Quality First International

Do medical devices used in psychology receive the attention they deserve?

An article published by London-based medical device regulatory consultancy Quality First International explores whether the design, regulation and evidence-base of medical devices used in cognitive psychology is sufficiently accommodated and specified to permit achievement of clinical effectiveness.

London, 30 September 2019

The London-based medical device regulatory consultancy Quality First International has published a research paper on the use of medical devices to treat mental disorders.

Mental health is a global health concern, with the number of people being affected by mental illnesses increasing and therefore positioning mental disorders as one of the leading causes of illness and disability worldwide. Less known to a wider public, medical devices are not only used for physical illness, they are also used in the field of psychology and hence can be used to diagnose and treat mental illnesses.

Medical devices used in psychology include neuroimaging machines, which can be used to help diagnose conditions like depression and epilepsy, or apparatus used to treat mental illnesses such as brain stimulation devices like electroconvulsive shock or even nerve stimulation devices. Using these devices is becoming an increasingly more popular form of treatment, therefore it is important that there are effective regulations and design processes in place to ensure safety and conformity, as there are various ‘off-label’ types.

It is also crucial that there is an understanding of the effect devices may have on psychological wellbeing, which has not previously been included as a regulation that manufacturers must follow. A device can add extra stress or anxiety, which has been discovered to prevent people recovering.

“A large challenge encountered during the research was that there was little information on the regulation of devices used in psychology, which at first was a problem but then became a revelation and precipitated a proposal that this gap should be filled”, states Eleanor Brown, the author of the article and Research Student at QFI.

The research paper explores if the design, regulation and evidence-base of medical devices used in cognitive psychology is sufficiently-accommodated and specified to permit achievement of performance (clinical effectiveness), taking into account human factors, psychological impact, transcranial magnetic stimulation, electroconvulsive therapy, nerve stimulation, dermal response and mental models.

The article may be ordered direct from QFI: enquiries@qualityfirstint.com, Price: £49 (plus VAT as applicable), reference: “Review of the design, efficacy and regulation of medical devices used in psychology, The psychological impact of medical devices and how psychology is incorporated in the design of medical devices” | Quality First International.

About Quality First International (QFI)

QFI is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting edge, minimally invasive and cardiovascular products and implants. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.

For further information please contact:
Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com, Website: www.qualityfirstint.com.