Chapter 1

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:

  1. the number of deaths and injuries attributed to accidents involving mobility scooters in Australia since their introduction;
  2. the causes of these accidents;
  3. any current regulations governing the use of mobility scooters throughout Australia;
  4. comparison of Australian regulations with international standards;
  5. what support structures are in place to ensure the safe operation of mobility scooters;
  6. the regulatory role of government and non-government bodies; and
  7. 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 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:

'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:

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:

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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