DOCUMENT 3 FOI 24/25-0889
Research – Omeo powered mobility device
The Omeo powered mobility device is being prescribed for participants as an alternative to standard power wheelchairs. The device is based on Segway technology, and is controlled through seating (core) adjustments of the user and/or hand controls.
The Agency has evidence of at least one incident where the participant has been thrown from the device, and as part of a current AAT matter, we are being requested to provide sufficient response as to why we consider the device is not safe and therefore does not meet reasonable and necessary. (The provider has stated that the incident was due to user error).
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Can you please identify any evidence of Segway based seated powered Brief mobility and Segway based standing powered mobility devices and identify any data regarding safety (injuries and accidents).
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Can you please identify whether the Omeo device meets any Australian Safety Standards?
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Can you please identify whether devices which are being used in the context of providing mobility to people with functional/physical mobility issues should be approved by the Therapeutic Goods Administration?
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Can you identify if there are any consumer reports regarding the Omeo device?
Date 17/03/21
s47F - personal pr Requester(s) Naomi ‐ Senior Technical Advisor (TAB)
s47F - personal priv Researcher Jane (Research Team Leader ‐ TAB)
Cleared N/A
Please note:
The research and literature reviews collated by our TAB Research Team are not to be shared external to the Branch. These are for internal TAB use only and are intended to assist our advisors with their reasonable and necessary decision‐making.
Delegates have access to a wide variety of comprehensive guidance material. If Delegates require further information on access or planning matters they are to call the TAPS line for advice.
The Research Team are unable to ensure that the information listed below provides an accurate & up‐to‐date snapshot of these matters.
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2 Summary ……………………………………………………………………………………………………………………….. 2
3 Contact with suppliers and manufactures ………………………………………………………………………….. 2
4 Research Evidence ………………………………………………………………………………………………………….. 3
5 Assistive Technology Standards, License and Insurance ………………………………………………………. 4
5.1 Standards ……………………………………………………………………………………………………………….. 4
5.2 TGA ………………………………………………………………………………………………………………………… 4
5.3 Licence & Insurance Requirements ……………………………………………………………………………. 4
6 RACV Report on New Recreational Transport Devices …………………………………………………………. 5
6.1 Victoria …………………………………………………………………………………………………………………… 5
6.2 Northern Territory …………………………………………………………………………………………………… 5
6.3 Queensland …………………………………………………………………………………………………………….. 5
6.4 Australian Capital Territory ……………………………………………………………………………………….. 6
6.5 New South Wales …………………………………………………………………………………………………….. 6
6.6 South Australia ………………………………………………………………………………………………………… 6
6.7 Tasmania ………………………………………………………………………………………………………………… 6
6.8 Western Australia ……………………………………………………………………………………………………. 7
7 References …………………………………………………………………………………………………………………….. 7
2 Summary
No information on whether the device meets Australian Standards o At this time, no information on safety has been provided by the manufacturer Device is not listed on the ARTG, however, this is due to its classification as a personalised mobility device Very little evidence investigating these types of seated Segway devices o A conference presentation and one paper show various issues relating to braking distance, safety, stability and trunk support o Wheelchair skills and confidence testing showed that scores in manual wheelchairs were significantly higher compared to the Nino
3 Contact with suppliers and manufactures
s47F - p Spoke to s47F - personal privacy at electric vehicles oceania on 17/03/21. stated that recent changes to TGA requirements meant that personal mobility device such as the Omeo and s47F - p the Genny (a very similar device) are no longer required to obtain regulatory approval. wasn’t clear as to why this was but one can assume it is because they are considered personal mobility
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s47F- perso devices rather than a medical device. also stated that the Genny had previously obtained TGA s47F - p approval before the certification requirements were changed. did not know whether the Omeo s47Fs47F- -personalpersonalprivaprivacy s47F - met any Australian Standards but was keen to find out stated that would contact [s47F - personal privacy](/foi-library/releases/759e22e37354-foi-24-25-0593-decision-document/release-materials/material-001__s47f-personal-privacy/) Omeo Technology.
s47F- perso When asked about client testimonials commented that 100% of those who had purchased the Omeo found them to be life changing. When asked about the lack of straps to hold the participant in s47F - the device commented that this would be worse as then the person would become stuck under the device if it were to flip/roll over. I asked a follow up question about the device rolling over and s47F - s47F - said that had heard of cases of clients falling out of the Omeo but this was due to ‘misuse’ of the device. An email enquiry was sent to Omeo Technology s47F - personal privacy on 17/03/21. Still awaiting a response.
4 Research Evidence
A systematic review of the literature focusing on Segway Personal Transporter relating injuries was conducted by [1] in 2017. A total of six articles were included in the study that included data on 135 patients. Sample size per study varied from 1 to 41 patients. Studies occurred in both the emergency department and inpatient settings, including medical‐surgical wards, and intensive care units. The most commonly reported injuries were orthopedic cases (n = 45), maxillofacial cases (n = 13), neurologic cases (n = 8), and thoracic cases (n = 10). Conclusions: The Segway Personal Transporter is an innovative transportation method; however, its use is associated with a wide range of injuries. Many of these injuries require hospital admission and surgical intervention, incurring significant morbidity and high costs. Due to voluntary nature of the included studies, the true incidence of Segway injuries is likely much higher.
An abstract investigating the potential hazards of the Nino two‐wheeled electric auto‐balancing seated vehicle was presented at the Rehabilitation Engineering and Assistive Technology Society of North America (RESNA) annual conference in 2019 [2]. The authors found a hazard relating to stopping distance. Braking requires the user to lean backwards so that the whole device tilts, good core strength/centre of gravity is required to perform this function. The braking distances of the Nino ranged from 1.5 to 6.1 m depending on speed. At higher speeds, the measurement was higher than the company’s reported braking distance of 4 m. The measured and reported braking distances are also much higher than those of conventional PWCs, which have braking distances of about 1.3 m from speeds of 6 to 12 km/h [3]. “The braking distance of the Nino may be a concern for end‐users and prescribers, especially depending on the use cases”. During testing of the emergency braking, for an unknown reason the left wheel stopped braking causing a 90⁰ spin. The tester had to put feet down to keep from falling [2].
The Nino has also been investigated in a single‐site cross sectional study including 12 participants with spinal cord injury or multiple sclerosis [4]. The Wheelchair Skills Test and the Wheelchair Use Confidence Scale were used to compare skills across manual wheelchairs and the Nino. Scores were significantly higher for manual wheelchair compared to the Nino across all tests. Tasks participants were most challenged with included skills such as:
Turning 90 degrees while rolling backwards
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Parallel parking Descending 5 and 10 degree slopes Picking items up from the floor Avoiding moving obstacles
While additional training and experience with the Nino would likely improve users’ ability to do these skills, these potential limitations could have a negative impact on users’ day to day activity and participation.
Several safety concerns about use of the Nino emerged from this study. For instance, researchers observed participants having difficulties stopping quickly and avoiding unpredictable obstacles. Those with higher‐level injuries or decreased hand function appeared to have more difficulty with turning and fine movements. And many participant’s spoke of how lack of trunk support contributed to negative impressions of safety and stability
Results from this study indicate that the Nino may not be a suitable device to replace a motorised wheelchairs at this time as it lacks the necessary adaptability, safety, and functionality required for typical users. The data suggested that the Nino may be beneficial as a tool to conserve energy during mobility related occupations, recreational or outdoor mobility device however further research must be conducted to assess this potential.
5 Assistive Technology Standards, License and Insurance
Assistive Technology Australia lists the below standards for assistive technology and licensing in NSW [5].
Standards
Some assistive technology needs to meet Australian or other standards. Standards may relate to materials, manufacturing and installation. Products that meet Australian or international standards will have written certification. To find out if a product meets Australian Standards ask the supplier to show you the certificate. For more information about standards also see http://at‐aust.org/home/assistive_technology/standards.html
TGA
Many of the items on the Assistive Technology Australia website are categorised as a Medical Device. Medical devices that are approved for use in Australia have been entered into a national database called the Australian Register of Therapeutic Goods (ARTG), which is maintained by the Therapeutic Goods Administration (TGA). You can ask the supplier for the ARTG number for the device you wish to purchase and search the ARTG for the entry. To access information on the ARTG visit www.tga.gov.au
When buying a medical device it is advisable to only choose a medical device that is recommended by a healthcare professional and has been included on the ARTG.
Licence & Insurance Requirements
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In NSW, motorised wheelchairs that weigh less than 110 kg and cannot travel at more than 10 km/h do not have to be registered, provided they are being used by a person with mobility problems. A person driving a motorised wheelchair under these circumstances is defined as a pedestrian under the Australian Road Rules and is permitted to travel on a footpath or nature strip adjacent to the road.
Vehicles exempt from registration are covered by the nominal defendant scheme (administered by the State Insurance Regulatory Authority) if they are at fault in an accident in NSW on a road or road‐related area and cause injury to another person. However, this cover is only valid in NSW.
6 RACV Report on New Recreational Transport Devices
The Australian Road Rules specify rules for motorists, motorcyclists, cyclists and pedestrians. In the Road Rules, wheeled recreational devices and wheeled toy users are treated as pedestrians. Current regulations and safety advice is provided for recreational wheeled devices across Australia in a report by the RACV. Below will summarise the regulations/rules surrounding Segway’s.
Victoria
Regulation: Segway’s can only be used on private property with property owner’s approval. Devices can also be used on footpaths or predetermined routes with a commercial tour operator’s licence. Safety equipment: The safety equipment requirements depend on individual tour operators.
Northern Territory
Riders must be 12 years and above, with supervision required for those between 12 and 15 years. Not to be used on roadways; use is limited to footpaths and nature strips with a speed limit of 12 km/h. Segway’s must adhere to the normal rules when on a footpath/shared path; i.e. keep left and give way to pedestrians. There are requirements for fitting a warning device (bell or horn) and wearing an approved helmet. There is a further requirement for lights when the device is used at night. Segways are currently exempt from registration, motor accident compensation, vehicle design standards and driver licensing requirements when ridden on a footpath or shared path. They may, however, be used on roads in specific circumstances: o Where there is an obstruction on the path, and the Segway travels less than 50 m on a road to avoid the obstruction o Where use is permitted by the relevant authority with control and management of the road, provided care is exercised.
Queensland
Individuals do not require a commercial tour licence to operate these devices. The rules surrounding their use include footpath and nature strip use only (unless there is an obstruction), minimum rider age of 12, helmet wearing at all times, prohibition of mobile phone use, and adult supervision of riders aged 12–15. The device must also be fitted with a horn or bell.
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Exemptions apply in Queensland to the Australian Design Rules for Segway’s and other devices that fit the personal mobility device definition.
Australian Capital Territory
The ACT permits the use of Segway’s for licensed commercial tour operators. The legislation permitting Segway use stipulates that the devices be: Speed limited to a maximum speed of 12 km/h Be fitted with reflectors and warning devices Minimum age of 12 years Use of bike helmets and a minimum height requirement There is a predetermined route and area for Segway use and additional road rules such as prohibiting pushing or towing of devices across pedestrian crossings, prohibiting riding on a dividing strip or median and complying with pedestrian road rules also apply.
New South Wales
Road rules for wheeled recreational devices in NSW are similar to the Australian Road Rules. The definition of a wheeled recreational device is also similar to that of Victoria and in the Australian Road Rules, where motorised devices are not considered wheeled recreational devices.
In NSW, motorised wheeled recreational devices (such as a Segway), regardless of output or speed, are classified as vehicles. Therefore, they require registration, licensing and third party insurance cover. As these devices do not meet the minimum requirement under the Australian Design Rules and therefore cannot be registered, and this restricts their usage to private property.
South Australia
The rules for wheeled recreational devices and the definition of these devices is similar to the Australian Road Rules. The rules state that motorised wheeled recreational devices cannot be used on footpaths, public roads or nature strips and can only be used on private property. Segway’s are included in this definition and therefore it is considered illegal to use them outside of private property.
Tasmania
The rules for wheeled recreational devices and the definition of these devices is similar to the Australian Road Rules. Furthermore, motorised scooters with a maximum power output of up to 200 watts can be used on footpaths, nature strips and public roads.
Segway’s can be used on public roads with a commercial tour operator licence, otherwise they can only be used on private property. In the case of tour operators, similar rules to those in Queensland apply; i.e. the device is speed limited to 12 km/h and the user must wear a helmet, and be 12 years or older. Weight and height restrictions apply. Route and other rules are also stipulated.
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Motorised wheeled recreational devices with an output of more than 200 watts (regardless of top speed) are classified as ‘vehicles’, but as stated previously, they do not meet the requirements of the Australian Design Rules.
Western Australia
The rules for wheeled recreational devices in Western Australia are similar to the Australian Road Rules and Australian Design Rules.
Motorised wheeled recreational devices cannot be used on footpaths, nature strips or public roads. They can be used on private property.
7 References
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Pourmand A, Liao J, Pines JM, Mazer‐Amirshahi M. Segway® Personal Transporter‐Related
Injuries: A Systematic Literature Review and Implications for Acute and Emergency Care. The Journal of Emergency Medicine [Internet]. 2018 2018/05/01/; 54(5):[630‐5 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S073646791731185X. 2. Dougall RH, Denison I, Borisoff JF. Seated Auto‐Balancing Mobility Devices: Preliminary Testing Of Potential Hazards During Use. RESNA annual conference 2019. 3. Cooper RA, Dvorznak MJ, O’Connor TJ, Boninger ML, Jones DK. Braking electric‐powered wheelchairs: Effect of braking method, seatbelt, and legrests. Archives of Physical Medicine and Rehabilitation [Internet]. 1998 1998/10/01/; 79(10):[1244‐9 pp.]. Available from: https://www.sciencedirect.com/science/article/pii/S0003999398902696. 4. Mattie J, Tavares J, Matheson B, Smith E, Denison I, Miller WC, et al. Evaluation of the Nino® Two‐Wheeled Power Mobility Device: A Pilot Study. IEEE Transactions on Neural Systems and Rehabilitation Engineering [Internet]. 2020; 28(11):[2497‐506 pp.]. Available from: https://ieeexplore.ieee.org/abstract/document/9211445. 5. Assistive Technology Australia. Omeo product detail 2020 [Available from: https://at‐ aust.org/items/13575.
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