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My (not so) trusty old tape measure

getback™ Co-Founder and Clinical Director Geoffrey Mackay explains why having getback devices Classified as Class 1 Medical, Measuring and Rehabilitation Devices by the TGA in Australia is a game changer.

I’m not sure how many people have attempted to measure someone’s legs with a tape measure, but if you have, you’ll understand how variable the measurements are. 

Researchers have actually taken the time to prove that leg measurements between trained Physiotherapists may vary up to 10 per cent. They also concluded that a discrepancy of greater than 1.2cm between legs is significant!

Perhaps it was something I missed in my training, but during my clinic life I could never work out how to measure 1.2cm accurately. 

Despite this, measuring a patient’s leg was a standby clinical test for me. Over time I applied the above knowledge and realised that for me, the critical point was about 0.5cm difference. Anyone with a discrepancy of greater than 0.5cm was an indication to check all the joints along the shorter limb and check a patient’s upright posture. 

Today, having getback devices Registered as Class 1 Medical, Measuring and Rehabilitation Devices with the Therapeutic Goods Administration (TGA) in Australia is a game changer.

The TGA regulates therapeutic goods – in our case the Class 1 Medical Devices – through pre-market assessment; post-market monitoring and enforcement of standards; licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.

A TGA-registered product is certified to be manufactured according to internationally recognised standards for quality, safety and performance. 

In our case, quality relates to the build of the devices. To meet this quality, the facility in Finland where the devices are built must demonstrate high manufacturing standards which are assessed annually. 

Safety refers to how safe the devices are to use. For example, has the manufacturer mitigated any potential risk associated with using the devices? Can the manufacturer clearly demonstrate that the benefits of the device outweigh any risks? 

Performance specifically relates to the device’s scientific capabilities. getback™ devices were designed by teams of Doctors, Biomechanists and Exercise Physiologists with expert knowledge. For a device to have scientific capabilities it must be able to demonstrate that the specific structure that the device measures (in our case, the Multifidus muscle) can be successfully, reliably and repeatably measured. 

Reliably means the same therapist can do the same test a number of times and achieve a consistent result. Repeatably relates to the ability of multiple Therapists to perform the same test on the same person and get consistent results.

Clinically, we can now impose basic scientific research to increase our knowledge base of how best to rehabilitate a patient following an episode of back pain. This knowledge base enables getback Physiotherapists and Exercise Physiologists to devise individual treatment plans and methodology to help people live without the often debilitating burden of back pain. 

Because our devices can be used as both scientific measuring devices and rehabilitation devices, there is a direct carry over between the science and its application by our Therapists, leading to better outcomes for patients.

Unlike my tape measure, where the science suggested an outcome and I had to find my own way to apply this knowledge, getback provides a direct link between the science and the application of this science. 

getback™ Co-Founder and Clinical Director Geoffrey Mackay explains why having getback devices Classified as Class 1 Medical, Measuring and Rehabilitation Devices by the TGA in Australia is a game changer.

I’m not sure how many people have attempted to measure someone’s legs with a tape measure, but if you have, you’ll understand how variable the measurements are. 

Researchers have actually taken the time to prove that leg measurements between trained Physiotherapists may vary up to 10 per cent. They also concluded that a discrepancy of greater than 1.2cm between legs is significant!

Perhaps it was something I missed in my training, but during my clinic life I could never work out how to measure 1.2cm accurately. 

Despite this, measuring a patient’s leg was a standby clinical test for me. Over time I applied the above knowledge and realised that for me, the critical point was about 0.5cm difference. Anyone with a discrepancy of greater than 0.5cm was an indication to check all the joints along the shorter limb and check a patient’s upright posture. 

Today, having getback devices Registered as Class 1 Medical, Measuring and Rehabilitation Devices with the Therapeutic Goods Administration (TGA) in Australia is a game changer.

The TGA regulates therapeutic goods – in our case the Class 1 Medical Devices – through pre-market assessment; post-market monitoring and enforcement of standards; licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.

A TGA-registered product is certified to be manufactured according to internationally recognised standards for quality, safety and performance. 

In our case, quality relates to the build of the devices. To meet this quality, the facility in Finland where the devices are built must demonstrate high manufacturing standards which are assessed annually. 

Safety refers to how safe the devices are to use. For example, has the manufacturer mitigated any potential risk associated with using the devices? Can the manufacturer clearly demonstrate that the benefits of the device outweigh any risks? 

Performance specifically relates to the device’s scientific capabilities. getback™ devices were designed by teams of Doctors, Biomechanists and Exercise Physiologists with expert knowledge. For a device to have scientific capabilities it must be able to demonstrate that the specific structure that the device measures (in our case, the Multifidus muscle) can be successfully, reliably and repeatably measured. 

Reliably means the same therapist can do the same test a number of times and achieve a consistent result. Repeatably relates to the ability of multiple Therapists to perform the same test on the same person and get consistent results.

Clinically, we can now impose basic scientific research to increase our knowledge base of how best to rehabilitate a patient following an episode of back pain. This knowledge base enables getback Physiotherapists and Exercise Physiologists to devise individual treatment plans and methodology to help people live without the often debilitating burden of back pain. 

Because our devices can be used as both scientific measuring devices and rehabilitation devices, there is a direct carry over between the science and its application by our Therapists, leading to better outcomes for patients.

Unlike my tape measure, where the science suggested an outcome and I had to find my own way to apply this knowledge, getback provides a direct link between the science and the application of this science. 

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