Are pressure area care support mattresses being under-regulated? - Talley Group
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
Community matters
In each issue we investigate a hot topic currently affecting you and your
community practice. Here, we ask...
Are pressure area care support
mattresses being under-regulated?
W
hile regulation is common
in many walks of life
— health care, the food This is such an interesting article and has really
industry, the building trade, to name highlighted potential issues and responsibilities, while
but a few — it has become a national raising awareness of the difficulties nurses encounter
hobby to rail against the imposition every day.
of standards imposed from above.
In my experience, most trusts procure contracts
The phrase ‘health and safety gone
mad’ has become common parlance, with a provider of pressure-relieving equipment,
and is cheerfully bandied about thus it is their overall responsibility to ensure that the equipment nursing
whenever builders are asked to put teams can order is ‘fit for purpose’. The nurse is required to undertake an
on a hard-hat, chefs are ordered to individualised patient assessment and order the appropriate equipment
wash their hands, or you require from a predetermined source. In addition, I am aware that regular audits
a triplicated insurance certificate
of equipment are undertaken and if a patient develops pressure damage
to put up a shelf in your lounge
(the last one is an exaggeration, an investigation is initiated, which involves assessment of any pressure-
obviously, but you get the point). relieving equipment utilised. This can then lead to changes in equipment via
the procurement process. However, this process may be different in other
Some regard government areas, so the issues raised in this article are invaluable.
regulation as an over-reaction to the
potential dangers inherent in going Annette Bades
about their daily life, seeing it as District nursing specialist practitioner, Lancashire Care NHS
a set of unnecessary rules, usually Foundation Trust
handed down from the EU, and
policed by an army of ‘jobsworths’ people would probably assume independent Notified Body to prove
armed with clipboards and poor that all medical devices are subject device safety and efficacy before
social lives. to similarly stringent regulation their products are awarded a
as medicines (‘Medical devices: CE mark.
In health care, however, conformity assessment and the CE
regulation is there for a very good mark’ – www.gov.uk). Manufacturers of ‘low risk’
reason; to enforce standards and devices, such as sticking plasters,
ensure that medical equipment is In reality, this couldn’t be bed frames, walking aids, are able
safe, effective and does not harm further from the truth, and it is to ‘self-certify’ their products as
patients. Regulation ensures that the the classification of the device that safe and effective and they can
drugs we take do not contain toxins; dictates the level of regulation and therefore assign their own CE mark
that the wound dressings we apply independent scrutiny that products to the products without involving
are uniformly manufactured; that are subjected to prior to being an independent Notified Body
the theatre nurse who is attending awarded a CE mark. to validate any claims of device
to our operation is wearing the right performance or safety.
kind of gloves. Manufacturers of ‘medium’ to
‘high risk’ medical devices, such Instead, medical devices are
HOW DOES PRODUCT as hip joints, breast implants classified and carry a CE mark to
REGULATION WORK? wound dressings, intravenous ensure that the devices you — or
(IV) equipment are required to your trust procurement department
Since it is a legal requirement for undertake stringent clinical trials — are buying, such as gloves, IV
all medical devices sold in the and/or provide comprehensive equipment, wound care dressings
EU to carry the CE mark, most Clinical Evaluation Reports to an etc, meet European safety standards.
JCN 2018,
2013, Vol 32,
27, No 34 11
Device classification is
governed by a set of rules and it is This is a very informative article, which highlights the
the manufacturers’ interpretation vital considerations when selecting pressure-relieving
of these rules which dictates the equipment that many would not consider. Within many
class of device that their product organisations, whether NHS, social or private sector,
fits into. While it is usually although patient safety is the main consideration, cost
straightforward for manufacturers
effectiveness of medical devices purchased or hired
to determine which class of
device their product falls into, is the second biggest driver and this influences what
powered pressure area care pressure-relieving equipment is purchased.
(PAC) support surfaces currently It is essential that purchasers and clinicians have an understanding of
fall into a grey area in terms of what terms associated with medical devices mean in order to ensure safety
medical device classification and and reliability. With this understanding, a balanced decision can be made to
manufacturers can opt for a Class I
protect patient safety.
(unregulated) or a Class IIa (highly
regulated) classification. My colleagues and I have often discussed our concerns with regard to
healthcare providers making uninformed choices in their attempt to protect
It is a requirement for all Class those in their care. And, have also been challenged and frustrated by the
IIa, IIb and III devices to be checked minefield of inadequate legislation/quality measures related to pressure-
by a Notified Body, i.e. a commercial relieving surfaces.
company designated by the UK
This also applies to the general public, as we often come across
Medicines and Healthcare Products
Regulatory Authority (MHRA) to individuals who have taken responsibility of their own care or that of a
provide quality assurance (‘UK loved one and purchased equipment in the belief that it would reduce their
notified bodies for medical devices’ risk or heal their pressure ulcers, only to find that it is not adequate for
– www.gov.uk). Medical devices are their needs.
categorised as per Table 1. Hopefully this article will provide direction on what questions to ask
and consider when being sold equipment under the guise ‘that apples and
Most of you would probably
assume that all medical devices oranges are the same fruit’!
are checked in some way, audited
by a panel of industry experts, for Julie Evans
example, to make sure that they Tissue viability nurse, Morriston Hospital, Abertawe Bro Morgannwg University
meet some kind of minimum Health Board, Swansea
standard and that their claims of
safety and performance are accurate.
But, as you can see from the efficacy, the CE mark is the same There have always been doubts
classification categories in the table, regulation that, as reported in the about the effectiveness of the CE mark
some products (Class I devices) Guardian, a Chinese company, for system to regulate medical devices
are not audited at all, but are still example, would require to sell toys safely. This was exposed by a joint
permitted to have a CE mark. across the European Union (‘Medical investigation by the British Medical
devices and Chinese toys share Journal and the Daily Telegraph, where
In fact, rather than being a same level of safety checks’ — www. an application was submitted for a
guarantee of safety and clinical theguardian.com). hip prosthesis to a notified body in
Slovakia; the specifications of the hip
prosthesis mirrored a previous product
Table 1: Medical device classifications that had been withdrawn from the
Device class Type of product Audit required by an market for releasing metal ions into
independent patient’s blood (‘Joint BMJ/Telegraph
Notified Body investigation exposes flaws in
Class I Non-invasive equipment such as pressure-relieving devices, No regulation of medical devices’ — www.
bed frames, walking frames, stethoscopes BMJ.com). The fake hip prosthesis was
passed for certification.
Class IIa Active devices designed to administer or exchange energy, Yes
including pressure-relieving devices, invasive devices,
dressings
And why does this matter? It
matters because the Class I products
Class IIb Active therapeutic devices designed to administer or exchange Yes that carry a CE mark do not have
energy in a potentially hazardous way, including invasive to undergo any audit by a notified
devices, complex wound dressings, ventilator equipment,
regulatory body before being
intensive care monitoring equipment
awarded a CE mark, nor at any
Class III Implantable devices such as heart monitors, balloon catheters, Yes point during the product lifecycle.
pharmaceuticals Therefore, as clinicians, how do we
12 JCN 2018,
2013,Vol
Vol32,
27,No
No34
know Class I devices are safe and
effective? Not only that, but Class I I find the concept of pressure-relieving equipment
products include powered pressure- quite daunting and extremely challenging. As
relieving support surfaces; products someone who visits many settings where health care
that help prevent potentially life-
threatening pressure ulcers from
is delivered, both private and in a patient’s home, I
developing or becoming worse. find myself continually questioning the effectiveness
and appropriateness of equipment provided. In fact,
With safe and effective patient fairly recently I was asked to assess a patient who
care driving reductions in avoidable had developed category 3 pressure damage following
harms, healthcare providers, a relative purchasing and using an aid that was marketed as a pressure
clinicians and patients must be
confident that the products they are
ulcer prevention product. This product looked more akin to a washable
using are both safe and effective. incontinence sheet and the evidence on the website was even more shocking
and may well mislead less informed individuals.
THE ROLE OF PRESSURE IN While in the NHS sector we would expect pressure-relieving products
TISSUE DAMAGE to be rigorously tested, the evidence examined and then numerous clinical
evaluations undertaken, I am unsure if this happens consistently across the
Pressure ulcers are a recognised
avoidable harm and develop because
NHS and am even less confident about what happens within the
the patient’s tissue, typically that private sector.
lying over bony prominences in I have also found that obtaining information on a device’s CE registration
vulnerable areas, such as the sacrum, is not an easy task. In fact, I have looked on manufacturers’ websites of
coccyx, and heels, is exposed to mattresses I have seen in some private sector homes and research on how
prolonged pressure or pressure effective the products are is sadly lacking. The National Institute for Health
associated with shear causing
occlusion/reduction in blood supply
and Care Excellence (NICE, 2014) does reflect this and recognises that
to the skin, for example, a patient’s evidence for pressure-relieving products is poor and mostly industry-led. With
heels dragging on a bed sheet. this in mind, maybe it is time for our regulating bodies to take more interest in
what is available. I think that stronger guidance and recommendations would
Pressure damage commonly be welcome, especially in ensuring that all pressure-relieving products are
affects patients with mobility issues, registered as Class IIa, and regulated accordingly.
for example, those with a spinal
cord injury, older patients with
Last, it is important to remember that a pressure-relieving device is
frail skin who spend long hours only a tool in our box of pressure ulcer prevention and treatment strategies,
sitting down or in bed, people and should not be considered in isolation. We should not forget that skin
who are acutely ill, or the very examination, repositioning, risk assessment and management of nutrition
young. Pressure ulcers can begin and incontinence need to be undertaken in conjunction with the use of
as superficial injuries that affect appropriate pressure-relieving aids if pressure ulcers are to be prevented or
the epidermis and dermis, but can
quickly move into the subcutaneous
treated effectively.
tissues and involve muscle, tendon
Kirsty Mahoney
and bone. Not only are many
Clinical nurse specialist, wound healing, Cardiff and Vale University Health Board
healthcare-associated pressure
ulcers now being classified as
avoidable events, there is a drive to
reduce the significant costs to
the NHS budget of this kind of Similarly, the use of active Specialist support surfaces are
tissue damage. (those that provide alternating low specifically manufactured to improve
and normal pressure) and reactive tissue perfusion and thereby increase
Support surfaces, such as (those that provide a constant lower the viability of the patient’s skin and
mattresses and cushions, generally pressure) support surfaces help underlying tissue. The international
fit into two categories — powered to manage the levels of pressure prevention and treatment of pressure
or non-powered. Non-powered experienced by the immobile patient. ulcer guidelines recommend using
support surfaces include foam Reactive support surfaces apply an active support surface (overlay or
mattresses and static air-filled constant pressure to the tissue until mattress) for individuals at higher
mattresses, whereas powered the patient moves or is repositioned, risk of pressure ulcer development
support surfaces include dynamic whereas active support surfaces when frequent manual repositioning
alternating surfaces; some of these periodically redistribute pressure is not possible (see point 2 on
include air-filled sacs that alternately underneath the body, particularly page 29 of the National Pressure
fill and empty, while others laterally for patients who cannot be Ulcer Advisory Panel/European
rotate to provide relief from pressure. repositioned regularly. Pressure Ulcer Advisory Panel/
JCN 2018, Vol 32, No 3Pan Pacific Pressure Injury Alliance IIa devices, with manufacturers provenance. You have to decide if you
[NPUAP/EPUAP/PPPIA], 2017 quick voluntarily accepting audit by an are safeguarding your patients by
reference guide — www.epuap. independent Notified Body. purchasing a cheaper support surface
org/wp-content/uploads/2016/10/ that comes with a lower regulatory
quick-reference-guide-digital-npuap- So, what does this mean in audit threshold.
epuap-pppia-jan2016.pdf ). practice? In short, it results in a grey
area where the procurement team, Safe and effective harm-free
The National Institute for Health risk management, tissue viability care is a clear and consistent theme
and Care Excellence (NICE, 2014) and prescribing nurses may not across the Department of Health
recommends that anyone admitted be aware that, even though the and Social Care, the NHS Outcomes
to secondary care or at high risk powered support surface they have Framework, the Care Quality
of developing pressure damage in chosen carries a CE mark, it may Commission, NICE and Sign up
primary or community care should not have been externally audited. to Safety. Therefore, the aim for all
have at least a pressure-reducing Which, in turn, means that you, as healthcare providers and any nurse
foam mattress on their bed. a professionally accountable nurse, should be to eliminate, as far as
could be treating your patients with possible, the risk of harm to patients.
HOW DOES THIS a product that does not require any
AFFECT PATIENTS? technical information to be compiled It is vital that clinicians involved
for audit, nor undergoes any kind in the procurement and prescribing
Choosing the correct support surface of clinical evaluation to confirm of powered PAC support surfaces
can both help to prevent pressure any claims of product safety or are aware of how low the regulation
ulcer development, and, for a patient performance. is set for Class I devices, and how a
with a pressure ulcer, be crucial to lack of awareness of medical device
their recovery. However, as Heidi WHAT CAN YOU DO? classification in itself poses a risk to
Guy writes in the Nursing Times, patient safety. Educating colleagues
‘the selection of the correct support First, you need to remember that, about the differences in support
system for each individual involves as a nurse, you are entrusted with surface classification and the variation
many factors and can, therefore, be safeguarding your patients. This between Class I and Class IIa medical
quite complex’ (‘Preventing pressure means that you should understand devices is part of the nurse’s duty to
ulcers: choosing a mattress’ — www. the provenance of any equipment provide safe care.
nursingtimes.net). you use, and be confident of its
safety. When it comes to pressure It is clear, then, that powered
According to the EPUAP, choice damage, one way to ensure this support surfaces play an important
of support surface should ‘take into is to make sure that any powered role in the treatment and prevention
consideration factors such as the support surface you recommend of potentially life-threatening
individual’s level of mobility within or procure is registered as a Class pressure ulcers. It is also clear that
the bed, his/her comfort, the need for IIa medical device and CE marked in the world of powered support
microclimate control, and the place appropriately. This will ensure that surfaces, not all are made equal. It is
and circumstances of care provision’ any manufacturer’s claims about important that, before nurses make
(‘Prevention of pressure ulcers: quick safety and performance have a clinical decision, they are able to
reference guide’ — www.epuap.org). been independently checked by a educate themselves about different
registered Notified Body before the products, the evidence for those
Nurses’ decision-making is CE mark was awarded. products, as well as the individual
complicated by the amount of needs of the patient.
products to choose from. Pressure- As NHS budgets become ever-
relieving equipment alone includes more restricted, individual clinicians As a nurse, only you can
standard foam mattresses, high- can also come under pressure to decide if you are prepared to use a
specification pressure-reducing foam administer, recommend or procure powered PAC support surface that
mattresses, non-dynamic overlays, products that are cheaper, while is manufactured and sold without
hybrid mattresses and true dynamic appearing to offer similar clinical having to undergo any clinical and
pressure-relieving mattresses. benefits. Powered pressure area regulatory checks. Simply ignoring
care (PAC) support surfaces are a the evidence really would be health
The current guidelines perfect example. After all, it would be and safety gone mad. JCN
surrounding medical device easy to assume that there was little
classification do not help. For difference between a cheaper support
example, some manufacturers surface with a Class I CE mark, or a REFERENCE
classify their powered support potentially more expensive version
surfaces as Class I devices, which with a Class IIa CE mark. While National Institute for Health and Care
means that they can effectively self- clinical decisions are down to the Excellence (2014) Pressure ulcers:
regulate their product and release individual nurse, it is important not prevention and management. Clinical
it without any external overview, to be influenced to invest in cheaper guideline 179.. NICE, London. Available
while others are classified as Class products that do not have a proven online: /www.nice.org.uk/guidance/cg179
JCN 2018, Vol 32, No 3You can also read
