Section 4 - The Squirrel Medical approach to patient safety and regulatory compliance

The Squirrel Diamond is a full replacement, alternating air mattress, which has been specifically designed in partnership with physiotherapists, tissue viability nurses and Occupational Therapists to meet the needs of carers and the most vulnerable patients.
The system offers outstanding performance in pressure ulcer prevention and as an aid to the treatment of established pressure ulcers.

This full replacement airflow mattress is made up of 58 air cells which gently support the user and with our proven alternating cycle redistribute body mass, simulating natural body movements, and prevent the starvation of oxygen to tissues and the build-up of cellular waste. The gentle movement also facilitates increased permeability of blood capillaries within the area, increasing blood flow. All of this is achieved in a mattress which is only 12.5 cms or 5 inches deep enabling its safe use on virtually all nursing and hospital beds, even when standard height bedrails are used, and ensures compliance with HSE regulations.

Low cell depth also has other important benefits for care providers. By limiting tissue distortion, a common feature of large cell air mattress systems, it’s possible to reduce shear forces, (a key component in pressure ulcer formation) and improve comfort, providing a significant benefit for clients with muscular and skeletal conditions.

Safe Use of Bed Rails DB 2006(06) is freely available as a download from the Medicines and Healthcare products Regulatory Agency web site:
http://www.mhra.gov.uk/Publications/Safetyguidance/DeviceBulletins/CON2025348
Bed Rail risk management SIM 07/2007/06 is freely available as a download from Health & Safety Executivesweb site: HSE - Local Authority Health and Safety Enforcement Managers in 2007

http://www.hse.gov.uk/foi/internalops/sectors/public/070706.htm

In  2001 the Medical Devices Agency, later known as the Medicines and Healthcare products Regulatory Agency,  or MHRA, raised concerns over the problems of using bedrails in clinical practice and issued guidance for their safe use. This was later amended in 2006 when its document Safe Use of Bed Rails DB 2006(06)was published. This sets out the role of bedrails, the areas of concern in bedrail use, the importance of regular inspection, maintenance and training.
The Health and Safety Executive or HSE works closely with specialist groups such as the MHRA to ensure that safety is paramount within the workplace. In the case of bedrails, the HSE published guidance for Local Authority Health and Safety Enforcement Managers in 2007 (Bed Rail risk management SIM 07/2007/06) following the publication of the MHRA guidelines.
This document outlined the risks involved in the use of bedrails in the clinical environment and highlighted where individuals could be at risk unless certain assessments and corrective actions were undertaken. The document instructed inspectors how failure to comply with the guidance could put care managers and owners in breach of health and safety legislation. Armed with this guidance, organizations such as the Care Quality Commission (CQC) and local authority inspectors have the tools to ensure compliance with the recommended guidelines and the powers in law to ensure safe practice. Failure to adequately protect service users can result in the HSE issuing improvement notices (or even closure notices) and could lead to criminal proceedings.
The key components of the guidance regard the need to assess the suitability and needs of clients before fitting bedrails, the importance of regular maintenance, the need to fit bed rails or side rails correctly, the need to undertake staff training and the need to maintain clear, accurate and timely documentation of all bedrail-related issues. A substantial amount of the regulations relates to what the National Patient Safety Agency refers to as “mind the gap”.
Bed rails or cot sides are also responsible for a huge amount of deaths and injuries each year due to an issue called bed rail entrapment. This dreadful and quite avoidable situation occurs due to a combination of issues. These normally include using the incorrect bed rails in relation to the bed and / or not maintaining the bed rails correctly. Other causes of bed rail entrapment are the use of outdated nursing or hospital beds produced prior to the safety standards Ben1970 and or IEC60601-2-38. The use of such outdated or unmanaged equipment, which are by their very design complex class 1 medical devices, often leaves the care provider without insurance cover and open to substantial litigation.
Bedrails, cotsides or side rails need to be fitted in such a way as to prevent cot side entrapment by carers and users. There are specific dimensions given for the spaces allowed between bars and between the bars and various parts of the bed frame and headboard. A key issue for many care givers is in relation to the required height of bed rails above the support surface. To prevent users from falling over the upper most bed rail, and causing major injury, the top of the bed rail must be at least 22 cms above the non-compressed surface of the mattress
The majority of bedrails are designed for use with a 5 inch foam mattress. This makes their use with standard full replacement air mattresses, which are normally 9 inches deep, or with an overlay air mattress or airflow mattress potentially in breach of the regulations.
Using incorrectly fitted, poorly maintained or defective bedrails places clients at risk and could result in care staff and nursing home owners liable to prosecution under Health and Safety regulations. This includes the use of bed rails or cot sides that are too low to safely prevent client bed falls.
Bed Rail or cot side extensions are available for retrospective fitting to some beds but these have issues and can pose serious risks for both clients and healthcare workers. The higher the side rail extension from the floor - the further a patient can fall from bed. Anyone who has seen the results of a bed fall to an elderly fragile patient will understand the implications of their use.

The smaller cell construction and static lower-layer air cells provide a robust and stable base for self-initiated client movement, physiotherapy and patient rehabilitation; encouraging self movement, maintenance of client mobility and independence. Users with partial mobility can transfer somewhat easier either partially assisted or unassisted to a walker, wheelchair or commode. Independent wheelchair transfer is a huge benefit to those seeking independence and comfort in either their own home or to those in a ward or care establishment. Safe wheelchair transfer demands a stable low height airflow mattress to facilitate improved independent living.
This stability is perfectly suitable for self transfer to wheelchair or walker - however the Squirrel Diamond also has an enhanced static mode button which enables carers to over-ride the alternating cell cycle for up to 20 minutes, while delicate care and medical examination is undertaken. Once completed, the carer can return the system to its normal alternating mode with the press of a button, otherwise the system will automatically return to alternating mode after 20 minutes, continuing to provide optimum pressure relieving prevention.

Some critically ill patients are still placed on alternating air mattresses that have been “cleaned” rather than professionally decontaminated. This is extremely dangerous. Urine and most detergents will soon remove the invisible waterproof laminates of most waterproof mattress covers. This means that the mattress covers become quite porous - the perfect breeding ground for bacteria.

The Squirrel Diamond comes with a dual cover option. This means that the entire cover is replaced in-between patients with a fresh one – and the old one can be professionally decontaminated at an approved decontamination centre. This is the safest and most cost effective solution to infection control procedures.

Many products on the market appear low cost but have hidden costs which are not apparent until you’ve used them for some time. The Squirrel Diamond is designed to be highly cost-efficient with low-maintenance costs and low running costs. The mattress and pump are designed to work in the highly demanding primary care field. They are manufactured in a modular format which makes parts quick and easy to change in the rare event of failure. Parts are generally available next day, and are so simple to fit that in most cases repair can be undertaken in minutes, keeping your system in service 24 hours a day.
The Squirrel Diamond offers a high-specification product specifically designed with both the client and the carer in mind. It offers outstanding performance, and peace of mind. Cost effective, clinically effective pressure relief, designed and delivered with our patients in mind.
For a free no quibble 14 day trial please contact:
Squirrel Medical – 0845 003 7979
Free Videos
Squirrel medical offer a range of free video tutorials, designed to support the training policies of the care provider. These can be adapted to include the care providers logo and can be viewed at:
www.squirrelmedical.com
Important Reading
Squirrel Medical facilitates links to various training and safety agencies. We encourage all those involved in the provisioning of air mattresses and beds  to review the following documents.

NHS Approved Supplier

Squirrel Medical has been successfully added to the NHS preferred suppliers list for its range of high specification digital pressure-relieving mattresses. This tender process considered ‘best value’ criteria based on several factors including price, performance and reliability as well as safety and regulatory compliance.