Surgical mesh and implantable devices

Up-classification of surgical mesh and implantable medical devices

The following information outlines a range of HSV activities to assist health services in implementing the Therapeutic Goods Administration (TGA) requirements.   

Effective 1 December 2021, the TGA has up-classified implantable surgical mesh devices from:

• Class IIb (medium-risk devices) to Class III (high-risk devices).  
• Class III medical devices need to meet more stringent criteria than Class IIb medical devices. 

All surgical mesh devices available on HSV contracts meet TGA requirements in line with the up-classification. HSV is working closely with suppliers to ensure supply continuity and that all new TGA requirements are being met.  

The TGA has put in place arrangements to ensure that suppliers have flexibility to maintain ongoing supply. 

Patient information requirements for implantable medical devices  

From 1 December 2021, the TGA requires all implantable medical devices to have accompanying Patient Implant Card (PIC) and Patient Information Leaflet (PIL) information available for provision to patients.  

The Patient Implant Card provides patients with a record of the exact device(s) they have had implanted, including model, batch number and the manufacturer’s contact details. The information recorded on the card helps hospitals to trace the device if there are any issues or recalls.  

The Patient Information Leaflet can be used to inform discussions before surgery on the decision to implant a type of medical device. It will help patients and doctors discuss:

• the type of medical device being considered and the medical conditions it is used for
• the intended purpose of the device
• what may happen after the surgery.

The patient information leaflet  also provides information about possible adverse events and malfunctions and how to report serious incidents to the TGA. 

What suppliers need to do 

From 1 December 2021, implantable medical device suppliers will need to ensure Patient Implant Cards and Patient Information Leaflets are available for provision to the patient. PICs will usually only be able to be provided after surgery, when the exact implantables used in the patient’s operation are known.

Suppliers should discuss with healthcare providers what arrangements work best for patients and hospitals and take this into consideration when developing their implementation plans.  

Suppliers may provide this patient information in various formats, such as electronically or in hard copy form. The regulations provide for a range of options to accommodate patient, surgeon and hospital considerations.

Where a supplier is unable to provide patient information with an implantable medical device, they will be expected to deliver it separately to the health service. 

What health services need to do 

From 1 December 2021, all implantable medical devices that health services use will require accompanying Patient Implant Cards and Patient Information Leaflets to be available for provision to patients.

Health services should discuss how patient information is to be provided with suppliers, Where a supplier is unable to provide patient information with an implantable medical device, they will be expected to provide these materials to health services. Health services that do not receive the required patient information from 1 December 2021 can contact HSV for assistance.  

The TGA has no legal authority over hospitals or surgeons to require them to pass on the information to their patients. However, as advised by the Safety and Quality Commission, it is desirable that hospitals have processes in place to help patients access information about implantable medical devices before they undergo surgery, and also following surgery and implantation of these devices. 

Health services will also need to update their relevant policies and procedures to reflect the requirements. 

HealthShare Victoria support  

HSV is collaborating with the TGA, Medical Technology Association of Australia  (MTAA), the private healthcare sector, other jurisdictions and suppliers to support the roll-out of the patient information cards and leaflets. We are:  

• working with implantable medical device suppliers to ensure they are able to provide the required patient information and to address any issues
• acting as a contact point and support for health service concerns or questions and coordinating with the MTAA on responses to questions about the patient information requirements
• providing updates about implantable medical device information to health service clinical product advisors
• engaging with the Implantable Product Reference Group to represent health service feedback and concerns.  

Further information and resources

Medical Device Patient Information presentation

The Medical Technology Association Australia (MTAA) presentation for clinical staff about the new medical device patient information regulations. 

Further information is available from the TGA and Safer Care Victoria:  

• TGA information for medical practitioners about the up-classification of medical devices and implantable surgical mesh  
• TGA information about medical devices and patient information
• Advice from Safer Care Victoria  

Contacts 

If you have any concerns or questions about these changes, please contact us.  

• HSV Helpdesk: helpdesk@healthsharevic.org.au or phone 03 9947 3900.  

Frequently asked questions

What is the process for reporting a missing PIC/PIL from 1 December?

Suppliers are required to make the patient information materials available for provision to the patient.

If an implantable device does not arrive with a patient implant card or patient information leaflet, it may still have been provided to the patient through a different means. Your first point of contact should be with the supplier of the device if you have concerns. If the supplier is unable to provide access to the patient information, then you may wish to report this to the TGA. Information about how to report missing patient information is available on the TGA website.  

When an implant requires removing, do we need to track down an old PIC?

If, in the future, an implant requires removal, there is no requirement for the patient to return the  patient implant card to the supplier upon removal of a device.

Does the regulation apply to devices supplied prior to 1 December 2021?

Suppliers won’t need to provide patient information cards or leaflets for implantable medical devices that have been supplied prior to 1 December 2021.