Paintable electronic tattoos – is that a medical device?

Tattoo artist with gloves operates a tattoo machine in a tattoo parlor setting

Medical devices can be used to diagnose, prevent, treat, and monitor medical conditions. They include things like implants, software,    surgical equipment, pacemakers, baby incubators, and other items.

Conventional electrodes that collect electrical signals from the human body for wearable health monitors and human-machine interfaces struggle to remain adhered to hairy and sweaty skin during exercise and the movements of daily life. To address this, research is progressing on a conductive ink to be painted directly to the skin. After drying, it’s aim will be to act as a functional electrode and may help improve comfort and reduce stigma in patients undergoing continuous health monitoring. Find out more about Paintable electronic tattoos monitor heart, brain, and muscles . Consumers Federation of Australia (CFA) engages with these issues by supporting a representative to the Standards Australia technical committee HE-030 Biological and clinical evaluation of medical devices working on standardization of the approach to biological and clinical evaluation of medical devices, including design and manufacture and implementation of regulatory frameworks. Participation allows Australian government, industry and health and consumer representatives to have input into the maintenance and continuing development of these core safety standards in medical technology regulation.

Find out more about the CFA Standards Project which plays a critical role in ensuring consumer interests are represented in the standards development process. The Project recruits, facilitates, and supports expert CFA consumer representatives to Standards Australia technical committees and associated international committees.  Find out how to get involved and register your interest.

Anyone can view an Australian standard FREE in the Standards Australia – Reader Room, after registering you will have access to three (3) unique standards in one calendar year, with unlimited access to each standard for a 24-hour period, find out more on this video.