements Devices exempt from the new requirements are:
· dental filings
· dental braces
|· tooth crowns|
Meeting the new requirements
The Sponsor and Manufacturer are responsible for understanding these new requirements and determining the best way to meet them. As defined within the guidance, Sponsors and manufacturers must ensure that consumers and healthcare professionals have ready access to the patient information leaflet. It is expected that unless it is impracticable or inappropriate to do so, the leaflet is provided with a medical device. In the event a manufacturer can provide the information electronically, which should be very carefully considered, they will also be responsible for ensuring compliance with the advertising code. Any breach of these requirements can lead to the ARTG registration being suspended, or cancelled.
An important additional requirement will be the need for formal document version controls, and importantly, consideration of who the materials are targeted at. The guidance suggests that information must be provided in a way that ensures that it is easily understood by consumers. Leaflets that are very long or unnecessarily complex may not be useful to patients. Consider having consumer leaflets reviewed for readability.
We will be actively reaching out to our clients in the coming weeks to ensure they continue to understand and meet these new Australian requirements.
If you’re only just hearing about this, or would like to discuss these new requirements with one of our team members, be sure to contact us at contact us for a free, no obligation discussion. Email [email protected] or call us:
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