Device-Related Pressure Ulcers SECURE Prevention

International
Consensus Document
Device-related pressure
ulcers: SECURE prevention
SPONSORED BY
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Peter Worsley mCSP PhD, Assistant Professor in
Authors: Rehabilitative Bioengineering, Clinical Academic Facility in the
Amit Gefen PhD, Professor of Biomedical Engineering, School of Health Sciences, University of Southampton, UK
The Herbert J. Berman Chair in Vascular Bioengineering,
Department of Biomedical Engineering, Faculty of Review panel:
Engineering, Tel Aviv University, Tel Aviv, Israel
Joyce Black Professor at College of Nursing, University of
Paulo Alves RN, MSc, PhD. Assistant Professor and Nebraska Medical Center. Nebraska, US
Coordinator Wounds Research Laboratory, Universidade
Católica Portuguesa, Institute of Health Sciences, Center for Michelle Barakat-Johnson Skin Integrity Lead, Sydney Local
Interdisciplinary Research in Health, Portugal Health District; Clinical Senior Lecturer, Faculty of Medicine
and Health, University of Sydney, Australia
Guido Ciprandi MD, PhD, Chief Wound Care Surgical Unit,
Division of Plastic and Maxillofacial Surgery, Bambino Gesu’ Dimitri Beeckman Professor of Skin Integrity and Clinical
Children’s Hospital, Research Institute, Rome, Italy Nursing, Ghent University, Ghent, Belgium
Fiona Coyer RN, Dip Nurs (Distinction), PGCEA, MSc Nursing, Jacqui Fletcher Independent Nurse Consultant, UK
PhD, Professor of Nursing, Joint appointment, Intensive Care Holly Kirkland-Kyhn PhD, FNP, GNP, CWCN, FAANP,
Services, Royal Brisbane and Women’s Hospital and School Director of Wound Care. University of California Davis
of Nursing, Queensland University of Technology, Australia. Medical Center, US
Visiting Professor, Institute for Skin Integrity and Infection Nils A. Lahmann PD, PhD, MSc, BA, RN, Deputy Director,
Prevention, University of Huddersfield, UK Geriatrics Research Group, Charité University Berlin, Germany
Catherine T Milne MSN, APRN, ANP/ACNS-BC, CWOCN- Zena Moore PhD, MSc, RGN, Professor and Head, School of
AP, Connecticut Clinical Nursing Associates, Bristol Hospital Nursing and Midwifery. Director, Skin Wounds and Trauma
Wound and Hyperbaric Medicine, Bristol, Connecticut, US Research Centre, Royal College of Surgeons in Ireland, Dublin,
Karen Ousey PhD, RGN, MA, PGDE, BA, RN, FHEA, CMgr Republic of Ireland
MCMI, Professor of Skin Integrity, Director, Institute of Yohan Payan CNRS, Research Director, Laboratoire TIMC-
Skin Integrity and Infection Prevention, School of Human IMAG, University Grenoble Alps, France
and Health Sciences, Huddersfield University, UK; Clinical
Professor, Queensland University of Technology, Australia; Anna-Barbara Schlüer Advanced Nurse Practitioner in
Visiting Professor, Royal College of Surgeons in Ireland, Paediatric Skin and Wound Management and Head of the
Dublin, Republic of Ireland Paediatric Skin Centre, Skin and Wound Management and
Department of Nursing Science, University Children’s Hospital
Norihiko Ohura MD, PhD, Professor, Department of Plastic, Zurich, Switzerland
Reconstructive and Aesthetic Surgery, Kyorin University
School of Medicine, Japan
Nicola Waters PhD MSc RN, Associate Professor, School
of Nursing, Thompson Rivers University, Kamloops, British
Columbia, Canada
Th is document was supported by: MÖlnlycke Health Care, PolyMem, Smith & Nephew and Stryker
Suggested citation for this document: Gefen A, Alves P, Ciprandi G et al. Device related pressure ulcers: SECURE
prevention. J Wound Care 2020; 29(Sup2a): S1–S52 https://doi.org/10.12968/jowc.2020.29.Sup2a.S1
Editors: Tracy Cowan and Rachel Webb

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S2 JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020

Contents
Foreword S4
Introduction S5
Pathophysiology S10
Devices S16
Risk assessment S22
Safe use of devices: prevention and management of DRPU S28
Changing the focus of health professionals and policy-makers S37
Future research and guidelines for product development S41
JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S3

Foreword
M
any of the most commonly used medical academia, research and industry, this consensus
devices, such as endotracheal and statement is an evidence-based review of the aetiology,
nasogastric tubes, oxygen tubing, non- assessment, prevention and management of DRPU. It
invasive ventilation masks, urinary catheters, cervical describes how medical devices and objects that come
collars and casts, have changed little in decades. It is into contact with skin or apply forces onto it can cause
not surprising that these traditional devices, which deformation damage at the cellular and tissue level.
interface with vulnerable skin and soft tissue, are The consensus statement identifies and discusses
frequently associated with device-related pressure devices most commonly associated with DRPU and
ulcers (DRPU). These wounds are commonly hospital- the biomechanical reasons for the risks they represent.
acquired and can: An important and innovative element of the panel’s
● Increase the risk of potentially life-threatening work has been to evaluate which engineering concepts
infections, such as sepsis and technologies can be used to protect the skin and
● Cause pain and leave scars, which may be highly deeper tissues from DRPU and assess if device-related
visible and cause distress tissue damage can be reversed. It also outlines
● Result in permanent hair loss, altered body image strategies for changing the mindsets of health
and/or reduced quality of life professionals and policy-makers on the need for DRPU
● Increase length of hospital stays and consume prevention, including how to increase global
additional resources (time and products). awareness about their root causes, the scale of the
Moreover, as DRPU almost always develop in problem and their financial implications.
healthcare institutions, in many countries they are a Greater awareness of DRPU will lead to better
cause of lawsuits. adoption of prevention protocols and much-needed
The global scale of the problem is considerable, new designs and technologies. The consensus statement,
particularly in clinical settings where devices are used therefore, specifies the requirements that will make
intensively, such as in operating theatres, intensive medical technologies effective in DRPU prevention.
care units and emergency departments. Patients of all To guide the medical device industry, the panel has
ages are affected, with the typical scenario being an listed design recommendations for the shape, materials
environment dense with equipment, tubing, electrodes and construction of medical devices. The consensus
and wiring. All too often, these devices interact with statement discusses how bioengineering design can
fragile skin and tissues, such as that of children and reduce high pressure and shear points, alleviate
aged individuals. frictional forces and stress concentrations on skin and
In February 2019, an international group of within deeper tissues, and optimise the microclimate.
medical, clinical and bioengineering experts met in In conclusion, for the fi rst time in the literature,
London, UK, to develop the fi rst international detailed advice is presented on how to safely apply
consensus statement on DRPU. Following a rigorous medical devices and improve biomechanical and
process of scientific discussion, this consensus thermodynamic tissue conditions at the skin-device
statement was drafted. It was then reviewed by an interface. Future research work required, including
international committee of experts who were external laboratory tests, clinical trials and computer
to the panel. Accordingly, this consensus statement is modelling for DRPU prevention, is also discussed.
a comprehensive synthesis of current understanding Multidisciplinary efforts are the key to mitigating
of the aetiology of DRPU and the technologies and DRPU. The consensus group’s team effort provides the
clinical protocols that can be used to mitigate them. cornerstone in working towards this goal.
Aimed at generalist and specialist clinicians, as
well as biomedical and non-biomedical engineers in Amit Gefen — panel chair

Introduction
P
ressure ulcers (PU) are defined by the European
Pressure Ulcer Advisory Panel (EPUAP), the Key points
National Pressure Injury Advisory Panel ● A device-related pressure ulcer (DRPU)
(NPIAP, formerly National Pressure Ulcer Advisory may be caused by a medical device or a
device, object, or product without a
Panel) and the Pan Pacific Pressure Injury Alliance medical purpose
(PPPIA) as:1,2 ● Paediatric patients are particularly
susceptible to DRPU
‘Localised damage to the skin and underlying soft ● Examples of devices associated with DRPU
include: continuous positive airway
tissue usually over a bony prominence or related to a pressure (CPAP) masks, endotracheal
medical or other device. The injury can present as tubes, orthotic devices, bed frames and
intact skin or an open ulcer and may be painful. The spectacles
injury occurs as a result of intense and/or prolonged ● There is little or no published evidence on
the costs associated with DRPU
pressure or pressure in combination with shear. The ● There is a need for greater recognition of
tolerance of soft tissue for pressure and shear may DRPU, their causes, management and
also be affected by microclimate, nutrition, perfusion, prevention. This document is intended to
comorbidities and condition of the soft tissue’. stimulate action
Th is general definition defines all PU types and In order to differentiate device-related pressure
encompasses various causal factors. However, the ulcers (DRPU) from PU arising from body weight
focus of this consensus statement is pressure forces, the panel proposes defining a DRPU as follows:
ulceration related to device use and/or misuse.
The key causal components of PU formation are ‘A DRPU involves interaction with a device or object
pressure and shear. Friction contributes to shear but that is in direct or indirect contact with skin ... or
on its own is not a direct cause of PU. In many PUs, the implanted under the skin, causing focal and
main cause of pressure and the associated shear localised forces that deform the superficial and
forces is body weight—for example, when a patient is deep underlying tissues. A DRPU, which is caused
immobilised in a supine position for extended periods by a device or object, is distinct from a PU, which is
on a support surface. Such pressure, friction and shear caused primarily by body weight forces. The
cause tissue deformation, inflammatory oedema and localised nature of device forces results in the
ischaemia that, together, lead to pressure ulceration appearance of skin and deeper tissue damage that
in bony anatomical sites such as the sacrum, ischium, mimics that of the device in shape and distribution.’
trochanter and heel.
In contrast, the NPIAP states that medical device- The term ‘medical device-related pressure ulcer’
related pressure ulcers (MDRPU):3 focuses the health professional and others on pressure
ulceration related only to medical devices.
‘…result from the use of devices designed and applied Importantly, a device-related pressure ulcer (DRPU)
for diagnostic or therapeutic purposes. The resultant may be caused by a medical device, object or product
pressure injury generally conforms to the pattern or without a medical purpose. Th roughout this
shape of the device.’ consensus statement, the term ‘DRPU’ is used to
emphasise the importance of understanding that a PU
The NPIAP extended the definition of a medical may be related either to medical or non-medical
device to include objects such as spectacles and other devices. Th is is covered in more detail in the third
devices without a medical purpose. chapter of this document.

Introduction
Briefly, medical devices associated with PU may

include products used to sustain life in sick patients— A note on terminology
for example, continuous positive airway pressure Globally, a number of different names are used
(CPAP) masks, oxygen therapy tubing and to describe pressure ulcers (PU). Pressure
endotracheal tubes, or less critical devices such as injury (PI) is currently used by National
Pressure Injury Advisory Panel (NPIAP;
orthotic devices, indwelling lines and bed frames.
formerly National Pressure Ulcer Advisory
Paediatric patients are particularly susceptible. Panel). 3 Other terms proposed are
Devices or objects associated with PU that do not have ‘deformation injury’ and ‘pressure damage’. To
a specific medical purpose may include the patient’s date, PI has been adopted in Australasia,
own property and objects left on the patient’s bed or although not entirely in the US and Canada,
and not in Europe. The terminology used may
support surface, such as cellular phones and jewellery.
be specific to a hospital or university.
Like PU, DRPU can be categorised as I–IV or
unstageable, depending on their depth and the The term ‘deformation injury’ focuses on the
number of tissue layers involved. 3 However, DRPU can primary fast-acting damage mechanism—
be difficult to classify as they often occur in regions tissue deformation—that leads to rapid cell
death and tissue breakdown.
with minimal soft tissue such as nasal bridge and
ears. Nevertheless, most DRPU are category I and II, Throughout this document, the term PU is
but up to a quarter may be unstageable.4 A DRPU on used. It should be taken to encompass the
the bridge of the nose, where the tissue has no padding, other terminologies used to cover tissue
may rapidly progress from category I to category IV damage or injury caused by pressure, shear
and tissue deformation.
or unstageable.
International pressure acquired PU (HAPU), depending on the care setting

and patient subpopulations.6,7 Despite this, DRPU is
ulcer guidelines an understudied area.
Guidelines on the prevention and management of PU, There are some prevalence and incidence data on
including to varying extents DRPU, have been DRPU. A recent systematic review and meta-analysis
published by a number of international consensus reported that the estimated pooled incidence and
groups and wound management societies. prevalence of DRPU in over 126,000 patients in 29
The EPUAP/NPIAP/PPPIA guidelines are the most studies was 12% and 10%, respectively,8 although, as
widely cited. Th is consensus statement has taken the authors state, these data are limited by the
account of guidelines used globally, including those heterogeneity of the data collection.
from EPUAP/NPIAP/PPPIA.1-3
Occurrence by setting
Is a consensus statement Devices used in intensive care are particularly
associated with DRPU.9–11 In a recent systematic
specific to DRPU needed? review of the incidence, prevalence and severity of
Patients managed using medical devices are more DRPU in intensive care units (ICU), pooled data
likely to develop a PU or skin breakdown.4,5 For revealed incidence rates of 0.9% to 41.2% and
example, in an American hospital setting, the overall prevalence rates of 1.4% and 121%. Again, the wide
rate of PU in inpatients was 5.4%, of which 34.5% were ranges reflect the heterogeneity of the data collection
DRPU.4 Elsewhere, it has been observed that DRPU between the 13 studies evaluated.10 Coyer et al.
may account for as much as 61–81% of all hospital- reported a DRPU prevalence of 3.1% in intensive care

Introduction
patients,12 while Wille et al stated that the overall Occurrence by anatomical

incidence of DRPU or skin breakdown caused by pulse location
oximeters in a surgical ICU may be as high as 5%.13 In terms of anatomical location, a national audit of PU
Occurrence rates can be lower in other settings. An prevalence in the US reported that approximately 10%
unpublished incidence audit of DRPU in Kyorin of all PU in a variety of healthcare settings were device
University Hospital, Japan, conducted over 12 months related, with DRPU most often occurring on the face
from 1 February 2018 to 31 January 2019 clearly and ears, sacrum/coccyx, heels and buttocks.24 DRPU
demonstrated the difference between ICU and general were common across several medical specialty units.
wards. The incidence of DRPU in ICU was 2.8%, which Data derived from these studies reveal that DRPU
is consistent with published data. By comparison, constitute a significant percentage of institution-
that on general wards was 0.4%. Th is lower incidence acquired PU and require significant attention from
is likely to be a result of the higher number of devices clinical, academic and commercial leaders. Table 1
used in the ICU setting compared with general wards. summarises the key results.
Neonates, infants and paediatrics Cost of DRPU

DRPU account for up to 50% of all PU in some high- The costs associated with PU in general are widely
risk patient populations, such as neonatal and reported and are extremely high, with a rising trend
intensive care settings.14,15 A third of all PU in children as populations age and as the incidence of chronic
aged over one year are device related.16 Infants who diseases such as diabetes increases markedly.
develop DRPU are likely to be younger post-partum, In the US, the total cost of HAPU has been
with shorter gestation; they develop DRPU more estimated at $26.8 billion.25 The total cost of PU to the
rapidly than patients with PU caused by body weight.17 National Health Service (NHS) in England has been
Mechanical ventilation and a respiratory diagnosis estimated at over £530 million, based on a patient
are associated with higher risk of DRPU in this database audited between May 2012 and April 2013.26
population.18 In newborns, devices may severely affect These figures are not directly comparable because
and distort nasal cartilage. of the different health organisations involved and
The incidence of PU in paediatric patients may be methods used to collect data and the settings to which
as high as 28%, with non-invasive mechanical they relate. However, it is clear that, even if simple and
ventilation associated with PU formation (relative low-cost prevention measures work, preventing PU
risk ratio 12.24).11,19–23 will save substantial costs.27
Nevertheless, there is little or no published
Occurrence by type of device evidence on the costs associated with DRPU,
Regardless of setting, there is a high association particularly the substantive indirect costs associated
between DRPU and respiratory devices. Up to 68% of with litigation and insurance (in premiums or loss of
DRPU are associated with respiratory devices,9 of coverage) as most DRPU are HAPU. Lawsuits related
which 20% are linked with bilevel positive airway to DRPU often end with undisclosed court-approved
pressure (BiPAP) or CPAP devices, where ulceration settlements negotiated behind closed doors. The
has occurred on the bridge of the nose and/or indirect effects of rising insurance premiums on
nasolabial fold.6 In general-hospital patients with clinicians and facilities have not been reported but,
respiratory failure managed by non-invasive based on the known extent of litigation activities, it is
ventilation or CPAP, prevalence may be over 14%. 5 reasonable to assume they are considerable.
Ham et al found a high association between trauma Box 1 lists the elements that contribute to the cost
patients and endotracheal and nasogastric tubes.7 (economic and other) of DRPU.28,29 Often-overlooked

Introduction
Table 1. Summary of medical device-related pressure ulcers incidence and prevalence

Reference Setting Finding
Overall Black et al.4 American hospital inpatients (n=2079) PU occurrence: 5.4%
trends DRPU occurrence: 34.5%*
Jackson et al. 8 Systematic review of 29 studies Pooled DRPU incidence: 12%

Pooled DRPU prevalence: 10%
Data from Barakat-Johnson et Systematic review of 13 studies Pooled DRPU incidence: 0.9–41.2%
intensive al.10 Pooled DRPU prevalence: 1.4–121%
care
Coyer et al.12 Six ICUs in two major medical centres DRPU incidence: 3.1%
settings
(one in US and one in Australia)
Wille et al.13 125 patients in a surgical ICUt Frequency of pulse oximeter-induced

digital injury: 5%
Data from Kyorin University ICU and general wards in a DRPU incidence in ICU: 2.8%
other Hospital unpublished Japanese hospital DRPU incidence in general wards: 0.14%
settings DRPU audit
Schlüer et al.16 204 children in 13 Swiss hospitals Prevalence of PUs: 26.5%
Prevalence of DRPU: 38.5%
Visscher and Taylor17 741 neonatal intensive care patients Premature neonates: 1.5 PU per 1000 days
Term infants: 2.7 PU per 100 days
DRPU–device-related pressure ulcer; ICU–intensive care unit; PU–pressure ulcer
are the psychological and emotional costs to patients, ● The patient’s inability to sense the device and the
which can contribute to the direct and indirect costs associated pressure, friction and shear on their
of patient care. The long-term impact on the wellbeing skin due to sedation, encephalopathy or neurologic
of a patient disfigured following a DRPU can be disease
devastating, particularly as a significant proportion ● The patient’s inability to reposition themselves.4
occur on the face and neck, with scarring having ● Duration of device use
inevitable social and psychological challenges. ● The perceived need to secure a device tightly to
DRPU represent a large economic burden on ensure correct function.5,31
healthcare systems, especially when indirect costs of DRPU develop faster than non-DRPU because of
litigation and insurance policies are factored in. the vulnerability of the patient and body sites affected.
Plaintiffs will typically sue the institute/organisation They are most likely to be facility-acquired and
and, sometimes, the clinicians who provided the care. located on the face and neck, 32 exit sites and stomas.
Even a conservative cost estimate based on a 10% Many factors are implicated in their development (for
prevalence implies a significant burden to patients, more detail, see chapter 3). Specific factors include:
families and healthcare institutions. ● Devices often do not fit patients properly due to
their generic designs and limited range of size,
Factors implicated especially in paediatrics

● Device materials are often very stiff and do not
in DRPUs conform to tissue shape, causing localised skin
Multiple factors increase the likelihood that an ICU distortions when they interact with skin and
patient will develop a PU. 30 Factors that increase the underlying soft tissue
risk of DRPU include: ● Inadequate guidance is provided on device

Introduction
where there is potential loss of range of motion) and

Box 1. Costs associated with device-related permanent hair loss.
pressure ulcer (DRPU)
The panel met to address the need for greater
● Medical costs of pressure ulcer (PU) recognition of DRPU and its causes, management and
management
prevention. Th is document is intended to stimulate
● Practitioner time
● Personal impact on the patient action and covers:
● Reduced quality of life for the patient and
their family ● The anatomy and tissue composition in relation to
● Psychological and emotional impact, such
the patient’s age
as disfigurement of the face and head
● Reimbursement withheld for hospital- ● The pathogenesis of DRPU, with particular focus
acquired pressure ulcers (HAPU) on why devices are associated with PU
● Fines in some jurisdictions ● Devices, both medical and non-medical, associated
● Litigation costs
with DRPU
● Potential court-ruled damages
and settlements ● Assessment of DRPU
● Cost of insurance policies, which are ● Safe positioning and use of devices to prevent or
affected by the institution’s litigation history manage DRPU
● Cost of device abandonment (e.g.
● Initiatives to raise awareness of DRPU among
prosthetics and orthotics)28
● Cost of changing medical intervention—for health professionals
example, when continuous positive airway ● Medical device design characteristics and features
pressure (CPAP) fails in neonates, some relevant to DRPU and its prevention
need to be re-intubated29
● Future research required on prevention of DRPU,
with particular reference to product design,
application by both commercial suppliers and regulation and monitoring technologies.
clinical educators The ultimate objective for this consensus document
● Many individuals have comorbidities that limit is to improve patients’ outcomes and safety during
their tolerance to mechanical loads on vulnerable episodes of care.
skin and soft tissue sites and/or lead to uncontrolled
oedema and a hostile local tissue microclimate
● Lack of clinician awareness of the importance of
repositioning, offloading, rotating devices or
correctly fitting or securing them.
The management of skin health is also complicated
by the fact that medical devices often have a diagnostic
or therapeutic purpose. For example, a respiratory
device may be required for critical life support, so it
may not be possible to remove or reposition it without
compromising the patient’s survival. Thus, the need to
maintain device in situ may prevent skin assessment,
leading to an existing DRPU not being identified.4
DRPUs have an adverse impact on the affected
patient by causing additional morbidity and reducing
quality of life. Th is often extends beyond discharge—
for example, in cases of visible scarring (including

Pathophysiology
T
his chapter reviews the pathophysiology of PU
and DRPU. Table 2 summarises the key Key points
similarities and differences between PU and
● Principal causes of pressure ulcers (PU) are
DRPU.33 Principal causes of PU are pressure, friction
pressure, friction and shear, and the
and shear, and the resulting sustained cell and tissue resulting sustained cell and tissue
deformations, the effects of which are exacerbated by deformations. These effects are exacerbated
moisture and temperature (Fig 1).1,34-41 by moisture and temperature
● There do not appear to be specific risk
Cell deformation factors for device-related pressure damage

(DRPU) aside from the actual use of the
Patients who develop PU frequently have multiple risk device
factors and comorbidities.42–44 In most cases, a PU ● A crucial difference between PU and DRPU
is that body weight forces play a less
forms at an anatomical location where there is a bony
prominent role in DRPU, with the force
prominence beneath the skin. When an individual exerted from a device that is typically
spends prolonged periods in a bed or chair, pressure strapped or taped to the body
and frictional forces caused by gravity act on the skin ● Neonatal and paediatric skin are different to
adult skin
over the bony prominences, which compress, stretch
● Most DRPUs can be prevented by improving
and shear tissues, deforming the cells and extracellular the design of devices
matrix (ECM) components and obstructing vascular
Table 2. Overview of features associated with pressure ulcers and medical device-related pressure ulcers.
Adapted from Bader et al. 33
Pressure ulcers Device-related pressure ulcers
Aetiology Both result from physiological responses of soft tissue involving cells, the interstitial space within
extracellular matrix and blood and lymph vessels, with the importance of each depending on
different magnitudes of strain and time173
Cause of deformation- Gravitational forces due to body weight Caused by external applied forces (strapping and tape)
induced damage
Individual Immobile and/or insensate patients. Areas Illness, possibly with comorbidities; examples are
vulnerability with previous tissue damage patients in intensive care unit (ICU), patients with
diabetes, and patients who cannot communicate
discomfort or pain. Skin and soft tissue sites with
previous damage.
Nature of Examples are support surfaces, cushions, Generic designs of medical devices not matched to
medical devices mattresses, bedside chairs, toilet seats, individual characteristics
based on individual risk
Prevention strategies Pressure redistribution/relief and periodic Improved design of devices; pressure relief through
repositioning application of an alternative device; adequately
designed prophylactic dressings
Vulnerable tissue Adjacent to bony prominences such as Any body site, but commonly the head or neck;
areas sacrum or ischium application of load to tissues with limited prior
mechanical conditioning.
Microclimate Affected by support surface design, Affected by device interface, including any seal the
ambient conditions and individual’s sweat device creates with the skin or therapeutic heating
response and clothing or humidity

Pathophysiology
and lymphatic flow. The compression, which is always The magnitude and duration of the deformation
combined with shear, causes local ischaemia by will determine the extent of cell and tissue damage and
occluding the microvascular network of capillaries in subsequent inflammation, as well as the degree of
the skin and deeper tissue. Pressures required to cause ischaemia. For example, direct deformation causes
local ischaemia depend on the magnitude of the shear pathological change to deep tissue in minutes.50 Tissue-
and the individual’s vascular functionality engineered living model systems indicate that skeletal
(cardiovascular system health).45,46 muscle tissue is irreversibly injured by sustained
Inflammatory changes initially occur in cells deformation after approximately one hour of loading.51
directly exposed to sustained force and deformation. In contrast, the time it takes for purely ischaemic
Fig 2 shows how progressive loss of cytoskeletal and muscle damage to develop is 6–8 fold longer.
plasma membrane integrity in these cells impairs their
control over mass transport and homeostasis.47 Distorting effect of friction
Inflammatory mediators48 secreted from damaged Friction distorts tissue resulting in shear forces, which
and nearby immune cells lead to progressive cause skin and subdermal damage, leading to pressure
inflammatory oedema, which increases interstitial ulceration. Friction-related PU often develop in patients
pressures, the mechanical distortions of cells and who are partially mobile or have neurological
tissues, and the growing obstructions within the dysfunction that causes repetitive involuntary
vasculature and lymphatics.49 Damage may be movement, such as in Parkinson’s disease and Guillain-
amplified in ischaemic tissue after reperfusion Barré syndrome.52 In these fragile cases, inadvertent
through the release of reactive oxygen species (ROS), damage from friction or burns is frequently seen.53–56
termed reperfusion injury. The patient, who may already be compromised because
External forces Change in microclimate
Vessel Relative humidity

Deformation
occlusion increases
Temperature
increases
Transepidermal
water loss Inflammation
(TEWL) increases threshold decreases
Increase in
moisture and heat
Biochemical
Device-related tolerances of the
pressure ulcer epidermis, dermis
develops and deeper soft
Coefficient of
friction increases tissues are reduced
Fig 1. Factors involved in medical device related-pressure ulceration. Adapted from Kottner et al.41
JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S 11

Pathophysiology
In some circumstances, some manual handling

Undeformed cell
procedures may increase the likelihood of tissue
damage. For example, when a patient slides down a
surface, this can result in friction and high tissue
distortions, causing shear if not controlled with the use
of low-friction interfaces, such as slide sheets.
ECM Frictional forces acting on the skin are affected by
the local microclimate, with increased skin hydration,
increasing the coefficient of friction by 26–43%.58
Attention must be paid to children with neurological
or neuromuscular disease, such as Guillain-Barré or
Miller Fisher syndromes, which is characterised by
muscle weakness and abnormal muscle coordination
that limits mobility. Neurological or neuromuscular
diseases can also impair a child’s ability to maintain
Deformed cell
natural conscious body positions (also known as body
position biometry). Muscle spasms (‘cramps’) prevent
natural body positioning and limit the range of joint
movement. This decreases mobility and may cause the
bony prominences to push against a support surface or
other object, increasing the risk of DRPU.
Articulated beds, which are widely used in hospitals
to adjust the patient’s positioning, are associated with
an increased risk of friction and shear damage because
the heel may be dragged up to 15cm during articulation,
such as when the bed-head is raised.59 Friction between
the skin and the surface causes the skin to deform
Plasma membrane sites tangentially, causing shear forces60 and subdermal
become porated due to loss
tissue distortions. The tissues may be damaged because
© Professor Amit Gefen
of cytoskeletal integrity and

support of either the physical force61 (which causes necrotic cell
ECM–extracellular matrix death and mechanical failure of the extracellular
Fig 2. Loss of cytoskeletal and plasma
matrix) or apoptotic cell death resulting from
membrane integrity in cells impairs their deformation-inflicted necrotic cell death and the
control over mass transport and homeostasis inflammatory response. Recent evidence suggests that
apoptotic cell death may be instigated by signals
of their skin morphology and/or involuntary repetitive released during mechanically-induced cell membrane
movements or have reduced tissue tolerance, may exert changes. In either case, the capacity for the tissue repair
pressure and frictional forces—for example, on a heel is compromised.40
as they push with their feet to reposition themselves.
High friction can cause delamination of skin and Risk factors for DRPU
skin tears, particularly in older people and those with There do not appear to be specific risk factors for DRPU
less mechanical strength in the dermo-epidermal aside from the use of the device.4 However, a crucial
junction.57 difference of DRPU to PU is that body weight forces play

Pathophysiology
a less prominent role, with the device typically strapped ‘the climate in a local region that differs from the
or taped to the body and exerting forces that drive the climate in the surrounding region (ambient climate).
tissue deformation and distortion. The affected soft It consists of temperature, humidity and airflow.’
tissues may also be ‘sandwiched’—that is, compressed,
stretched and sheared between a device and bony Excessive moisture at the skin interface and subsequent
surface. There are examples of DRPU caused by body overhydration leads to softening of stratum corneum,
weight: prosthetics (stump ulcers) and foot orthotics. increased permeability, susceptibility to irritants,
Often, the device or object has a small surface area, barrier disruption of intracellular lipid lamellae and
such as the edge of a face mask or a connector for an tissue breakdown by faecal/urine enzymes.41
indwelling line. Although the load applied by such Under-hydrated skin is also more susceptible to
devices is typically small, the small surface area results mechanical damage, cracks, fissures and inflammation
in pressure magnitudes of >200mmHg against the because the epidermis has increased structural
skin.62 Of particular note are large pressure gradients stiffness. Dry skin may also be a contributory factor in
(where an area of high pressure is adjacent to an area of PU development.65
low pressure), which can cause large stresses and strains Temperature changes adjacent to the skin are also
in the underlying skin and soft tissues. associated with local physiological changes. These
Devices such as antiembolic stockings are often used include an increase in cutaneous stiffness under loading
inappropriately with no assessment of underlying conditions,66 a decrease in dermoepidermal adhesion67
perfusion or sensation, and so often cause damage. In and an increase in metabolic demand. Thus, the skin
many cases, the skin and underlying soft tissues where may be less able to deform and there is a higher
the device is placed are not conditioned to take external susceptibility to injury.
loads, reducing tolerance to pressure and shear forces Some devices, such as humidified air/drug delivery
and increasing the likelihood of injury.33 This is not the (nebulisers) used in non-invasive ventilation, are a
case with more traditional PUs, where sacral, ischial source of heat and moisture.
and heel tissues are regularly exposed to pressure and
shear forces (in lying or sitting postures), so have Neonates and paediatrics
adapted over time to accommodate this. Much information on the aetiology and development of
Paediatric patients and/or patients with psychiatric PU is based on its pathogenesis in adult skin. However,
disorders, dementia, under anaesthesia, receiving the skin (and its overall tissue composition) in neonates
analgesia, unconscious or partially conscious, who have and children is different to that in adults.68 Box 2
a central nervous system injury (brain or spinal cord), summarises the key features of neonatal skin.
neurological damage (stroke or multiple sclerosis) or Neonates and premature babies do not move or
peripheral neural damage (diabetic neuropathy) may be reposition themselves spontaneously, so are at higher
unable to communicate discomfort, pain and the need risk of PU.69 Skin of paediatric patients (from newborn
for repositioning, resulting in loads that lead to DRPU.63 neonate to 18 years of age) develops and changes over
time.70,71 Therefore, prevention of PU and DRPU must be
Microclimate targeted differently for children of different ages.
Changes in skin physiology and its microclimate can It is a clinical challenge to maintain skin integrity in
lead to a higher risk of DRPU. Skin properties are injured neonates and children in ICU. Devices are the
influenced by intrinsic (age, medications, systemic main causative factor for DRPU in paediatric
diseases) and extrinsic (temperature and humidity of ICU, which predominantly occur on the face and scalp,72
the skin surface) factors. The local microclimate followed by the heel, which, in contrast to adult patients,
adjacent to the skin has been defined as:64 cannot be safely offloaded only by changing position.73
Pathophysiology
The increased fragility of the skin associated with

Box 2. Skin features in neonatal patients prematurity and its associated comorbidities is
● Underdeveloped subcutaneous fat tissue challenging for clinicians to manage, with practice
● Immature cohesion between epidermis and
often relying on anecdotal evidence to prevent skin
dermis
● Dermal instability damage.82
● Alkaline skin surface Infant skin has more adipose tissue, with a higher
● Neonatal skin undergoes multiple water-to-lipid ratio, than adult skin. Full functionality
physiological changes after it leaves the
amniotic environment
and the acid mantle take several weeks post-partum to
● Fat, zinc and metallic deficiencies develop.17,83 A dehydrated infant may be hypoxic
(molybdenum, chromium, calcium, iron, because of poor skin perfusion, and the affected tissue
cobalt and sulphur) may break down with only minor insult.71
● Increased risk of trauma (shearing and
friction forces) because of low Infants with multiple organ dysfunction syndrome
dermoepidermal cohesion are particularly at risk of PU.84 Furthermore, an infant’s
● Reduced calorie storage immune system is immature, with underdeveloped
● Reduced insulation and loss of surface
monocytes and neutrophils that respond poorly to
temperature because of lower level of
subcutaneous fat inflammatory cytokine stimuli.85
● Reduced secretions and sebum production As a consequence of all these factors, infant skin
(the so-called mechanical coat protection) is fragile and less tolerant of mechanical loading77,86 and
injury.17
Neonates, both pre-term and full term, are at high
risk of DRPU17 because of the immaturity of their Inflammation
skin,68,74,75 its barrier function and their immune The overt visual signs of skin damage result from
system, particularly the inflammatory response. The inflammation. The damaged cells and ECM release
stratum corneum develops relatively late in gestation; inflammatory mediator signals that promote
in pre-term neonates its development may be related to infiltration of neutrophils and monocytes into the
exposure to the external environment.76 The skin of injury site. This increases the permeability of the
neonates (particularly pre-term) and infants is thin and vasculature and lymphatics, orchestrating a cascade of
does not have the protective function of adult skin.68,71 inflammation that is intensified by prolonged exposure
Desquamation70,77 is abnormal in very premature to the forces and loads on the tissue.87–90
infants for some weeks after birth, signifying Increased vascular permeability allows fluid to enter
hyperproliferation of the epidermis.78 Skin maturation the extravascular space, leading to build-up of oedema,
and adaptation to the post-partum environment which is initially not visible to the naked eye.
happens over an extended period of time, during which Furthermore, newborn infants have a physiological
desquamation slowly increases.79 oedema. The forming oedema gradually adds
Compared with older adults, neonates, infants and mechanical stress to cells and tissues and, if not
children show a visible ‘turnover’ and increased contained, may exacerbate tissue damage.
production of keratin in hair, skin and nails. Several ROS and proteinases90,91 further degrade the tissue,
observations suggest that infant mechanisms of eventually leading to visible tissue damage in a
differentiation and desquamation are underdeveloped mechanism common to most hard-to-heal ulcers.
or poorly regulated compared with adults.80,81 DRPU are caused by the same mechanisms as PU.
Furthermore, a high metabolic rate and physiological The amount of time in which the tissues are continuously
oedema—common in sick children—increases risk of distorted has a critical effect on whether a DRPU
DRPU in these populations. develops or not.

Pathophysiology
Tissue loads may be exacerbated by changes that with elasticated straps or tapes. This immobilises
happen in the patient after the device has been fitted. the device, but generates pressure and frictional forces
For example, in patients undergoing fluid resuscitation at the device-skin interface, ultimately causing
or with lymphoedema or heart failure, oedema can visible tissue damage at the skin surface94 and/or
develop after a device has been fitted.4,91 This increases subdermal damage, where interface pressures can be
the volume of tissue under the device, resulting in cell high. Oxygen face masks may create interface pressure
and ECM distortion while the vascular and lymphatic at the nasal bridge of 47.6–91.9mmHg.95 Oximeter
networks in the affected area are impaired. Unless the devices clipped onto the earlobe may apply
device is refitted, the load applied to the skin will local pressure that exceeds capillary pressure.96
increase, heightening the risk of DRPU. Health Humidified therapies, may increase the amount
professionals sometimes tighten the fi xation system in of moisture present, in turn increasing the risk of
an attempt to avoid device failure. The resulting DRPU DRPU. This causes local changes in the function of the
heightens the inflammatory response, exacerbating stratum corneum.97
the localised oedema. Internal tissue stresses and Some devices, such as spinal boards and cervical
deformations increase, and blood perfusion and collars, are designed to create a mechanical constraint
lymphatic function is reduced. Fig 3 is an example of an that protects the patient. However, the rigid nature of
oedema-related DRPU. these designs can cause substantive pressure, shear,
thermal loads and tissue deformations on the skin and
Effects of different types of device underlying soft tissue.93,98
on inflammation
The designs of some medical devices have not taken Summary
into account the amount of heat trapped between the ● Devices may generate high stress concentrations in
device and skin, which can be substantial—for example, tissues, leading to cell and tissue damage pathways
under contours of oxygen masks.92 Heat trapping under associated with sustained deformation86,99,100
devices increases moisture and skin fragility, while ● Devices intended to alleviate pressure and tissue
elevating the metabolic demands of tissue at a time loads may themselves increase load and thus the
when there is a progressive shortage of metabolic risk of DRPU86
supplies and clearance of waste products is impaired. ● Insensate patients are especially at risk of localised
Medical devices, such as oxygen masks for high-tissue deformation, stresses96 and stress
non-invasive ventilation,93 are sometimes held in place concentrations
● Everyday activities such as toilet sitting increase
tissue loads and reduce perfusion101 and tissue
oxygenation, placing individuals with reduced
sensory and/or mobility at high risk.
Most common causes of DRPU can be prevented
by improving the design of medical devices or
by adding smart materials and structures at the
interface between the skin and device. Use of
technology-aided risk assessment (based on sensor
readings and data analytics) and digital monitoring of
Fig 3. A device-related pressure ulcer related to devices and the health status of tissues underneath
oedema: the sustained deformation-inflicted them will help mitigate DRPU. This is addressed further
injury has triggered an inflammatory response40
in chapters 6 and 7.
Devices
M
ost medical devices that come into contact
with a patient’s skin and/or pass through it Key points
can expose the individual to the risk of
● Device-related pressure ulcers (DRPU) are
DRPU. Paediatric patients may be predisposed to
mostly associated with tubing such as
DRPU due to factors outlined in Table 3. oxygen tubing and endotracheal tubes,
Table 4 gives examples of medical and non-medical respiratory masks, splints, intravenous
devices that can be associated with DRPU.4 Devices catheters and cervical collars
● Common anatomical sites include the
can be classified in a variety of ways. In Table 4, medical
face, ears, lower leg and heels. However,
devices are classified according to their primary DRPU can occur anywhere that the skin is
medical/clinical use. in contact with a device
● Extended use of devices is associated with
a higher and increasing risk of DRPU
Range of devices that can ● Devices responsible for DRPU vary
cause skin damage between clinical settings
Devices (sometimes more than one per patient) can be

used across clinical specialties, depending on the ● Respiratory masks including CPAP
patient’s clinical needs. They might also be used either ● Splints
temporarily during an acute-care episode (e.g. ● Intravenous catheters
respiratory devices, patient-monitoring devices and ● Cervical collars.
indwelling lines) or for the rest of the patient’s life (e.g.
orthotics and prostheses, or wearable glucose Graduated compression stockings present a DRPU
monitoring meters). Increasingly, patient care is taking risk for ICU patients.102 Respiratory devices, which are
place in the community setting, with therapeutic and often critical for patient survival, require an effective
diagnostic devices being used over prolonged periods:8 air seal, which is determined by the size and shape of
DRPU are common across several medical specialty the mask. Ill-fitting masks create focal pressure
units. Devices commonly associated with DRPU are: points and localised frictional forces that can lead to
● Tubing devices such as oxygen tubing irreversible tissue damage within hours or less.
● Nasogastric tubes and endotracheal tubes; Examples of DRPU in adults are shown in Fig 4.
Table 3. Characteristics of neonatal skin that increase its vulnerability to device-related pressure
ulcers (DRPU)174
Serum albumin levels <2.5mg/dl Stratum corneum is 50–70% thinner than that of adults
Reduced protein, arginine, vitamin A, C and zinc Suprapapillary epidermis is <80% of adults
content
Absence of acid mantle (pH>5.5) Small corneo-keratinocytes due to high cell turnover rate
Thinner dermis than in adults (1–10 times less) Skin microflora alteration
Reduced water content Delayed full functioning of melanocytes
Reduced sebum production Reduced skin capillary pressure
Immature sweat response for temperature regulation Reduced amount of natural moisturising factors
Faster skin absorption

Devices
Table 4. Devices and objects associated with device-related pressure ulcers*
Devices with medical purpose
Respiratory devices: oxygen face masks (non-invasive ventilation); continuous positive airway pressure (CPAP) masks;
bilevel positive airway pressure (BiPAP) masks; endotracheal tube or securement devices; nasal prongs and tubing;
high-flow nasal prongs; extracorporeal membrane oxygenation (ECMO); tracheotomy tube and securement
Faecal and urinary devices: stoma devices; urinary and faecal catheters; bed pans; toilet seats; condom catheters;
penile clamps; bowel management systems
Access devices: all types of lines (catheter (arterial or venous) and associated lines/tubing); intercostal catheters; chest
tubes and lines
Support and immobilisation devices: cervical collars; external fixators and pins; air casts /pneumatic support
devices); restraints (not used in UK); splints (including for arterial lines); orthopaedic immobilisers, donut head
supports; intraoperative devices such as frames used in neurosurgery
Feeding and nutrition: nasogastric tubes; orogastric tubes; percutaneous endoscopic gastrostomy tubes
Patient handling: spinal boards; transferring devices; wheelchairs
Patient monitoring: oxygen saturation probes/pulse oximeters (clamped on finger, toe or ear); blood pressure cuffs;
electrocardiogram (ECG) dots and lines; electroencephalogram (EEG) electrodes and wiring; wearable monitoring
devices/sensors (e.g. for blood glucose); intracranial pressure (ICP) monitoring (cannulae and tubing); extraventricular
drains (EVD); forehead saturation probes; temperature probe devices/sensors
Compression and deep vein thrombosis prevention: sequential compression devices (SCDs); thromboembolic
deterrent (TED) stockings; compression hosiery; all cotton elastic (ACE) wraps; heel offloading devices
Treatment: dialysis involving cannulae and tubing/lines; negative pressure wound therapy (NPWT); tubing associated
with NPWT; intra-aortic balloon pumps (IABP) involving cannulae and tubing/lines; plaster casts including total contact
casting to offload diabetic foot ulcers; ointment gauze175 bandages used on patients with critical limb ischaemia
Prosthetics and orthotics: above- and below-knee prostheses; knee orthosis (braces); ankle foot orthoses
Surgical devices: forceps; tools; instruments
Miscellaneous devices and objects: bandages; identity bands on wrist/ankle; pens/scissors/flashlights/other

healthcare provider personal items (dropped in beds)
Hospital furniture: bedframes; foot rests and any other rests
Device components that are removed before use: packaging elements, e.g. tops from syringes
Devices used in tissue viability: devices and objects associated with risk management; patient-positioning devices
used for staff safety during repositioning or transferring; aircast boots; crutches; casts; wedges (foam and/or rubber);
wheelchairs
Objects without direct medical purpose/patient’s or other’s property
Mobile/cell phones; jewellery; hearing aids; glasses; remote controls; office supplies
Anything the patient sits/lies on that is a foreign object, such as a hairbrush
*Examples are provided; the list is not intended to be exhaustive

Devices
DRPU caused by neck brace DRPU caused by oxygen tubing
DRPU caused by tube clamp DRPU caused by a nasogastric Mark from office supplies
tube (paperclip)
DRPU associated with a knee DRPU caused by bandage in a DRPU caused by non-invasive
brace patient with critical positive pressure ventilation
limb ischaemia mask and lip wound from
endotracheal tube
Fig 4. Examples of device-related pressure ulcers (DRPU) in adults
In paediatrics, the following devices are particularly Impact by type of device

associated with DRPU.103,104: respiratory devices, casts Common anatomical sites for DRPU include the face,
and orthotics, intravenous arm boards, intravenous ears, lower leg and heels. However, DRPU can occur
tubing, oximetry probes and cervical collars. anywhere a device contacts the skin.105 Common sites
EEG leads, extracorporeal membrane oxygenation include lips from endotracheal tubes, nose from
(ECMO) cannulae and cooling blankets may cause nasogastric tubes, hand from splints, arm from arterial
DRPU on toes, neck, chin, head, arms, feet, nose, chest, line tubing and occiput following use of cervical collars.
ears, earlobe, face, knuckles and buttocks of infants.17 Mucous membranes are also at risk.
In all patients, other devices associated with DRPU Extended use of devices is associated with a higher
include nasal prongs, anti-embolism stockings, ankle and increasing risk of DRPU. Cervical collars are
bands and epistaxis balloons.9 Examples of DRPU in associated with a higher incidence of DRPU after
pediatric patients are shown in Fig 5. five days of continued use, with many of these being

Devices
DRPU associated with tubing DRPU associated with Tracheostomy tie

and thermometer peripherally inserted central
catheter (PICC)
Mask and retaining straps
Fig 5. Examples of paediatric device-related pressure ulcers (DRPU)
category IV.31 Procedures and treatments administered day. Cumulative data collected for one year (from 1
concomitantly with a device may increase risk. For February 2018 to 31 January 2019) showed that DRPU
example, the use of pulse oximetry during vasopressor associated with elastic stockings were most prevalent
therapy13 is associated with a higher incidence of (n=13) in general wards, followed by compression
DRPU. bandages (n=4). In all of these cases, the devices were
The type of device associated with PU will vary used to prevent DVT. The following devices were
depending on the setting. Th is is illustrated by the associated with DRPU in ICU but not the general
results of a (unpublished) DRPU incidence audit wards: those used to manage body temperature (n=1),
undertaken at Kyorin University Hospital in Tokyo, measure blood pressure (n=1) or use for pulse oximetry
Japan, which were shared by a panel member. Th is is (n=3), surgical drainage (n=3) and splinting (n=8).
an acute care hospital with 1153 beds, 38 medical Some devices were associated with DRPU in both
departments and an average of 2177 outpatients per general wards and ICU, but had a higher incidence in
day. The ICU consists of five critical care units, ICU: invasive arterial blood pressure measurement
including one for neonates. The hospital undertakes a (n=7), tracheal cannulae (n=3) and non-invasive
DRPU survey at a fi xed point every month on the same positive pressure ventilation (NPPV) masks (n=9).
Devices
Results are presented in Fig 6. These findings are sustained over long periods and causes substantial
consistent with published data from other centres.106 static frictional forces and shearing (Table 5). These
devices include splints, pulse oximeters, non-invasive
Categorisation blood pressure cuffs (NIBP) and identity bands.
Table 5 presents an example of categorisation of Products used in deep vein thrombosis (DVT)
medical devices, based on how they interact with the prevention, such as elastic stockings and intermittent
skin and the aetiology of the subsequent DRPU. Th is pneumatic compression (IPC) with or without elastic
method of categorising devices focuses the health stockings, also fall into this category.
professional on the reasons for the associated DRPU There is also a category for devices that present risk
risk. Devices comprised of hard materials and that through moisture accumulation or pH alteration, which
have a small contact area with the skin create high reduces the skin’s tolerance to external stresses. This is
localised pressure and frictional forces, and are a particular issue with respiratory devices as moisture
commonly associated with DRPU. Devices with large expelled during respiration can causes humidification.
skin-contact areas create lower pressure that is Devices in this category include NPPV masks, nasal
Full offloading of the heel  ICU 2.8%

Tourniquet  General wards 0.14%
Arm sling
Body temperature and management system
Automatic cardiac massage
Non-invasive blood pressure monitor
Pulse oximeter
ID wristband
Resistant device
Surgical suction drain
Nasogastric tube
Indwelling bladder catheter
Support corsets
Cervical collar
Splint
Splint for intravenous catheter
T-shaped stopcock
Invasive arterial blood pressure
Intravenous catheter
Equipment for fixing tracheal cannula
Tracheal cannula
Oxygen nasal cannula
High-flow nasal cannula for oxygen therapy
Non-invasive positive-pressure ventilation mask
Elastic bandage
Intermittent pneumatic compression and elastic stocking
Intermittent pneumatic compression
Compression bandage
Elastic stocking
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14
No. of cases
Fig 6. Incidence of device-related pressure ulcers (DRPU) in intensive care unit (ICU) and general wards

Devices
Table 5. Aetiological classification of device-related pressure ulcer
Small (small contact area) Large (large contact area) Devices that reduce the
Hard material Hard material tolerance of the skin
Skin Skin Skin

surface surface surface
Aetiology High pressure Low pressure Moisture

Sustained pressure Sustained pressure pH
Tissue deformation Tissue deformation
Device Nasogastric tube Splint Respiratory

Non-invasive positive pressure
Indwelling bladder catheter Pulse oximeter
ventilation (NPPV) mask
Intravenous catheter and Non-invasive blood pressure
Oxygen nasal cannula
three-way stopcock (NIBP) cuff
Invasive arterial blood
ECG patch Tracheal tube
pressures
Central venous catheter ID wrist band Tracheal cannula
Epidural catheter
Masks DVT prevention
Monitors Elastic stocking
Intermittent pneumatic
Core thermometer compression and elastic Stoma products
stocking
Body temperature
management system
ECG code
NIBP tube and connector
oxygen cannulae and tracheal tubes and cannulae. Other relevant devices associated with a DRPU risk
Stomas are included in this category, as leakage of are external orthopaedic fixators, which are made of
gastrointestinal contents onto the skin can causes rigid (metal) components, often with curved, thin, sharp
chemical irritation and ingress of bacteria. Digestive or geometrically-irregular elements and surfaces.108
and pancreaticobiliary enzymes in gastrointestinal
contents increase the risk of skin damage.107
Some devices have risks associated with more than
one category. The immature skin barrier in paediatric
patients may be susceptible to toxicity, especially under
occlusion. Stomas are included in this category because
leakage of gastrointestinal contents onto the skin causes
chemical irritation and bacteria infiltration.
Risk assessment
A
s with any PU, assessing a patient’s risk of DRPU
is a critical step in prevention. Expert guidelines Key points
and best practice statements stress the
● Risk assessment should be part of
importance of risk assessment.1,2,109-115 This involves an routine practice
awareness not only of the risk factors for pressure ● Risk assessment tools (RATs) should be
ulceration in general, but also recognition of the used to identify skin changes and direct
management
additional risk posed by the use of devices.
● Patients being managed with a
Examples of critical device-related, patient-related medical device should be considered at
and organisational risk factors are listed in Box 3. high risk of device-related pressure
Clinicians, patients, their family and other ulceration (DRPU)
● It can be difficult to assess skin
healthcare workers should be aware of the risks posed.
under some devices, such as external
Their responsibilities are outlined in Box 4. orthopaedic fixation frames, plates or
It is not enough merely to conduct one PU or DRPU splints
risk assessment: risk assessments must be part of daily ● RATs specific to DRPU need to be
developed
routine practice. The assessment should be used to
direct the patient’s management pathway, which
should include strategies to prevent both PU and DRPU.
An example of a template that can be used to Box 3. Examples of device-related,
highlight the risk of DRPU to clinical staff is given in Fig patient-related and organisational risk
factors for device-related pressure ulcers
7. The template is derived from one used in a medical-
surgical ward in a US-based hospital and can be Patient-related risk factors
adapted for use in wards, units or other settings. The ● Focal or large area pressure
form requires users to note whether a patient has DRPU ● Shear

● Humidity
and document when high-risk medical devices are
● Moisture
being used. This should lead to staff undertaking a full ● Duration of device use
risk and skin assessments in these patients.
Patient-related risk factors
Risk assessment tools ● Age
A large number of PU risk assessment tools (RATs) ● Medical condition

● Comorbidities
has been published. When conducting a risk
● Perfusion level, risk or skin changes
assessment, it is important to recognise that all identified by risk assessment tools (RATs)
patients with a medical device in place are at risk ● Skin condition
of pressure ulceration. RATs should be regarded as ● Presence of a device and previous PU or
other injury at the site where the device
diagnostic tools for the identification of skin
will be applied
changes and trigger their management. RATs should
therefore be used routinely and supplemented, where ● Organisational risk factors
necessary, with information on the medical device and ● The care setting
clinical judgement. ● Skill level of health professionals
Most RATs rate a patient’s risk level using a ● Lack of access to devices that come in a
range of shapes and sizes
numerical score, which indicates whether a patient is
● Lack of access to appropriate equipment,
at low, high or intermediate risk of pressure ulceration. ● The need to prioritise other potentially
However, it may be more appropriate to consider life-threatening issues
specific risk factors for the patient.

Risk assessment
Team safety huddle date

Box 4. Risk awareness: key responsibilities ___________________
for health and allied professionals Assessment/measure 07.00 19.00
Patients, carers and family No. of patients on the ward
No. of observation patients
● Be aware of risks posed by personal
Pending admissions
possessions
Stress test/surgery
● Take action to minimise risk
Invasive arterial blood pressures
● Inform clinical staff of any discomfort or
Central venous catheter
pain at the device site
Core measures: CVA / TIA
● Inform clinical staff of any objects left
CHF
between the patient and support surface COPD
● Move or adjust the device if there are signs
Haemodialysis
that the patient is in discomfort or pain No. of days since last fall
No. of days since last surgical site event
Health professionals and other health No. of days since last PU/DRPU
workers including porters and No. of days since last employee injury
housekeeping staff No. of days since last employee assault
● Be informed about the risks posed by Detox / CIWA
devices, objects and personal possessions One-to-one staff patient ratio
● Record use of devices in patient charts or High fall risk / safety concerns
bedside boards used to identify risk of falls Abusive / difficult patients
● Be aware of the risks in adult, paediatric Patients with PU
and neonatal patients and, specifically, Patients with DRPU
patients who cannot sense or report High-risk devices: Foley/Foley
securement device
discomfort or pain
Oxygen tubing
● Conduct device-specific risk assessment as
BIPAP/CPAP
part of routine pressure ulcer risk Nasogastric tube
assessment Suprapublic catheter
● Assess the risks to skin at the device site Tracheostomy tube
● Modify the care plan/pathway in Cervical collar
accordance with the identified risk Orthopaedic device
● Take proactive action to minimise the risk IPC
of device-related pressure ulcer (DRPU) NPWT
● Conduct regular skin assessments Patients with other skin concerns
according to the risk level associated with Anticipated discharges
the device and any patient-related factors Staffing
● Report any device-related injury Location of specialty bed and pump
● Interact with manufacturers to identify and Equipment issues
suggest design changes that will reduce Specialist equipment on unit
the risk of DRPU Medication-dispensing machines are Yes No Yes No
clear of discrepancies? (tick)
● Develop local protocols for risk assessment
Good catches / staff recognition unit /
and use of medical devices organisational news. Anything to address?
● DRPU–device relate pressure ulcer Document pain scores and reassessment within 1
hour. For pain meds, as needed, in accordance
with parameters, you must follow order as written
or obtain new or Rx order from MD
Validated risk assessment tools BIPAP–bilevel positive airway pressure; CHF–congestive heart failure;
CIWA–Clinical Institute Withdrawal Assessment for Alcohol; COPD–chronic
for use in paediatrics obstructive pulmonary disease; CPAP–continuous positive airway pressure;
CVA–cerebrovascular accident; DRPU–device-related pressure ulcer;
The Braden QD Scale has been shown to have acceptable IPC—intermittent pneumatic compression; NPWT–negative pressure
wound therapy; PU––pressure ulcer; TIA–transient ischaemic attack
predictive value for DRPU formation in the acute
paediatric care setting. However, it is non-specific to the Fig 7. Example of a template that could used to
type of device(s) used and assesses risk only by the total highlight the risk of DRPU to health professionals. One
template needs to be completed per ward
number of devices used on a patient.116 Other paediatric-
Risk assessment
focused RATs are by Sterken et al.,117 Peterson et al.,118

Kiss and Heiler,119 and Willock et al.12 or still in Box 5. General principles of skin
assessment176
development.
All patients managed with a medical device
Assessment must undergo a skin assessment
Any patient being managed with a medical device Skin should be assessed by:
should be considered as at high risk of DRPU. The ● Colour
management plan must include frequency of ● Moisture
assessment, as well as strategies to reduce risk. There is ● Oedema
● Turgor/firmness
no predetermined frequency for assessments, which
● Bogginess
should be determined by the risk posed by the device, ● Temperature (heat and cold)
the patient’s condition and clinical judgement. ● Presence of signs of skin irritation, or tissue
Inevitably, the frequency will be higher for high-risk damage, or potential damage
devices or where the risk is associated with either a (non-blanchable/non-blanching erythema:
skin that blanches and slowly returns to its
systemic condition, nutritional status or other patient-
normal colour)
related factors. The local condition of the skin and ● Bruising
underlying soft tissue, such as scars from previous ● Presence of devices
injuries that have resolved but left fibrous tissue ● Scaling and dryness
inclusions, local atrophy changes or oedema, should

Frequency of assessment:
also be considered.
● Determined by the risk level associated with
Health professionals should also be aware of the risk the device, the patient’s condition and
associated with devices and objects with no medical clinical judgement
purpose. Any object or patient’s possession that might ● More frequent assessment is required by
become trapped or act as a focus for localised pressure patients managed with high-risk medical
devices, or are considered at high risk
must be noted and a management plan developed.
Examples are given in Table 5, page S21.
An example of advanced practice in assessment is
Paediatric patients the use of a skin-integrity protocol embedded in the
The most common site for body weight-related PU in clinical information system at the ICU at the Royal
paediatric patients is the occiput, where the largest Brisbane and Women’s Hospital, Queensland,
bony prominence and highest interface pressures are Australia.125 The protocol requires staff on each shift
located.15 Risk factors for PU in paediatric patients to complete a full head-to-toe, back-to-front skin
include sedation, hypotension, sepsis, spinal cord injury, assessment that includes skin under medical devices.
traction devices, terminal illness, spina bifida, cerebral Staff are guided to check under devices every three
palsy, cardiovascular bypass surgery.121–124 lengthy hours and to reposition the device or patient if
surgical procedures, ECMO bridge-for-life connections, necessary, ensuring that the device is not wedged or
and cerebral and cardiovascular activity probes. positioned such that it presents an risk of injury. The
assessment is documented in the clinical information
Example of a skin-integrity system using a series of drop-down menus and options
assessment protocol to describe colour, warmth, moisture and turgor of
The general principles of skin assessment are listed in the skin, as well as the presence of any skin injury
Box 5. When risk is identified, the assessment must and/or oedema. An example of a drop-down menu is
focus on the early signs of skin and tissue damage. shown in Fig 8.

Risk assessment
Intensive care unit: nursing assessment form
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07/01/2020 13:34
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Equipment & Respiratory/ Skin
Neuro CVS GIT
patient safety Renal integrity
Skin integrity/ assessment Assessment comments
Skin temp

Skin colour
Skin turgor 

Skin moisture

Skin texture
Normal
Skin oedema
Dry
Oral mucosa Diaphoretic
Oily
Nare mucosa
Pressure injury/risk assessment Available links/ tips
Pressure injury risk assessment


Pressure injury
Mattress/bed type prevention WUG

CVS–cardiovascular system; GIT– gastrointestinal tract; WUG–work unit guideline
Fig 8. Computer drop-down menu with options to describe colour, warmth, moisture, oedema and turgor of
the skin and the presence of a skin injury
Inspecting skin under large It may be possible to assess the skin using direct
devices and in insensate patients palpation. A cervical collar stops the neck moving. To
It is not always possible or easy to observe the skin under palpate the occiput, the neck must be flexed. The occiput
devices such as external orthopaedic fi xation frames, may be inspected after removing the anterior collar
plates, splints and cervical collars. In such cases, if the and, with the help of neurosurgery or trauma staff, log
patient is alert, the health professional should ask rolling the patient with the anterior collar in place, with
(mindful of the position of the device) if they are in any the head held by a trained health professional. Braided
pain/discomfort or if there is an unusual sensation or beaded hair, particularly if it is dark, can present
under the device, and then use their clinical judgement difficulties during assessment. A DRPU can develop and
to complete the assessment. Clinical judgement is bleed into the hair without being easily seen.
especially important for patients who do not have intact
neurovascular function under the device or cannot Paediatric patients
verbalise discomfort. In such cases, non-verbal cues, Priorities for assessment of neonates, infants and
such as grimacing or agitation, should be observed for. paediatrics are listed in Box 6. It also describes
Risk assessment
Box 6. Assessment of neonatal and

Developing bespoke risk
paediatric patients15 assessment tools
Frequently assess skin under: Facilities should develop their own device-specific RAT
● Blood pressure cuffs that will work with their own protocols, based on the
● Transcutaneous oxygen pressure probes
patient populations that they serve. The checklist in Fig 9
● Tracheostomy plates
covers two settings: the operating room (OR) and the
● Nasal prongs and masks (continuous
positive airway pressure, CPAP) ICU. The checklist should be filled in at each staff
● Arm boards changeover; the presence on a patient of specified
● Plaster casts devices should be noted with a check or cross, and any
● Traction boots
skin injury associated with the device documented.
Documentation of the presence of a device should
In growing children, frequently readjust:
● Orthotics
lead to device-specific assessment, which should in turn
● Wheelchairs inform the patient’s care pathway.
● Wheelchair cushions
Inspect beds, cribs and isolettes to ensure Next-generational risk

tubing, leads, toys and syringe caps are not
under or on top of the patient’s skin
assessment tool
Current conventional RATs have low sensitivity and
Pressure damage assessment should be specificity for predicting PU formation,127-131 their use
conducted for: does not necessarily lead to targeted PU prevention132,133
● Skin around nasogastric and
and they are not comprehensive enough to capture the
orogastric tubes
● Head dressings
specific risks associated with devices.
● Hats It is important, therefore, that RATs specific to DRPU
are developed, based on both biomedical and clinical
research, potentially using innovative technology that
adjustments that might need to be made to devices to allows assessment of tissue status. Such technologies
avoid the risk of DRPU. Fig 9 gives an example of a include:
checklist approach to assessment of neonatal and ● Imaging
paediatric patients in ICU.15 ● Biocapacitance measurements
● Inflammatory biomarker measurements
Other clinical challenges ● A combination of the above.
Assessment can be difficult in some circumstances. To the panel’s knowledge, no medical device has an
Skin changes that signal potential injury are less visible integral sensing and monitoring capability that will
in darkly pigmented skin. alert health professionals to impending local skin
Furthermore, skin may be at higher risk of damage damage, either on or under the skin. This is a clear
because of age-related changes.126 opportunity for industry. This is discussed in more detail
Risk assessment should focus on the body site onto in chapters 6 and 7.
which the device has been or will be applied. However,
patients with oedema or lymphoedema may be at risk, The SEM scanner
despite having skin that is generally in good condition. A hand-held non-invasive device, the SEM Scanner (BBI),
As noted previously, oedema may develop in previously that assesses sub-epidermal moisture (SEM) has been
non-oedematous skin after a device has been applied. launched.134 The device, which scans at-risk skin sites

Risk assessment
(sacrum and heels), is able to identify tissue regions that Device-related pressure ulcer (DRPU) checklist: devices
used in paediatric/neonatal intensive care units
may break down several days before damage becomes
Monitors Respiratory
visible. SEM accumulates before visible skin changes can Core thermometer NPPV mask
be detected by eye, causing tissue biocapacitance (a Body temperature Oxygen nasal cannula
measure of the fluid content in skin and underlying soft management system
ECG patch and code Equipment for fixing
tissue) to increase due to the greater interstitial fluid tracheal cannula
content. The more fluid present, the greater the Pulse oximeter Tracheal tube
biocapacitance.135–137 Tissue biocapacitance is associated NIBP cuff, tube Tracheal cannula
and connector
with localised inflammation and oedema in the early
Tubes Others
stages of pressure-induced tissue injury.138 The scanner
Nastrogastric tube ID wrist band
therefore warns health professionals about elevated SEM
Indwelling bladder Splint
several days before damage is visible at the skin surface.139 catheter
Other (specify)
The SEM Scanner has not yet been validated for other Intrevenous catheter and
3-way stopcock
skin sites and cannot assess skin under non-removable
Invasive arterial blood
devices such as casts. In addition, the current size of the pressures
sensor makes it unsuitable for assessing relatively small CV catheter
anatomical regions such as the nose, lips or bridge of the Epidural catheter
nose. Deep vein thrombosis prevention
Elastic stocking
Requirements for future risk IPC and elastic stocking
assessment tools DRPU checklist: operating room/surgical theatre devices

The panel proposes that, in the future, visual skin Monitor Respiratory
assessments should be replaced with technology-aided Core thermometer NPPV mask
skin evaluation procedures that use, for example, Body temperature Oxygen nasal cannula
management system
biophysical markers (such as tissue biocapacitance) or
ECG patch and code Equipment for fixing
biomechanical markers (such as inflammatory tracheal cannula
mediators collected at the skin) to indicate skin health Pulse oximeter Tracheal tube
and extrapolate risk.48,62,93 It may be possible to include NIBP cuff, tube Tracheal cannula
and connector
visual markers on the device that can indicate load, BIS monitor Others
tissue status, alert staff of the need to initiate other risk Tube ID wrist band
measures, monitor biomarkers and change colour when Nastrogastric tube Other (specify)
thresholds are detected. Indwelling bladder Option
catheter
Tourniquet
Clinical emergencies Intravenous catheter and

three-way stopcock Fixation equipment from
lateral
Clinical management of risk may present challenges. If Invasive arterial
blood pressures
the medical device creating a risk of DRPU serves a
Central venous catheter
critical purpose, moving or adjusting it will simply not
Epidural catheter
be an option, as this would seriously compromise the
Deep vein thrombosis prevention
patient’s health. If the patient is having a clinical Elastic stocking
emergency, such as airway instability, the position of the IPC and elastic stocking
device and the forces it is exerting on the lips or other For abbreviations, please see page S51
tissues suddenly become lower clinical priorities and Fig 9. Device-related pressure ulcer (DRPU) intensive
periodic assessments may not be completed. care unit and operating room
Safe use of devices:
prevention and
management of DRPU
P
revention of DRPU can be viewed from a variety
of perspectives. These include: Key points
● Fundamental elements of prevention
● Protocols and standard procedures
include risk assessment, skin assessment,
● Clinical practice care planning, care delivery and
● Product design documentation
● Education and training ● The physical form of a device, the clinical
goal associated with its use, the type of
● Procurement.
tissue and the anatomical area affected all
Education and training are covered in chapter 6, need to be considered
‘Changing the focus of health professionals and ● Consider introducing a clinical champion
policy-makers’. Th is chapter discusses the other with the appropriate education and clinical
background to develop and maintain
aspects of prevention listed above, as well as the
standard procedures, and ensure their
management of DRPU. distribution
● Use the SECURE mnemonic (Skin/tissue,
Education, Champion/collaborate,
Key aspects of DRPU Understanding, Report, Evaluate) when
prevention developing pathways
● Procurement services should be aware of
PU or DRPU prevention requires a high level of their role in device-related pressure ulcer
awareness and rigorous adherence to practices that (DRPU) prevention
● Prophylactic dressings should
minimise the risks. The basic considerations for PU
be considered
prevention are listed in Box 7. However, it is vital that ● Fundamentals of managing DRPU are
health professionals also consider all the variables similar to those for other types of
and characteristics related to DRPU.140 Th is involves pressure ulcer
accounting for the physical form of a device, the
clinical goal for its use, the type of tissue onto which it
will be/is being placed, and the anatomical area reduce the incidence of DRPU. Vigilance, adherence
affected. Th is will help identify interventions that will to best practice for device application and awareness
of potential causes of risk can help avoid poor
placement of devices, mistakes and mitigate lack of
Box 7. Pressure ulcer prevention: steps and
staff training.141 In this way, health professionals can
procedures
reduce the risk of skin breakdown.
● Risk assessment
Th is is especially important in neonatal and
● Skin assessment and care
● Surface selection and care pediatric patients admitted to critical care and during
● Regular moving or repositioning of person transport between units.104 Devices applied to
or device newborn and infants in an ICU may take up 25–30% of
● Incontinence and moisture management
the body surface, underlining the importance of
● Nutrition and hydration
● Give information and share learning— careful and consistent observation to prevent DRPU.
involve patient and carers and document Standard care based on expert consensus
care delivered recommendations should be followed (Box 8).1,111,142
● Use pressure reducing or redistributing
The UK NHS National Institute for Health and Care
support surfaces
Excellence (NICE) and the NPIAP/EPUAP/PPPIA

Safe use of devices: prevention and management
specifically recommend steps and procedures for general overview.148 They include photographs of
neonates, infants and paediatric patients admitted to DRPUs that commonly occur in each setting and
secondary or tertiary care and other settings if risk advice on prevention. Box 8 lists NPIAP guidance for
factors are present. They recommend the Braden Q preventing for PU and DRPU.2
scale be used for assessment. Skin assessment in The standard of care protocols should include all
paediatric patients should be from head-to-toe, with steps and procedures that need to be followed. The
focus on the occipital area, ears, bony prominences, protocols should be described in enough detail for the
genital area, feet, heels and elbows. Skin temperature protocol to be a stand-alone document that can be
and erythema should also be assessed. implemented without reference to another document.
For patients of all ages, more frequent skin There may be circumstances where a protocol does
assessment is warranted in high-risk patients. not cover every possible eventuality—for example,
when a patient suffers a life-threatening change in
Working as a team to implement their clinical condition that requires immediate
protocols for best practice action. In such cases, clinical judgement and
Fundamental elements of PU prevention include risk experience must be used.
assessment, skin assessment, care planning, care Protocols are also needed for devices used
delivery and documentation. The objective of a DRPU palliatively by allied health professionals on paediatric
prevention care plan is to minimise the risk posed by
the use of a device.
Box 8. NPIAP recommendations for
DRPU prevention requires a team approach, where
prevention of device-related pressure
every health professional or worker who comes into ulceration2
contact with a patient makes it a priority from the
● Adults and children on whom medical
outset.143 A simple method of ensuring such focus is to devices are applied are at risk
incorporate DRPU into ward or facility documentation, ● Devices with the least potential to cause
as shown in Fig 7 (page S23). damage should be used
● Devices should be sized and
DRPU prevention requires a high level of cross-
fit appropriately
functional collaboration and communication, which ● Manufacturers’ instructions for use should
can be facilitated by documentation. The panel be followed
recommend that all facilities should have documented ● Ensure securement without creating
additional pressure
procedures, protocols and guidelines for device use
● Inspect the skin under the device twice
(Boxes 8 and 9) that are available to all health daily and more frequently in patients who
professionals and other staff who come into contact are vulnerable to fluid shifts and/or with
with patients. Standard procedures should cover general or localised oedema
● Use NPIAP classification scheme (note
device selection and application with appropriate
mucosal pressure ulcers cannot be staged)
tapes and fi xation methods. Each facility should ● Remove devices as soon as
nominate a clinical champion to develop standard medically feasible
procedures, disseminate them and ensure compliance. ● Maintain clean and dry skin under devices
● Reposition the patient and/or device to
Th is approach has been shown to be effective.144
redistribute pressure and decrease shear
A facility’s standard procedures should be based ● Where possible do not place the patient on
on recognised published guidelines and RATs. The the device
NPIAP has published one-page guides on the ● Rotate or reposition devices when possible
● Decrease pressure and shear with support
prevention of DRPU in critical care,145 paediatric
● Consider use of prophylactic dressings
populations146 and in long-term care147, as well as a
Box 9. Prevention of device-related pressure ulcer (DRPU): key procedures for device management
● Inform patients and carers that devices and ● Neonates, paediatric and bariatric patients
personal possessions can cause pressure should be regarded as at high risk
ulceration ● Special attention should be paid if oedema is
● Stress the need for visitors to remain vigilant present
about this at visits ● Reposition the medical device at frequent
● When selecting a device, consider its shape and intervals, if possible
size (relative to the patient), the patient’s age ● Consider changing the device interface when
and the type of intervention required delivering an intervention. For example, swap
● Always follow the manufacturer’s instructions nasal prongs with a full-face mask for the
for use delivery of respiratory support
● Use additional measures to reduce pressure ● Stop using a device as soon as is clinically
and shear. Make sure they are compatible possible
with the device. ● Incorporate DRPU prevention into existing PU
● Where possible, do not place the device over a prevention pathways
pressure ulcer (PU) or broken skin ● Ensure that DRPU prevention is part of the
● Document the device and its level of risk facility’s routine practice
● Notify relevant staff of any risk associated with ● Monitor DRPU incidence and prevalence; use
the device rigorous and consistent procedures for this
● Assess the patient’s risk status ● Work collaboratively and refer across
● Conduct frequent skin assessments and check specialties to prevent DRPU
the skin under the device ● Give feedback to industry and collaborate with
● More frequent assessment will be required for device developers and manufacturers
high-risk patients
patients at the end-of-life. Non-medical devices can Health professionals and decision-makers in
pose significant risks: examples include bedding that hospitals and care settings should be open to
may fold under the patient, creating pressure and implementing evidence from all levels of the evidence
localised shear points, especially in neonates. hierarchy and not rely solely on randomised controlled
Additional examples and management approaches are trials (RCT). Evidence from cohort and case studies
given in Table 6.
Evidence base Box 10. Responsibilities of procurement

services
There is limited published evidence on the
effectiveness of many prevention measures and ● Liaise with procurement services to increase
awareness of their role in device-related
interventions. Th is may reflect institutional cultures pressure ulcer (DRPU) prevention
where DRPU is under-reported due to risk of litigation. ● Inform procurement about the role of
However, where evidence is available, it should be materials used in medical devices (adhesives,
evaluated and integrated into procedures and silicones, additives and latex) in DRPU
prevention. Obtain supporting information
protocols. For example, a recent meta-analysis from the device manufacturer, as required
suggested that hydrocolloid dressings can help ● Procurement services are often governed
prevent DRPU during non-invasive ventilation,149 by local practices, laws and regulations.
probably because they provide cushioning at the skin- Ensure that those involved in procurement
are fully informed of the regulations
device contact interface.150 However, it should be relating to medical devices and prevention
noted that no commercial dressing has been designed of patient harm
specifically to prevent DRPUs.151

Table 6. Clinical practice approaches for the prevention of device-related pressure ulceration (DRPU)
Device type/resource Approach
Bilevel positive airway Select an appropriately sized mask

pressure (BiPAP) mask-related
Ensure effective delivery of respiratory therapy
pressure ulcer (PU) in
paediatric patients177 Update interface used to relieve pressure
Skin should be assessed by a nurse or respiratory therapist every 4 hours
Update record templates
BiPAP/ continuous positive Collaborative approach
airway pressure (CPAP)
Protective foam under all masks
mask-related DRPU in surgical
spine patients6 Mask not padded
Stock dressings near masks and/or bundle them together
Shape and fit dressings using patient-specific templates
Do not use ill-fitting full face masks
Oronasal masks178 Personalised mask fitting device, designed using three-dimensional scanning
Modified SSKIN bundle72 Use devices with surfaces that are appropriate to the size of the patient
Assess the need for adhesives
Skin inspection by risk area and anatomical site, including the face and scalp
Rotate devices
Protect the skin under devices
Incontinence management
Optimise nutrition
State actions needed: referral to a clinical specialist or no action
should be considered, as well as bioengineering research number of settings. The following example describes
involving laboratory tests, computer (finite element) how implementation of a care-bundle approach
modelling and simulations relevant to device-design reduced the rate of tracheostomy-related PU in
evaluations in the context of DRPU prevention. This is children on invasive and non-invasive mechanical
especially important because ethical considerations ventilation being transferred from a quaternary care
may seriously limit patient studies on DRPU in both children’s hospital to the home setting.
paediatrics and adult populations. The Joanna Briggs The Plan-Do-Study-Act (PDSA) framework153 was
Institute provides useful guidance on how to critique used to develop a care bundle for tracheostomy-
and appraise research evidence.152 related PU. During the bundle development phase,
tracheostomy-related PU reduced from 8.1% to 2.6%.
DRPU prevention Once developed and implemented, it reduced still
further to 0.3%. The process included online or
in practice didactic training of all nurses in the unit on PU risk
Care bundle approach assessment, full skin assessment and identification,
Where evidence exists, prevention strategies have and prevention of tracheostomy-related PU. Strategies
been shown to reduce the incidence of DRPU in a included displaying information on the bundle in the
staff room and publication of brochures explaining

Box 11. Requirements for reporting device-
the risks, which were shared with patients. related pressure ulceration (DRPU)
The care bundle included the components that are
● The DRPU category, if not on a
listed below: mucosal membrane
● Daily Braden Q RAT assessment ● Anatomical location of the DRPU
● Daily full-body skin assessment ● Size and shape of the DRPU
● Device assessments, which were undertaken on ● Type of device involved
● Brand and model of device
every 8-hour shift ● Control or serial number of device
● Keeping device interfaces moisture-free ● Expiry date of device
● Using a hydrophilic foam barrier under the ● Method of application
tracheostomy tube flange and around the stoma to ● Method of securement
● Protection or prevention strategy used with
wick away fluid device
● Reducing pressure and frictional forces, and using ● Adjustments made during use
extended tracheotomy tubes in children whose ● Degree of adherence to the
necks were not clearly exposed or whose behaviour manufacturer’s instructions for use
resulted in them pushing the tube down
their sternum. specific information is provided on risk assessment,
selection and prevention. The importance of obtaining
The team provided feedback to the manufacturer informed consent from patients and their families
of the tracheostomy tube to aid its design and is highlighted.
development, with the aim of reducing pressure
at three locations where tracheostomy-related Optimising local implementation
PU develop. A helpful mnemonic for an integrated pathway for
The care bundle was incorporated into the facility’s DRPU prevention is SECURE (Fig 10), which stands for:
electronic medical records (EMR) system, embedding
it in the nurse workflow. Tracheostomy-related PU are ● Skin/tissue
reported in real time, tracheostomy tubes are changed ● Education
according to the patient’s anatomy, and tubes are ● Champion/collaborate
placed during the tracheostomy in collaboration with ● Understanding
otolaryngologists. Staff uptake of the bundle reached ● Report
100% in four months, demonstrating sustained ● Evaluate.
quality improvement.153
Th is approach is transferable to other facilities and Frontline clinicians with hands-on experience of
has been included in the panel’s recommendation for devices and the risks they pose are well placed to drive
prevention of DRPU. the adoption of devices with the least risk of causing
harm. Such an approach could work in a facility where
Publication of a guide suboptimal devices are used—for example, because of
Another example of a DRPU prevention initiative is formulary constraints or lack of access to a wider
from Japan, where a detailed guide for general nurses range of device sizes and designs. Health professionals
and medical staff without a full understanding of could also drive this by working closely with
DRPU was developed. The guidebook includes ten procurement and formulary staff (Box 10), presenting
classifications of medical devices commonly evidence, when available, to support the adoption of
associated with DRPU (Table 7). For each classification, different devices.

Management of DRPU Table 7. Classification of medical devices

according to device-related pressure ulcer risk
The fundamentals of managing DRPU are similar to as presented in a Japanese clinical setting179
those PU in general. These include use of a recognised
1. Elastic stockings used to prevent deep venous
classification system, such as the NPIAP system, 2 to thrombosis
describe the DRPU. Th is requires:
● Full patient assessment Intermittent pneumatic compression (IPC)
● Accurate assessment of areas at risk of pressure 2. Non-invasive positive pressure ventilation

damage
3. Fixation device of orthopaedics, splint, cast
● Ongoing assessment, measurement and
documentation of the DRPU 4. Indwelling bladder catheter
● Assessing and documenting progress
5. Faecal management system
● Assessing, preventing and managing pain
● Using a high standard of local wound care. 6. Vascular access devices:
DRPU present different challenges to PU, as body Intravenous catheter
weight forces are not a dominant aetiology. It should Invasive arterial blood pressure monitors
be noted that DRPU on mucous membranes cannot
be categorised.2 7. Nasogastric tube
Considerations specific to DRPU include issues 8. Paediatrics nasogastric tube

with continued use of devices for medical reasons. A
DRPU caused by a mask may be managed by changing 9. Respiratory-related devices used in
paediatrics:
to a different design—for example, from a mask that
transfers forces to the bridge of the nose to a full-face Oxygen nasal cannula
mask that transfers forces to the forehead. If it is not Equipment for fixing tracheal cannula
possible to change the make for clinical reasons, Tracheal tube
measures to reduce the causative factors should be
Tracheal cannula
used, when possible. Th is includes increased
monitoring and use of prevention measures such as 10. Paediatrics fixation device for catheter, splint
effective interface materials and structures.
Although it may not be possible to reposition a interfaces, where the public, patients or health
device such as a face mask to relieve pressure, professionals can report harm caused by therapeutic
repositioning or changing the means of securement use of a device. Other countries have similar reporting
may help to address this. For example, thin, soft systems.
interface structures with adequate mechanical and Unfortunately, it is unclear how frequently health
thermal energy absorption capacities may protect professionals use these reporting tools, and DRPU
tissue by cushioning and/or redistributing load, while itself is not routinely reported. As such, there is little
avoiding heat trapping. cumulative evidence on which medical devices
commonly compromise the health of skin and
Reporting DRPU underlying soft tissue. Typically, information about
Medical device regulatory bodies, such as the Food this is mainly communicated during institutional
and Drug Administration (FDA) in the US, Health service evaluations or quality improvement
Canada,154 Medicines and Healthcare products activities.155,156
Regulatory Agency (MHRA) in the UK and the Medical This means there is no consensus on which devices
Device Directive in the EU have developed reporting would benefit from further study on their design. To
S E C U R E
Skin/tissue Education Champion/ Understanding Report Evaluate

collaborate
Thorough Health Lead the Develop a Ensure DRPU Evaluate

assessment, professionals, adoption of thorough is correctly devices for
daily or more the patient, evidence- understanding reported their ability to
frequently carers, family based devices of the causes of in a timely minimise DRPU
depending and industry developed DRPU, patient manner by thoroughly
on risk. A through assessment and analysing
handover collaboration correct product support data
may be with use and conducting
required manufacturers clinical
to ensure and health evaluations in
continuity professionals the facility’s
of care patient
population
Fig 10. SECURE mnemonic for an integrated pathway for device-related pressure ulcer (DRPU) prevention
provide high-quality, safe patient care, rigorous and read, understand and adhere to these instructions.
consistent data on DRPU are required. Thus, a robust, However, medical devices are often taken out of their
evidence-based policy for reporting DRPU is essential packaging away from the point of use, resulting in
to improve DRPU prevention. 32,156–159 In short, a instructions for use not being available at the bedside.
culture of open reporting, supported by regulatory This is an issue that must be addressed. Occasionally, a
agencies, is required. Th is should result in health professional will improvise an (off-label) solution
manufacturers of unsafe devices reviewing and for avoiding skin damage when using a device. However,
improving their products. this may have biomechanical implications that are not
DRPU should be reported separately to PU. A root fully understood, with the risk of unintended
cause analysis should be conducted to inform the consequences. Therefore, it is important to follow the
reporting of the DRPU. In the UK, NHS Improvement instructions for use and adhere to evidence-based
has issued new guidance on reporting of DRPU.160 protection measures.
Further details on reporting requirements for DRPU
are given in Box 11. Regulators need to take action
We need to encourage regulators to ensure that
Adhere to instructions for use medical devices are clearly labelled according to their
Manufacturers should provide instructions for use risk of DRPU, based on clinical research evidence.
with their devices, which must consider the risk of There is also an opportunity to develop standards
DRPU. Health professionals are in turn expected to to ensure that medical devices are designed with input

from bioengineers and undergo laboratory testing. and thus the risk of deformation injury and pressure
Regulators should require companies to comply with ulceration. Quantitative measures were provided by
these standards and document their devices’ exposure to tissue loads for each design variant.98
performance in terms of patient safety and DRPU In addition, technologies are available that sense
prevention. Regulatory requirement that industry interface pressure, shear, temperature and
publishes its compliance with these standards will humidity.161,162 Incorporating these technologies into
enable informed decision-making by healthcare medical devices will help avoid DRPU.
institutions on purchasing and risk management. It is vital that manufacturers constantly engage
Th is approach has, of course, been successfully with users of their products: this will help identify
used in the car industry for many years, where the risks associated with existing devices and the
results of crash tests, conducted in accordance with development of strategies to minimise or eliminate
regulatory standards, are published for the benefit of them. Health professionals should be closely involved
buyers and users. in all stages of the design process. Th is approach
Furthermore, the regulatory bodies have not proved successful when designing a paediatric
investigated reports of medical device harm, raising malnutrition assessment device.163
questions about the role of regulatory agencies in this The medical device design process includes:
field.158
● An initial definition of user needs
Medical device industry ● Identification of functional attributes required to

meet these needs, including minimum
and manufacturers performance standards
Computer (finite element) modelling and phantoms ● Identification of existing technologies that meet
can be used to design medical devices that minimise these functional needs
risk of DRPU.33 This approach should be adopted when ● Design inputs including minimum performance
designing new medical devices or improving designs of standards
existing ones. It should also be used when evaluating ● Design validation
the mechanical and thermal energy absorbance of ● Final prototype selection
interface materials and structures. New designs need ● Clinical evaluation plan.
to take the causative factors of DRPU into account,
including presence of sharp or curved device-surface Particular scrutiny is needed when creating new
geometries, frictional properties (high-friction designs for devices associated with a high risk of
coefficients), hard materials, pressure, shear and DRPU or indicated for high-risk patients. For example,
humidity, as well as their tissue loads and stress the design of a device for neonates and paediatrics
distributions and thermal energy management considered the proportional anatomical differences
properties. The functional objectives of medical device and tissue composition between this group and
design are shown in Box 12. adults.164
Th is approach was used to design a long soft- The clinical evaluation plan should evaluate the
layered spinal board that would minimise the risk of potential risk of DRPU that could be attributed to the
DRPU. MRI scans of the sacral area in three volunteers design. The product will be need to be redesigned if
were taken to inform a computer model of the tissue this risk is considered too high.
deformation that occurs when a patient lies on a Manufacturers should change the labelling on the
spinal board. Th is preclinical modelling showed that packaging to clearly indicate the level of risk of DRPU
the soft-layered design reduced tissue deformation that might be associated with the device. The
instructions for use should include clear and detailed

information on: Box 12. Functional objectives of medical
device design
● How the device’s design features address the risk of
DRPU ● Match stiffness or elastic modulus in design
● Instructions on application, fitting and securement so that the elements contacting the skin are
at a stiffness that is near that of skin and
● Instructions on how to continuously monitor and
underlying soft tissue. Elastic modulus is an
adjust the device engineering measure of the stiffness of a
● Information on the presence of interface materials material, indicating the ratio between the
and structures within the device that have been mechanical stress and deformation (strain)
level
shown to be effective in preventing DRPU ● Smooth tissue load gradients by matching
(supporting published bioengineering and clinical device-tissue stiffness as described above
evidence on their efficacy should be cited). and avoiding sharp or curved geometries in
the device surfaces that contact the skin
● Minimise the coefficient of friction at the
Health professionals interface between devices and skin, thereby
reducing frictional contact forces and shear
and clinical researchers distortions in skin and subdermally
Health professionals have a responsibility to apply ● Minimise sustained tissue deformations,
both at the skin surface and in deeper tissues
medical devices in accordance with the instructions ● Absorb mechanical loads applied by a
for use and to document this in the patient records. device, so that as little as possible reaches
Clinical educators must ensure that carers and the body tissues
patients are aware of the potential harm associated ● Improve thermodynamic effects by thermal
energy management: minimise heat
with medical devices and consequently the need for trapping between the device and skin, and
correct application. Th is is particularly important in allow heat clearance from devices that
the community setting—for example, when orthotics produce heat and/or adequate conduction
or prosthetics are applied. Devices should be carefully of heat from tissue metabolism to
the environment
selected to ensure a good fit with the patient’s anatomy ● Use sensors to provide information on the
and contours. It should also be possible to be able to mechanical loads applied, tissue
adjust them in response to changes in tissue temperatures and heat accumulation, the
characteristics, volume and contours (e.g. when tissue health status and potential harms
● Use a shape and size of device that is relevant
oedema forms). For example, clinical evidence shows to the patient and can be adjusted if there is
that improved fit is highly likely to reduce the risk of a change in volume or contours (e.g. as a
tissue damage on the nasal bridge when face masks result of oedema or lymphoedema)
are worn.94 ● Ensure the device is compatible with
incontinence management
Issues with specific products and device models ● Manage moisture or wetness resulting from
should be reported and documented, and the results use of the device
shared with the developers, manufacturers and, ● Provide continuous tissue protection by
where necessary, regulatory authorities. Th is will put minimalising any frictional properties at the
skin-device interface, even if there is a
pressure on industry to redesign existing products build-up of perspiration or moisture, that
and create new designs that specifically reduce the temporarily increases skin and subdermal
risk of DRPU. Clinical research evidence should be tissue tolerance to loads
rigorously collected from all relevant settings to make
a strong case to industry and/or the relevant
regulatory bodies.

Changing the focus of
health professionals and
policy-makers
R
educing the incidence of DRPU will require a
change in the mindset of health professionals, Key points
health-service managers/decision-makers and
● Many health professionals and managers
policy-makers working in government and regulatory
underestimate the psychosocial, clinical
bodies. Health professionals and administrators will and economic impact of device-related
need to be aware of the risks that medical devices and pressure ulcers (DRPUs)
other objects pose in terms of tissue injury. Health ● There is a need to increase awareness on
DRPU through education, training, and
professionals will also need to know how to assess and
improved documentation and reporting
minimise risk. Administrators will need to ● Education can be provided by health
understand the potential consequences of DRPU in professionals, academics, bioengineers or
terms of human suffering, healthcare costs, risk of industry (if supported by independent
experts). It is most likely to be effective if it
litigation and effects on insurance premiums or
includes practical demonstrations and
potential loss of coverage. They will then need to act exercises on best practice for the
on this understanding. Finally, policy-makers will application of devices.
need to recognise the human, clinical and economic ● lt is vital that health professionals demand
manufacturers provide robust evidence on
burden of DRPU.
the clinical efficacy of their medical
devices in preventing DRPU
Increasing awareness ● Healthcare organisations should develop
At present, health professionals and administrators written guidance on best practice for the
use of medical devices most associated
are often not even aware of the importance of DRPU
with DRPU in their facilities
and its associated risks.9,106 Similarly, chart templates
and patient documentation may not pay much
attention to DRPU prevention.9 There is a need, Education and training.
therefore, to raise awareness of DRPU through Administrators and decision-makers involved in
education, ongoing training and consistent reporting. purchasing medical devices need education on DRPU.
Preventing DRPU is not the sole responsibility of a Th is will increase awareness and ensure that, as a
tissue viability specialist or equivalent: the likelihood minimum, the fundamentals of DRPU risk assessment
of a DRPU prevention programme being successful and management are disseminated to all relevant
when led by a single group of specialist clinicians in a areas of the institution. Ongoing education should
healthcare facility is low. All health professionals who also be routinely provided on innovations in medical
manage patients in contact with devices must be device technology that can reduce the risk of DRPU.
aware of both the risks of DRPU and the strategies to
prevent it. Administrators, purchasers, liability Sources of education
specialists (legal teams) and risk management staff in Education and training can be delivered by health
all types of medical facilities should be aware of the professionals, academics or bioengineers. In addition,
consequences of DRPU from financial (cost-benefit), manufacturers are increasingly offering education
legal and insurance (litigation) perspectives. Indeed, and training on their products; it is vital this includes
in English ICUs between 1995 and 2012, PU was among DRPU prevention. Education and training by industry
the harms that most commonly led to substantial should be accepted, provided it reflects best practice
compensation following litigation.165 and is supported by independent experts who can
The key to increased awareness is to monitor and critically review the statements and claims made.
document staff performance to ensure their Health professionals often use only medical
knowledge of DRPU is sufficient and up to date. devices available on local contracts and formularies.
Changing the strategies of health professionals and policy-makers
Stakeholders therefore need to assess that the medical be used to measure the effectiveness of education and
devices listed are fit-for-purpose. Th is will, in turn, implementation of best practice. Industry can use the
drive the need for clinical education on this topic. data to inform the design of better and safer devices.
Online training modules can be developed for clinical
Formats settings that do not have access to simulation suites.
Education and training is most likely to improve
outcomes if it is practical, with hands-on, real-time Staff considerations
experience. Current understanding of DRPU and the It must not be assumed that, because a health
supporting evidence base should be presented at an professional has been trained in the use of one type of
appropriate level for the target audience. a device, such as a catheter, that they know how to use
The effectiveness of such education provision can all designs or variants of that device. Training must be
be assessed with formal objective structured clinical provided for different designs and design variants
examination or simply by observing practice, with a where device use and securement differ, or where a
view to comparing the level of knowledge pre- and facility’s protocols may differ from those of other
post-education. The insights gained can be used to facilities. This is particularly important when staff are
improve the educational sessions and, eventually, transferred from one facility to another.
clinical outcomes.166 Digital databases on staff performances are highly
valuable as they can be used to identify gold standard
Bioengineering input practice in a facility. New staff members can be trained
Hands-on education and training can be delivered in to meet this standard.
the wards, and often involves demonstrating how to New employees must receive training on how to use
apply devices onto real patients. However, another and secure devices, with a view to minimising DRPU.
option is to use imaging phantoms, dummies or For undergraduates, this information needs to be
mannequins in simulation suites, which replicate incorporated into education on PU prevention
clinical settings, patient conditions and emergencies, modules. Health professionals who must be trained
thereby avoiding any risk of harm to patients. Although include undergraduates, postgraduates and all
clearly the ideal, to date no phantoms, dummies or members of the multidisciplinary team including
mannequins have been fitted with implanted pressure allied health professionals and medical staff.
sensors for training purposes. From bioengineering
and industry perspectives, this is necessary to provide Carers and relatives
optimal training on, for example, how to avoid Non-professional carers and family must also be made
overtightening oxygen masks to the face.166 aware of the risk of DRPU. They should be taught how
Bioengineers need to develop better phantoms, to inspect for signs of DRPU and to immediately notify
with sensors linked to software that provides feedback a trained health professional if a medical device is
to trainees specifically on DRPU prevention. This has misplaced and/or might cause tissue damage. They
the potential to provide quantitative performance should also be informed of the risks associated with
scores, based on good practice protocols, to health personal belongings and other objects used by the
professionals. Moreover, quantitative data, such as patient and taught how to manage these risks. Box 13
how much force a health professional has applied onto lists instructions that could be given to carers and
the face of the phantom to tighten a mask, can be family. However, as this is a safety issue, carers and
stored in digital databases, enabling comparison of family who do not have the confidence or ability to
feedback within departments and between follow these guidelines should be advised to seek
departments, facilities and medical settings. This can immediate help from a health professional.

competitors. Th is could be achieved through

Box 13. Advice and information for carers
and family laboratory studies and, potentially, clinical research.
Laboratory evidence will be able to demonstrate the
● Regularly inspect the skin near and under
the device for redness, swelling and
extent to which individual designs reduce the risk of
breakdown tissue deformation, stresses and heat trapping. Th is is
● Pay particular attention to areas where the important because products from different
skin is depressed by the device or any of its manufacturers may differ in shape, structure or
components
● Ensure the device is not placing undue
material composition. (Research techniques used for
pressure on the skin area with which it is in this comprise computer (finite element) modelling
contact studies, phantom studies or both.)
● Regularly move tubing and any method of High-quality published research evidence should
securement so that one area of skin is not
continuously exposed to risk
be requested for any protective device, such as
● Ensure the patient does not lie on the device interface materials and structures, that the
● Ensure there is no object left between the manufacturer claims will reduce the risk of tissue
patient and the surface they are sitting or deformation or heat trapping. The research should be
lying on
● Ask the patient about discomfort or pain
based on rigorous studies and clinical performances.
associated with the device It is vital that published peer-reviewed research is
● Call the nurse or clinical specialist if any also available in a format that is accessible to non-
problems are observed technical clinical or administrative staff. Th is can
include executive summaries, infographics,
Accessing evidence presentations at a variety of conferences aimed at
different audiences, including nurses, physicians,
about devices administrators, and use of digital and social media.
A critical step in reducing the incidence of DRPU is to As a minimum, the evidence should comprise a
raise awareness about it. Health professional are the paper on a design, brand or model of the device and be
most important link in the awareness chain; they are published in a peer-reviewed journal. The clinical
the people faced daily with DRPU and the harm it evidence base should include outcomes of well-
causes. Health professionals can also drive awareness designed, statistically-valid studies, conducted on
about DRPU among manufacturers and law and relevant patient populations, demonstrating reduced
policy makers. Health professionals therefore need incidence of DRPU, ease of implementation and
access to all available information and evidence on health-economic benefits.
devices, including the materials used in their
construction, and how to use them safely. However,
there are barriers that prevent them from obtaining Role of policy-makers
this information. and regulators
Unfortunately, very few products have published Policy-makers (from healthcare organisations as well
peer-reviewed evidence demonstrating that their use as insurance and regulatory bodies) have a role to play
is associated with low exposure to tissue deformation in DRPU prevention by ensuring the provision of
and minimal heat trapping. Manufacturers should be education, training and guidance on prevention,
petitioned to conduct or disclose such evidence. procurement of safe devices and implementation of
Ideally, evidence should be based on standard test best practice.
methods (STM), where the relative performance of a Organisations must have written guidelines on the
device can be compared with that of market use of medical devices associated with a high-risk of
DRPU in their facility. The guidance must include should then be responsible for assessing industry
information on how to select the correct size of device compliance with these standards.
and apply it in accordance with the manufacturer’s A rating system for the level of risk of DRPU
instructions for use. The policy must be updated after associated with medical devices needs to be devised.
each new purchase decision or change of equipment. Based on this, icons can be developed and printed on
Ideally, an institution’s education policy should be the packaging, denoting the product’s DRPU risk
led by a specified and skilled individual, such as a level. As an industry-wide standard, a medical device’s
tissue viability nurse, lead nurse or equivalent person instructions for use should include detailed
responsible for DRPU prevention. Their responsibilities instructions on how to avoid DRPU during use.
should include: There is a strong case for incorporating this into
the existing information for all medical devices,
● Inviting developers and companies to demonstrate particularly those considered to be high risk. However,
medical devices it should be compulsory for all new devices and
● Interviewing company representatives about how variants of existing ones. There could be a special
their medical devices reduce the risk of DRPU and/ category for high-risk devices (with both new or
or how they should be applied established designs).
● Inviting experts to speak on biomechanics, clinical As an integral part of the technology and product
risk and approaches for reducing the risk of DRPU evaluation process, manufacturers should be asked to
● Ensuring that there is a document on fi le on DRPU present evidence to regulators on how they have
prevention for each device used in the institution mitigated the risk.
● Updating education and training modules when Finally, regulators should require a post-marketing
new devices, models of existing devices or database be set up on the occurrence of DRPU,
evidence-based practices become available detailing the site of injury by device make and model
● Holding routine training sessions and monitoring to enable researchers/manufacturers to identify and
their quality and impact via examinations, online address areas of concern and alert health professionals.
questionnaires and observation of practice The database would need to be transparent and
● Establishing a succession plan that ensures that accessible to all.
knowledge of and expertise on DRPU prevention is
passed on—for example, through dedicated
lectures, hands-on training and mentoring
● Acknowledging the needs of specific patient groups
in device development.
Need for standards

and systems for rating risk
The panel recommends that regulators explicitly
recognise the risks posed to patients by medical
devices that are being or will be placed in contact with
skin, and develop requirements for the design,
evaluation and application of devices to address this.
These standards should be developed by independent
experts in tissue mechanics and biomechanics in
collaboration with industry partners. Regulators

Future research and
guidelines for product
development
M
any devices have not changed in design or
the materials used since the 19th century Key points
when, for example, respiratory tubing and
● There is greater understanding of how the
equipment as we know them fi rst appeared. As a design, structure and materials used in
result, the unintended consequence of DRPU was not medical devices contribute to device-
foreseen. Now that we understand more about the role related pressure ulcers (DRPU)
of medical devices in the aetiology of DRPU, ● Health professionals, bioengineers and
industry need to work closely together to
manufacturers have an opportunity to redesign develop designs for medical devices that
existing devices to reduce the risk of DRPU. Th is could will reduce the risk of DRPU
involve, for example, developing a range of sizes for all ● The aim is to ensure that medical devices
patients, gender-specific devices, and adapting are designed in such a way that they
reduce, to the greatest extent possible,
designs for all ages and anatomical structures. tissue deformation and stresses, while also
There is an opportunity for health professionals minimising heat trapping at the device-
and manufacturers to work closely with biomedical skin interface
and biomechanical engineers to develop designs for ● Laboratory tests can provide standardised
quantitative evaluations to determine if
existing and new devices that will reduce the risk of these new designs are likely to achieve the
DRPU. Th is can be achieved by designing different desired safety outcomes
shapes, developing new materials and structures, and
incorporating advanced technologies—all supported
by contemporary laboratory methodologies for There have been important recent advances in
medical device research, development and design. understanding of the causes of DRPU and the role
played by device design. 33,167 The influence of device
Limitations in existing shapes and sizes, the materials used to manufacture
them and their structural effects are better
medical devices understood. Specifically, the effects of the geometrical
Although it is possible that increased awareness of features and components of devices that will or might
DRPU and good practice will reduce some of the risks contact the skin are clearer. The impact that a product
associated with existing medical devices, they are design can have on tissue deformation and heat
unlikely to be eliminated. Current limitations on risk clearance from either the device or the body tissues
reduction are the result of: can be estimated.
● The design of existing medical devices and Nevertheless, these new research advancements
materials used in their construction are limited in have not been incorporated into device designs and
terms of DRPU prevention medical technologies. There is a general lack of
● No technologies for the early diagnosis of DRPU or awareness in the medical device industry and among
mitigation of their risks are available for use in health professionals that any device that will or might
clinical settings contact the skin needs to be designed to minimise the
● No dedicated protective means have been developed risks of DRPU.168 Health professionals are also
● Health professionals may expect DRPU to develop unaware that they should be pushing for peer-
based on experience. The expectation becomes reviewed published evidence from the leading
‘that’s just what happens’. bioengineering and medical/clinical journals.

Future research and guidelines for product development
Reducing the incidence and prevalence of DRPU in ● How it might be used by non-professional carers
all patient populations is a critical clinical and and relatives
economic objective. Advances in device design and ● The care pathways used: who does what, to who,
the development of new interface materials and and with what?
structures that protect tissues from DRPU are needed ● Other products, devices and interventions used
to reduce DRPU. Multidisciplinary work by academics, alongside the device or that could interact with the
developers and manufacturers, including regulators it
and health professionals, is needed to develop the ● Possible harms that can be caused by medical
testing means, standards and protocols specific to the devices: DRPU in particular, but also others.
field, which could then be enforced by regulators.
Complete elimination of DRPU appears to be an Th is information is used to define clear functional
unrealistic goal, given the research, development and objectives, select materials, develop structural and
technological gaps identified in this document. geometrical features for the device design, identify
However, where knowledge and best practice can be possible sizes and constituent parts, and determine
deployed effectively, DRPU can and must be addressed. other design inputs and prototyping with quantitative
measurable performance limits. Health professional
Input from developers and input will also help minimise risk. Box 14 suggests key
design inputs that should be addressed.
manufacturers
Medical device developers, manufacturers and
Box 14. Key design inputs for device
industry can play a leading role in DRPU prevention. developers and manufactures
Medical device regulations, in most jurisdictions, are
● User goals: what does the end user want
risk-led, with product classifications defined by the to achieve?
level of risk posed by the product. During its ● Human factors: how will the device be
development, the risks related to a device are used? How can the design minimise risk?
● Primary function of the device: ventilation,
identified by a thorough understanding of user goals
feeding, clearance of body fluids, access,
and needs. These are related to: support etc?
● Shape and size of the device relevant to the
● The setting in which a device will be used, such as patient population: age, ethnicity, body
habitus and body mass index (BMI)
hospital or community ● Mechanical properties of the device: its
● The target patient population: age, morbidities, key rigidity and stiffness compared with those
clinical objectives of tissues, its ability to minimise pressure,
● The relevant characteristics of specific patient frictional forces and tissue deformation
● Management of humidity: moving wetness
populations, such as the quality of their circulation and moisture away from the skin/urine
and perfusion; their tissue structure and management etc
composition, including skin fragility; presence of ● Minimising heat trapping at the skin-device
possible atrophy changes and/or chronic interface
● Indications and alarms for medical staff
conditions such as diabetes; effect of age on their when tissue is exposed to elevated forces or
skin or connective-tissue stiff ness and strength there is an immediate risk of device-related
● Any intrinsic or extrinsic factors that may pressure ulcer (DRPU)
● Other protective features to increase tissue
compromise skin and subdermal tissue health and
tolerance to forces and heat exposure,
integrity, such as incontinence, extreme supported by published evidence
temperatures, humidity and comorbidities

Avoiding tissue deformation manufacturers of devices and manufacturers of

and stress prophylactic dressings.
The medical device must be designed to manage, to the
greatest extent possible, tissue deformation and Thermal energy management
stresses. It should also minimise the transfer of thermal Some devices may actively create heat, whereas others
energy to tissues and heat trapping at the skin-device allow heat trapping. It is critical that thermal energy
interface, both for heat originating in the device and (heat) management is addressed in the core design at
that released from body tissues. The design should also an early stage in the process. Developers and
prevent the potential accumulation of moisture and manufacturers should ensure that heat is transferred
wetness at the skin-device interface. away from the skin and not conducted into tissues.
Tissue deformation and stress are addressed by
selecting materials/material compositions with Role of computer modelling and
mechanical properties that reduce pressure and shear technology in the design process
gradients created by the device. For example, soft or The design research described above should be done
mechanical-energy absorbing interface materials or using computer modelling86,98,164,171 and informed and
structures might be used, as long as they are not too reinforced with laboratory experiments, including
soft and do not ‘bottom-out’. The choice of material with use of phantoms, dummies or mannequins.172
must be balanced with the device’s clinical function. It is also important to consider the strong interaction
As mentioned previously, the contours of any device between tissue deformation, stress and heat transfer.
that will or might contact the skin must not include Multiphysics computer (finite element) models can be
sharp surfaces or elements or highly curved regions as used to depict the concurrent biomechanical (tissue
these will produce high localised deformations and deformation/stress) and thermal state of tissues,
tissue stress concentrations. including any possible structural-thermal interactions,
Reducing the frictional forces between the device and so should inform the design process.
and skin by as much as possible will also minimise Advanced phantoms or mannequins that replicate
tissue deformation and exposure to stress. This can be biological, mechanical and dimensional features of
achieved by using low-friction surfaces or coatings on babies, paediatrics,young adults and older patients, or
the device, lubricants, or a combination of the two. For other patient groups such as those with spinal cord
example, a ventilation mask must maintain a seal to injuries or who are obese, cachectic, receiving palliative
function, which requires application of pressure and care or have diabetes, or women in delivery, are
static frictional forces onto facial skin. The key to required.
adequate device design is determining how to minimise These should have integrated sensing, data-
these pressures and frictional forces while still allowing sampling and user-feedback systems to provide in-use
the mask to fulfil its medical purpose. data on pressure and shear distributions, internal
All of the above considerations should be carefully tissue deformations or stresses, as well as temperature,
considered at the design stage. Outcomes of studies on humidity, moisture, pH or wetness at the ‘skin’ surface.
pressure redistribution at the interface of masks show
that this approach reduces skin and subdermal tissue
stress.169,170 Robust quantitative data on the
Input from health
effectiveness of other medical devices are still lacking professionals
in the literature. Health professionals are the gatekeepers for clinical
The development of bespoke offloading devices is research. Key areas that should be initiated and led by
required, potentially in collaboration between health professionals are listed in Box 15.
awareness campaigns. These are valuable data that

Box 15. Key topics for additional device- have the potential to influence administrators and
related pressure ulcer (DRPU) research decision-makers.
● Case studies including root cause analyses It is vital that health professionals work closely with
of DRPU multidisciplinary teams when involved in the
● Health economics of DRPU
development, improvement or design revisions of any
● Barriers to improving practice
(psychosocial research) device that will or might contact the skin or apply
● Innovation in teaching DRPU prevention forces on a patient’s body. This will help ensure that
● Development of educational and practical aspects of device use are weighed and
training modules
integrated into the engineering design process.
● Implementation research
Recommendations to managers of facilities,
Researchers in academia
●
administrators and procurement about
products that better mitigate the risk for Researchers in universities and industry should
DRPU, based on published peer- reviewed
develop physical and in silico (computer simulated)
evidence
● Feedback to industry and regulators based patient models for creating bench-tests for medical
on published evidence devices, to evaluate the associated risk of DRPUs. For
● Management strategies to prevent DRPU example, computer models of three-dimensional,
● Involvement of patient and public
anatomically-realistic body parts of paediatric, adult
involvement groups
● Design innovation and older patients (including cachectic or obese
patients, where appropriate) can be used to perform
objective, methodological, quantitative and
Health professionals should clearly express their standardised comparisons of the tissue stress
clinical goals in order to drive innovation, the concentrations caused by design variants of a device or
development of effective materials and structures, and alternative device modifications, or by applying
designs with standardised quantitative performance interface materials and structures to a device. This
outcomes. Product design that is informed by health would identify the most biomechanically effective and
professionals should focus not only on the device’s cost-beneficial solution for each device and
primary clinical goal(s), but also on the parallel goal of medical problem.
minimising DRPU. Researchers should develop new methods,
Health professionals may wish to consider technologies and products for risk assessment and
undertaking clinical research into the causes, early detection of tissue damage specific to DRPU,
prevention and psychosocial effects of DRPU, based on (expected or assessed) individual tissue
potentially using advanced trial designs such as step- tolerance and physiology.
wedge and adaptive design. There is also potential to be Lastly, researchers could develop smart devices and
involved in clinical research on physical and chemical protective materials or structures that absorb
biomarkers of DRPU to drive better real-time mechanical and thermal energy, thereby preventing or
monitoring and diagnosis of tissue breakdown. at least minimising their potential adverse effects on
Lastly, health professionals in lead roles, tissue body tissues.
viability teams and head nurses and physicians can Sensor technologies and mechanisms that alert
collect cost data for evaluations on the economic health professionals when excessive forces occur
burden of DRPU in their institutes and the cost-benefits between skin and a device161 or when tissues show an
of changing equipment, products or suppliers, inflammatory response to the applied forces are
providing education and training, and implementing another promising route for bioengineers to follow. An

example is pressure and shear sensing to measure as excessive force, tissue deformation, thermal
stress at the limb residuum or socket interface for challenges, moisture, wetness, biocapacitance and
prosthetics.161 pH changes, and perhaps also monitor levels of
inflammatory biochemical markers secreted from
Technologies for skin
Real-time monitoring of at-risk skin and underlying
prevention
●
soft tissue for harmful changes
Sensing and analysis technologies for pressure, shear ● Minimisation of friction, both static and dynamic,
stress and other biomechanical markers93,94,161,162,166 at the device-skin interface through the use of
and measures are already available or in development, materials, coatings and lubricants (or a combination
as are biocapacitance examinations based on of these) with a low coefficient of friction
measurements of extravasated tissue fluid (an early ● Translational research on interface materials
marker of inflammation).134 Ultrasound can also be and structures
used to assess physiological changes in tissue.136 ● Research on mechanobiological approaches to
University research laboratories have developed improve the tolerance of skin and deeper tissues to
technologies to detect other physiological markers, sustained cell and tissue deformation and stresses
particularly biochemical markers. Biomarker assays for the time periods relevant to the device
for analyses can be expensive, as they require application
molecular biology techniques and a high level of ● Computer and laboratory bioengineering models,
expertise. Hence, chemical biomarkers are not feasible such as multiphysics anatomically-realistic finite
for routine clinical use at this time. Furthermore, the element computational models and instrumented
optimal chemical biomarkers, which may be a phantoms that recapitulate the features and
combination of different types of markers, have yet to responses of soft tissues to deformations, stresses
be identified.50 and thermal conditions caused by application of
The development of lab-on-chip sensing is changing medical devices. As stated above, these should
the face of translational (from laboratory research to become standardised tests for evaluating and
clinical application) biomarker research and has had a rating the effectiveness of medical device design
significant impact in other healthcare areas, including variants.
blood lactate monitoring of patients with diabetes.
Key areas for innovation in technologies include: Sensors
DRPU prevention is likely to be best addressed by
● Interface materials and structures to absorb technologies, embedded in devices, that are capable of
compressive and frictional forces and manage real-time monitoring and can report critical indicators
humidity and moisture of potential harm to tissues. These technologies should
● Interface materials and structures to dissipate detect, measure, map and alert to critical values or
thermal energy from devices, thereby minimising conditions:
conduction to skin and underlying soft tissue
● Use of durable materials and structures in medical ● Pressure and shear stress under devices, specifically
devices associated with DRPU, to ensure their indicating when excessive forces are applied by a
mechanical properties are not impaired with use or device
over time ● Physiological sensing and monitoring of potential
● Sensing technologies that accurately detect inflammation at the skin-device interface or in
biomechanical factors associated with DRPU, such underlying tissues in the vicinity of that interface
● Thermal, heat or pH challenges, which should be standards and cost-benefit analyses. It would also
mitigated by the device assist reporting to government, regulatory, insurance
● Humidity, moisture and wetness, which should be and other bodies and authorities.
mitigated by the device Such data should also be useful to academia and
● Incorrect device application or potentially harmful industry: they can be used to quantify goals for device
fitting and/or securement. design, including outcomes that need to be achieved.
This vision is not so far in the future as it may seem.
Sensing technologies at the device interface offer In fact, all the technologies mentioned above exist and
the potential for immediate and automatic remedial are available, at different levels of maturation. It is only
interventions when high-risk conditions are detected— their improvement, integration and commercialisation
for example, relief of the mechanical loads applied by that require effort, time, translational research and
the device or turning the heat-generating element of investments. Understanding the scale and threat of
the device off. DRPU and the heavy burdens it imposes on society—in
suffering and costs—should lead the way towards a
The future new generation of medical devices specifically designed
Future technologies may minimise or even eliminate to minimise the risk of DRPU.
the possibility of DRPU. Suspended contactless devices,
for example based on magnetic fields, may be developed
for the most fragile skin and critical areas such as ICU,
where the largest number of these instruments is
required to save lives.
Dedicated protective technologies, smart materials
or structures, and tissue and environmental monitoring
could potentially be fully integrated into a facility
connected to a central or cloud computer system,
enabling (big) data management and mining.
Continuously updated normative data for a patient
population could be used to determine the real-time
risk presented by all devices attached to a patient in
each type of ward or facility. In addition, data from
sensors monitoring an individual could be analysed in
real-time, e.g. via cloud computing, to detect trends
indicating possible deterioration in tissue health
status. Such digital risk assessments would be
instantaneously communicated to the relevant patient
carers, via wireless devices. Outputs that fall outside
the normal ranges, not just with respect to a normative
range but also with respect to the patient’s historical
data, would trigger such alerts.
Data would also be available to demonstrate
whether or not best practice, according to current
standards, had been applied. This would be useful for
education, training, evaluation of clinical practice

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overview
Activities associated with the SECURE mnemonic (see page S34 for its use in pathway development
Skin tissue
● Regularly assess the
patient’s skin status
● Check the skin under the

device at least twice daily
● High-risk patients will

require more frequent Education
Evaluate assessments
● Identify which
● Consider clinical medical devices are
S
evaluations associated with DRPU in
your facility
● Lobby industry to
consider DRPU ● Inform patients and carers
prevention in device about the risk posed by
design
E E non-medical devices
● Ask patients and

visitors to be
Always assess
the patient’s
risk status
Report R C Champion/
collaborate
● Monitor DRPU
incidence/prevalence ● Liaise and refer to other
U
specialities to prevent DRPU
● Always report DRPU correctly
and quickly ● Notify relevant staff of any risk
associated with an object
● See page S32 for reporting
● Incorporate DRPU
criteria Understanding
prevention into existing
● Neonates, paediatrics, care pathways or
bariatric and elderly patients care
are at high risk
● Ensure medical devices used

fit the patient
● Never apply additional

pressure when securing
a device
DRPU–device-related pressure ulcer
Fig 9 (see page S27) abbreviations

BIS–bispectral index; IPC–intermittent pneumatic compression;
NIBP– non-invasive blood pressure cuffs; NPPV–non-invasive
positive pressure ventilation.

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Device-Related Pressure Ulcers SECURE Prevention

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International

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Editors: Tracy Cowan and Rachel Webb

© MA Healthcare Ltd 2020

Cover Image: Adobe Stock: Angelov

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Risk assessment S22

Safe use of devices: prevention and management of DRPU S28

Changing the focus of health professionals and policy-makers S37

Future research and guidelines for product development S41

JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S3

S4 JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020

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JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S5

Briefly, medical devices associated with PU may

International pressure acquired PU (HAPU), depending on the care setting

S6 JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020

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patients,12 while Wille et al stated that the overall Occurrence by anatomical

Neonates, infants and paediatrics Cost of DRPU

JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S7

Table 1. Summary of medical device-related pressure ulcers incidence and prevalence

Jackson et al. 8 Systematic review of 29 studies Pooled DRPU incidence: 12%

Wille et al.13 125 patients in a surgical ICUt Frequency of pulse oximeter-induced

DRPU–device-related pressure ulcer; ICU–intensive care unit; PU–pressure ulcer

Factors implicated especially in paediatrics

S8 JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020

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where there is potential loss of range of motion) and

JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S9

Cell deformation factors for device-related pressure damage

Pressure ulcers Device-related pressure ulcers

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External forces Change in microclimate

Vessel Relative humidity

JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S 11

In some circumstances, some manual handling

of cytoskeletal integrity and

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The increased fragility of the skin associated with

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cause skin damage between clinical settings

Devices (sometimes more than one per patient) can be

Reduced water content Delayed full functioning of melanocytes

Reduced sebum production Reduced skin capillary pressure

Faster skin absorption

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Table 4. Devices and objects associated with device-related pressure ulcers*

Devices with medical purpose

Patient handling: spinal boards; transferring devices; wheelchairs

Surgical devices: forceps; tools; instruments

Miscellaneous devices and objects: bandages; identity bands on wrist/ankle; pens/scissors/flashlights/other

Hospital furniture: bedframes; foot rests and any other rests

Objects without direct medical purpose/patient’s or other’s property

Anything the patient sits/lies on that is a foreign object, such as a hairbrush

*Examples are provided; the list is not intended to be exhaustive

JOURNAL OF WOUND CARE CONSENSUS DOCUMENT VOL 29, NO 2, FEBRUARY 2020 S 17

DRPU caused by neck brace DRPU caused by oxygen tubing

In paediatrics, the following devices are particularly Impact by type of device