Pillow Talk ……Pssst!
Pillow Talk ……Pssst!
Q: When is a pillow not a pillow?
A: When it’s a medical device!
What is a medical device?
In Australia the Therapeutic Goods Administration (TGA) is responsible for regulating the supply, import, export, manufacturing and advertising of therapeutic goods, such as medical devices.
Medical devices :
- are used on humans
- have therapeutic benefits
- generally, have a physical or mechanical effect on the body or are used to measure or monitor functions of the body.
Medical devices range from a bandage that you would put on a scratch to high risk products such as pacemakers that are implanted in your body.
Gong Life Care Solutions is the sole supplier in Australia of the remarkable LASAL Embracer support pillow - a specialist positioning pillow classified as a medical device. It is made in Denmark, and is certified by the TGA and by European Conformity (CE).
Australia's regulatory system
In an article on the TGA website on 4 April 2019, the regulator stated the following:
The regulatory requirements for medical devices in Australia are some of the most stringent in the world. Compliance by industry with these requirements is never optional or voluntary. The obligations are based on globally aligned requirements that regulate different products according to their risk. While Australia recognises evidence provided to other international regulatory agencies, the Therapeutic Goods Administration (TGA) carries out additional reviews for medium and high-risk devices.
Medical device regulation in Australia is based on scrutiny of the products before they are approved for the market, surveillance of products once on the market and compliance and enforcement activities. The TGA has a range of powers including compelling sponsors to provide information, suspending or cancelling supply or legal actions such as civil and criminal penalties if requirements are not met.
The level of review prior to the TGA approval depends on the risk that the medical device presents to patients or the end user. The approach balances the need to provide patients and the healthcare system with timely access to innovative new technologies with the appropriate level of scrutiny for product safety, performance and effectiveness.
Medical devices are categorized based on their risk, with more evidence required for higher risk medical devices such as pacemakers and joint replacements; and less evidence for lower risk medical devices like bandages and tongue depressors. The risk-based classification system is used by international regulators including the United States, the European Union, the United Kingdom, Canada and Japan.
The information on the TGA site goes on to describe their current Action Plan to further strengthen the regulatory system and continue to improve the safety, performance and quality of medical devices in Australia and improve health outcomes for patients who require medical devices.
The LASAL Embracer Pillow – a TGA Class 1 medical device
Our LASAL Embracer Pillow is classified by the TGA and is also certified CE, which verifies that our product has been assessed and meets the European Union requirements for safety, health and environmental protection.
The pillow has a strong inner case, and the outer covering is 100% OEKO-TEX certified cotton. It is completely washable.
It is the perfect aid for those who have spine conditions or lower back pain, or for added comfort and posture control for people who are restricted to sitting most of the time due to mobility problems.
Quality of life can be affected by discomfort, pain, lack of control over the body’s position, fear of falling……. if you or someone you are caring for, are restricted to bed rest or sitting in a chair, our LASAL Embracer positioning pillow will give you more comfort and confidence. As the name of this pillow suggests - it is a positioning cushion/pillow, that looks and acts like a giant embrace! It will help to improve your posture, reduce pain and improve relaxation and comfort.
Health benefits of improving posture
Sitting up, either in bed, in a wheelchair or in a chair, can assist people to feel much more a part of the home environment, and sitting upright definitely assists with lung function and reduces pressure on the spine – provided the person is well-positioned. However, comfort and good positioning are sometimes difficult to attain. The right aids are important, and can assist carers to optimize comfort and safety when caring for someone at home.
Ordinary bed pillows or sitting pillows can be difficult to place to achieve comfort and support in bed or in the chair – you often need several to attain the right “feel” of comfort and support, and then one move and the stack can all come tumbling down! No more pillow-talk!
This then leaves the user unsupported and literally “listing to starboard”, or flopping forwards or backwards, or sliding downwards – all of which can lead to a sore neck and back pain, and sometimes skin breakdowns from the shearing forces caused by sliding.
The one-pillow solution!
The LASAL positioning cushion is placed with the narrowest piece behind the neck and shoulders and the cushion "arms" surrounding the user around the shoulders and arms. It adjusts to the body shape. In the sitting or reclining position, the Embracer makes it possible for the user to relax in both arms from the neck to the fingertips without the arms falling to the side. The pleasant feeling you get in this embrace allows the user to relax and feel safe.
It is ideal for users who have a tendency to slip down, or to lean to their weaker side, for example, after a stroke.
The LASAL Embracer medical chair pillow provides support and stabilization for a person using a wheelchair, a chair, or sitting or reclining in bed. It is equipped with a belt, which makes it possible to fasten the Embracer to the back of a chair or wheelchair in order to prevent the cushion from sliding down every time the person moves.
See our web site for more information - https://gonglcs.com.au/products/lasal-embracer
Our safety and mobility equipment and rehab supplies are quality products, helping people to maximize independence and safety.
We are happy to answer any question you may have, personally.
- Australian Government, Department of Health, Therapeutic Goods Administration, https://www.tga.gov.au/what-medical-device
- Australian Government, Department of Health, Therapeutic Goods Administration, https://www.tga.gov.au/publication/action-plan-medical-devices 4 April 2019
Contact us on 1300 907 280, Tues to Fri, 8.00 am – 5.00 pm AEDT
We deliver free anywhere in Australia.
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