A point-of-care assessment app designed to help detect pain in people with dementia has gained approval for use as a medical device in Australia and Europe.
The Electronic Pain Assessment Tool (ePAT) is a mobile application tool, which has evolved from research undertaken by Curtin University over the past four years, that aims to assess and monitor pain in people who cannot communicate verbally.
The company developing the tool, ePAT Technologies, announced on Wednesday the app had met the regulatory requirements for use as a “Class 1 medical device” in the Australian and European markets.
The regulatory approval follows a peer-reviewed study confirming the validity and reliability of ePAT in people with moderate to severe dementia that was accepted for publication in Journal of Alzheimer’s Disease (JAD) earlier this month.
These two critical milestones provide scientific validity to the research and allow the app to be released for sale, said Professor Jeff Hughes, co-inventor of the app at Curtin University and the chief scientific officer with ePAT Technologies.
“Our vision to ensure no person who cannot speak will suffer in silence with pain is closer to being a reality,” Professor Hughes told Australian Ageing Agenda.
Simple and reproducible
ePAT uses the camera in a mobile device and facial recognition technology to detect micro expressions indicative of pain.
It combines this with information also captured through the app on non-facial pain cues, such as vocalisations, behaviours and movements, to calculate a pain severity score.
Both residents and care staff stand to benefit, Professor Hughes said.
“For people with dementia, it’s a more reliable way for their pain to be assessed and hence a reduced likelihood that it will go undetected or unmanaged.”
It offers residential aged care staff looking after people with dementia a simple reproducible means of assessing and monitoring pain, he said.
“This should result in better pain management and a reduction in pain related behavioural problems, in turn decreasing the need for psychotropic medications.”
CEO of ePAT Technologies, Philip Daffas said the regulatory approval meant the app would be available in Australia in the final quarter of 2017.
“Our commercial model will be based on a subscription model that fits with the needs of the enterprise market, such as the carers in aged care facilities and carers for home use,” Mr Dafas said.
Being a Class 1 medical device differentiates the ePAT app from the many wellness apps on the market that typically have not gone through the regulatory process and are not recognised as medical devices, he said.
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