Introduction and background
Referral of inquiry
1.1
On 6 December 2017, the following matters were referred to the Senate
Rural and Regional Affairs and Transport References Committee (the committee)
for inquiry and report by 20 September 2018:
The need for regulation of mobility
scooters, also known as motorised wheelchairs, including:
- the number of deaths and injuries attributed to accidents involving
mobility scooters in Australia since their introduction;
-
the causes of these accidents;
-
any current regulations governing the use of mobility scooters
throughout Australia;
-
comparison of Australian regulations with international standards;
-
what support structures are in place to ensure the safe operation of
mobility scooters;
-
the regulatory role of government and non-government bodies; and
-
any related matter.[1]
Conduct of the inquiry
1.2
The inquiry was advertised on the committee's webpage. The committee
also wrote to relevant Commonwealth and state government departments and
agencies seeking submissions. The committee also wrote to disability service
organisations and lobby groups, groups representing older consumers, academic
and research institutions, mobility device suppliers, health and ageing
professionals and rehabilitation providers, to invite submissions.
1.3
Details regarding the inquiry, and associated documents are available on
the committee's webpage at https://www.aph.gov.au/Parliamentary_Business/Committees/Senate/Rural_and_Regional_Affairs_and_Transport.
1.4
The committee received 133 public submissions. A list of submissions is
included at Appendix 1. Public submissions to the inquiry are also published on
the committee's webpage.
1.5
The committee held one public hearing in relation to its inquiry. The
hearing was held in Melbourne on 23 July 2018. A list of witnesses who appeared
at the hearing is included at Appendix 2.
Acknowledgements
1.6
The committee would like to thank all the organisations and individuals
who provided written submissions to the inquiry, or provided evidence at the
public hearing held in Melbourne. Your efforts greatly assisted the committee
in its deliberations.
Note on references
1.7
References in this report are to individual submissions as received by
the committee, not to a bound volume. References to the committee Hansard are
to the proof Hansard transcript and page numbers may vary between the proof and
the official Hansard transcript.
Structure of the report
1.8
This chapter provides some background to the committee's inquiry and clarifies
some of the terminology that is commonly used in relation to mobility scooters
and motorised wheelchairs.
1.9
In undertaking this inquiry, the committee has become aware of the
efforts currently being made by a number of organisations – including
Australian road transport and traffic agencies – as they work toward the
development of a nationally consistent approach to mobility devices. This
chapter outlines the committee's approach to the inquiry, which is informed by evidence
provided by these organisations, and other key stakeholders.
1.10
Chapter 2 provides an overview of recent inquiries, including those
undertaken by the Australian Competition and Consumer Commission (ACCC), and
the NSW Parliament. The chapter also examines the issue of both historic and
current reporting of accidents, injuries and deaths attributed to mobility
scooters. The chapter also examines the findings of a recent national survey of
mobility scooter users, jointly undertaken by a number of stakeholder groups,
including the ACCC, the National Roads and Motorists' Association (NRMA),
CHOICE, EnableNSW and Flinders University.
1.11
Austroads and the National Transport Commission (NTC) are currently
involved in developing a consistent, national framework focused on informing
the use of motorised mobility devices and improving the safety of both mobility
scooters and motorised wheelchairs. The process currently being undertaken by
these two organisations is also outlined in Chapter 2.
1.12
Chapter 3 describes the current regulations governing the use of mobility
scooters throughout Australia, and summarises the state and territory road
rules which determine which mobility devices are permitted to be used on roads,
footpaths and bike-paths. Also outlined in this chapter is the process by which
Australian Transport Standards and Australian Road Rules (ARRs) are developed,
maintained and administered.
1.13
Chapter 4 provides a summary of the committee's inquiry, including the
key issues raised by stakeholders. The chapter also provides a summary of the
committee's key findings, its primary views and its recommendations.
Terminology
1.14
From the very early stages of this inquiry, it was obvious that the
terminology used in relation to mobility devices is less than clear. Mobility
scooters – or motorised mobility scooters – are also frequently called
'buggies', 'scooters', 'motorised mobility devices' or 'gophers'. They are also
at times classified and grouped together with other motorised mobility devices
under generic terms such as 'motorised wheelchair', 'motor chair' or 'power
chair' by the various state road authorities and transport organisations.
1.15
Adding to this general confusion is the fact that mobility scooters,
motorised wheelchairs and other mobility devices can also be categorised as either
'medical devices' or 'therapeutic goods'.
1.16
A number of Commonwealth and state jurisdictions have established their
own definitions in relation to 'mobility scooters' and 'motorised wheelchairs'
for the purpose of administering their individual regulatory frameworks. The Commonwealth
Department of Health (Department of Health) and the Commonwealth Department of
Infrastructure, Regional Development and Cities (Department of Infrastructure) indicated
that:[2]
-
The Australian Competition and Consumer Commission (ACCC) –defines
a mobility scooter as having three or four wheels attached to a frame,
supporting a chair and steering wheel.
-
New South Wales regulations – classify mobility scooters
or 'gophers' as motorised wheelchairs. The NSW regulations also describe
motorised wheelchairs as mobility aids with two or more wheels, which have a
top speed of 10 km/h on level ground. (Under NSW regulations, a motorised
wheelchair does not include a wheeled recreational device such as a motor
scooter, pram, stroller, trolley or any other motor-assisted machine).
-
Western Australian regulations – motorised wheelchairs
under WA regulations include electric mobility devices for people with physical
disabilities such as electric wheelchairs and devices formerly referred to as
'gophers' or 'scooters'. Under the WA Road Traffic Code 2000, motorised
wheelchairs and other mobility devices used by people with a physical
disability fall within the single definition of 'motorised wheelchair'. To be
considered a 'motorised wheelchair', the device must be designed so it is not
capable of a speed exceeding 10 km/h. Under WA legislation, people with a
physical disability, who operate motorised wheelchairs at or below the limit of
10 km/h, are classified as 'pedestrians'.
-
The Australian Human Rights Commission (AHRC) – defines
mobility scooters as battery powered three or four wheeled mobility devices,
for one user only, that are specifically designed to travel on footpaths. They are
simple vehicles with few working parts which require a relatively low level of
maintenance. They are also referred to as 'motorised mobility devices'.[3]
-
The Department of Infrastructure – controls the
importation and supply of road vehicles to the Australian market and
administers the Motor Vehicle Standards Act 1989 and the Motor Vehicle
Standards Regulations 1989. The Department of Infrastructure has its own set
of definitions, and defines a motorised scooter as a device that:
-
is designed to be used by a single person;
-
has two or more wheels and a footboard supported by the wheels;
-
is steered by handlebars; and
-
is propelled by a motor or motors having a combined maximum power
output not exceeding 200 watts.
The Department of Infrastructure
indicated that if the maximum output of a motorised scooter exceeds 200 watts,
it is then considered to be a 'moped' or a 'motorcycle' under Australia's
national standards (and must comply with additional import requirements).[4]
Differences between mobility
scooters and power wheelchairs
1.17
A significant number of submitters were keen to stress the importance of
clarifying the terminology around mobility scooters, with many arguing that the
major differences between mobility scooters and power wheelchairs needed to be
more properly understood.[5]
During the initial stages of its inquiry, the committee acknowledged the views
put forward by key stakeholders and noted – via the inquiry's webpage – that while
in some states and territories, 'motorised mobility scooters' and 'motorised
wheelchairs' are grouped together, they are in fact two different vehicles.
1.18
In order to avoid confusion, the committee accepted evidence in relation
to both types of vehicles, and they were regarded as separate devices for the
purpose of the inquiry.
Mobility scooters
1.19
Although there are obviously a range of views regarding specific
definitions, there is, however, some common ground. There was general
agreement, for example, that mobility scooters are often used by people who
have a disability, but have sufficient mobility to walk short distances (within
their own home environment). These people use mobility scooters to access their
local community: including visits to their local shopping centre, attending
medical appointments, making use of sporting and recreational facilities and
visiting friends and neighbours. Mobility scooters provide these people with a
means to access their local community otherwise denied to them by the longer
distances required to walk.
1.20
It was noted that, in contrast to power wheelchairs, mobility scooters
are often classified as a 'mode of transport', with some state and territory
government authorities not permitting the use of mobility scooters on public
transport, or in wheelchair accessible taxis.
1.21
The ACCC's survey of mobility scooter usage, conducted in 2012,
identified two separate user groups:
-
those who use their mobility scooter as a secondary means of
transportation – as an adjunct to walking; and
-
those for whom a mobility scooter is a primary means of
transportation – a 'lifeline' for maintaining their independence.[6]
'Power' or 'motorised' wheelchairs
1.22
There was also some consensus around the definition of 'power' or
'motorised' wheelchairs. Submitters agreed that, generally, power wheelchairs
are mobility devices designed for people who have a permanent disability, are
unable to walk, and who use these devices as their primary or only mode of
mobility. It was noted that power wheelchairs are often compact enough to be
used at home as well as on public transport, and in private vehicles and
wheelchair accessible taxis.
1.23
Motorised wheelchairs are mobility devices used by disabled people to
support their independence and participation in their community. These
wheelchairs are prescribed by a qualified professional, fitted to meet specific
needs and are often expensive.[7]
1.24
Ms Stacey Christie, who has used a motorised wheelchair since she was a
child (and is now in her mid-20s) explained that her latest motorised
wheelchair was funded through the National Disability Insurance Scheme (NDIS):
It was prescribed by a qualified physiotherapist and custom-fitted
for my needs. It's got a backrest fitted for my back, a reclining backrest,
moveable leg rests and other features – all customised to make the wheelchair
comfortable for me because I spend many hours in my wheelchair each day. It's
also got advanced safety features that makes the wheelchair virtually
impossible to tip over e.g. the wheelchair automatically slows down when
turning a corner. My wheelchair costs close to $30,000.[8]
1.25
In its submission, the Tasmanian Department of Health and Human Services
noted that whilst in Tasmania motorised scooters and power wheelchairs are both
a form of powered mobility, they are considered to be different devices, with
different intended purposes. The difference between the two devices was
summarised particularly well:
A mobility scooter is a battery powered three or four-wheeled
mobility device designed to travel on footpaths. They are activated by a simple
throttle, operated with finger controls, which controls both speed and braking.
Steering is via centrally located handlebars. In Tasmania, mobility scooters
are commonly used by the ageing population and people with declining physical
capacity, often as a vehicle replacement.
A powered wheelchair is a four to six wheeled powered
mobility device designed to replace independent ambulation. Typically they are
controlled by a unilateral steering mechanism such as joystick or toggle.
Generally, in Tasmania, powered wheelchairs are most often used by people with
a higher level of disability and are more likely to be prescribed by a
therapist.[9]
1.26
For the purposes of this report, where appropriate, the general term
'motorised mobility device' is used and where relevant, the committee has
distinguished between 'mobility scooters' and 'motorised wheelchairs' in
accordance with the following diagram.
Figure 1: Motorised Wheelchair
Figure 2: Mobility Scooter
Classification of mobility scooters
1.27
The Department of Health noted that the "risk based classification
system for medical devices is based on the intended purpose of the
device".[10]
Under current regulations, it is a requirement that all medical devices comply
with the 'Essential Principles',[11]
which relate to the "safety and performance characteristics of the medical
device, as well as classification rules and conformity assessment
procedures".[12]
Under the classification system, unless there are risks which warrant a higher
classification, (for example: the device stores, channels or modifies blood, or
has contact with injured skin), non-invasive devices are usually categorised as
Class 1. Currently, in Australia, mobility scooters are routinely classified as
low risk – Class 1 – medical devices. Higher risk medical devices on the other
hand, require independent certification to support their inclusion on the
Australian Register of Therapeutic Goods (ARTG) (and approval for supply in
Australia) with these requirements increasing in line with the risk of the
device.[13]
1.28
In the case of Class 1 medical devices, manufacturers self-certify the
device's compliance with the relevant provisions of the 'Essential Principles',
the classification rules and the conformity assessment procedures. Effectively,
this means that there is no further assessment of the application by the TGA
prior to the device being included in the ARTG, which, according to the
Department of Health, typically occurs overnight.[14]
1.29
To comply with ongoing obligations under the medical device regulatory
framework, sponsors[15]
must:
-
report any serious adverse events (which resulted, or could have
resulted, in serious injury or death);
-
report any overseas regulatory actions;
-
report the results of investigations undertaken by the
manufacturer (such as further clinical studies and reviews of adverse events);
-
obtain information requested by the TGA from the manufacturer;
and
-
maintain distribution records.[16]
1.30
The Department of Health indicated that the TGA uses adverse event
reports to monitor the safety of medical devices. The committee was advised
that that since 2012, 13 adverse event reports for 11 devices have been
received for mobility scooters and motorised wheelchairs.[17]
It was also noted that the TGA has also undertaken recall actions for mobility
scooters and motorised wheelchairs – one in 2002 and two in 2009 – but none
have been identified after July 2012.[18]
International regulations
1.31
Akin to Australian regulations, similar devices are also generally
classified as Class 1 in both Europe and Canada. In Europe, conformity of Class
1 medical devices is self-assessed by the manufacturer. In Australia, the
sponsor includes the device on the ARTG, while in Europe they must register
their operation with the medical device regulator in the relevant European
member state prior to supplying within Europe. In Canada, manufacturers or
importers of Class 1 products must have an 'establishment' licence for their
operation, but individual Class 1 devices are not assessed by the regulator.[19]
1.32
In the United States, mobility scooters are either Class 1 or Class 2
devices requiring pre-market approval based on a comparison to other already
approved devices. Assessment is undertaken by the US Food and Drug
Administration (USFDA) prior to approval.[20]
1.33
It is noted that in each of these international jurisdictions,
"additional requirements, such as speed limits, may apply under regulatory
regimes separate to medical device regulations".[21]
Medical Devices Regulatory Framework
1.34
As previously noted, mobility scooters and motorised wheelchairs can
also be categorised as 'medical devices' or 'therapeutic goods'.
1.35
The regulation of medical devices, including mobility scooters, is
required under the Therapeutic Goods Act 1989, and related regulations,
including the Therapeutic Goods (Medical Devices) Regulations 2002.[22]
The Department of Health, through the Therapeutic Goods Administration (TGA), regulates
the supply, import, export, manufacturing and advertising of therapeutic goods
– including medical devices.
1.36
The Therapeutic Goods Act 1989 defines medical devices as
including:
...any instrument, apparatus, appliance, material or other
article ... intended ... to be used for human beings for the purpose of ...
alleviation of or compensation for an injury or disability (s.41 BD,
(1)(a)(ii)).[23]
1.37
The Department of Health submitted that mobility scooters are routinely
classified as low risk (Class 1) medical devices in Australia, but also argued
that:
...they are also potentially captured by the Therapeutic Goods
(Excluded Goods) Order No. 1 of 2011, which intends to exclude personal aids
for people with disabilities from the operation of the Therapeutic Goods
Act 1989.[24]
Approval to supply medical devices
1.38
The Department of Health advised that, unless a specific exemption
applies, for a medical device to be supplied in Australia it must be included
on the ARTG. Prior to an approval to supply, the regulation of medical devices
includes:
-
classifying the medical device based on different levels of risk
to the user (based on the intended purpose of the device);
-
assessing compliance with a set of internationally agreed
Essential Principles for their quality, safety and performance; and
-
implementing appropriate regulatory controls for the
manufacturing processes of medical devices.[25]
1.39
It was also noted that once medical devices are available for supply,
they are subject to ongoing obligations and monitoring by the TGA, which
includes the reporting and analysis of adverse events.[26]
1.40
While some mobility scooters are included in the ARTG, it was submitted that
many mobility scooters supplied in Australia may not in fact be included on
this register. The Department of Health noted that as a consequence of this
anomaly, the scope of medical device regulation for mobility scooter products was
currently being reviewed "in an effort to ensure appropriate boundaries
for the regulatory framework, and clarity of requirements for suppliers of
these products".[27]
1.41
It was also noted that a review of the Excluded Goods Order is part of
broader reform in relation to low risk medical devices, which has come about as
a result of the 2015–16 Expert Panel Review of Medicines and Medical
Device Regulations which advised at Recommendation 23 that:
...the Australian Government undertake a review of the range of
products currently classified as Class 1 medical devices, with a view to reclassifying
products as consumer goods in circumstances where the product poses little or
no risk to consumers should it not perform as specified, or malfunctions.[28]
1.42
The committee was advised that the Government had accepted
Recommendation 23, and that in addition to assessing low risk medical
devices, the proposed review would assess the scope of the exclusion of 'aids
for people with disabilities', including considerations of the NDIS. It was also
noted that the review, which would involve consultation with consumers,
industry, health professionals and other Commonwealth regulatory bodies, is
expected to be completed by the end of 2018.[29]
1.43
It was noted that the medical devices regulatory framework recognises
these products as therapeutic goods. While the TGA regulates the import,
export, manufacturer and advertising of therapeutic goods, it does not regulate
their operating parameters or use. These operational aspects are outside the
TGA's scope, while specific design issues or equipment failures which impact
safety are within its remit.[30]
Excluded goods
1.44
Under the Therapeutic Goods (Excluded Goods) Order No. 1 of 2011, a
number of items are declared not to be therapeutic goods or medical devices.
These include 'household and personal aids' or 'furniture and utensils for
people with disabilities'. The Department of Health submitted that, depending
on the intended purpose, for a person with a disability, a mobility scooter may
be considered a 'personal aid'. In that situation, the requirements under the
medical devices regulatory framework do not apply.
1.45
A review of the range of scooters supplied in Australia revealed that
many of the mobility scooters currently on the market may not be included on
the ARTG. It was argued that this situation reflects a level of ambiguity (in
the interpretation of this aspect of the regulatory framework) and also a lack
of awareness on the part of companies selling mobility scooters.[31]
1.46
The Department of Health also raised questions about the way various
'personal aids' are categorised:
At present the performance of a range of disability aids are
regulated as medical devices, but it is not clear where is it appropriate to
draw a line between medical devices and 'personal aids'. For example, products
such as can openers and tap turners for people with severe osteoarthritis might
also be considered medical devices (in that they compensate for a disability),
but regulating them as medical devices may be unnecessary (and so they would
appropriately be excluded from the purview of the TGA).[32]
Exempt goods
1.47
Custom-made medical devices are exempted (not excluded) from being
included on the ARTG. The requirements of the medical devices regulatory
framework still apply for exempt medical devices, but it is not a requirement
that they be included on the ARTG prior to supply. Commercially supplied
mobility scooters – even those modified for a specific user – would not usually
be considered custom made. There are, however, some motorised wheelchairs which
are more likely to be considered custom made.[33]
Transport and Infrastructure Regulatory Framework
1.48
In addition to ensuring compliance with the regulatory framework for
medical devices, sponsors and manufacturers are also required to comply with
any other applicable legal requirements. This includes Australian corporations
law and consumer law, as well as any Commonwealth, state, and local government
health and safety requirements.
1.49
The department responsible for the design and implementation of the
Commonwealth government's transport, infrastructure and regional development
policies and programs is the Department of Infrastructure. In its submission,
the Department of Infrastructure specifically addressed term of reference (c) –
any current regulations governing the use of mobility scooters throughout
Australia.[34]
1.50
The Department of Infrastructure used the term 'motorised mobility aids'
to encompass both 'mobility scooters' and 'motorised wheelchairs' and explained
that motorised mobility aids are not road vehicles, but devices primarily
intended to assist those with disability and/or limited mobility, to travel off
the road network. Further, it was noted that because motorised mobility aids
are not classified as road vehicles, they do not fall under the scope of the Motor
Vehicle Standards Act 1989 (MVSA).[35]
1.51
The use of mobility scooters and motorised wheelchairs is regulated by state
and territory governments. States and territories have their own road rules
which govern – amongst other things – the type of devices that are permitted to
be used on footpaths and bike-paths. The Commonwealth does, however, work in
partnership with the states and territories to develop and support 'national
model laws'. The model laws – or Australian Road Rules (ARRs) – are
administered by the NTC. The Department of Infrastructure advised that it is
the ARRs which set mass and speed restrictions on mobility scooters when they
are used on footpaths.[36]
Moving toward a national framework
1.52
As Australia's population ages, the ability for older people to remain
mobile, and retain both their independence and connections with the community will
become increasingly more important. Motorised mobility devices have become one
way older Australians, and those with a disability are able to access services
and maintain their links with the community. Mobility scooters and motorised
wheelchairs allow independent travel and a way for people to access shopping
centres and recreational facilities, attend medical appointments and maintain
social networks.
1.53
Motorised mobility devices, the committee was told, can (and do) provide
a range of benefits for users. They provide a relatively inexpensive way for
people to maintain their quality of life and enhance their overall health and
wellbeing, and their feeling of social inclusion.
1.54
Balanced against these positives, however, the committee received a number
of submissions which raised concerns about the increasing use of motorised mobility
devices – particularly mobility scooters. A number of submitters questioned the
safety of these devices and provided specific examples of accidents, incidents
and near‑misses involving both mobility scooters and motorised
wheelchairs. Concerns were raised about motorised mobility devices –
particularly mobility scooters – being used by people under the influence of
drugs or alcohol, or being driven at inappropriately high speeds. To counter
such misuse, a number of stakeholders argued that mobility devices should be
licensed, registered and appropriately insured.
1.55
Unfortunately, the rules in relation to motorised mobility devices are
inconsistent, complex, and frequently difficult to access. There is limited
understanding of the extent to which these devices are used, the nature of
their use, or the safety implications of their use – particularly by older
Australians.[37]
1.56
From the very early stages of the inquiry, submissions from road
transport and traffic agencies, community organisations and individuals
expressed clear support for the development of a nationally consistent approach
to motorised mobility devices. Submitters stressed the importance of finding a
way to achieve both consistency and clarity in relation to the use (and safety)
of both mobility scooters and motorised wheelchairs.
1.57
A number of organisations – particularly those representing people with
a disability – expressed support for clear, accessible, and straightforward regulations.
Muscular Dystrophy Queensland (MDQ) submitted that all users of pedestrian
spaces need to have clear and consistent regulations, and argued that any regulations
should be inclusive of the rights of people with disabilities as well as those
of pedestrians.[38]
1.58
While there was clear support for developing a nationally consistent
approach to the regulation of mobility scooters and motorised wheelchairs, stakeholders
acknowledged that achieving this outcome represents a challenge, from both a
policy and legislative perspective.[39]
The area of motorised mobility device regulation and safety is, in itself,
complex. The sheer number of stakeholder groups, including academic
institutions, road transport authorities, state and federal government
departments, aged care and disability groups, local councils and consumer
groups makes the task even more complicated.
1.59
Fortunately, there has been an increasing awareness over the past decade
that any new policy framework in relation to mobility scooters and motorised
wheelchairs needs to be based on a solid, evidence-based foundation.
1.60
Over recent years, organisations such as the ACCC, Monash University,
Flinders University and the University of the Sunshine Coast have recognised
the need to collect appropriate data in relation to mobility devices, and have
conducted several very useful research projects.
1.61
Valuable research is also currently being undertaken by Austroads and
the NTC: organisations which have specific expertise in the areas of transport,
safety, policy development and the drafting of road rules. The work currently
being undertaken by these organisations is outlined in Chapter 2. This research
should form the basis of a national framework.
1.62
The committee's report provides a valuable summary of the views
expressed by the wide range of stakeholders who provided evidence to the
inquiry. The committee provides its report in the hope that the views expressed
by stakeholders and the recommendations made by the committee will supplement
the information available in relation to motorised mobility devices – their use
and their safety.
1.63
The committee also recommends that its report is taken into
consideration by Austroads and the NTC as they work toward a nationally
consistent set of regulations which govern the use of motorised mobility
devices – including mobility scooters and motorised wheelchairs.
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