Regulatory and Safety
Simple up is the original and best solution to your patient and Radiographers weight bearing problems created out of a genuine desire to benefit both the patient and the healthcare professional.
Beware of imitations!
When choosing a solution to your health and safety issues, it is important that your choice does not create another health risk for patients and staff.
Quality of design and manufacture is at the heart of the Simple UpCL™ providing a professional solution fit for healthcare professionals:
H & S law
NHS manual handling guidelines based on the European Directive 1992 (HSE 2004).
The European directive expects employers to risk assess their manual handling activities with the expectation that they should work to avoid or reduce the need for manual handling operations through a greater investment in mechanisation.
The Medical Device Directives is a 'New Approach' directive relating to the safety and performance of medical devices which were harmonized in the EU in the 1990s. For a manufacturer to legally place a medical device on the European market the requirements of the Directive have to be met and a CE mark applied.
Any medical device placed on the European market must comply with relevant legislation. Manufacturers' products meeting 'harmonized standards' have a presumption of conformity to the Directive. Products conforming with the Directive must have a CE mark applied. The core legal framework consists of three directives:
- Directive 90/385/EEC regarding active implantable medical devices (AIMD)
- Directive 93/42/EEC regarding medical devices (MDD)
- Directive 98/79/EC regarding in vitro diagnostic medical devices (IVDD)
All medical devices must fulfil the essential requirements set out in the above mentioned Directives. Where available, relevant standards may be used to demonstrate compliance with the essential requirements defined in the Directives list of harmonized standards.
Simple Up™ is tested and approved safe
Approved MDD 93/42/EEC compliant
Lifting Operations and Lifting Equipment Regulations (LOLER) 1998
LOLER is aimed at ensuring that all lifting operations are properly planned, lifting equipment is used in a safe manner and that, where necessary, it is thoroughly examined at suitable intervals by a competent person.
To decide whether LOLER applies you need to answer two questions – is it work equipment and, if so, is it lifting equipment?
Is it ‘work equipment’?
The fact that equipment is designed to lift or lower a load does not automatically mean that LOLER applies. The equipment has to be defined as ‘work equipment’, which is defined in the Provision and Use of Work Equipment Regulations 1998 (PUWER)2 as ‘any machinery appliance, apparatus, tool or installation for use at work (whether exclusively or not)’.
If so, is it ‘lifting equipment’?
The definition of a ‘lifting operation’ in LOLER is ‘an operation concerned with the lifting or lowering of a load’. It applies to equipment which lifts or lowers loads as a principal function. Much equipment in health and social care premises has an element of lifting as part of its normal operation, for example a variable-height bed or dentist’s chair. However, the principal function of these items is as a bed or chair, and not as a device for lifting or lowering of loads. Height adjustability alone does not mean that LOLER applies to the equipment.
Periodic thorough examinations during the life of the equipment may not always be required. They are only required for lifting equipment exposed to conditions which cause deterioration likely to result in dangerous situations (i.e. likely to result in a serious or fatal injury). The interval between periodic thorough examinations should be in line with the intervals given in the Regulations:
6 months or less for equipment lifting people and lifting accessories;
A competent person must determine the scope of the thorough examination. They should have enough practical and theoretical knowledge and experience of the lifting equipment to detect defects or weaknesses, and assess how important they are in relation to the safety and continued use of the equipment.