Medical Adhesive Related Skin Injury (MARSI) and Medical Device

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Transcript Medical Adhesive Related Skin Injury (MARSI) and Medical Device

Bridging Safety and Clinical Practice
Unexpected Sources of Skin Injury:
Medical Devices and Medical Adhesives
Laurie McNichol, MSN, RN, CNS, GNP, CWOCN, CWON-AP, FAAN
Cone Health
Greensboro, North Carolina
Objectives

Identify leading causes of medical device related pressure injuries
(MDRPI)

Describe strategies to reduce the risk of medical adhesive related skin
injury (MARSI)
McNichol 2016
Disclosures

Ms. McNichol is contracted for the provision of education by 3M, St. Paul,
Minnesota
McNichol 2016
In Defense of Alphabet Soup
McNichol 2016
New nomenclature is never introduced
without a great deal of thought

In clinical practice, conundrums
are identified every day

clinicians are treating those
problems, studying them and some
are even writing about them

Until we name them and all call
them the same thing, we cannot
understand the scope of the
problem

People who need the information
cannot find it because they may
look for information using a
different term
McNichol 2016
Medical Device Related Pressure Injuries
(MDRPIs)

Definition: Pressure injuries associated with the use of devices
applied for diagnostic or therapeutic purposes … the pressure
injury that develops has the same configuration as the device.



Reduced incidence of pressure injuries over bony prominences
(and Root Cause Analysis process) has contributed to increased
recognition of MDRPI
May develop quickly because many sites associated with these
injuries lack subcutaneous tissue and are therefore very vulnerable
May involve skin (MDRPI-S) or mucous membrane (MDRPI-MM)
Black et al. 2015. Use of wound dressings to enhance prevention of pressure ulcers caused
by medical devices. Int Wound Journal 12(3): 322-27.
McNichol 2016
Medical Device Related Pressure Injuries

Classification/documentation ALERT!

MDRPI-MM injuries should not be staged because the
anatomy of mucous membranes is different than that of skin
– they should be measured and described

MDRPI-S should be Staged; however, they frequently involve
areas with no subcutaneous tissue so Staging may need to be
modified: 1, 2, _, 4, Unstageable, DTPI (may not have Stage
3)
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Medical Device Related Pressure Injuries

Prevalence and incidence
Limited data – but suggestive this is a significant problem
Coyer et al (2014): 3.1% in ICU patients
 Black et al (2015): 34.5% of Hospital Acquired Pressure Injuries
 Apold & Rydrych (2012): 29% of reportable (serious) ulcers in MN
 Up to 50% of HAPIs in pediatric population


Significance
Potentially serious injuries (risk of pain, infection, scarring)
 Almost always preventable

Coyer et al 2014. A prospective window into MDRPUs in intensive care. Int Wd Journal
11(6): 656-664.
Black J et al. 2015. Use of wound dressings to enhance prevention of pressure ulcers
caused by medical devices. Int Wd Journal 12(3): 322-327
McNichol 2016
How Big is the Problem?

Apold and Rydrych (2012)
- 74% of MDRPI (then “U”) were not identified
until they were Stage 3, 4, or Unstageable
- 63% of cases had no documentation of:

Skin inspection

Device removal every shift

Pressure relief
Apold J Rydrych D 2012. Preventing device related
pressure ulcers. Using data to guide statewide change, J
Nurs Care Qual 27(1): 28-34.
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Apold and Rydrych (2012)
Location
Device
Non Device
Head/face/neck
70.3%
7.8%
Other multiple
21.9%
5.8%
Heel/ankle/foot
20.3%
16.9%
Coccyx/buttocks
7.8%
67.5%
Sacrum
1.6%
16.9%
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Medical Device Related Pressure Injuries

Risk Factors
Neonatal and ICU patients highest risk populations
 Specific risk factors


Sensory impairment

Compromised ability to communicate pain/discomfort

Morbid obesity

Edema in area of device

Incorrectly sized device

Inadequate preventive care/monitoring
Bryant & Nix. (2016). Developing and maintaining a pressure ulcer prevention program. In
Bryant & Nix, Eds. Acute & Chronic Wounds, 5th ed. Elsevier.
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Medical Device Related Pressure Injuries

High-risk Devices/Common Sites of MDRPI






Cervical collars (44% incidence after 5 days in one study): neck,
occiput, clavicle, chin, mandible
Respiratory devices (ET tube, face masks - NIPPV, oxygen tubing,
tracheostomy): lips, tongue, nose, face, ears, neck
Immobilizers, splints, braces, fixators, compression wraps/stockings:
ankles, wrists, heels, legs, feet, back of knees
N/G, G-tube, J-tube: nose, abdomen
Bed trash: back, posterior thighs, flanks
Catheters: urethra, thighs, buttocks, perianal area
Black et al. 2015. Use of wound dressings to enhance prevention of pressure ulcers caused by
medical devices. Int Wound Journal 12 (3): 323-327.
McNichol 2016
Medical Device Related Pressure Injuries

Pathology

Localized pressure (impact enhanced by edema)

Maceration

Friction (especially if device fits poorly)
McNichol 2016
Medical Device Related Pressure Injuries

Prevention Guidelines (General)




Fit correctly if applicable (e.g., stockings)
Avoid placement on sites of pressure injury
Secure without tension (e.g. use commercial devices or tensionfree taping approach to secure ET and N/G tubes)
Use protective dressings to pad, redistribute pressure and absorb
moisture from areas in contact with medical devices and fixators
 Strength of evidence = B (should probably do this)
 Foam, glycerin gel, hydrocolloid, transparent film
 Studies show significant reduction in MDRPI rates when
protective dressings are used
 Dressings with padding and absorption properties (foams,
hydrocolloids, etc.) more effective than transparent films
McNichol 2016
Prevention: MDRPIs (General)

Avoid placing dressings that increase the pressure between the device and the
skin/MM

Avoid placing immobile patient on any devices or lines or catheters

Reposition at routine intervals (e.g., at each turn) unless contraindicated
(SOE = C)

Monitor/inspect skin under device each shift or at least daily; monitor for skin
changes and for edema and adjust fit and location as indicated
Black et al. 2015. Use of wound dressings to enhance prevention of pressure ulcers caused by medical devices. Int Wd Journal 12(3): 322-327.
Bryant R, Nix D. 2016. Developing and maintaining a PUPP. In Bryant & Nix, Eds. Acute and Chronic Wounds: Current Management Concepts. Elsevier.
McNichol 2016
Prevention MDRPIs: Device Specific

ET tube: Commercial stabilizers to protect face and lips
Reposition within mouth without changing depth
Combine skin inspection/tube care with oral care

N/G tube: Liquid skin barriers and commercial stabilization devices to
provide tension-free securement
Skin assessment at least daily

Oxygen masks: Collaborate with respiratory therapy to fit correctly
Apply protective dressings to bridge of nose, etc.
Use the least tension required to assure proper function
Inspect skin under mask each shift or more often

Collars, splints, braces: Collaborate with PT to assure correct fit
Remove each shift for skin inspection; pad as needed

Stockings: Remove each shift for skin care and skin inspection
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MDRPI Prevention: System Wide Measures

Ensure that procedures include component for release of
devices and skin inspection beneath them
Note: Documentation of these two steps is essential

Document alterations in skin integrity according to agency
protocol

Notify MD

Stage damage according to NPUAP Staging Classification
System

Treat using wound care principles

Provide ongoing education and consciousness-raising:
MDRPIs are preventable and not just an unfortunate
consequence of illness and health care!
McNichol 2016
Setting-specific Posters for Education
Regarding MDRPI
Available for free download
at www.npuap.org

Critical Care

Long Term Care

Pediatrics

All
McNichol 2016
Medical Adhesive Related Skin Injury
(MARSI)
McNichol 2016
Background/Disclosure

The consensus conference described in the first part of this presentation was
a 2-day roundtable discussion held December 10-11, 2012 in St. Paul
Minnesota and was made possible by an unrestricted educational grant from
3M, St. Paul Minnesota.

The three-member Task Force investigating this problem were gerontological
CNS, L. McNichol, neonatal CNS, C. Lund and dermatologist, Dr. T. Rosen.

The manuscript referred to in this presentation was published in the J Wound
Ostomy and Continence Nurs. 2013 July/August; 40(4):365-380
McNichol 2016
Why Are We Talking About This?

“Isn’t this just something
that happens?”

“Some people have fragile
skin and we need to use
adhesives-it can’t be
helped.”

“It’s no one’s fault.”
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Today’s Focus: Patient Experience

Part of a patient’s evaluation of
their care experience pertains to
management of (and protection
from) pain

A “matter-of-fact” attitude
regarding injury is generally not
understood/appreciated

Most consumers are fearful of
injury/error while in our care
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Today’s Focus: Cost of Care

Skin injury results in increased
cost of care

Average cost associated with
injuries has not been explored,
so we do not know to what
extent these injuries impact
cost of care

Failure to standardize care for
these injuries makes the cost
of care a challenge to track
McNichol 2016
Today’s Focus: Culture of Patient
Safety
Patient centered outcomes
translates to adverse events
trending downward, e.g.

Falls

Pressure ulcers

Catheter-associated UTIs

Surgical site infections

etc.
McNichol 2016
A Future Category: Skin Injury?

If proper technique for
application and/or removal
of adhesive products is not
used, tissue trauma can
occur, impacting patient
safety, quality of life and
increasing healthcare costs
McNichol 2016
Consensus Conference

Three colleagues formed a Task
Force and convened to study the
problem in July 2012.

This group conducted extensive
literature review.

They determined that a consensus
panel on this topic was needed.

A facilitator was identified.

Twenty interdisciplinary key
opinion leaders with specialized
expertise were invited to
participate in a consensus
conference.

Twenty-five (25) guideline
statements were written.
McNichol 2016
Outcomes of Consensus Conference:
2 Definitions


Definition of Medical Adhesives (abbreviated from US Food and Drug
Administration's Definition)
“A medical adhesive is a product used to approximate wound
edges or to affix an external device (i.e., tape, dressing, catheter,
electrode, pouch, or patch) to the skin.”
Definition of a Medical Adhesive-Related Skin Injury (MARSI)
“A medical adhesive-related skin injury is an occurrence in which
erythema and/or other manifestation of cutaneous abnormality
(including, but not limited to, vesicle, bulla, erosion, or tear)
persists 30 minutes or more after removal of the adhesive.”
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Two Concepts Embraced
1.
Medical Adhesive Mechanics

Pressure sensitive: firm pressure “activates” the adhesive

Over time, adhesive warms and flows to “fill in” the gaps
between the adhesive and the irregularities of the skin
surface, increasing the strength of the bond
McNichol 2016
Two Concepts Embraced (continued)
2.
Time is of the Essence

The length of time for maximum adhesion differs.

Softer adhesives such as silicone have a lower surface tension
and fill in the gaps quickly, maintaining the same level of
adherence over time.

Other adhesives, such as acrylates, act more slowly and their
adherence increases over time.
McNichol 2016
25 Consensus Statements
1.
Assessment (4 statements)
2.
Prevention (18 statements)

General

Selection

Application/Removal

Electrodes

Infection Prevention
3.
Treatment (2 statements)
4.
Future Research (1 statement)
McNichol 2016
Understanding MARSI
Five Presentations
(3 Categories)
Mechanical
Skin tears
Epidermal stripping
Tension injuries
MARSI
Maceration
Folliculitis
McNichol 2016
Contact
Dermatitis
Allergic
Dermatitis
Mechanical Injury: Skin Tears

Wounds caused by shear, friction and/or blunt force resulting in separation of
skin layers; can be partial or full thickness.
LeBlanc K , Baranoski S . Skin tears: state of the science: consensus statements for the prevention, prediction, assessment, and treatment of skin tears.
Adv Skin Wound Care. 2011 ; 24 ( 9 )( suppl 1 ): 2-15 .
McNichol 2016
Mechanical Injury: Skin Tears

Skin tears result when the skin-to-adhesive attachment
is stronger than the skin cell-to-skin cell interaction.

Epidermal layers separate or the epidermis separates
completely from the dermis.
Association of Women’s Health, Obstetric and Neonatal Nurses (AWHONN). Neonatal skin care. 2nd ed.
Evidence-based clinical practice guideline. Washington, DC: AWHONN;2007.
McNichol 2016
Consensus Statements
McNichol 2016
Mechanical Injury: Skin Tears

Critical concern in the elderly and in those with compromised skin

Adhesive tape is cited as the 3rd most common cause of skin tears
following hospital bed injuries and those injuries sustained during
patient transfers.

In the International 2010 Skin Tear survey, dressing removal was cited
as one of the top causes of skin tears.
LeBlanc K, Baranoski S. Skin tears: state of the science: consensus statements for the prevention, prediction, assessment, and treatment of skin tears. Adv
Skin Wound Care. 2001;24(9)(Suppl 1):2-15.
Pennsylvania Patient Safety Authority, 2006
McNichol 2016
Mechanical Injury: Epidermal Stripping

Adhesive removal results in detachment of superficial cell layers
(stratum corneum).

Lesions are frequently shallow and irregular in shape and the skin may
appear shiny; open lesions may be accompanied by erythema and blister
formation.

Repeated application and removal results in changes in skin barrier
function, initiating the wound healing response and inflammation.

Most prevalent at the extremes of life, but can occur at any age.

Pediatric prevalence of skin stripping is between 8-17%.
Brett DW. Impact on pain control, epidermal stripping, leakage of wound fluid, ease of use, pressure reduction, and cost-effectiveness. J Wound
Ostomy Continence Nurs. 2006;33(Suppl 6): S15-S19.
Lund CH, Nonato LB, Kuller JM, Franck LS, Cullander C, Durand DJ. Disruption of barrier function in neonatal skin with adhesive removal. J Pediatr.
1997;131(3):367-372.
McNichol 2016
Mechanical Injuries: Tension Injuries/
Blisters

Injury (separation of the epidermis from the dermis) caused by shear force as
a result of distension of skin under an unyielding adhesive tape or dressing,
inappropriate strapping of tape or dressing during application, or when a joint
or other area of movement is covered with an unyielding tape.
Koval KJ , et al. Tape blisters following hip surgery: a prospective, randomized study of two types of tape. J Bone Jt Surg Am Ser A. 2003 ; 85 (10): 18841887 .
McNichol 2016
Mechanical Injury: Tension Injury/
Blisters

Rigid tape backing can lead to
injury if there is skin movement.

Tension injuries are best
documented in the orthopedic
population (incidence of 6-41%
following hip or knee surgery), but
the phenomena exists in the post
operative ostomy and other
populations as well.
Polatsch DB, Baskies MA, Hommen JP, Egol KA, Koval KJ. Tape blisters that develop after hip fracture surgery: a retrospective series and a review of the
literature. Am J Orthop. 2004;33(9):452-456.
McNichol 2016
Maceration

Changes in the skin resulting from moisture being trapped against the skin for
a prolonged period; skin appears wrinkled and white/gray in color; softening
of the skin results in increased permeability and susceptibility to damage
from friction and irritants.
McNichol 2016
Folliculitis

Inflammatory reaction in hair follicle caused by shaving or entrapment of
bacteria; appears as small inflamed elevations of skin surrounding the hair
follicle; may be non-suppurative (papules) or contain pus (pustules).
McNichol 2016
Folliculitis

Adhesives may occlude the skin and removing tape
inappropriately (too rapidly, at too high an angle) can
result in injury and inflammation of the hair follicle.
Photo courtesy of T. Conner-Kerr
Bryant RA. Saving the skin from tape injuries. Am J Nurs. 1988;88(2):189-191.
Richards GM, Oresalo CO, Halder RM. Structure and function of ethnic skin and hair, Dermatol Clin. 2003;21(4):595-600.
McNichol 2016
Irritant Contact Dermatitis

Medical adhesive products are a
common cause of non-allergic,
irritant contact dermatitis.

Such reactions are more likely to
occur with extended exposure and
reflect the shape of the irritant.

Some increase in incidence is
noted when skin sealants do not
dry prior to adhesive application.
Dermatitis from medical devices, implants, and equipment. In: Reitschel RL, Fowler JF Jr, eds. Fisher’s contact dermatitis. Philadelphia, PA: Lippincott
Williams & Wilkins; 2001:336-41.
McNichol 2016
Allergic Dermatitis

A cell-mediated immunologic response to a component of the
adhesive with reaction extending beyond the area of exposure.

The incidence of true allergic dermatitis is not known;
suspected allergic dermatitis should be considered for referral
and/or appropriate investigation (such as patch or scratch
tests).
Usatine RP, Riojas M. Diagnosis and management of contact dermatitis. Am Fam Physician. 2010;82(3):249-255.
Widman TJ, Oostman H, Storrs FJ. Allergic contact dermatitis from medical adhesive bandages in patients who report having a reaction to medical
bandages. Dermatitis. 2007;19(1):32-37.
McNichol 2016
What’s happened since 2013?
In 2015, members of the WOCN Society reviewed the 25 original general practice
statements and came to consensus on eight (8) WOC specialty-specific Best Practice
Statements

2 General statements

2 Wound statements

2 Ostomy statements

2 Continence statements
A manuscript depicting that process and disseminating those statements has been
submitted to a peer reviewed journal and accepted for publication in the Jan/Feb
issue (JWOCN)
Others from around the world are publishing on this phenomenon, adding to the
evidence base in the areas of prediction, prevalence and incidence and treatment
McNichol 2016
Future Research
Other specialty organizations can now either endorse the WOCN’s
specialty practice statements or prioritize and refine the original
Consensus Statements and make them more relevant to their practice
Expand scientific knowledge of adhesive performance and use

mechanisms of injury

prediction

prevention

assessment

documentation

treatment
McNichol 2016
Next Steps
Global Best Practice Guidelines are being considered to assist those using
medical adhesives to:

Use them correctly

Identify patients at risk for skin injury

Implement standardized treatment strategies
In the meantime, healthcare providers
as advocates
Health care providers can change the outcome for patients at risk for and
with medical adhesive related skin injury (MARSI)

We must lead by example in our own practice and integrate best
practice techniques into our daily routines. This may mean
abandoning old practices and beliefs.

We must educate others (professional colleagues as well as patients
and their families) on safe use of medical adhesives

We must advocate for access to skin-friendly medical adhesives
McNichol 2016
How to begin?

Share information about MARSI with your colleagues and decision
makers

Begin using the new nomenclature widely (e.g., in documentation,
communication)

Design and participate in research (even small) studies; contribute to
the evidence by publishing and presenting

Include MARSI in your prevalence and incidence quality studies for
other conditions (e.g., pressure injuries) to determine the baseline in
your practice and begin work toward improving outcomes
In Summary
MDRPI and MARSI

New nomenclature worth learning
and incorporating into your clinical
conversations and procedures

By adopting these terms it allows
us to use consistent language
making collection of data and
reporting of our findings easier and
more valuable
McNichol 2016
Don’t wait.
The next injury might have been preventable.
References

Farris MK, Petty M, Hamilton J, Walters SA, Flynn MA. Medical Adhesive
Related Skin Injury among adult acute care patients: a single-center
observational study. Journal of Wound, Ostomy and Continence Nursing 2015;
42(6): 589-98.

Grove GL, Zerweck ZR, Houser TP, Smith GE, Koski NI. A randomized and
controlled comparison of gentleness of 2 medical adhesive tapes in healthy
human subjects. Journal of Wound, Ostomy and Continence Nursing 2013;
40(1): 51-9.

Matsumura, H et al. A model for quantitative evaluation of skin damage at
adhesive dressing removal. International Wound Journal 2013, 10(3): 291-4.
LMcNichol, 2016
References

McNichol, L., Lund, C., Rosen, T., Gray, M. Medical Adhesives and Patient
Safety: State of the Science: Consensus Statements for the Assessment,
Prevention, and Treatment of Adhesive-Related Skin Injuries. J Wound Ostomy
and Continence Nurs. 2013 July/August; 40(4):365-380

Ratliff CR. Descriptive study of the incidence of medical adhesive related skin
injuries (MARSI) in an ambulatory wound clinic. Journal of Wound, Ostomy and
Continence Nursing 2015; 42(supplement): S1-S74 (abstract).

National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory
Panel and Pan Pacific Pressure Injury Alliance. Prevention and treatment of
Pressure Ulcers: Clinical Practice Guideline. Emily Haesler (Ed.). Cambridge
Media: Osborne Park, Western Australia; 2014
Thank you for your attention.
[email protected]