Post-market review of silicone tubing used in dialysis devices

As part of the review, we required all sponsors of dialysis devices included in the ARTG to provide information about their products, including:

• the method used to cure silicone components
• any design change relevant to the tubing
• supply data and expected service life of the device
• evidence of testing conducted by the manufacturer
• the manufacturer’s risk assessment and risk mitigation strategies
• an evaluation of whether the device poses any risk to patient health during normal use.

The post-market review is ongoing. We will update this page as new information or recommendations become available.

Some sponsors that had dialysis products containing peroxide-cured silicone have updated their product designs to use a different material, which removes the potential risk of patient exposure to PCBs and PCBAs.

During the post-market review, some sponsors decided to cancel their ARTG entries. A sponsor may do this at any time and a reason for their withdrawal from the market is not required to be provided to us.

Table 1 and Table 2 outline the current status of devices included in the review. Table 1 lists ARTG entries that contain or contained peroxide-cured silicone, and Table 2 lists ARTG entries that do not contain peroxide-cured silicone. These tables will be updated to reflect progress and outcomes.

NOTE: Some ARTG entries are included in both tables as there are multiple different products included under the entry.

Table 1 In-scope silicone tubing devices - contain chlorinated peroxide-cured silicone

Table 2 Out-of-scope silicone tubing devices - do not contain chlorinated peroxide-cured silicone

Note: An ARTG entry may be cancelled in two ways: (1) The sponsor (the supplier within Australia) may voluntarily cancel the entry or (2) the TGA may cancel the entry. The sponsor can cancel their entry at any time and is not required to provide a reason to the TGA.

We understand that haemodialysis and peritoneal dialysis devices are essential for patient care. Healthcare providers should continue working closely with patients to ensure they receive the treatment they need. At this time, healthcare professionals may consider the following:

• continue providing dialysis treatments to your patients
• stay informed about updates and recommendations from the TGA or from device manufacturers
• report any concerns or issues to us.

Information for consumers

If you have any concerns about your dialysis treatment or device, please speak with your healthcare practitioner.

Reporting problems

We encourage consumers and health professionals to report problems with medical devices. Your report will contribute to our monitoring of these products. For more information, see TGA Incident reporting and Investigation Scheme (IRIS).

We cannot provide advice about individual medical conditions. You are strongly encouraged to talk to a healthcare professional if you are concerned about a possible adverse event associated with a medical device.