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Disabled People: Independent Living Equipment

Answer

It is the responsibility of individual employers to ensure that their staff are appropriately trained and competent for the role that they perform. We would therefore expect staff providing care in all settings to promote the safe and appropriate use of all equipment or medical devices, and expect providers of regulated health and adult social care to ensure that staff who use such devices:

are aware of the associated risks; and

have access to training and support to develop and maintain their knowledge and skills.

In addition, all providers of regulated health and adult social care activities in England must be registered with the Care Quality Commission (CQC) and meet the essential requirements of safety and quality. The requirements include making suitable arrangements to protect people who use services from the risk of harm caused by unsafe equipment or incorrect use of equipment. CQC can take enforcement action where a provider is not meeting the requirements.

CQC is responsible for developing and consulting on its methodology for assessing whether providers are meeting the requirements and has published its Guidance About Compliance, including a schedule of applicable publications, which is available on its website.

The department is aware of the community equipment code of practice scheme (CECOPS) and the Secretary of State has corresponded with its chair, Sir Bert Massie. While it is for the local NHS, social care providers, voluntary sector organisations and other key partners to determine local priorities, the code of practice is a useful tool which the department will bring to the attention of NHS England and other partners as part of ongoing discussions.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the competent authority in the United Kingdom for the EC medical devices directive (MDD). Where disability and independent living equipment are class 1 medical devices, when initially placed on the market they must comply with the essential safety, quality and performance requirements of the MDD. All medical devices must be supplied with appropriate instructions for use to enable them to be used safely and maintained appropriately. Manufacturers are required to maintain a post-market surveillance system to ensure that any problems or risks associated with the use of their devices once freely marketed are identified early and reported to the competent authorities and acted upon.

The MHRA operates an adverse incident reporting centre for incidents involving medical devices to be reported by manufacturers, healthcare personnel and members of the public. Serious incidents may result in the MHRA issuing a medical device alert to advise users of specific problems or revised instructions for

use. The MHRA also publishes device bulletins on specific issues, for example the safe use of bed rails in hospitals and care homes.

Under the MDD, class 1 medical devices are able to be certified with a CE mark by the manufacturer, to demonstrate that the product meets essential quality, safety and performance requirements.

The information requested on fatalities and injuries linked to use of equipment is not kept centrally.

Secondary information

Type

Written question

Reference

744 cc362-4WA; HL6651

Session

2012-13

Subjects

Disability aids NHS Staff Training Social services

Link

View this Written question on www.publications.parliament.uk