New Requirements for button batteries and hearing aids
After member queries, Audiology Australia recently sought clarification from the Therapeutic Goods Administration (TGA) about the applicability of the Australian Competition and Consumer Commission (ACCC) "Industry Code for Consumer Goods that contain Button Batteries" (the Industry Code)" to the use of button batteries in hearing aids.
In 2016, the ACCC released the Industry Code in order to help minimise the risks to children posed by ingestion of button batteries. In Australia, two children have died from button battery-related injuries. An estimated 20 children visit an emergency department each week for removal or treatment of a swallowed or inserted button battery.
The Industry Code makes several recommendations regarding the safety features of products with button batteries such as battery storage, accessibility and labelling.
The TGA has confirmed that the Industry Code applies to hearing aids. Hearing aids are classed as a medical device and all medical devices marketed in Australia must meet the requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). This includes the Essential Principles that set out the requirements for the safety and performance characteristics of medical devices such as:
• 'the design and construction of a device must conform with safety principles, having regard to the generally acknowledged state of the art' - Regulations, Schedule 1, Essential Principle 2(1). For the purposes of assessment of devices containing button batteries, the TGA considers the Industry Code to be the state of the art.
• the manufacturer must: (a) first, identify hazards and associated risks arising from the use of the device for its intended purpose, and foreseeable misuse of the device, and (b) second, eliminate, or reduce, these risks as far as possible by adopting a policy of inherently safe design and construction019 - Regulations, Essential Principle 2(2).
• A post-marketing system complies with this subclause if the system requires the manufacturer of the device: (b) to implement appropriate means to apply any necessary corrective action in relation to the design or production of such devices' - Schedule 3, Clause 6.5(2) of the Regulations, post-marketing system.
As button batteries from hearing aids are as dangerous as those from other home-use devices and were found during the ACCC's investigations to be involved in 8 per cent of incidents where children swallowed batteries the TGA requires the same level of battery security as in other home use devices. Therefore, the TGA is requiring Sponsors of hearing devices to meet the Industry Code in full in order to demonstrate compliance with the Essential Principles.
In line with the ACCC's Industry Code, the options for safe button battery securement in hearing devices are:
• Have the battery sealed into the device such that it cannot be accessed, or
• Have the battery compartment cover require a tool to remove, or
• Have the battery compartment cover require two, independent movements to remove and have a warning on the packaging that the device contains button batteries.
It is important for members to be aware of these requirements when advising clients about the most appropriate hearing device for their clinical needs and personal circumstances.
If you have any comments or queries regarding this information, please contact Audiology Australia's Research and Policy Manager firstname.lastname@example.org