We will have limited operations from 15:00 Tuesday 24 December 2024 (AEDT) until Thursday 2 January 2025. Find out how to contact us during the holiday period.
Since 2016, the Therapeutic Goods Administration (TGA) has been assessing home-use medical devices, such as thermometers and glucose meters, to ensure they are designed in a way that button battery hazards for children are minimised. The TGA had relied on compliance with the Industry Code for Consumer Goods that Contain Button Batteries published by the Australian Competition and Consumer Commission (ACCC), as well as requirements specified in relevant medical device standards, as guidance and requirements for manufacturers.
In December 2020, the Federal Government introduced four mandatory safety and information standards to reduce the risk of death and injury associated with access to button and coin batteries in consumer products, which has replaced the Industry Code.
The following two standards are the most applicable to sponsors and manufacturers of medical devices, as they relate to medical devices that may contain button batteries and are used in a home setting, such as thermometers, glucose meters, and hearing aids. Hearing aids (and their associated accessories) are considered exempt from the safety standard but must comply with the warning requirements in the information standard:
- Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020
- Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020
The ACCC has developed A Guide for Business on the Application of Mandatory Standards to assist in understanding the requirements for secure battery compartments, child resistant packaging, and warnings and information. In addition, the ACCC has developed a fact sheet that summarises the requirements of the new standards.
The new mandatory standards do not differ greatly from the previous Industry Code in terms of securing button batteries in home-use devices. However, as these standards are mandatory, manufacturers will need to be able to demonstrate compliance to both the safety and information standards.
As of December 2020, new applications for inclusion in the Australian Register of Therapeutic Goods (ARTG), for home-use medical devices with button batteries, are required to comply with the mandatory standards. Whilst for consumer goods with button batteries that were already being supplied in Australia prior to the implementation of the mandatory standard, there is a transition period of 18 months to reach compliance, with the standards taking effect from June 2022. Due to the previous post-market review, the TGA anticipates the majority of home-use medical devices, currently included in the ARTG, are already compliant with battery security requirements.
For further information on button battery safety please see the Product Safety Australia Website.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
© Commonwealth of Australia 2021
This work is copyright. You may reproduce the whole or part of this work in unaltered form for your own personal use or, if you are part of an organisation, for internal use within your organisation, but only if you or your organisation do not use the reproduction for any commercial purpose and retain this copyright notice and all disclaimer notices as part of that reproduction. Apart from rights to use as permitted by the Copyright Act 1968 or allowed by this copyright notice, all other rights are reserved and you are not allowed to reproduce the whole or any part of this work in any way (electronic or otherwise) without first being given specific written permission from the Commonwealth to do so. Requests and inquiries concerning reproduction and rights are to be sent to the TGA Copyright Officer, Therapeutic Goods Administration, PO Box 100, Woden ACT 2606 or emailed to tga.copyright@tga.gov.au.
For the latest information from the TGA, subscribe to the TGA Safety Information email list.
For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.