Press release: Inappropriate or incorrectly fitted posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs could be fatal warns medical devices regulator

Press release

Date:	05 Jun 2008
Time:	11:00
Subject:	Alert over posture/safety belts fitted to assistive technology medical devices
Contact:	Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) continues to receive reports of fatalities and injuries due to the inappropriate use, fitting, adjustment and maintenance of posture/safety belts which are fitted to assistive technology medical devices such as supportive seating, stair lifts, hoists and wheelchairs.

Since 2005 the MHRA has received six reports of fatalities, several serious injuries and other near misses. These have been caused by occupants slipping down in their seats and suffering positional asphyxiation or falling from the seat.

The MHRA is asking users, carers, staff in the NHS, the community in education and in social care and the private sector to:

• Ensure that all posture/safety belts for seating, stair lifts, hoists and wheelchairs are fitted, adjusted, used, cleaned, checked and maintained in accordance with the manufacturer’s instructions.
• Ensure that guidance on how to check, adjust, clean and maintain each posture/safety belt is passed on to the user or carer.
• Before each use, ensure that the posture/safety belt is in a satisfactory condition, is appropriate for the user, and is adjusted correctly.
• Ensure that reviews of an individual’s needs includes consideration of the appropriateness of the posture/safety belt for the user and carers.
• Report any inadequacies in the manufacturer’s instructions to the MHRA.

Clive Bray, Director of Device Technology and Safety at the MHRA said, “The incorrect fitting or use of a posture/safety belt can result in very serious injuries. People should follow our advice and also continue to report any safety related issues concerning medical devices to the MHRA by calling our Adverse Incident Hotline on 020 7084 3080 or www.mhra.gov.uk.”

A Medical Device Alert (MDA) has also been issued today to all those involved in the provision and maintenance of assistive technology medical devices. These include Healthcare Trusts, Primary Care Trusts, social services, care providers and in particular physiotherapists, occupational therapists rehabilitation engineers, service managers and managers of equipment stores.

› MDA/2008/037 - All posture/safety belts fitted to seating, stair lifts, hoists and wheelchairs

Notes to Editor

Examples of reports to the MHRA include:

1. Fatalities or injuries due to inappropriate use, fitting, adjustment and maintenance of posture/safety belts fitted to assistive technology devices. A poorly fitted or adjusted belt will lead to the occupant slipping down and possibly out of the seat. See Medical Device Alerts MDA 2005/025, MDA 2006/059, MDA 2004/031 and MDA 2008/010 for specific examples. www.mhra.gov.uk

2. Please see below an example of a correct belt position and an incorrect belt position.

Figure 1 - Correct belt position
Occupant sat in or near 90° sitting position.

Posture/safety belt fixed near to the corner of the seat/base with the belt at approximately 45° to the seat base with a snug fit over the pelvis.

 

Figure 2 - Incorrect belt position
Belt positioned above the pelvis against soft tissue area of lower abdomen. The hips are forward in the seat giving a reclined posture.

The belt will not generally stop the person slipping further down in the seat.

Incorrect position can be caused by:

• the occupant being unable to attain a 90° sitting position
• the occupant slipping down in the seat due to inappropriate fitting/adjustment or the belt being held away from the occupant by a part of the seat system (e.g. belt over top of armrests or over hip/thoracic supports).

3. The MHRA is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. No product is risk-free. Underpinning all our work lie robust and fact-based judgements to ensure that the benefits to patients and the public justify the risks. We keep watch over medicines and devices, and take any necessary action to protect the public promptly if there is a problem. We encourage everyone –the public and healthcare professionals as well as the industry – to tell us about any problems with a medicine or medical device, so that we can investigate and take any necessary action. www.mhra.gov.uk