Post-market review of medical devices containing mercury
Learn more about the TGA's post-market review of mercury-containing medical devices.
We have undertaken a post-market review of all devices in the Australian Register of Therapeutic Goods (ARTG) that may contain mercury.
These products included all non-electronic blood pressure monitors or gauges and thermometers.
Background
Mercury is a highly toxic heavy metal that can harm humans and the environment.
The Minamata Convention on Mercury - external site (the Convention) is a global environmental agreement. Australia is part of the agreement. It aims to protect human health and environment from the harmful effects of mercury.
Mercury may be found in different types of medical devices such as:
- non-electronic thermometers, blood pressure monitors or gauges (sphygmomanometers),
- plethysmographs (used in measuring lung capacity), and
- dental amalgams.
The Convention requires parties to take steps to prohibit or restrict the import, export, and manufacture of therapeutic goods containing mercury. The Convention also includes phase out dates for mercury-added products.
In line with the Convention, we have undertaken a review of non-electronic sphygmomanometers and thermometers, and plethysmographs included in the ARTG that may contain mercury.
Outcomes and actions
We contacted all sponsors of non-electronic sphygmomanometers and thermometers, and plethysmographs included in the ARTG to determine whether their medical devices contain mercury.
The review excluded:
- non-electronic measuring devices installed in large-scale equipment, or
- those used for high precision measurement, where no suitable mercury-free alternative is available.
All the mercury-containing devices that were included in the post market review have been cancelled from the ARTG.
The below table reflects the status of ARTG entries for devices included in the post market review.
ARTG | Sponsor | Manufacturer | Device/product name | Current status | Date effective |
|---|---|---|---|---|---|
147760 | Arthur Bailey Surgico Pty Limited | G H Zeal Ltd | Thermometer, capillary, mercury | Sponsor initiated cancellation | 24 October 2023 |
152068 | Cabrini Health | Tanaka Sangyo Co Ltd | Sphygmomanometer, mercury | Sponsor initiated cancellation | 2 November 2023 |
130798 | Cabrini Health | Erka Kallmeyer Medizintechnik GmbH & Co KG | Sphygmomanometer, mercury | Sponsor initiated cancellation | 2 November 2023 |
188903 | Livingstone International Pty Ltd | WA Baum Co Inc | Sphygmomanometer, mercury | Cancelled by the TGA (non-response to request for information) | 10 January 2024 |
123645 | Livingstone International Pty Ltd | Wuxi Hongguang Medical Equipment Co Ltd | Thermometer, capillary, mercury | Cancelled by the TGA (non-response to request for information) | 10 January 2024 |
98471 | Livingstone International Pty Ltd | Wenzhou Bokang Instruments Co Ltd | Sphygmomanometer, mercury | Cancelled by the TGA (non-response to request for information) | 10 January 2024 |
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.
For more information on the Convention and regulatory changes, visit the Department of Climate Change, Energy, the Environment and Water - external site website.
Information for stakeholders
Mercury sphygmomanometer
A manual device for measuring blood pressure. It has an inflatable cuff, bulb for controlling the air pressure in the cuff and a mercury manometer.
Clinical mercury thermometer
A device used to measure body temperature using the thermal expansion of mercury.
All thermometers and sphygmomanometers do not contain mercury. Generally, electronic/digital thermometers and sphygmomanometers are mercury-free. They are not included in this review.
Plethysmograph
The device measures lung capacity and may include a mercury strain gauge.