Written by experts from the BHTA Beds and Support Surfaces and Pressure Care and Seating Sections.
The ISO 20342 series of standards covers various aspects of safety, performance, and technical information relating to mattresses and related products, products described in the standards as “Assistive Products for Tissue Integrity” or “APTIs”. Part 1 of the series covers General Requirements, and these are applicable to all APTIs. The information set out within the general requirements standard is intended to help ensure the safety of users.
The devices covered by this standard include all pressure redistributing mattresses and overlays manufactured using a range of materials including foam, gel, air, and foam in combination with air (i.e. hybrid mattresses). Products within the scope of this standard also include all reactive (non-powered) and active (powered) mattresses and overlays. This standard does NOT include wheelchair cushions.
Aspects relating directly towards the clinical efficacy of a product (and therefore the safety-related properties in prevention or management of pressure injuries, for example) are not addressed in this standard, but are topics covered by tests prescribed in other parts of the ISO 20342 series.
The aim of this article is to give the reader a feel as to why they should be aware of the standard’s content and provide an overview of what the standard covers in depth, and therefore its importance in the design, selection, and use of an APTI.
BS EN ISO 20342-1 is the first mattress and related device international safety standard. It sets the minimum threshold a device should reach in order to protect the safety of users.
BS EN ISO 20342-1 covers the key safety elements from an APTI-specific standpoint. These include management of potential hazards and addresses specific areas of mechanical, electrical, and materials safety. Table 1 contains a summary of the areas covered by the standard.
| Clause | Content |
|---|---|
| 4. General requirements and safety | 4.1 General; 4.2 Intended use; 4.3 Risk management; 4.4 Usability; 4.5 Design controls; 4.6 Clinical evaluation; 4.7 Foreseeable misuse; 4.8 Test conditions; 4.9 Lifting and carrying means |
| 5. Safety requirements | 5.1 Information supplied by the manufacturer; 5.2 APTI that can be dismantled; 5.3 Resistance to corrosion; 5.4 Noise and vibration; 5.5 Sound audible acoustic energy; 5.6 Default indicators; 5.7 Feedback |
| 6. Flammability | 6.1 General; 6.2 Flammability; 6.3 Moulded parts used as enclosures for electrical equipment |
| 7. Mechanical safety | 7.1 Prevention of traps; 7.2 Moving and folding parts; 7.3 V-shaped openings; 7.4 Surfaces, corners, edges and protruding parts; 7.5 Folding and adjusting mechanisms; 7.6 Instability hazard; 7.7 Temperature of parts in contact with skin; Ergonomic principles; Additional considerations |
| 8. Safety of electrical equipment | 8.1 General; 8.2 Electromagnetic compatibility; 8.3 Liquid ingress; 8.4 Interruption of power supply; 8.5 Hold to run activation; 8.6 Emergency stop functions |
| 9. Biocompatibility | 9.1 Biocompatibility and toxicity; 9.2 Animal tissue |
| 10. Contamination | 10.1 Liquid ingress; 10.2 Cleaning and disinfection; 10.3 Cross infection and microbial contamination |
| Annex A. General Information | A.1 General; A.2 Design controls; A.3 Packaging; A.4 Noise and vibration; A.5 Flammability; A.6 Ergonomic principles; A.7 (EMC) immunity; A.8 Cleaning and disinfection; A.9 Moisture vapour permeability/microclimate management |
| Annex B. Environmental and consumer related guidance | Covers Hazardous Substances in an APTI. B.1 General; B.2 All materials; B.3 Textiles; B.4 Plastic materials; B.5 Metals; B.6 Wooden parts |
| Annex C. Periodic inspection |
This standard clearly sets out the expected safety requirements for all mattress surface devices, irrespective of which medical device classification they fall into. To deliver safe, effective, harm-free care to patients, it is not unreasonable to assume the use of devices which meet the required level of safety and do not inadvertently introduce any additional risks to users.
With pressure ulcers recognised as a preventable harm and pressure ulcer incidence metrics typically reported at board meetings as a key indicator or care quality, it is prudent for providers to use products that meet the required levels of safety.
Clinicians will benefit from clear statements around the intended use, intended users, and any device claims around performance and safety, including minimum and maximum user weight on the device.
Furthermore, supporting documents, such as the clinical evaluation and instructions for use, will give additional information about the suitability of the device for local patients/residents. Requesting relevant evidence as part of a tender process will help ensure that claims of device performance are substantiated with appropriate levels of evidence and supporting documentation. This can be particularly helpful when looking to substantiate claims for self-certified, Class I medical devices, which are otherwise externally-unregulated devices.
Where manufacturers’ products align with this standard, it demonstrates that the manufacturers are seeking to attain minimum levels of device safety and that their claims around device performance can be supported by suitable data and evidence, thereby giving clinicians peace of mind when prescribing the products for patients.
Medical device manufacturers typically strive to deliver the safest, most effective products to the market. Since elements of BS EN ISO 20342-1 will apply to every APTI sold in the UK it would be a concern to understand why a manufacturer would not want their products to comply with this standard.
Healthcare providers can help encourage uptake of these standards by listing compliance as a prerequisite on mattress tender submissions. If manufacturers need to comply with specific elements of the ISO 20342 series of standards (e.g. Part 1, General Requirements) to be considered for the tender, this would greatly encourage this area of the medical device industry to meet the requirements for BS EN ISO 20342-1:2002.
BS EN ISO 20342-1:2022 – TC | 31 Aug 2022 | BSI Knowledge (bsigroup.com)
For a broader background to the ISO 20342 series of APTI standards, see the BHTA article: ‘New standards for testing mattresses and related products – An Introduction’
Written by experts from the BHTA Beds and Support Surfaces and Pressure Care and Seating Sections.
A series of International Standards is being published encompassing the testing of mattresses and related products that are designed to be surfaces to interface with the body, to manage the health of the body’s skin tissues when lying down. These standards are being published in the ISO 20342 series.
The aim of this article is to highlight the importance and relevance of these standards to procurement, prescribers (clinicians/nurses), and healthcare providers. Each of these stakeholders will benefit from having a recognised ‘minimum standard’ of safety for these products.
In addition, these standards will also enable stakeholders, during a product selection process, to undertake a more meaningful comparison of important performance metrics, such as pressure redistribution, moisture vapour transfer rates, etc, across products. Some measures carry pass/fail criteria, while others provide a value along a scale where a higher value may be more beneficial for some individuals, whereas other people will be better off at the other end of a scale.
NOTE. The standards have been prepared by an ISO committee, but where they have been adopted in Europe, they have this added as EN in front of the ISO number, and where adopted in the UK, BS is added in front of the number e.g. BS EN ISO 20342-1. This lettering applies to the full standards, whereas the Technical Reports and Technical Specifications have CEN and PD prefixes instead of EN and BS respectively.
The standards have coined the acronym APTI, which stands for “Assistive Products for Tissue Integrity when lying down”. The scope of the ISO 20342 series includes devices that are intended to remain in situ during periods of lying and to prevent and/or treat pressure injuries. This encompasses a range of different lying support surfaces including mattresses, mattress overlays, and mattress coverings for pressure injury prevention mattresses.
In addition, these standards also cover assistive products primarily intended for tissue integrity both for changing a lying position, and for maintaining a lying position. This includes devices for changing position or direction of a person using sliding or turning techniques, where they are intended to be used on a person in a lying position and remain in situ as part of the lying support surface. Other product areas within the scope include positioning pillows, positioning cushions, and positioning systems, along with bedding such as draw sheets.
These devices are likely to include all pressure redistributing mattresses and overlays manufactured using a range of materials including foam, gel, air, and foam in combination with air (i.e. hybrid mattresses). These devices may be reactive (non-powered) or active (powered) mattresses and overlays.
This series does not apply to lying support surfaces used in combination with incubators or operating/surgical tables, nor to wheelchair seating products.
Medical devices are placed on the market with specific clinically related claims. The manufacturer has to justify these claims and also show that the product is safe and fit for purpose. Testing to, and passing, recognised standards is part of this process.
Historically, mattress manufacturers have typically used their own test methods to quantify and report on the key performance characteristics of their products, for example pressure reduction. Whist these metrics can help users understand the level of performance offered by one specific product, the significant variability between test methods, test equipment, and how the results are reported or presented by manufacturers typically precludes any meaningful comparison of the test results from different products.
This series of ISO 20342 standards, and the associated test methods described within them, are designed to enable stakeholders involved in mattress provision (i.e. clinicians, prescribers, compliance, procurement, medical engineering, etc.) a framework within which they can confirm device safety and compare relevant specific device performance characteristics across different support surfaces, without having to undertake their own internally-designed bench tests.
The standards set out a series of validated tests and ‘best practice’ for manufacturers to align with, where appropriate.
Where a manufacturer employs the standards, it demonstrates that they are seeking to attain the highest levels of device safety and that their claims around device performance can be supported by data from validated test methods.
When a healthcare provider goes out to tender for new mattresses, numerous devices are often considered simultaneously. It can be time-consuming and complex for the provider to assimilate the information supplied by the tendering manufacturers or suppliers and previously it has often been impossible to make meaningful comparisons between products from different manufacturers.
Because the standards describe detailed test processes utilising validated test methods, results from performance testing to ISO 20342 test methods can be tabulated, thereby permitting the same performance characteristics across products from different manufacturers to be compared directly with one another.
This enables the healthcare provider to perform an initial ‘desk-top’ comparison of various mattress device performance metrics which will help the provider determine which products to take forward to a local user evaluation with their staff and patients or residents.
The suite of ISO 20342 standards covers various aspects of device safety, performance, or technical information, including pressure redistribution, shear (horizontal stiffness) and microclimate. See Table 1 for a full listing of characteristics covered by the BS EN ISO 20342 standards.
Key:
SAFETY Standard = red
TECHNICAL Standard = yellow
PERFORMANCE Standard = green
| Standard Part | Standard Title (and coverage) | Published |
|---|---|---|
| BS EN ISO 20342-1:2022 | Assistive products for tissue integrity when lying down. General requirements (Principally broader safety elements – see separate BHTA report) | 2022 |
| PD CEN ISO/TR 20342-2 | Microclimate (Heat and moisture vapour dissipation at the skin and device interface) | TBC |
| BS EN ISO 20342-3 | Strength and impact (Tensile strength of materials, bursting strength/distension, seam/weld strength, carry handles, bottoming out, etc.) | TBC |
| BS EN ISO 20342-4 | Durability (Resistance to repetitive loading, ageing (drop test/lifespan test/wear and tear/loading and unloading, etc.) | TBC |
| BS EN ISO 20342-5 | Cleaning and disinfection (Test method to determine the resistance of waterproof coated textiles to liquid disinfectants and cleaning methods) | TBC |
| BS EN ISO 20342-6 | Horizontal stiffness (Shear) | TBC |
| PD CEN ISO/TR 20342-7:2022 | Assistive products for tissue integrity when lying down — Part 7: Foam properties, characteristics and performance. (Resilience; density; hardness; compression set; tensile strength; tear strength; air flow/permeability; resistance to fatigue; and microbial resistance) | 2022 |
| BS EN ISO 20342-8 | Pressure redistribution (Immersion, envelopment, and pressure relief) | TBC |
| BS EN ISO 20342-9 | Flammability (Resistance to ignition by a specified heat source e.g. a smouldering cigarette equivalent) | TBC |
| PD CEN ISO/TS 20342-10:2022 | Assistive products for tissue integrity when lying down. Guide to cleaning, disinfecting and care of polyurethane APTI covers. | 2022 |
The ISO 20342 series currently consists of ten published or in-preparation parts, however this is an ongoing programme of work within ISO and whilst the parts listed above cover the essential elements of safety and performance testing, it is likely that additional parts will be added in future.
No. Certain elements of the standards such as Part 1 General Requirements or Part 9 Flammability are likely to be relevant to almost all devices. However, it is envisaged that manufacturers will only perform testing in areas where they make a performance claim i.e. they will test against Part 8 if they are making claims of pressure relief or redistribution and Part 4 if they are making claims relating to durability.
Testing can be performed in house (where manufacturers have the capability of running the specified tests) or at an independent external test house. Some tenders may require the testing to have been carried out by test labs audited to ISO 17025.
Compliance with ISO standards is not generally mandatory, unless this is stipulated within a tender document, stipulated by local regulations, or where an ISO standard has been harmonised in the EU.
Most manufacturers are aware of the standards, and many of these manufacturers will be actively working towards ensuring that their products are compliant with the elements of the standard that apply to their devices. Where products have medical claims these products will be UKCA marked for GB and CE marked for Europe – the results of testing to the standards will be part of the Declaration of Conformity technical files.
Although the European Medical Device Regulation (MDR) and its predecessor the Medical Device Directive (MDD) (which is still in force in Great Britain), offer a broad framework for what is expected from a safe, compliant medical device, there has never been a clearly defined safety standard that is APTI specific and applies to every APTI irrespective of device classification.
ISO 20342-1:2022 is the first APTI specific safety standard. As well as providing some general guidance on certain aspects of device performance, it sets the minimum threshold a device (i.e., replacement mattress or mattress overlay) should reach in order to maximise the safety of users.
Due to the way in which the medical device classification rules are written, APTIs may either be designated as Class I medical devices or Class IIa medical devices.
Whilst APTIs classified as Class IIa devices are regulated by Independent Notified Bodies for CE marking (or GB Approved Bodies for UKCA marking), APTIs that are classified as Class I medical devices are self-certified by the legal manufacturer and are thus unregulated by an independent, external body.
The resulting differences in regulation and approach to APTI classification is less than ideal and can cause confusion in the marketplace, both from a manufacturer’s perspective and that of the healthcare provider and product prescriber.
Healthcare providers can help encourage uptake of these standards by listing compliance with them as a prerequisite on mattresses and related devices tender documentation. If manufacturers have to comply with specific elements of the standard (e.g. Part 1, General Requirements) to be considered for the tender, this would greatly encourage industry compliance with these requirements from the ISO 20342 series.
BS EN ISO 20342-1:2022 – TC | 31 Aug 2022 | BSI Knowledge
Guidance relating to this standard has been compiled by the BHTA in the document: Guidance to the mattress and related devices General Requirements standard BS EN ISO 20342-1:2022
PD CEN ISO/TR 20342-7:2022 | 31 May 2022
Further guidance on foams used in mattresses can be found in the BHTA publication: What Lies Beneath
PD CEN ISO/TS 20342-10:2022 | 31 Jul 2022 | BSI Knowledge
Further guidance on cleaning and disinfection of mattresses can be found in the BHTA publication: Protect, Rinse and Dry
Further information on Standards is available from the BHTA article: An introduction to understanding standards
Augmentative and alternative communication (AAC) services help people to communicate as effectively as possible when speech is impaired.
The term AAC covers a wide range of techniques that support or replace spoken communication. Techniques include gestures, signing, symbols, communication boards and books, as well as powered and computerised devices such as voice output communications aids (VOCAs).
AAC is used to help people express themselves who may have no clear speech. There are many possible causes including cerebral palsy, stroke, head injury, motor neurone disease, or a learning disability.
Since April 2013, NHS England became responsible for commissioning services with the most complex needs. These 15 specialist services are commissioned and funded with a national service specification for AAC. AAC services are organised and funded differently in the different countries in the UK.
This has been described as the AAC “Hub and Spoke” model with the regional “hubs” able to provide specialist services and support to a number of local centres, or “spokes” offering AAC services. Funding for local AAC services (spokes) is within the remit of Clinical Commissioning Groups (CCGs). In Wales, Scotland, and Northern Ireland there are specialist AAC services set up to assess children and adults with the most complex needs. These services are funded by the NHS and/or education.
Local AAC services carry out assessment and provide AAC equipment for individuals who are not yet eligible for specialised services. They also implement equipment provided by the specialised services.
Your local AAC service should support a managed care pathway for children and adults with less complex needs, make appropriate referrals to specialised AAC hubs and other relevant services, and coordinate the support required. You may be referred to a multidisciplinary team that typically would include speech and language therapists, occupational therapists, educational professionals, and experts in assistive technology.
Aided communication involves additional equipment that may be paper-based or electronic, often referred to as ‘low-tech’ or ‘high-tech’.
Low-tech communication systems do not need a battery to function. Examples are pen and paper to write a message or draw, alphabet and word boards, communication charts or books with pictures, photographs, and symbols or objects used to represent activities or items.
High-tech communication systems need power from a battery or mains. Most of these systems speak and or produce text. They range from simple buttons or pages that speak when touched, to very sophisticated systems based on familiar equipment such as mobile devices, tablets, and laptops. Some high-tech communications systems are based on equipment specially designed to support communication.
To find the nearest centre to you, please visit the Communications Matters here.
Assessment services will be able to advise about funding. A thorough assessment is necessary before requesting funding from health or education services. NHS England has a system for the provision of communication aids. Scotland, Wales, and Northern Ireland have their own systems.
Top ten tips for making communication successful:
Choose a quiet place so you can both concentrate on the conversation.
However, remember not all children and youngpeople will be happy, or able, to look you in theeye. Those with autism may find this particularlydifficult, and young people using a communicationaid will have to look at what they are doing.
This will give the other person the opportunity to show you the best way to communicate with each other.
Ask them to show you how they use their AAC system to help you understand what, if anything, you need to do to make communication successful.
This may not always be the obvious nod and shake of the head.
This sounds obvious. For some people it may take them longer than you may usually wait for an answer.
Sometimes it can be tempting to finish off a person’s sentence for them, and some welcome this as a way of speeding up communication. However, others may find this annoying, so always ask if the other person is happy for you to do this.
This will give the other person opportunity to explain points that have been understood or ask for support.
It’s important to give time to the conversation.
When finishing a conversation, make sure that you both agree you have said all what you wanted to and check you have both understood everything that was communicated.
Resources: http://www.communicationmatters.org.uk/resources
The BHTA has worked with the Don’t Call Me Mum campaign initiative to produce this article. We want to help professionals and companies working with carers and families of adults and children with additional needs to demonstrate their respect of parents as partners.
When you enter a family’s house, it is also their home, their place of comfort, and a safe space. Whilst keeping this in mind, professionals should understand the potential anxieties and fears families may have around outsiders entering their home and the decisions that may be made. Working with parents/carers and involving them at every stage of a meeting/assessment will help gain their respect and trust.
Companies, professionals, and parents are all the experts in their own right. Bringing together everyone’s skills, knowledge and resources creates the best outcome because when parents are partners; everyone, especially the person with the disability, wins.
Every family has a story. Every interaction is part of an ongoing journey littered with complications, emotions and challenges.
Every person has a different set of priorities and expectations. When each party openly communicates their agenda and priorities, progress can be made.
We have established some top tips to help when working with families.
The BHTA is one of the UK’s oldest and largest healthcare trades association. To find out more about the BHTA and see other useful guidance articles, click here.
To become a supporter of ‘Don’t Call Me Mum’ and show that your company, department, or school acknowledges the essential contribution parents make, order your supporters pack and contact us to add our logo to your website. Email us: info@dontcallmemum.com or visit the Don’t Call Me Mum website.
With thanks to Born at the Right Time bringing a family’s perspective to professional practice and pioneer of the Don’t Call Me Mum initiative.
Hand hygiene is widely acknowledged to be the single most important activity that reduces the spread of infection. Hand hygiene should be performed immediately before and after every episode of hands being contaminated.
There are four aspects to quality hand hygiene:
There needs to be more education and awareness regarding the appropriate use of soap and water and alcohol-based hand sanitisers. There must be a clear understanding of how and when these different applications should be used.
Hand cleansing using the correct technique, with a mild soap and water and then dried with a disposable absorbent paper towel, is the best policy to help prevent the spread of germs and for cleaning visible dirt from hands as well as many bacteria and viruses.
Hand sanitising with an alcohol-based sanitiser with a minimum of 60 percent alcohol as an active ingredient can be a very good substitute provided hands are not actually dirty, for use without water, to kill germs and provide a high level of hand hygiene and skin disinfection on visibly clean hands.
The World Health Organization (WHO) claims that: “Hand sanitising may be of benefit when used after hand cleansing but it should not be regarded as a substitute for soap and water since sanitisers will not remove any contamination from the hands. It should therefore be remembered that alcohol sanitisers are not suitable for use on hands that are dirty, contaminated and soiled, e.g. faeces and secretions, or during outbreaks of diarrhoeal illness, e.g. Norovirus and C diff. In these instances, washing hands with mild soap and water is necessary.”
There is a common misconception that anti-bacterial soaps provide a better level of protection than ordinary soaps and therefore should be used widely. In reality, infection control nurses advocate that the use of a mild soap (preferably dermatologically tested) that is kind to the hands and therefore encourages regular hand washing, coupled with good hand washing technique, is much more important than the use of an antibacterial soap.
In a study which split a thousand households into two groups, one group received anti-bacterial cleaning soaps and the other plain soaps. Neither the researchers nor the participants knew which type of soap they were using. “In terms of infection rates and sickness, we found absolutely no difference between anti-bacterial soap and regular soap,” said Dr Elaine Larson, Director of the Centre of Disciplinary Research on Anti-Microbial Resistance at Colombia University.
Antibacterial soap is not recommended for wide use, as there is a concern that germs will develop resistance and those using it will become lazy from using high-tech soaps. It is however recommended that antibacterial soap is to be used in certain high-risk areas such as food preparation and handling areas, in surgical conditions, treatment rooms, and clinical areas.
The risk, when using low-specification soaps, is that they can contain harsh chemicals that irritate the skin, leading to drying out, cracking, and redness which in turn can cause occupational dermatitis. This then leads to less regular hand washing for fear of exacerbating the problem and hand hygiene levels deteriorate, hence the importance of using a good quality mild soap.
| Alcohol-based | Alcohol-free | |
|---|---|---|
| Kills 99.9 percent of germs and bacteria | Y | Y |
| Fragrance-free | N | Y |
| Flammable | Y | N |
| Irritates skin/causes cracking | Y | N |
| Non-damaging to floors and other surfaces | Y | N |
| Extended persistency | N | Y |
| Breaks through dirt | N | Y |
| Recognised by the CDC and WHO | Y | N |
| Antiseptic (can be applied to wounds) | N | Y |
| Organic compound | N | Y |
| Imbedded moisturiser | N | Y |
| More cost effective | N | Y |
| Leaves residue after use | Y | N |
Examples of further research findings for using soaps can be reviewed within the below link for interest only: https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm378393.htm
The Centers for Disease Control and Prevention (CDC) in the USA says that washing hands with soap and water is the best way to reduce the number of microbes on them in most situations.
If soap and water are not available, it is recommended to use an alcohol-based hand sanitiser that contains at least 60 percent alcohol as the active ingredient and use enough to cover all surfaces of the hands and fingers to achieve effective disinfection. The average hand sanitiser contains about 62 percent alcohol.
The main two types of soap dispensers are safe, sealed cartridge systems and bulk fill or refillable dispensers, and it is really important to understand why one is so much more hygienic than the other.
We wash our hands with soap to kill germs and bacteria, however, if we are using soap from a bulk fill or refillable soap dispenser, we could be washing our hands with contaminated soap as bulk fill soap dispensers are a breeding ground for bacteria and are often inadequately cleaned. The issue is you can’t always see the harmful germs and bacteria, but they can result in the risk of germs spreading.
Refillable bulk dispensers can leave hands with 25 times more bacteria after washing. Once the lid is removed and refilled with soap, airborne germs and bacteria can enter the reservoir and contaminate the soap. Dispensers are rarely cleaned and filled correctly, and there is an increased risk of spreading germs and bacteria by washing hands with contaminated soap.
There are typically more bacteria in a bulk filled soap dispenser than in a toilet in the same bathroom; the CDC warns to not add soap to a partially empty soap dispenser. This practice of topping off dispensers can lead to bacterial contamination of soap.
The safe alternative to bulk fill dispensers is hygienically sealed cartridge systems, which are ultrasonically airtight being free from complete air and gases for maximum hygiene.
We often say that hand washing is the key to preventing the spread of illness. But wet hands increase the risk of transmitting bacteria, “so drying is an equally important step in prevention,” says urgent care specialist Theresa Lash-Ritter, MD.
Lots of research has focused on handwashing and hand drying techniques. In one study, microbiologists compared jet air dryers with warm air dryers and paper towels. What they found was disturbing:
The way each method works helps to explain the results.
Drying your hands with paper towels not only dries them faster, but the friction also dislodges bacteria to leave them cleaner.
The CDC recommends the following method:
See the diagram in this article titled ‘How to wash your hands effectively’.
If soap and water are not accessible, hand sanitisers that contain at least 60 percent alcohol (WHO guidance recommends a minimum of 60 percent compliant with BS EN 1500:2013) can be used, but do note they won’t clean visible dirt or grease, they can’t kill all germs and they can’t remove harmful chemicals. For effective disinfection, it is advisable to cover all surfaces of the hands and fingers.
There are several reasons why religious and cultural issues should be considered when dealing with the topic of hand hygiene and planning a strategy to promote it in healthcare settings.
Alcohol-free hand sanitisers entered the market to address the concerns and complaints that stemmed from the use of gels. In many ways, they have succeeded. Typically, these solutions are much easier on the hands and pose much less of a threat in cases of accidental ingestion and also pose a lesser potential as a fire hazard and are non-damaging to surfaces.
One other clear benefit is the extended persistence that occurs. The product’s ability to kill bacteria ends once the product has dried on the skin whereas the benzalkonium chloride-based low alcohol-free products continue to provide protection well after the solution has dried.
One possible drawback with the alcohol-free solutions is that they most often come in the form of foam. While this usually results in a more pleasing experience for the user (as opposed to gels), it does require a special foaming mechanism in the dispenser, often making converting from a non-foaming system cost prohibitive, as it could require new hardware to be installed.
Despite some clear benefits, alcohol-free based products have yet to gain real traction in the health market. Alcohol-based gels continue to be favoured by health organisations and are therefore seen as a more credible solution by many in the field. It’s not that these organisations don’t recognise the effectiveness of benzalkonium chloride-based solutions, however, the term “alcohol-free” could apply to any number of products on the market. (It’s a broad term that makes it impossible for agencies like the FDA and the WHO to endorse.)
Because both types of products do more or less the same job in killing harmful microbes, choosing the right product is a matter of assessing your needs against your environment, budget, and personal preference.
For example, if you work in a school, care home, a mental health hospital, or manufacturing workplace, an alcohol-free system would most likely provide you the most peace of mind and protection from ingestion or fire. If you work in a hospital that requires you to follow strict guidelines set by the NHS, you may need to go with an alcohol-based gel.
Whatever your needs, having an effective hand sanitiser as part of your preventative defence against illness and disease is a crucial part of a healthy environment.
Visit this BHTA page and search for “Decontamination and Infection Prevention” to find a list of reputable manufacturers and suppliers.
This article was put together by industry experts at the BHTA.
We all come across items in our daily lives that are regulated by standards, even if we do not know it. Meeting standards leads to increased safety, better compatibility between items, and better practice.
In this article, we cover the hierarchy of standards across the world as they benefit us in the UK and reflect on their importance, with particular reference to medical devices and ultimately the safety of our customers, clients, and patients.
Most of us will have come across the BSI Kitemark™. The BSI Kitemark originated as the British Standards Mark in 1903 for use on tramway rails when standardisation reduced the number of rail sizes from 75 to five. Today the BSI Kitemark can be seen on hundreds of products from manhole covers to condoms, from security locks to fire extinguishers and riding helmets.
Having a BSI Kitemark associated with a product or service confirms that it conforms to a particular standard: each BSI Kitemark scheme involves a determination of conformity to the relevant standard or specification of the product and an assessment of the management system operated by the supplier. This symbol is one that is trusted across the UK, and indeed across the world.
So what are these standards that are being referred to?
A standard is an agreed way of doing something. It could be about making a product, managing a process, delivering a service, or supplying materials. Standards can cover a huge range of activities undertaken by organisations and used by their customers.
Standards are the distilled wisdom of people with expertise in their subject matter and who know the needs of the organisations they represent, such as manufacturers, sellers, buyers, customers, trade associations, users, or regulators.
BSI, in its role as the UK National Standards Body, has a portfolio that extends to more than 30,000 current standards. They are designed for voluntary use so it’s up to you – you’re not forced to follow a set of rules that make life harder for you, you’re offered ways to do your work better.
Standards are knowledge. They are powerful tools that can help drive innovation and increase productivity. They can make organisations more successful and people’s everyday lives easier, safer, and healthier.
As a result, standards share good ideas and solutions, technological know-how, and best management practices. They identify safety issues of products and services and make products compatible so that they fit and work well with each other. An example of the latter are the HDMI or USB ports on your computer.
There is a generally accepted hierarchy of standards, starting with the International Organization for Standardization (ISO*) being adopted worldwide, the European Committee for Standardization (CEN)’s EN standards being adopted across Europe, and national standards being created and adopted by individual countries (e.g. BS standards in Britain, under the auspices of the BSI (British Standards Institute)).
Some International standards will have been adopted (and ‘harmonised’) across the EU and also adopted in, say, the UK, and as a result will have the letters BS, as well as EN and ISO, in front of them.
The added bit of fun is that at each level, the adopting body can add its own foreword to make minor alterations to the standard, for their local jurisdiction.
*Notice that ISO’s acronym doesn’t match ISO’s name? It’s not meant to. “ISO” is derived from the Greek word isos (equal), so that it’s the same in all languages.
Standards are prepared by Technical Committees (TCs – e.g. ISO TC173 Assistive Products or CEN TC 293 Assistive Products and Accessibility). Each TC has its own field of operation (scope) within which a work programme of identified standards is developed and executed. TCs work on the basis of national participation by the ISO or CEN Members, where delegates represent their respective national points of view. This principle allows the TCs to take balanced decisions that reflect a wide consensus.
A Subcommittee (SC) can be established within a TC, in the case of large programmes of work. The real standards development is undertaken by Working Groups (WGs) where experts, nominated and appointed by the ISO or CEN country members, but speaking in a personal capacity, come together and develop a draft that will become the future standard. This reflects an embedded principle of ‘direct participation’ in the standardisation activities.
The aim of the WGs is to have a balance across potential stakeholders, from commercial providers, public sector, etc, through to end user.
Individual countries opt to be participating members of any committee, or observers (where in this case they do not have a vote), or decide not to participate at all. Each country that participates tends to have its own national ‘mirror’ group, which feeds back each country’s comments and votes to the TCs and thereby the WGs.
In addition to ‘normative’ (i.e. prescriptive) standards, some will be called Technical Reports (TR) or Technical Specifications (TS), and these are informative.
A number of these informative standards become updated to become normative standards, as the material in them has been shown to stand the test of time. In the UK, BSI also produces Publicly Available Specifications (PAS), which, with time, can move onto being BS (British Standard) versions.
Standards go through an iterative process on the road to final acceptance and publication. ISO tends to have more steps than CEN or BSI. The ISO steps are generally as follows, though often the Working Groups get permission to skip a step or two. The earliest stage is when a perceived need for a new standard, or revision of a standard, has been identified, and this goes out to international vote, at which stage it is called a NWIP (New Work Item Proposal). When approved by a minimum of 5 countries (who also have to put forward experts to work on the project), it becomes an AWI (Approved Work Item).
The document itself it may start as a WD (Working Draft) or as a CD (Committee Draft), which is put out for international comments and vote. The Working Group then works through the comments, and if the feeling is that these have been addressed, the next stage is a DIS (Draft International Standard – the European equivalent is prEN) (or else it goes back for another round of CD comments and voting).
At the DIS stage any technical concerns should have been addressed, so when this draft goes out for voting, any comments coming back should really be editorial, unless some technical issues had been overlooked. If everyone agrees technically with the DIS, then it can be agreed to go straight to publication (with any editorial corrections addressed), or else it goes for one more round of voting as an FDIS (Final Draft International Standard – the European equivalent is FprEN), after which with majority approval it can be published. The drafts from DIS onwards can be referenced and worked with in the public domain.
Most standards have to be purchased, and are available through the BSI shop. For the ISO standards, it is possible to download the Introduction, Scope, and Terms and Definitions, for each standard for free from the platform: https://www.iso.org/obp/ui
Medical devices are placed on the market with specific clinically-related claims. The manufacturer has to justify these claims and also show that the product is safe and fit for purpose. Testing to, and passing, recognised standards is part of this process. If the manufacturer claims that their product is a medical device, they have to have it CE/UKCA marked in the EU and Great Britain respectively.
The placement of a CE or UKCA mark, and the MD symbol, on the product and its packaging, indicate that the product has been assessed against these criteria and registered in the relevant marketplaces.
Testing to ISO standards is voluntary, but if a manufacturer chooses to take another route, they need to have strong justifications not to use a recognised published standard. Where a product is sold in the EU or Northern Ireland, and there is a harmonised EN standard, then it is appropriate that the standard be followed.
Outside the regulatory framework above, as a prescriber you are following better practice for client safety and product assurance if you select an item that has been tested to, and passed, one or more of these recognised standards, than if the product is selected on, say, purely price grounds. The price may be slightly higher, but you will have the peace of mind that the manufacturer has picked up the costs of product testing, and thereby that your client is protected.
While some standards cover product testing, others provide guidance to best clinical practice, as well. Over and above the latter standards, there are also other sources of guidelines, such as the BHTA range of guidance publications, the Posture and Mobility Group Best Practice Guidelines, and RESNA’s position papers, all of which are free to download from these respective organisations.
BSI, and the Working Groups, welcome all applications to become a standards maker: you only need to have relevant knowledge and experience, or to represent a relevant group of stakeholders such as BHTA.
Please get in contact with BSI via standardsmakers@bsigroup.com
Technical Committee: TC173 Assistive Products*
Sub-committees:
TC173 SC1 Wheelchairs, which has four active Working Groups
TC173 SC2 Classification and terminology
TC173 SC3 Aids for Ostomy and Incontinence
TC173 SC7 Assistive products for persons with impaired sensory functions
TC173 also has the following individual Working Groups:
Technical committee: TC293 Assistive Products and
Accessibility, which has a number of working groups:
Working Groups are disbanded when the standard they have been working on has been published, and they have nothing else currently on their work programme. TC293 Working Groups WG2, WG3, WG4, and WG8 are currently inactive for this reason.
CH 173 – ISO TC173 and TC293 Mirror Group
CH 173/1 – ISO TC173 SC1 and TC293 WG9 Mirror Group
*ISO TC173 has a website from which it is possible to link with some of the TC173 activities, and access documents which are in the public domain: https://committee.iso.org/home/tc173
This document was created in association with NHS Supply Chain and is endorsed by the Chartered Society of Physiotherapy.
View and download this guidance as a PDF here.
For years, the experience of patients trying to find the right walking aid has been a confusing one. Suppliers and manufacturers have described products in different ways, and the way patients are measured to find the right one for them has also differed.
To improve the experience for walking aid users and the professionals who support them, NHS Supply Chain has engaged with the British Healthcare Trades Association (BHTA) members, professional bodies and their members, suppliers and walking aid users to develop industry standard terminology, sizing criteria and ways of measuring patients.
NHS Supply Chain is asking everyone to adopt the first wrist crease as the initial measurement point, prior to using clinical reasoning and patient comfort in the final height decision.
The following terms and ranges have been agreed for implementation by NHS Supply Chain. Suppliers and distributors are being encouraged to adopt the same.
Width – Ultra Narrow, Narrow, Standard Width, Wide, and Extra Wide
Height – Small, Medium, Large, and Extra Large.
The agreed measurements of the above are detailed below.
| Ultra Narrow | ≤499mm |
| Narrow | 500mm – 550mm |
| Standard Width | 551mm – 600mm |
| Wide | 601mm – 650mm |
| Extra Wide | 651mm – no upper limit |
| Small | ≤649mm |
| Medium | 650mm – 849mm |
| Large | 850mm – 949mm |
| Extra Large | 950mm – no upper limit |
Where a product spans multiple height ranges then the naming convention would be the start and end bracket. For example, a product with a height of 720mm-1,010mm would be termed Medium-Extra Large.
An example product description would be: Double Adjustable Crutch, Medium-Large (650-900mm), SWL 160kg.