Patient selection critical after TGA cancels some spinal cord stimulator devices

The Therapeutic Goods Administration (TGA) has cancelled some spinal cord stimulator (SCS) devices from the Australian Register of Therapeutic Goods (ARTG), effective 21 August 2024. Further SCS devices have had supply conditions imposed.

The decision comes after the TGA completed a safety and performance review of SCS devices and highlights the importance for members who perform SCS surgery to obtain appropriate informed and documented patient consent.

The regulatory measures 

In 2022, in response to emerging signals, the TGA initiated a post-market review of all SCS devices included in the ARTG. The review was to assess the safety and performance of the devices. 

Subsequently, the ABC ran an investigative article in April this year expressing concerns in relation to the devices. 

The TGA has recently taken a range of regulatory measures, including: 

• cancelling 12 devices from the ARTG
• imposing conditions of supply on 70 devices
• amending any labelling and information including the instructions for use, if deficiencies were identified.

The TGA has stated where an SCS device has been cancelled from the ARTG, they are not being recalled from the market and do not need to be removed from patients if already implanted. The cancellation means no new patients will receive these implants.

Reporting an adverse event

In March 2023, legislation passed making it mandatory for public and private hospitals to report medical device related adverse events to the TGA. Regulations to support implementation are due by 22 March 2025. 

Consent is key

If you perform SCS surgery, the TGA has advised that careful therapeutic consideration needs to be taken – ensuring it’s the right treatment and the device is suitable for individual patients.  Appropriate patient selection is critical, especially considering the target population.

Avant recommends members complete a clear and detailed consent process with patients before SCS implantation. The discussion should include risks such as; infection, injury, that a reduction in pain cannot be guaranteed, device malfunction, the possibility of the need for re-operation or removal, and alternative options for pain management.  A shared decision-making approach is a good strategy.  Like other elective surgical procedures, we also recommend the discussion takes place over at least two consultations, allowing reasonable time for the patient to consider the information, ask questions and seek clarification if needed.  Document the consent discussion in the patient’s medical records, including a reference to any written material, aids or diagrams provided. 

If you have questions or concerns regarding ongoing maintenance of these devices, contact the sponsor of the device directly. This includes queries on the possible need for eventual replacement of parts for already implanted devices. 

Future of SCS devices 

The efficacy of SCS devices is an ongoing issue and evidence is emerging questioning that they may not be a reliably effective treatment for chronic back pain. Avant will continue to monitor the situation.

More information and member support

As a member benefit, our Risk Advisory Service can provide a complimentary review of your practice to address any concerns you may have. Schedule a review.

For medico-legal advice, please contact us on nca@avant.org.au or call 1800 128 268, 24/7 in emergencies.