Medical devices suppliers must now provide in simple language, a leaflet about medical device implants being supplied to health facilities. The leaflet can be provided either with the device or available on the sponsor (or manufacturers’ website). This leaflet may be used when discussing with a patient, treatment involving the medical device implant.
The leaflet is a summary document and is similar to a consumer medicines information sheet. It should contain information about the type of patient or medical condition the medical device is used for, information about how to use the device properly, possible adverse events etc. The information contained in the leaflet is aimed at providing additional information to help patients be better informed about the type of device they are in discussion with their doctor about before a procedure or may have been implanted with.
In addition, medical device suppliers are also required to provide patient implant cards bearing the name of the medical device that has been implanted, including model, serial number and details about the manufacturer’s website. This card should be made available to the patient after the device is implanted. The cards may be made available in a range of ways, including as a plastic or cardboard card or as part of discharge summary information.
Collectively these patient information materials will help the patient identify the medical implant that they have received, making it simpler to report any complications that may arise to the doctor or the Therapeutic Goods Association.
The new regulations are being implemented over a three-year period and will be fully rolled out by December 2021. Patient information leaflets are required now for all new implantable medical devices and patient implant cards for new urogynaecological mesh products.
Timelines for the full availability of the patient medical device information:
|Patient implant card||Device information leaflet|
|New devices||1 December 2018||1 December 2018|
|Existing devices||1 December 2019||1 December 2019|
|Implantable devices (other than those exempted)|
|New devices||1 December 2020||1 December 2018|
|Existing devices||1 December 2021||1 December 2021|
Note: Patient implant cards should be given to patients on discharge.
If you have any questions please contact: MDBInputs@health.gov.au
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