Understanding PUWER Regulations for Medical and Adjustable Beds

Complying with PUWER: A Guide to Bed Rail Safety in Accordance with HSE Guidelines

To comply with PUWER regulations, it is essential to assess the risks associated with bed safety rails and implement appropriate control measures.

Bed side rails, (also known as bed safety rails, bed rails or cot sides), play a crucial role in preventing falls and ensuring the safety of individuals using medical beds. However, it is essential to understand and adhere to the regulations set forth by the Provision and Use of Work Equipment Regulations (PUWER) to ensure the proper use and maintenance of bed side rails. In this comprehensive guide, we will explore the key aspects of PUWER regulations as they relate to bed side rails, including risk assessments, compliance requirements, and the importance of regular maintenance.

What are PUWER Regulations?

PUWER regulations are a set of guidelines and legal requirements established to ensure the safety of work equipment, including bed side rails. PUWER places duties and responsibilities on individuals and organisations who own, operate, or have control over work equipment. The regulations require that equipment provided for use at work is suitable, safe, and properly maintained. PUWER also emphasises the importance of providing adequate information, instruction, and training to individuals using work equipment.

The Scope of Work Equipment

Work equipment, as defined by PUWER, encompasses a wide range of machinery, appliances, apparatus, tools, and installations used in various work settings. This definition includes medical beds and their associated safety features, such as bed side rails. It is crucial to understand that the use of work equipment extends beyond the mere operation of the equipment and includes activities such as maintenance, servicing, and cleaning.

Compliance with PUWER Regulations

When it comes to bed side rails, compliance with PUWER regulations is of utmost importance to ensure the safety and well-being of individuals using medical beds. Compliance requirements include:

  1. Suitability and Risk Assessment: Before providing bed side rails, a comprehensive risk assessment must be conducted by a competent person. This assessment should consider the bed occupant, the bed, mattresses, bed rails, and all associated equipment. The assessment should determine if bed side rails are suitable for use as the appropriate solution to prevent falls and ensure the safety of the individual.
  2. Maintenance and Inspection: Bed side rails must be maintained in an efficient state, in good repair, and regularly inspected to identify correct installation and any faults or deterioration. A maintenance log should be kept up to date to track inspections and ensure the ongoing safety of the equipment.
  3. Training and Information: All individuals involved in the use, supervision, or management of bed side rails must receive adequate training, instruction and information. This training should cover the correct use of the equipment, potential risks, and the necessary precautions to ensure safety.
  4. Risk Control Measures: Effective measures should be implemented to prevent access to dangerous parts of the bed and to control the risks associated with falling or being trapped. This may involve the use of guarding, emergency stop devices, adequate means of isolation from sources of energy, clearly visible markings and warning devices, or other appropriate safety measures.
  5. Requirements For Mobile Work Equipment And Power Presses: Mobile work equipment – including self-propelled, remote-controlled work equipment – is subject to specific requirements in addition to the requirements for normal work equipment. The requirements for mobile work equipment in PUWER (regulations 25-30) are in addition to the general obligations under section 2 of the Health and Safety at Work Act in providing safe plant (equipment). T

Risk Assessment for Bed Side Rails

A thorough risk assessment is an integral part of ensuring the safe use of bed side rails. The assessment should be conducted by a competent person and take into account the individual’s specific needs, the bed and mattress dimensions, and any potential risks associated with the use of bed side rails. The assessment should address factors such as:

  •         Proper fitting of the mattress between the bed rails to prevent entrapment.
  •         Adequate positioning and secure fitting of the bed side rails to ensure stability and prevent accidental dislodging.
  •         Consideration of any compatibility issues with accessories like bumpers or pressure-relieving mattresses.
  •         Assessment of the patient’s clinical condition, mobility, and size to determine the most appropriate bed safety rail solution.

It is essential to regularly review and update the risk assessment to account for any changes in equipment, patient condition, or other relevant factors.

Importance of Regular Maintenance

Regular maintenance is crucial to ensure the ongoing safety and effectiveness of bed side rails. Maintenance should be carried out in accordance with the manufacturer’s instructions and service manual. This includes conducting routine inspections, replacing worn or broken parts, and addressing any identified issues promptly. Compliance with maintenance schedules should be monitored, and any outsourcing of maintenance should be closely monitored for adherence to the recommended schedule.

Manufacturers recommendation

Also important to follow manufacturers’ recommendations, which typically stipulate that an Annual Safety Check is undertaken, such as below:

Choosing Appropriate Maintenance And Repair Services

The healthcare organisation should carry out a risk-benefit analysis before finalising the specification of any maintenance and repair services. Cost alone should not be the determining factor. Where available, use a service provider or third-party repairer who complies with relevant quality system standards, such as European Standard BS EN ISO 13485: (2016) or BS EN ISO 9001:(2015). These standards ensure their work is consistently of the nature and quality intended. (ref MHRA, Managing Medical Devices: Guidance for health and social care organisations, January 2021)

Compliance with International Standards

To further enhance the safety of medical beds and bed side rails, compliance with international standards is recommended. In the case of adult beds, the BS EN 60601-2-52:2010+A1:2015 standard provides specific requirements to reduce the risk of entrapment. For beds designed for children and adults with atypical anatomy, the BS EN 50637:2017 standard should be followed. This standard takes into account the unique needs and dimensions of smaller patients to minimise the risk of entrapment.

Conclusion

Compliance with PUWER regulations is essential to ensure the safe use of bed side rails and promote the well-being of individuals using medical beds. Conducting thorough risk assessments, adhering to maintenance schedules, and providing adequate training and information are key elements of complying with PUWER regulations. By following these guidelines and considering international standards, healthcare organisations can create a safe and secure environment for individuals relying on medical beds and bed side rails.

For more information and specific guidelines on the management and safe use of bed side rails, please refer to the relevant resources provided by the Health and Safety Executive (HSE) and the Medicines and Healthcare Products Regulatory Agency (MHRA).

Note: The information provided in this article is for general informational purposes only and should not be considered as legal or professional advice. It is always recommended to consult with relevant authorities and experts to ensure compliance with applicable regulations and standards.

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Bakare® provide servicing and inspections to individuals & professional healthcare institutions such as care homes and hospices who need to ensure their beds comply with HSE PUWER & MHRA regulations & insurance policies.

Bakare® is a trusted provider of servicing and inspections for profiling beds, independently accredited to the international standard BS EN ISO 13485: (2016), and Bakare®’s engineers provide service, inspection, and maintenance of most models of medical beds.

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Bakare® are an ISO 13485:2016 accredited company. Bakare® is committed to delivering the best possible service to our customers, and our ISO 13485:2016 accreditation shows our commitment ensuring their satisfaction. Bakare®’s ISO 13485:2016 accreditation means that our customers can be confident that the service we provide is safe and and of the highest-quality. It also means that we have the systems in place to catch and correct any issues before they become problems.

What Does It Mean for Our Customers?

Bakare® is excited to announce that we have achieved ISO 13485:2016 accreditation. This certification is a testament to our commitment to providing the best products and services to our customers. It is an internationally recognised standard that ensures that we maintain the highest quality products and services. Our customers can rest assured knowing that their safety and satisfaction are our top priorities. ISO 13485:2016 sets the benchmark for quality and safety, and we are proud to meet and exceed these standards. This accreditation proves our dedication to delivering the best possible service and products to our customers, and our commitment to their satisfaction.

What is ISO 13485:2016?

ISO 13485:2016 is a standard that establishes the requirements for a quality management system for the supply of medical devices. ISO 13485:2016 ensures that medical device companies have the proper infrastructure in place to design, supply, and distribute high-quality medical devices and is intended to reduce the risk of harm caused by faulty devices.

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Q. Which standards do Bakare® operate under?
A. Bakare® supply, inspect and service medical beds according to BS EN 60601-2-52:2010+A1:2015 standard for adults, and BS EN 50637:2017 for beds designed for children and adults with atypical anatomy. please note that BS EN 50637:2017 is not applied retrospectively – only for products supplied since the standard was introduced in September 2020.

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