Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom, has issued a medical device safety alert concerning all posture or safety belts fitted to supportive seating, wheelchairs, hoists and bathroom equipment.

MHRA receives reports of injuries and fatalities because posture/safety belts on assistive technology devices that are not used, fitted or adjusted properly or they have not been maintained correctly. Problems include the person in the seat slipping down and suffering positional asphyxiation or strangulation, or falling out of the seat and being injured. There is a risk of serious injury or death of the person using a posture or safety belt that is not fitted or adjusted properly. For some people a belt alone cannot keep them in an appropriate sitting position and they may need other supports to stop them slipping down (e.g. tilt-in-space or supportive seating). This alert also applies to belts referred to as pelvic, lap, seat or waist belts and also straps or harnesses.

MHRA recommends affected users to take the following actions:-

• Ensure that all posture/safety belts for supportive seating, wheelchairs, hoists and bathroom equipment are fitted, adjusted, used, cleaned, checked and maintained in accordance with the manufacturer's instructions.
• Ensure all users and carers are aware of the manufacturer's instructions for use and have received training on how to check, adjust, clean, and maintain each device.
• Before each use, ensure that the posture/safety belt is in a satisfactory condition, is the right type for the user, and is adjusted correctly.
• Ensure that each review of an individual's needs includes a check that the posture/safety belt is the right one for the user and carers.
• Report all adverse events associated with the use of these devices to the manufacturer and MHRA.

https://www.gov.uk/drug-device-alerts/all-posture-or-safety-belts-fitted-to-supportive-seating-wheelchairs-hoists-and-bathroom-equipment-risk-of-serious-injury-or-death

Posted on 22 April 2015