Button Battery Safety Issues Paper

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Prevalence:
SA Health participates in national surveillance of button-battery related injury cases through national surveillance of calls made to Poisons Information Centres (as detailed in the ACCC Issues Paper) and national surveillance of severe injuries related to disc batteries collected by researchers conducting the Australian Paediatric Surveillance Unit (APSU – as detailed in the ACCC issues paper).

From December 2017-August 2018, the APSU study has identified 25 confirmed national reported cases of disc or button battery-related injuries in children under 16 years of age that required medical procedural intervention. Two of these cases, including one under 5 years of age were from SA. Both cases involved batteries greater than 20 mm in diameter and both required hospital admission, anaesthesia and removal of the battery from the oesophagus and stomach by endoscopy with one case experiencing tissue burn damage.

Of particular concern is the high proportion (8/25 cases) of national paediatric cases that have involved non-English speaking families. This emphasises the importance of a child-resistant battery compartment and battery packaging. In addition, label warnings and directions need to be designed for low literacy (e.g. use of info graphics) and in multiple languages and associated with education campaigns targeting consumers as well as retailers/importers/suppliers from different language demographics.
It should be noted that battery-related exposures and injuries are under-reported and the incidence of exposures and reporting is variably impacted by public education campaigns, English literacy and the expansion of uptake of button-battery devices, in addition to product compliance. These external factors can increase (poor literacy, greater uptake of non-compliant devices) or decrease (effective education, reduced uptake of unsafe devices) battery exposures, battery access, battery-related injury and subsequent injury and exposure reporting (can increase or decrease as a result of education campaigns – greater awareness of hazard and improved data capture). Therefore it is unwise to use injury data as the sole performance indicator for the effectiveness or failure of a regulatory response. However, the current picture of persisting severity and risk of fatalities related to button-battery injuries stands alone as justification for mandated safety requirements.
Evaluation of a new regulatory approach is best served primarily by surveillance of product compliance. Ongoing monitoring of severe injuries (APSU study) and exposures (national Poisons Information database) will support further evidence for any modifications needed to the approach but should not be the only indicator for success.

Costings:
Due to the wide variation in clinical interventions required for button-battery related injuries, it is difficult to provide appropriate health system costings. In line with national clinical protocols for suspected button-battery ingestions, the majority of cases require x-ray as the standard minimum intervention, with increasing levels of intervention. This means the costs will depend on the risk and severity of injury which ranges from sedation, anaesthesia and endoscopy through to enteral/parenteral feeding, clinical pathology (blood and urine diagnostic testing) through to multiple surgical gastrointestinal repair and reconstruction. Hospital admission costs with increasing length of stay required and costs of outpatient follow-up will also increase commensurate with severity of injuries and the long-term health impacts and treatments required and lifetime surveillance for malignancy.

Health services supply various medical devices powered by button batteries to adult and paediatric patients on discharge from hospital or at outpatient clinics including digital thermometers, blood glucose meters and hearing aids including cochlear implants. These devices will be used and therefore be accessible in home environments where children and vulnerable populations (including the elderly) live.

One South Australian case of serious battery-related injury involved a child accessing a battery from a glucose meter (in addition to another case from a different jurisdiction) which had a non-compliant compartment. The glucometer had been given to the mother at an antenatal visit 3 years earlier and the child (now three years old) accessed the glucometer from a drawer. This case emphasises that it is essential that all regulators align with the ACCC regulatory approach with a similar degree of urgency. It also highlights the long latency period between product acquisition and injury.

While the TGA initiated a process to survey device sponsors in 2016, information on its website refers to next steps in the process being to analyse and evaluate risk measures and their acceptability. No further update has been provided. It is important that the TGA report on this action and take immediate action where devices are non-compliant. The same measures should be applied to medical devices as applied to other household items.

The Code has not adequately reduced the risk of children accessing button batteries as demonstrated by the ongoing identification of unsafe button battery-powered devices and paediatric cases of ingestion and insertions of batteries with associated serious injury and long-term sequelae.

While the intent of the recommended safety actions i.e. battery compartment design and manufacture, child-resistant packaging for loose batteries and label warnings on batteries and devices are likely to be more effective in combination - the Code is not adequate because:
• The primary method for effective prevention of button-battery related injury
is avoidance of battery-powered devices completely or engineering
modification to eliminate the hazard. While the Code encourages suppliers to
consider this principle it does not provide a strong driver or incentive to do so
because these solutions are presented as ‘additional recommendations’
almost as an afterthought inferior to battery compartment security,
packaging and labelling.
Extract from the Code:
Additional recommended means of reducing or eliminating the hazards
Suppliers can further reduce the likelihood of young children being harmed
by button batteries by considering the following options during product
development or selection or sale.
o A primary consideration for your business should be whether you
supply goods containing coin-sized lithium button batteries at all. As
young children can ingest button batteries that have been replaced
and discarded, the best way of reducing the likelihood of this
happening is to reduce consumer demand for them by avoiding
ranging goods that require them.
o Certain goods such as novelty items, and toys could be powered by
other types of batteries, which are less likely to be swallowed by
young children and do not present the same degree of danger if they
are.
o Technical means of ensuring safety should be used where possible,
for example by designing the product so that it will not operate if
the battery compartment fastener is not present.


Apart from hazard elimination through complete avoidance, poisoning and
injury prevention is recognised to be most effective when a multifaceted
approach is taken incorporating elements referred to as the ‘E’s of injury
prevention and control’ — (1) engineering modifications (2) enforcement of
supporting legislation, (3) engagement (forming partnerships between
stakeholders and enlisting their collaborative assistance towards a common
prevention goal) (4) education (5) economic incentives (e.g. promoting or making
available cheaper alternatives), and (6) evaluation of the effectiveness of the
approach (References: Committee on Poison Prevention and Control, Board on
Health Promotion and Disease Prevention, Institute of Medicine of the National
Academies, 2004 Forging a Poison Prevention and Control System, The
National Academies Press, Washington DC, viewed at 12 July 2016
http://www.nap.edu/catalog/10971/forging-a-poison-prevention-and-control-
system . Mace S., Gerardi M., Dietrich A., Knazik S., Mulligan-Smith D., Sweeney
R., Warden C. 2001, Injury prevention and control in children, vol 38(4), pp 405 -
414).

• There is a lack of supplier/importer/retailer awareness of the existence of the
Code and understanding of the Code (as noted in recall of an educational
promotional bike light and a recall of a novelty promotional item from a
charity organisation in South Australia).

• There is supplier confusion around their responsibilities to comply and recall
non-compliant devices because the Code is not mandatory and is not seen to
apply to devices regulated elsewhere by TGA or other electrical regulation
that may not be nationally consistent.
• There are too many referenced Standards for suppliers/retailers/importers
to be confident they have covered all necessary intended requirements.
• The Australian and International Standards referenced in the Code are not
readily and freely available to suppliers/importers/retailers which
discourages compliance.
• The Code lacks of clear, easily understandable prescriptive requirements.
Instead it favours ‘deemed to comply provisions’ that are open to
interpretation and misinterpretation and wording that is too vague and
optional – leading to overall failure to protect public safety, for example:
o ‘such that batteries are not accessible to young children when…
subjected to normal use or reasonably foreseeable misuse’
o ‘suitable child-resistant packaging’
o ‘such tests may incorporate but are not limited to…’
o ‘suggested markings for the packaging can include the following’

A clear agreed set of minimum safety tests and minimum label requirements
(that includes text AND graphic illustrations) is necessary. An improved
regulatory approach requires specific details of the required torque and
tension, drop, lid pressure, robustness tests to be clearly listed (not just
referenced) to ensure the battery compartment is adequate and specific
guidance needs to be provided around what is deemed suitable child-resistant
packaging.

An example of a national guideline provided by the Australian Health Ministers
Advisory Committee (AHMAC) to be read in conjunction with relevant
provisions in State and Territory legislation that clearly identifies what storage
requirements for Schedule 6 and Schedule 7 poisons would be deemed by
regulators to comply with legislated provisions:
https://www.tga.gov.au/publication/national-guideline-retail-storage-
schedule-6-and-schedule-7-poisons.
• A single design feature – e.g. a well-constructed (cannot be separated away
from the device and does not break on impact) battery compartment that is
secured with a screw/mechanism requiring a tool to open – improves the
regulated user’s understanding of their legal responsibilities and maximises
compliance. It is recognised that even with a child-resistant battery
compartment, as with any child-resistant closure, consumers can still fail to re-
secure the compartment after battery replacement particularly if it is not easy
to remove and resecure, unless the product will not function without the
compartment being closed.

Further investigation is needed to understand the economic impact of
requiring a preferred single design feature on commercial/business interests,
and potential for flow-on consumer pricing (as Australia’s major trading
partners have no mandated battery-powered product restrictions). It is
important to determine if mandated safety requirements would create any
tangible barrier to trade to objectively assess potential economic impact. Any
regulatory impact assessment would need to include this.

Mandating safety requirements for button batteries and devices is an
opportunity for Australia to be world leaders in public health protection from
battery-related risk and to drive (and perhaps incentivise) innovative
engineering solutions to eliminate the hazard.

Yes safety actions should be made mandatory for the following reasons:

• In light of the extensive range of battery-powered products and the wide
variety of supply mechanisms (including charity promotional items and
agency/organisation educational items and second-hand/market outlets) and
traditional retail outlets (e.g. hardware, toy shops, pharmacies, supermarkets,
two-dollar shops etc. etc.) and online where consumers can obtain devices
and batteries it is important that a multi-faceted regulatory approach with
extensive reach is considered that is capable of regulating both
imported/online devices and batteries, and locally-produced devices. No
single tool is capable of addressing the scope of this issue. Therefore the best
approach to reduce the amount of new/second-hand non-compliant devices
and batteries is to use multiple regulatory tools.
• An enforceable mandatory safety standard adopted by reference in national
legislation (rather than depending on States and Territories to decide/agree
to adopt) would reduce the current supplier confusion about whether they
are legally expected to comply with a voluntary code.
• A mandatory safety standard would provide a legal framework to enforce
unsafe product recalls. Voluntary recalls of battery-powered devices appear
to be difficult to conduct due to the voluntary nature of the Code resulting in
low returns. A mandatory safety standard would provide this important
mechanism to maximise public health protection.
• A mandatory safety standard must be accompanied by an ongoing wide
consumer and retailer/supplier/importer national education campaign
including guidance in different languages for non-English speaking
suppliers/importers/retailers.
• A mandatory safety standard would provide legal clarity and support for
Australian suppliers/retailers/importers, but the economic regulatory
impacts need to be investigated and clearly defined.
• A mandatory safety standard would provide clarity to remedy non-compliant
products whether recall, expiation for offences etc.
• Improvements are needed on the recommended safety actions in the current
Code to provide clear prescriptive minimum requirements (reasons listed
above).
• Complementary regulatory tools need to be investigated:
o In particular banning the importation of non-compliant battery
products and battery packaging should be investigated. It may be
feasible to amend the Commonwealth Customs (Prohibited
Imports) Regulations 1956 Schedule 2 to include batteries and
battery-powered devices with requirements that align with an
ACCC mandatory safety standard.
o While it is not possible to prevent all non-compliant products from
entering Australia, and customs limited resources are
understandably likely to be focussed on illicit firearms, weapons and
drugs, such a regulation would educate importers about the safety
requirements and require some sort of compliance declaration to
accompany imports.
• Regulation of online sales is another difficult compliance point that would
require specific resourcing.

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Yes a mandated safety standard regarding the design and manufacture of battery compartments is likely to reduce battery-related injuries and fatalities based on the information collected about serious injuries in the APSU study that details the context of child access to batteries.

Case information indicates that injured children have accessed batteries directly from battery compartments – in some instances children have accessed batteries from a functioning battery closure that could possibly be interpreted to comply with the two independent actions requirement. This indicates that a screw, bolt or mechanism such that it requires a tool to gain access is likely to be the preferable requirement but cannot function as a standalone measure – needs to be supported by packaging, labelling and education.

A safety standard (not an information standard) for packaging and labelling of button batteries and battery-powered devices is likely to reduce the number of injuries and fatalities caused by button batteries in Australia if used in conjunction with child-resistant battery compartments particularly label warnings that need to be designed for low literacy (an infographic must feature) and in multiple languages as injury data indicates high number of non-English speaking families involved.

While child-resistant packaging is a well-recognised and proven effective poisoning prevention measure, particularly to reduce accidental ingestion of medicines, battery-related injury data suggests there are instances where a child has accessed loose batteries – this has occurred where battery packaging has been opened previously by another person. To reduce battery-related harm it is important that batteries are mandated to be packaged individually as well as the package meeting the Australian Standard for child-resistant packaging. Ideally, child-resistant packaging needs to consider a method of resecuring spent batteries (which still retain sufficient charge to cause injury when no longer able to power a device).

Yes a safety standard should require provision of Australian Poisons Information Centre details on the label because Australian Poisons Information Centres provide a 24/7 expert first response for battery-related exposures. Poisons experts providing this national advisory service have been trained to provide the appropriate clinical advice and direction to the public in battery-related ingestion and insertions and facilitate the appropriate rapid medical attention through clinicians that is required to avoid life-threatening consequences of battery harm. The Australia Poisons Centres are the centralised point of coordination to direct transport of patients to or remote/regional retrievals to the appropriate health facility that has the necessary equipment and clinical expertise required to effectively diagnose and remove ingested batteries or deliver necessary surgical interventions.

Yes injury data indicates that all size button batteries have been associated with injuries in children from either ingestion or insertion, supporting the need for packaging and labelling requirements need to apply to all size batteries.

As the ACCC issues paper states – ‘all button batteries present a risk when ingested or inserted’ so there is no justification to regulate any type differently. SA Health agrees that all safety requirements relating to design and manufacture of battery compartments, battery packaging and labelling should apply to all button batteries regardless of size or chemistry.

It would be preferable if all consumer products without a durable (for the life of the device) screw/mechanism closure battery compartment requiring a tool to open are banned from supply in Australia. A broad ban such as this would simplify regulation and is more likely to achieve the necessary level of public health protection commensurate with the risk of fatality.

Validated data that is able to describe the current level of voluntary compliance with the Code would provide an indication of the impact of mandatory safety requirements (perhaps the ACCC surveillance of non-compliant products vs compliant products would give an indication).

As well as the immediate, intermediate and long-term health costs associated with battery-related injuries and fatalities there are significant and enduring emotional, financial and mental health costs for families who have experienced such injuries that must be included. Any cost-benefit analysis of mandatory battery-related requirements must also include the current regulatory costs associated with product safety testing costs and legal costs incurred to effectively enforce current requirements. Estimates and analysis in the regulatory impact assessment for a proposed multi-faceted regulatory approach will be complex.

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While it may be considered reasonable to exempt scientific and industrial products from a mandatory safety standard there does not seem to be any reason to do so as the suggested safety requirements are not particularly onerous. Capture of these products would prevent unintentional ‘leakage’ of non-compliant products industrial products into the domestic environment.

There may be a case to be made for exempting certain medical devices from requirement for screw closure battery compartments if it is shown that this would have inadvertent negative consequences for disabled or elderly populations unable to use the devices as intended or reduce compliance for use if the battery was difficult to replace e.g. non-compliance of blood glucose monitoring due to lack of dexterity in some populations. As exposure data indicates that a source of batteries in both adult and some paediatric ingestions or insertions are hearing aids/cochlear implants, this requires further investigation of any discriminatory or potentially harmful consequences that disproportionately impacts vulnerable populations of aligning TGA regulation of battery-powered medical devices with a mandatory safety standard which improves the safety of battery compartments or CRC packaging for loose batteries. While there is concern that increased child-resistance of packaging and compartments may disadvantage some who are reliant on medical devices, on a practical level, many consumers already struggle to extract and replace batteries for devices such as hearing aids. This issue is a strong driver for cost-effective innovative engineering solutions to develop medical devices that remove the need for button batteries or remove the need for batteries that need to be replaced in these devices and investigation of options for packaging replacement batteries in a similar way as used for multi-dose pharmaceutical packs.

• It would be helpful to know which jurisdictions mandate the Australian
electrical safety regulation, which appears to have many of the desirable
safety requirements, and the relevant agency’s capacity to enforce to
understand if an ACCC mandatory safety standard would create duplication.
• It is important to maintain the wording Code’s recommended label direction:
KEEP BATTERIES OUT OF THE REACH OF CHILDREN, particularly for
devices intended for children. It is important to protect the integrity of the
historical poisoning prevention instruction, but it is important to clarify
keeping the batteries (not the device per se) out of reach when applying this
warning to devices such as toys and novelties specifically marketed for
children - otherwise there is mixed messaging.
• SA Health has assisted in facilitating several voluntary product recalls after
identifying novelty, promotional, educational devices that are non-compliant
with the Code where suppliers have included a Charity organisation and a
mutual service organisation. It is important that a mandated safety standard
can be enforced for all types of businesses, organisations or entities including
those offering or providing free gifts, promotional or educational devices
powered by button batteries.


The need for a mandatory safety standard was demonstrated in a case where
a bike-safety campaign delivered in South Australian schools by a key road
safety organisation involved giving children a non-compliant bike light (no
battery compartment/closure – just a pocket). In this case, a child required
medical treatment and removal of the battery for the gastrointestinal tract.
The parent had not made a conscious decision to bring a battery-powered
device into the home and was therefore unable to take precautionary actions.
The item was given to children without parental oversight and product safety
information. This context of exposure may often be the case with novelty and
promotional items. It emphasises the need to focus proactively on hazard
elimination for battery-powered promotional items or cost-effective
innovative engineering solutions that remove the need for button batteries
in devices altogether or remove the need for batteries that need to be
replaced rather than relying on reactive enforcement of mandatory
requirements for compartment design, packaging and labelling to minimise
risk of fatalities.
• A dangerous incident in South Australia during Easter 2019, demonstrates
the important role for avoidance and cost-effective innovative engineering
modifications for devices to eliminate the need for button batteries in devices
or remove the need for batteries that need to be replaced in these devices
and the inherent limitation of a safety standard to prevent battery-related
risk. At button-battery powered calculator inadvertently fell into a dough
kneading machine during the preparation of Hot Cross buns and was not
discovered until a customer found part of the electronic circuit board in a bun.
This incident triggered a State-wide food recall. But the battery was not
located. There was no reported health consequence in this case but this type
of incident can have fatal consequences and also cause significant
company/brand damage and loss of consumer trust. It should be recognised
that ultimately, this limitation in mandated safety requirements can only be
mitigated through complete avoidance or cost-effective innovative
engineering solutions to remove the need for button batteries in devices or
remove the need for batteries that need to be replaced in these devices.
• A national database similar to that in the USA would assist to make sure that
new regulatory approaches go far enough or are capturing and mitigating the
relevant aspects of button-battery related risk.
• There is a risk in introducing ‘safer battery’ alternatives such as the lower
current capacity batteries mentioned in the ACCC Issues Paper. It would be
difficult to distinguish the ‘safer’ battery from an ‘unsafe’ battery on X-ray –
so the medical management of ingestions or insertions would be have to be
the same until all ‘unsafe’ batteries had been phased out and removed from
the domestic environment. It is unlikely that there would ever be sufficient
certainty over the nature of a battery that would avoid full medical
intervention if identified on x-ray. Once again this residual risk supports the
need to drive (and perhaps incentivise) cost-effective innovative engineering
modifications to remove the need for button batteries in devices or remove
the need for batteries that need to be replaced in these devices.
• Careful analysis of the resources required to effectively enforce a mandatory
safety standard and a potential import ban on unsafe battery-powered
devices is required that includes investigating potential differences in
compliance and testing costs for regulators between a single requirement for
a screw/mechanism requiring a tool to open versus multiple requirements
either screw/mechanism or two or more independent and simultaneous
actions to remove cover.