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J Wound Ostomy Continence Nurs. 2015;42(2):151-154. Published by Lippincott Williams & Wilkins

WOUND CARE

Copyright © 2015 by the Wound, Ostomy and Continence Nurses Society™ J WOCN ■ March/April 2015 151

Patient safety and prevention of harm are foundational principles of healthcare, and nursing in particular, yet pa- tients continue to develop pressure ulcers while under our care. Hospital-acquired pressure ulcers (HAPUs) cause pain, loss of function, and infection, extend hospital stays, and increase costs. The cost of treating these wounds is approx- imately $11 billion a year. In spite of progress in wound care products, support surfaces, and prevention methods, occurrences of pressure ulcers persist. 1 Medical device-re- lated HAPUs are common in both adults and children in the acute care setting.

Medical Device–Related Hospital- Acquired Pressure Ulcers Development of an Evidence-Based Position Statement

Joyce Pittman � Terrie Beeson � Jessica Kitterman � Shelley Lancaster � Anita Shelly

■ ABSTRACT

Hospital-acquired pressure ulcers (HAPUs) are a problem in the acute care setting causing pain, loss of function, infection, extended hospital stay, and increased costs. In spite of best practice strategies, occurrences of pressure ulcers continue. Many of these HAPUs are related to a medical device. Correct assessment and reporting of device-related HAPUs were identifi ed as an important issue in our organization. Following the Iowa Model for Evidence-Based Practice to Promote Quality Care, a task force was created, a thorough review of current evidence and clinical practice recommendations was performed, and a defi nition for medical device-related HAPU and an evidence-based position statement were developed. Content of the statement was reviewed by experts and appropriate revisions were made. This posi- tion statement provides guidance and structure to accu- rately identify and report device-related HAPU across our 18 healthcare facilities. Through the intentional focus on pressure ulcer prevention and evidence-based practice in our organization and the use of this position statement, identifi cation and reporting of device-related HAPUs have improved with a decrease in overall HAPU rates of 33% from 2011 and 2012. This article describes the development and implementation of this device-related HAPU position statement within our organization. KEY WORDS: Evidence-based , Iowa Model , Medical device- related pressure ulcers , Position statement

A pressure ulcer can occur wherever external pressure impairs circulation to the skin. Pressure ulcers have been defi ned by the National Pressure Ulcer Advisory Panel (NPUAP) as “a localized injury to the skin and/or underly- ing tissue usually over a bony prominence, as a result of pressure, or pressure in combination with shear.” 2 (p6) This defi nition is helpful but many pressure ulcers occur as a result of external pressure from medical devices that do not completely fi t this defi nition. The NPUAP addressed device- related HAPUs, which develop on mucosal membranes by issuing a statement describing the inappropriate use of stag- ing/category classifi cation due to anatomical differences between mucosal membrane with skin structures. The National Database of Nursing Quality Indicators recom- mends using the term “indeterminate” when classifying HAPUs over mucosal membranes when reporting HAPU. 3 , 4 However, neither of these recommendations provides a clear and concise defi nition for all device-related HAPUs.

Hospital-acquired pressure ulcer development is con- sidered a quality indicator across healthcare systems. 5 Healthcare facilities are required to track and report HAPU rates. In our large academic healthcare system, prevention and accurate identifi cation and classifi cation of HAPUs are a high priority. Monthly skin audits within our facility found that a high percentage, often more than 50%, of HAPUs are device related. In addition, the identifi cation,

� Joyce Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Indiana University Health–Methodist, Indiana University School of Nursing, Indianapolis. � Terrie Beeson, MSN, RN, CCRN, ACNS-BC , Indiana University Health- University Hospital, Indianapolis. � Jessica Kitterman, BSN, CWOCN , Indiana University Health- Ball Hospital, Muncie. � Shelley Lancaster, MSN, CNS, CWOCN , Indiana University Health- West Hospital, Indianapolis. � Anita Shelly, MSN, CNS, CWOCN , Indiana University Health- Riley Hospital, Indianapolis. The authors declare no confl icts of interest. Correspondence: Joyce Pittman, PhD, ANP-BC, FNP-BC, CWOCN, Indiana University Health–Methodist, Indiana University School of Nursing, 1701 Senate Blvd, Room B651, Indianapolis, IN 46202 ( Jpittma3@iuhealth.org ).

DOI: 10.1097/WON.0000000000000113

Copyright © 2015 Wound, Ostomy and Continence Nurses Society™. Unauthorized reproduction of this article is prohibited.

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152 Pittman et al J WOCN ■ March/April 2015

defi nition, and reporting of these types of HAPU are in- consistent with high variation across this organization’s acute care facilities. Therefore, a task force was created and given the directive to explore this issue. The purpose of this article is to describe the process this task force used to address this important issue.

■ Development of the Project

When examining a practice issue or problem, it is helpful to use a model that provides a guide to identify areas of clinical inquiry through synthesis and application of research fi nd- ings. 6 One such model is the Iowa Model of Evidence-based Practice to Promote Quality Care (Figure 1). It provides guid- ance for nurses to use research fi ndings for improvement of patient care. Using this model, we fi rst created a task force that included members of our Pressure Ulcer Prevention sys- temwide committee. Task force members represented 4 of our adult acute care facilities and our childrens’ hospital. Four of the task force members were certifi ed WOC nurses, 3 were also masters prepared and/or a clinical nurse special- ist, and 1 member was doctorally prepared. Using the Iowa Model of Evidence-based Practice to Promote Quality Care, the task force identifi ed medical device-related pressure ul- cers as a problem-focused trigger, a clinical problem, and a priority of the healthcare organization. This was an impor- tant fi rst step because a topic that is aligned with the strate- gic goals of the organization and embraced by staff has a high likelihood of being adopted by those providing care. 6 In addition, connecting the knowledge gained from research to an organizational initiative that has relevance to both the organization and the WOC nurse creates an opportunity and environment for support that might not be available if the topic were chosen to fulfi ll local interests alone. 7

Developing a well-formulated purpose statement is benefi cial once the topic or problem is identifi ed. The purpose statement directs the evidence search, helps focus reading, and defi nes the boundaries and limits around the work to be accomplished. Finally, we advocate formulat- ing a clear and concise purpose statement to assist with developing an appropriate implementation and evalua- tion plan. The task force was charged with developing a standardized, evidence-based defi nition for device-related HAPU, which would support appropriate identifi cation and reporting of these pressure ulcers.

The next step in the Iowa Model is to appraise the evi- dence related to the question or purpose statement. In order to fi nd the most current new knowledge related to device-related pressure ulcers, a search was conducted of the current relevant literature. We searched the MEDLINE electronic database. Key search strategies were: (1) time frame: 1996 to September 2012; (2) exp *“Equipment and Supplies”/ (312834); (3) exp *Pressure Ulcer/ep, et [Epidemiology, Etiology] (851); (4) 1 and 2 (84); (5) limit 3 to (English language and humans) (78); and (6) from 4 keep 2–4, 6, 13, 16–17, 20, 23–24, 26–31, 35–39, 53–54, 64,

69–71, 76–78 (30). This search identifi ed 30 references, which were reviewed by our team.

The task force identifi ed the defi nition of medical de- vices by the Food Drug & Cosmetic Act as integral to de- veloping a defi nition of device-related HAPUs. The US Food and Drug Administration defi nes a medical device as “…an instrument, apparatus, implement, machine, con- trivance, implant, in vitro reagent, or other similar or re- lated article, including a component part, or accessory which is: recognized in the offi cial National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or pre- vention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achieve- ment of any of its primary intended purposes.” 8 (p1)

Another important piece of evidence was that of the NPUAP and its work surrounding pressure ulcers. The NPUAP hosted a consensus conference in 2010 and again in 2014 to discuss the complexities of avoidable versus un- avoidable HAPUs. As a result of this work, NPUAP has led efforts of the wound and pressure ulcer expert community in identifying key components related to pressure ulcer de- velopment and the complexities surrounding these wounds. This work is in its initial stages, but a state of the science article was published recently describing unavoidable pres- sure ulcer incidence and the key risk factors that infl uence them. 9 One of these key risk factors identifi ed is that of med- ical devices. Medical device-related pressure ulcers are diffi - cult to prevent as they are necessary for treatment. They are also challenging to assess due to the inability to remove them in certain instances, and they may produce compro- mise of underlying tissue due to moisture or edema.

Many states are recognizing the importance of HAPUs and are requiring the reporting of prevalence of HAPUs as a quality measure. Minnesota used data collected through mandatory statewide adverse health events reporting sys- tem to identify trends in causative factors for device-re- lated pressure ulcers. An interdisciplinary team convened to develop best practices for prevention of pressure ulcers related to the use of medical devices. 10 Although the fi nd- ings from this report are helpful, no defi nitive defi nition for device-related HAPUs was described.

■ Implementation of the Project

Using the US Food and Drug Administration defi nition for medical devices, evidence-based guidelines, and position statements from various organizations, and results of an ex- pert review, the task force defi ned device-related skin injury to those devices that were medical and external. The task force identifi ed 2 critical elements to be included in the

Copyright © 2015 Wound, Ostomy and Continence Nurses Society™. Unauthorized reproduction of this article is prohibited.

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J WOCN ■ Volume 42/Number 2 Pittman et al 153

Assemble Relevant Research & Related Literature

Critique & Synthesize Research for Use in Practice

NoYes

Yes

Is Change Appropriate for

Adoption in Practice?

Yes Institute the Change in Practice

No

Continue to Evaluate Quality of Care and New Knowledge

No

Disseminate Results

Problem Focused Triggers

1. Risk Management Data 2. Process Improvement Data 3. Internal/External Benchmarking Data 4. Financial Data 5. Identification of Clinical Problem

Knowledge Focused Triggers

2. National Agencies or Organizational Standards & Guidelines 3. Philosophies of Care 4. Questions from Institutional Standards Committee

1. New Research or Other Literature

Consider Other

Triggers

Is this Topic a Priority For the

Organization?

Form a Team

Is There a Sufficient Research

Base?

Pilot the Change in Practice 1. Select Outcomes to be Achieved 2. Collect Baseline Data 3. Design Evidence-Based Practice (EBP) Guideline(s) 4. Implement EBP on Pilot Units 5. Evaluate Process & Outcomes 6. Modify the Practice Guideline

Base Practice on Other Types of Evidence: 1. Case Reports 2. Expert Opinion 3. Scientific Principles 4. Theory

Conduct Research

Monitor and Analyze Structure, Process, and Outcome Data • Environment • Staff • Cost • Patient and Family

The Iowa Model of Evidence-Based Practice to Promote Quality Care

DO NOT REPRODUCE WITHOUT PERMISSION Revised April 1998 © UIHC

= a decision point Titler, M.G., Kleiber, C., Steelman, V.J., Rakel., B. A., Budreau, G., Everett, L.Q., Buckwalter, K.C., Tripp-Reimer, T., & Goode C. (2001). The Iowa Model Of Evidence- Based Practice to Promote Quality Care. Critical Care Nursing Clinics of North America, 13(4), 497-509.

REQUESTS TO: Department of Nursing

University of Iowa Hospitals and Clinics Iowa City, IA 52242-1009

FIGURE 1. The Iowa Model of Evidence-Based Practice to Promote Quality Care. Reprinted with permission from the University of Iowa Hospitals and Clinics and Marita G. Titler, PhD, RN, FAAN, Copyright 1998. For permission to use or reproduce the model, please contact the University of Iowa Hospitals and Clinics at 319-384-9098 or uihcnursingresearchandebp@uiowa.edu

Copyright © 2015 Wound, Ostomy and Continence Nurses Society™. Unauthorized reproduction of this article is prohibited.

JWOCN-D-14-00006_LR 153JWOCN-D-14-00006_LR 153 21/02/15 2:01 PM21/02/15 2:01 PM

154 Pittman et al J WOCN ■ March/April 2015

defi nition of device-related HAPUs: (1) NPUAP defi nition of pressure ulcers provides the basis of the defi nition and (2) device-related HAPUs will be limited to external medical de- vices. After a thorough review of the evidence and using clinical practice expertise, an evidence-based device-related HAPU defi nition for adults and pediatrics was developed. A device-related HAPU is defi ned as a localized injury to the skin and/or underlying tissue including mucous membranes, as a result of pressure, with a history of an external medical device at the location of the ulcer, and mirrors the shape of the device. This defi nition provides needed guidance, struc- ture, and process to assist with prevention, identifi cation, reporting, and treatment of medical device-related HAPU.

The task force used this evidence-based defi nition to de- velop the Medical Device-Related Pressure Ulcer Position Statement. Following the format example of the Wound, Ostomy and Continence Nursing Society and other organi- zations, a position statement was developed. In order to improve the content validity of the position statement, ex- perts in wound management and pressure ulcers were asked to review the content. Based on their recommendations, appropriate revisions were incorporated into the document.

The next step in the Iowa Model is to move the evi- dence into practice. Effective dissemination of evidence includes mindful communication among opinion leaders, change champions, core groups of infl uence, and aca- demic detailing. Opinion leaders were defi ned as those col- leagues who are viewed as important and respected sources of infl uence among their peers. Change champions embrace and demonstrate the persistence necessary to pro- mote the adoption of evidence.

The task force disseminated the position statement by informing various systemwide leadership groups involved in patient quality/safety, systemwide pressure ulcer pre- vention committee, facility-specifi c WOC nurse experts, and facility-specifi c direct-care nurse wound teams. Dissemination continues as the use of the Medical Device- Related Pressure Ulcer Position Statement is integrated into the process of conducting our monthly facility-wide pressure ulcer prevalence surveys.

■ Conclusion

A pressure ulcer may occur wherever external pressure im- pairs circulation to the skin. Pressure ulcers cause pain, loss of function, and infection, extend hospital stays, and in- crease cost. In addition, pressure ulcer development is con- sidered a quality indicator across healthcare systems. 5 Increased scrutiny and reduced payment or nonpayment for HAPU by the Centers for Medicare & Medicaid Services has made the prevention and early detection of pressure ulcers a prominent quality improvement initiative of healthcare systems across the country. A key component in

prevention and detection of pressure-related injury is an accurate skin assessment. In order to perform an accurate skin assessment, an evidence-based defi nition for device- related pressure ulcers is crucial. Our Device-Related Pressure Ulcer Position Statement guides practice, educa- tion, and research within this healthcare organization. This defi nition is used when identifying, reporting, treating, and developing prevention strategies for device-related HAPU. It has proven useful for distinguishing between pressure ulcers resulting from an external medical device versus nonmedical device. Through the intentional focus on pres- sure ulcer prevention and evidence-based practice in our organization and the use of this position statement, identi- fi cation and reporting of medical device-related HAPUs have improved with a decrease in overall HAPU rates of 33% from 2011 and 2012. This concise and evidence-based position statement supports appropriate and consistent identifi cation and reporting of medical device–related pres- sure ulcers. Staging of these ulcers continues to follow the staging recommendations of NPUAP and National Database for Nursing Quality Indicators reporting instructions.

■ References 1. Ayello E , Lyder C . Protecting patients from harm: preventing

pressure ulcers . Nursing 2007 ; 37 : 36-40 . 2. EPUAP/NPUAP . European Pressure Ulcer Advisory Panel and

National Pressure Ulcer Advisory Panel. Treatment of Pressure Ulcers: Quick Reference Guide . Washington, DC : National Pressure Ulcer Advisory Panel ; 2009 .

3. Berquist-Beringer S , Davidson J . NDNQI: Pressure Ulcer Training . 2013 . Accessed December 18, 2014 . at https://members.nursing quality.org/NDNQIPressureUlcerTraining/

4. NPUAP. Mucosal Pressure Ulcers: An NPUAP Position Statement 2012. Accessed December 18, 2014 at http://www.npuap.org/ wp-content/uploads/2012/03/Mucosal_Pressure_Ulcer_ Position_Statement_fi nal.pdf

5. Centers for Medicare & Medicaid Services. Hospital-Acquired Conditions and Present on Admission Indicator Reporting Provision. Accessed December 18, 2014 at http://www.cms .gov/Outreach-and-Education/Medicare-Learning-Network- MLN/MLNProducts/Downloads/wPOAFactSheet.pdf

6. Titler M , Kleiber C , Steelman V , et al. The Iowa model of evidence-based practice to promote quality care . Crit Care Nurs Clin North Am. 2001 ; 13 ( 4 ): 497-509 .

7. Stanley T , Sitterding M , Broome M , McCaskey M . Engaging and developing research leaders in practice: Creating a foundation for a culture of clinical inquiry . J Pediatr Nurs. 2011 ; 26 : 480-488 .

8. Food and Drug Administration . Is the product a medical de- vice ? http://www.fda.gov/MedicalDevices/DeviceRegulation andGuidance/Overview/ClassifyYourDevice/ucm051512.htm . Published 2013. Accessed December 16, 2013.

9. Edsberg LE , Langemo D , Baharestani MM , Posthauer ME , Goldberg M . Unavoidable pressure injury: state of the science and consensus outcomes . J Wound Ostomy Continence Nurs . 2014 ; 41 ( 4 ): 313-334 .

10. Apold J , Rydrych D . Preventing device-related pressure ulcers: using data to guide statewide change . J Nurs Care Qual .

2012 ; 27 ( 1 ): 28-34 .

The CE test for this article is available online only at the journal website, jwocnonline.com, and the test must be taken online at NursingCenter.com/CE/JWOCN.

Copyright © 2015 Wound, Ostomy and Continence Nurses Society™. Unauthorized reproduction of this article is prohibited.

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