Government releases guide to talk about safe use of medical equipment and what to do with failed devices
On 8th August, the Medicines and Healthcare products Regulatory Agency (MHRA) released an assistive technology guide to outline what it is, examples of medical devices, safety issues and what to do with a failed piece of equipment.
The guide initially defines assistive technology: “Medical devices [which] are intended to compensate for or alleviate an injury, disability or illness or to replace a physical function. There should be a direct link between the corrective function of the product and the individual using the product for it to be medical device.”
It also gives some examples of assistive devices, such as wheelchairs, scooters, walking aids, artificial limbs, hearing aids, pressure management solutions, hoists, slings and mattresses. The Government highlights that this equipment helps people carry out everyday activities.
However, the guide makes the important distinction that an item such as a shower stool is not regarded as a medical device because its primary function is personal hygiene, not a medical or mobility need.
Additionally, the MHRA states potential problems that could occur with medical equipment, from incompatibility with other devices through to leaks and design issues.
It then tells individuals what they can do with a failed device. Examples include not using the device if it feels unsafe; contacting the user’s healthcare professional or the retailer or manufacturer; and quarantining the device.
The guide informs people to report all assistive technology incidents to the MHRA, which will then review all incident reports. It explains what the MHRA does with reports, how it can help, and why people should report assistive technology failures.
To conclude, the Government suggests getting advice from other organisations as well such as the Department for Transport and the British Healthcare Trades Association.