Going above and beyond standards and guidance to ensure equipment is safe - for patients and practitioners alike.
Vigilance in patient safety is built into the fabric of our healthcare system - and into the design and production of equipment by responsible manufacturers.
In the UK, we are fortunate to have a word-class body focusing on compliance in our industry. The mission of the Medicines and Healthcare Products Regulatory Agency (MHRA) is to protect public health and patient safety by ensuring that healthcare products meet appropriate standards.
Its publication of guidelines and monitoring of accident statistics enables innovative companies to build industry-wide learning into their equipment designs, along with the associated training they offer to practitioners.
Emphasis on continuous improvement
A recent focus has been on incidents - injuries, and indeed deaths - caused by entrapment or falls relating to safety rails on hospital beds, trolleys and stretchers.
From 1 January 2018 to 31 December 2022, the MHRA received 18 reports of deaths related to medical beds, bed rails, trolleys, bariatric beds, lateral turning devices and bed grab handles, and 54 reports of serious injuries. The majority of these were due to entrapment or falls.
According to investigations, as published in National Patient Safety Alert (NatPSA/2023/010/MHRA), reasons for these included inadequate risk assessment, maintenance issues and inappropriate use - including where children and patients with atypical anatomy were concerned.
While many of these factors relate to how such devices are used and maintained, there are also written standards which manufacturers are required to comply with - setting out safety features to be built into the equipment itself - as these can help to reduce the margin for accidents / user error.
In the UK, those relevant to patient transport / mobile surgical platforms (stretchers and trolleys) are:
BS 5402 - Patient Trolleys:
Issued in in 1976 and yet to be updated, this standard only covers materials specifications, dimensions and the constructional and electrical safety requirements for patient trolleys. All relevant Anetic Aid products (QA3™ Patient and Emergency Stretcher ranges) comply with these. BS 5402 doesn't address new elements brought into later standards for devices such as medical beds (which came into force in 2015 - see further below), although Anetic Aid has taken learning from the new guidelines for the purposes of good practice and where they can be seen to be relevant. In other words, the QA3 range significantly exceeds this standard in terms of safety.
BS 6859-1 - Operating Tables. Specification for mobile general operating tables:
Although current, this standard (issued in 1987) is regarded as somewhat outdated as it lacks specific safety requirements later brought in to cover medical beds (see further below). Anetic Aid's QA4™ Mobile Surgery System not only meets BS 6859-1, but goes beyond in terms of safety features.
BS EN 60601-2-46 - Medical Electrical Equipment - Particular Requirements for The Basic Safety and Essential Performance of Operating Tables:
More relevant to safety issues, this standard covers a wealth of requirements, all met by the QA4 range. Full details can be obtained from BSI, but some of the key provisions include:
Protection against electrical hazards
Protection against mechanical hazards
Protection against instability hazards
Protection against hazards associated with tensile safety, static forces and dynamic forces
Protection against ingress of fluid
Electromagnetic compatibility
Again, Anetic Aid's QA4™ Mobile Surgery System not only meets BS EN 60601-2-46, but exceed many of the safety features specified in this standard.
Going above and beyond
So, what drives this 'above and beyond' approach to exceeding the current specifications?
Anetic Aid's designers and engineers have always taken time to listen to, and understand how, customers use its equipment. The company's representatives up and down the country gather direct feedback to take to their design team to support Anetic Aid's ethos of efficacy, practicality and value for money. This is all underpinned by the most important aspect of all, patient (and practitioner) safety. The company also carefully monitors industry findings and related guidelines - in recent years, incorporating specific insights drawn from a new standard introduced for medical beds as it continues to strive for 'best-in-class' status for its products.
The new standard for medical beds: 60601-2-52 (including BS EN 60601-2-52 and IEC 60601-2-52)
This updated standard was published in 2015, and specifically excludes devices for which the intended use is mainly examination or transportation under medical supervision (e.g. stretcher, examination table).
However, all such guidance is thought-provoking, and Anetic Aid's designers have been reviewing its provisions to see if there are practical innovations that can be built into its patient transport range (stretchers and trolleys) and mobile surgical platforms (operating tables), to enhance their safety even further.
Aspects identified included:
Protection against patient entrapment - While many relevant to a traditional hospital bed, section 201.9 Protection Against Mechanical Hazards is designed to guard against risks such as patient entrapment - and covers aspects like gaps and clearance areas. All Anetic Aid Stretchers comply with these guidelines where relevant.
Side Rails - Specifics within section 201.9 are provisions regarding Side Rails. 201.9.8.3.3.3 concerns strength and latch reliability - including lateral, longitudinal and vertical force cycling tests. Section 201.9.101 focuses on protection against inadvertent patient falls - setting the minimum height from the top surface of the mattress to the top of the side rail.
Height of side rail above the mattress - The standard states that when there is no mattress compression, the height of the side rail above the mattress should be at least 220mm. The height on Anetic Aid stretchers is 225mm, exceeding the minimum requirement.
Gaps within side rails - The standard requires that the gaps within side rails should not exceed 120mm. In the Anetic Aid stretcher side rails, the gaps are 75mm (at the head end) and 78mm (at the foot end) - well within guidelines.
Side rail length - Subclause 201.9.101 states that side rails should be at least 50% of the length of the mattress support platform. It also warns that if the side rail is too tall, it could increase the risk of injury should a confused or disorientated patient choose to climb over the side rail and fall. Both Anetic Aid's QA3 and QA4 ranges conform with these aspects.
Children and patients with atypical anatomy- Another standard, BS EN 50637, introduced in 2017, covers the particular requirements of medical beds for children, and also includes adults with atypical anatomy. While this standard specifically excludes devices intended for examination or transportation (stretchers / patient trolleys), both our QA3 and QA4 ranges are frequently used for these kinds of patients, so our designers have given careful consideration to its principles. The key aspect is again providing protection against the risk of entrapment - especially if patients move involuntarily. Our Padded Side Rail Covers (for both QA3 and QA4 ranges) are an ideal additional safeguard for these circumstances.
Conclusion
Anetic Aid is an ISO 13485 certified company that holds technical files to validate the safety of its product designs, in line with Medical Device Regulation requirements.
It has been supplying both the QA3 and QA4 in significant numbers since 1998 (QA3), 2004 (QA4™ Mobile Surgery System) and 2012 (latest models of the QA3™ Patient Transport and Emergency Stretcher).
In any year, there are approximately 26,880,000 patient journeys / procedures on Anetic Aid stretchers in the UK. This calculation is based on the fact that circa 35,000 models of either the QA3 or QA4 are in daily use with an estimated usage by four patients per day, four days per week, 48 weeks of the year - including use in a number of major children's units, along with adults of atypical anatomy.
You can download the full positioning paper by clicking the link here: Download Here
To contact the team for more info on our QA3™ Stretchers and QA4™ Mobile Surgery System, please use the form here: Contact Us