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). Many of the items on the Assistive Technology Australia website are categorised as a Medical Device. For more information about standards also see To find out if a product meets Australian Standards ask the supplier to show you the certificate. Products that meet Australian or international standards will have written certification. Standards may relate to materials, manufacturing and installation. Some assistive technology needs to meet Australian or other standards. Regular monitoring is recommended, particularly where the user's condition is changing. Users most at risk include those with physical or cognitive challenges or where the intended user's alertness is affected by medication. The device should not be used in circumstances where there is a gap between the vertical components and the mattress. Some bed occupants may try to climb over a bed rail to get out of bed.Ī risk assessment should be undertaken in each circumstance of use. Entrapment of limbs or body parts may occur with parts of the bed and the device.
The device may increase the risk of injury or even death to the bed occupant. This includes but is not limited to a bed pole (stick), bed rail or bed rail protector. In certain circumstances there is an element of risk involved in the use of a device that attaches to the side of a bed such that there is the possibility of entrapment between the device and the mattress. * The surface is non sticky and easy to sanitise for immediate reuse Considerations * Made from MediSkin+ antimicrobial fabric * Medical grade memory foam in triangular prism shape 45 degree wedge keeps the user's shoulders and hips properly aligned for more comfort. The positioning wedge can be used where the user needs firm support for pressure management.
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