Current post-market medical device reviews

A range of signals can trigger investigation

29 September 2016

Targeted post-market medical device reviews are part of TGA’s overall post-market regulation. They may be triggered by signals that include complaints or adverse event reports received by the TGA, international regulatory action, and information in publications regarding the safety and/or performance of a type of device.

Reviews often run concurrently and some of the current medical devices being reviewed include vinyl medical gloves, baby positioning pillows and pregnancy self-tests for human chorionic gonadotropin.

Various sponsors and manufacturers of vinyl medical gloves are currently under review as a result of surveillance laboratory testing to assess compliance with the relevant standard.

Several devices have been found to be non-compliant and are thus subject to on-going review and regulatory action.

Baby positioning pillows are being reviewed in relation to substantiation of medical claims being made.

A review was conducted in 2015 which resulted in the cancellation of three entries on the Australian Register of Therapeutic Goods (ARTG). There have been additional devices of this kind included on the ARTG this year.

The TGA is currently undertaking a review of all human chorionic gonadotropin (hCG) pregnancy self-test kits on the Australian market to ensure they meet sensitivity claims.

These kits rely on detecting the hCG hormone and some claim to be able to detect extremely low levels, as would be found in the first week after conception. Levels of hCG rise rapidly in subsequent weeks after conception and can be detected by less sensitive tests. Three pregnancy test kits have been subject to Australian recall actions so far in 2016 as they did not meet their sensitivity claims. These recalls have been completed and affected batches are no longer on the market.