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The Medicines & Healthcare products Regulatory Agency (MHRA) has released an updated version of its assistive technology guide for healthcare professionals and manufacturers, providing definitions, helpful examples, and information on potential safety issues and how to report problems.

Called ‘Assistive technology: definition and safe use’, the guide says that assistive technology refers to products that support and assist individuals with disabilities and reduced mobility to carry out functions that might otherwise be challenging or impossible.

An assistive product can be a medical device – which needs a CE mark and is regulated by the applicable legislation – or it can be an aid for daily living, depending on the claims made by the manufacturer.

Perhaps one of the most important aspects of the guide is the distinction between medical devices and non-medical devices, providing handy examples to help clarify this topic.

The MHRA states: “Just because a product is used in a healthcare environment or by a healthcare professional, does not automatically mean it is a medical device. It will only be considered a medical device if the manufacturer has stated it has a medical purpose and if the product’s primary mode of action is physical or mechanical.”

Examples of medical devices include hearing aids, orthopaedic footwear, patient hoists, walking frames and pressure relief cushions.

According to the guide, one key determining factor as to whether a device is medical or not is whether its intended use is for a specific individual or for everyone. If a manufacturer does not state its product is intended to be used by an individual for a specific medical purpose, then the device can be used by anyone, regardless of whether they have a medical condition or not.

The MHRA adds: “If a product can be used by anyone then it is unlikely to be a medical device.”

Within the guide, it gives the following example for more clarification on medical devices:

“A manufacturer sells 2 different kinds of portable wheelchairs: a self-propelled wheelchair intended for use by people with disabilities or difficulty in walking and another that is intended to be used by hospital porters to transport patients around the hospital.

“The first is a medical device because there is a clear link between the corrective function (compensation for injury or disability by providing a mode of transportation) and the individual (persons with disabilities or difficulty in walking).

“The second wheelchair is not a medical device because although the purpose is also to provide transportation, it is not specifically intended to be used only by those with disabilities or difficulty walking. It is an aid for the porter to transfer anyone around the hospital quickly and safely.”

The guide also outlines various different safety issues regarding what can go wrong with a device, such as inadequate repair instructions from the manufacturer, problems from storage conditions, device failures, and confusing device documentation. It recommends to users that if their assistive device fails, they should stop using it and contact their healthcare professional, retailer or manufacturer.

Additionally, the guide says that healthcare professionals should report suspected failures through their local incident reporting system and/or their national incident reporting authority as appropriate. Then, the MHRA reviews all reports and lets the healthcare professional know within 10 working days of receipt of the report of what it plans to do.

The MHRA importantly notes that healthcare professionals should report suspected failures in order to fulfil their duty of care. Reporting can also help notify the MRHA of device failures on a national scale and to help manufacturers issue corrective actions, as well as prevent serious harm to individuals.

To read the full report, click here

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