Development and Psychometric Evaluation of a Medical Device–Related Pressure Injury Risk Assessment Scale

ABSTRACT

Medical device–related pressure injuries are a significant and largely preventable patient safety problem, yet existing pressure injury risk scales do not adequately capture device‐specific risk factors in adults. This methodological study developed and psychometrically evaluated a standardized risk assessment scale to identify medical device–related pressure injury risk in hospitalized adult patients. An initial item pool was generated from an extensive literature review and clinical expertise, and content validity was assessed by seven experts using the Davis technique (content validity index = 0.96). The scale was administered to 160 adults receiving at least one medical device in medical, surgical and oncology wards and intensive care units of a university hospital. Construct validity was evaluated using binary logistic regression, exploratory factor analysis, and receiver operating characteristic curve analysis, demonstrating strong discrimination (area under the curve = 0.844, 95% confidence interval 0.728–0.961) with an optimal cut‐off score of 14.5 (sensitivity 70.6%, specificity 88.8%). Exploratory factor analysis of the final version of the MedRAS (Kaiser‐Meyer‐Olkin = 0.792) revealed a two‐factor structure (Device and Mechanical Factors; Patient and Tissue Factors) explaining 50.92% of the total variance, with all factor loadings above 0.30. The scale showed good internal consistency (Cronbach's alpha = 0.80) and very good inter‐rater reliability (Cohen's kappa = 0.806, p < 0.001). This device‐focused scale may support early risk identification and targeted preventive nursing interventions, with potential to improve patient safety and quality of care in inpatient/critical care settings.

Key Points

• MedRAS was developed to assess device‐related pressure injury risk in adults.

• The scale showed good discrimination (AUC = 0.844; cut‐off = 14.5).

• Two‐factor structure explained 50.9% of total variance.

• Good internal consistency (α = 0.80) and inter‐rater reliability (κ = 0.806).

• Supports early risk identification and targeted preventive nursing interventions.

1. Introduction

Medical device–related pressure injuries (MDRPIs) are pressure injuries that develop as a result of sustained pressure exerted by medical devices used for diagnostic or therapeutic purposes and typically mirror the shape or pattern of the device in contact with the skin or underlying tissue ([1]). In recent years, MDRPIs have attracted increasing attention in the literature due to their growing social and economic burden, such as extended hospitalization, additional healthcare costs, diminished patient quality of life, and increased risk of infection at injury sites [2]. The expanding body of evidence highlights the critical importance of early identification, accurate risk assessment, and the implementation of evidence‐based prevention and management strategies for MDRPIs [3, 4]. Notably, MDRPI risk is also influenced by the baseline skin health of the individual prior to device application, as pre‐existing tissue vulnerability may increase susceptibility to device‐related injury [1, 4].

Advances in healthcare technology and the widespread use of invasive and non‐invasive medical devices in contemporary clinical care have substantially increased the risk of MDRPI development [1, 5]. Current evidence indicates that the burden of MDRPIs is considerable. In a meta‐analysis including 28 observational studies with a total of 117 624 patients, the overall incidence of MDRPIs was reported as 19.3%, with notable regional variations [6]. Anatomical distribution analyses demonstrate that MDRPIs most frequently occur in areas of intense device contact, particularly in association with respiratory support devices such as non‐invasive ventilation or CPAP masks, endotracheal tube securement devices, and nasal oxygen delivery systems [4]. Other commonly implicated devices include urinary catheters, nasogastric tubes, intravenous and central venous catheters, cervical collars, and anti‐embolic stockings, each of which presents unique interface‐related risk factors depending on material rigidity, securement method, and anatomical placement site [7, 8].

However, contemporary guidelines emphasize that individuals should be considered at risk for pressure injuries as soon as a medical device is applied, regardless of age or clinical setting, and recommend reassessment whenever the clinical condition changes (NPIAP [9]).

2. Background

Evidence from Türkiye further underscores the clinical relevance of MDRPIs. In a point prevalence study conducted among 102 intensive care patients, MDRPIs were identified in 29.4% of individuals, most commonly affecting the nasal area and perinasal region (36.6%), the periauricular area (20%), and the subclavian region (20%) ([10]). In an earlier prospective descriptive study conducted in five adult intensive care units involving 175 patients, the rate of medical device–related hospital‐acquired pressure injuries was reported as 40% ([11]). In a national multicenter point prevalence study conducted by the Wound, Ostomy and Incontinence Nurses Association across 13 hospitals in 12 regions, the overall prevalence of pressure injuries was reported as 9.5%, whereas the prevalence of medical device–related pressure injuries was 10.7% [12]. Taken together, these findings indicate that MDRPIs represent a significant and largely preventable patient safety problem, and they highlight the ongoing need for standardized risk assessment approaches to support prevention strategies [3, 10, 12].

Due to their preventable nature, MDRPIs are considered nursing‐sensitive outcomes and constitute an important subgroup of hospital‐acquired pressure injuries (HAPIs). HAPIs are widely monitored and evaluated nationally and internationally as indicators of nursing care quality [13, 14]. Effective prevention strategies rely fundamentally on regular and comprehensive risk assessment. Early pressure injury literature primarily associated risk with factors such as immobility, impaired tissue perfusion, excessive skin moisture, and inadequate nutrition. Accordingly, widely used risk assessment scales, including the Norton [15], Waterlow [16], and [17] scales, were developed to evaluate these risk factors.

Currently, the Braden QD is the only scale that explicitly incorporates medical devices as an independent risk factor; however, it was originally developed for the paediatric population, ranging from premature infants to individuals aged 21 years, and evidence supporting its use in adult populations remains limited. In the only prospective study conducted among adult intensive care patients, the Braden QD demonstrated moderate discriminative ability for predicting MDRPIs (AUC = 0.69), underscoring the need for an MDRPI‐specific risk assessment tool tailored to adult clinical workflows and validated across diverse care settings [18].

MDRPI risk assessment should adopt a practical and clinically applicable approach that simultaneously considers device‐related factors, patient‐specific clinical characteristics, and care process–related variables [4, 19]. Although MDRPI‐specific risk assessment tools remain scarce, a recent methodological study introduced an adult‐focused MDRPI risk scale consisting of eight items grouped under two domains: the general condition of the patient and the effect of the medical device on the contact area [20]. This tool primarily emphasizes global physiological vulnerability (e.g., consciousness status and tissue perfusion) together with contact‐related aspects such as skin/mucosal integrity, friction at the device interface, the device being positioned under the body, use of pressure‐reducing materials, and exposure duration. However, given the wide variety of devices used in adult inpatient care and the multifactorial mechanisms underlying MDRPI development, there remains a need for a more comprehensive instrument that explicitly integrates patient‐related, device‐related, and care‐ and tissue‐related determinants within a practical bedside framework.

3. Aim

This methodological study aimed to develop the Medical Device–Related Pressure Injury Risk Assessment Scale (MedRAS) for identifying the risk of MDRPIs and to examine its psychometric properties.

4. Methods

4.1. Design

The study followed established scale development and psychometric testing procedures, including item generation, content validation, and evaluation of validity and reliability properties, in accordance with recommended methodological frameworks [21, 22]. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline was utilized in the reporting of this study.

4.2. Study Setting and Sampling

The study population consisted of adult patients (≥ 18 years) who were hospitalized in internal medicine, surgical, oncology wards, and adult intensive care units of a foundation university hospital in Istanbul with a bed capacity of 426. Eligible participants were those receiving at least one invasive or non‐invasive medical device at the time of data collection.

Sample size determination was guided by methodological recommendations for scale development studies, which suggest recruiting a minimum of 10 participants per item to ensure stable parameter estimation and adequate statistical power [21, 22]. As the preliminary version of the scale consisted of 14 items, a minimum sample size of 140 participants was targeted. To account for potential attrition and incomplete data, the study was completed with a total of 160 patients. A non‐probability convenience sampling method was used, which is commonly employed in methodological and instrument development studies conducted in clinical settings.

4.3. Inclusion and Exclusion Criteria

Patients were eligible if they (a) were aged 18 years or older, (b) were hospitalized in inpatient wards or adult intensive care units, and (c) had at least one invasive or non‐invasive medical device in place at the time of assessment. Patients receiving outpatient treatment and those who were clinically unstable such that repositioning for skin examination was not feasible were excluded.

4.4. Data Collection, Scale Development and Implementation Process

Data collection and scale development were carried out in parallel through a structured, multi‐phase process. The development and implementation stages of the scale are summarized in Figure 1.

FIGURE 1.

Stages of development, validation, and implementation of the Medical Device–Related Pressure Injury Risk Assessment Scale (MedRAS).

4.5. Stage I: Developing the Preliminary Item Pool

In the first phase, a preliminary item pool was generated based on an extensive review of the literature and relevant international guidelines. Key sources included consensus documents, systematic reviews, and clinical practice guidelines published by the National Pressure Injury Advisory Panel ([1]) and related professional organizations, as well as recent empirical studies addressing MDRPI risk factors ([3, 5]).

In addition to the literature review, the researchers' clinical experience in wound care and pressure injury prevention was incorporated to ensure clinical relevance and applicability. The initial item pool was designed to comprehensively reflect three main domains associated with MDRPI development: patient‐related factors, device‐related factors, and care and tissue‐related factors.

Following this process, a 14‐item draft scale was constructed to capture the multidimensional nature of MDRPI risk in hospitalized adult patients.

4.6. Stage II: Expert Consultation

Content validity of the draft scale was evaluated using the Davis technique. A panel of seven experts, including academic nurses with expertise in pressure injuries, wound care nurses with clinical experience, and researchers experienced in scale development, was invited to review the items. Experts independently rated each item using a four‐point scale: (a) appropriate, (b) appropriate but needs minor revision, (c) needs major revision, (d) not appropriate. The Content Validity Index (CVI) was calculated by dividing the number of experts rating an item as (a) or (b) by the total number of experts. A CVI value of ≥ 0.80 was considered acceptable [23].

Based on expert feedback, minor wording revisions were made to improve clarity and relevance. No items were removed at this stage. The overall CVI of the scale was calculated as 0.96, which exceeded the acceptable threshold of ≥ 0.80, indicating excellent content validity.

4.7. Stage III: Implementation and Psychometric Evaluation of the Scale

Following content validation, the revised MedRAS was implemented in the patient population. Data were collected through bedside, face‐to‐face assessments conducted by the same researcher to ensure consistency (January to April 2025).

For each participant, the Patient Information Form was completed first, followed by administration of the MedRAS. Assessments were based on direct observation of the patient, medical devices in use, and the condition of the skin or mucosal tissue at the device contact site.

The psychometric evaluation of the scale included analyses of construct validity and reliability. Construct validity was examined using exploratory factor analysis (EFA), binary logistic regression, and receiver operating characteristic (ROC) curve analysis to evaluate the scale's underlying factor structure and ability to predict MDRPI development [24]. Reliability analyses included assessment of internal consistency using Cronbach's alpha coefficient and inter‐rater reliability using Cohen's kappa statistic in a subsample of patients [25, 26].

4.8. Data Analysis

Data were analysed using SPSS (Statistical Package for Social Sciences) for Windows 28.0. Normality was tested with skewness/kurtosis values and the Shapiro–Wilk test. Descriptive characteristics were presented as means, standard deviations (SD), or percentages and frequencies.

In order to identify the most important items for the scale to predict future MDRPI, a series of univariate binary logistic regression analyses were conducted, one for each of the 14 items. Patients were followed until discharge or death, for a maximum of 30 days. In these analyses, the items were used as explanatory variables, and the development of new MDRPIs during the follow‐up time (yes vs. no) was used as the outcome variable. The strength and direction of the associations were expressed using odds ratios (ORs) and their corresponding 95% confidence intervals (CIs).

The ROC curve and the area under the curve (AUC) were used to evaluate the cut‐off point, sensitivity, and specificity of the scale. The Youden's index (J = sensitivity + specificity–1) was used to identify an appropriate cut‐off score with the best possible sensitivity and specificity [27].

EFA was conducted using principal axis factoring with oblimin rotation to examine the underlying factor structure of the final scale [21]. Prior to EFA, sampling adequacy was assessed using the Kaiser–Meyer–Olkin (KMO) measure, with values above 0.70 considered adequate, and the appropriateness of the correlation matrix for factoring was evaluated using Bartlett's test of sphericity [28]. Factor loadings of 0.30 and above were considered acceptable [29].

Cronbach's alpha coefficient was used to measure internal consistency reliability. Cronbach's alpha results were considered excellent (α ≥ 0.9), good (0.9 > α ≥ 0.8), acceptable (0.8 > α ≥ 0.7), questionable (0.7 > α ≥ 0.6), poor (0.6 > α ≥ 0.5), and unacceptable (0.5 > α) [30]. The inter‐rater reliability of the scale was examined using Cohen's kappa coefficient. Two independent raters (the researcher and a nurse) evaluated 30 patients. Kappa values 0.61–0.80 were considered to represent good and 0.81–1.00 as very good agreement [26].

4.9. Ethical Considerations

This study was performed in line with the principles of the Declaration of Helsinki. Ethical approval was obtained from the Institutional Clinical Research Ethics Committee (Decision No: 2024.331.IRB3.140). Institutional permission was also secured from the hospital administration. All participants were informed about the study objectives and procedures, and written informed consent was obtained prior to data collection. For patients who were unable to provide consent due to their clinical condition, particularly those hospitalized in intensive care units, written informed consent was obtained from their legally authorized representatives.

5. Results

5.1. Characteristics of the Sample

Table 1 presents the sociodemographic and clinical characteristics of the patients (n = 160). The mean age of the patients was 62.33 ± 16.36 years, and 50.6% were male. Most patients (86.2%) had at least one comorbidity, with malignancy (43.1%), hypertension (38.8%), cardiovascular diseases (28.1%), and diabetes mellitus (20.6%) being the most common conditions. More than half (56.3%) were hospitalized in surgical clinics. The mean length of hospital stay was 8.87 ± 23.98 days, and the mean Braden risk score was 18.50 ± 2.76.

TABLE 1.

Sociodemographic and clinical characteristics of the participants (N = 160).

Characteristics		N (%) or M ± SD
Age		62.33 ± 16.36
Gender	Female	79 (49.4)
	Male	81 (50.6)
Number of comorbid conditions	0	22 (13.8)
	1	29 (18.1)
	2–3	52 (32.5)
	≥ 4	57 (35.6)
Comorbidities type	Diabetes mellitus	33 (20.6)
	Hypertension	62 (38.8)
	Malignancy	69 (43.1)
	CAD/AF/HF	45 (28.1)
	Kidney failure	23 (14.4)
	COPD/Asthma	17 (10.6)
	Hypo/hyperthyroidism	23 (14.4)
	Chronic liver disease	14 (8.8)
	Stroke/Dementia/Epilepsy	14 (8.8)
	Other b	46 (28.8)
Clinic/unit	Surgery clinic	90 (56.3)
	Medical clinic	28 (17.5)
	Oncology clinic	32 (20.0)
	ICU	10 (6.2)
Length of hospital stay (days)		8.87 ± 23.98
Braden risk score		18.50 ± 2.76
Devices present in the patients a	NG tube	15 (9.4)
	Urinary catheter	51 (31.9)
	IV catheter	126 (78.8)
	CVC	33 (20.6)
	Port catheter	23 (14.4)
	Arterial catheter	8 (5.0)
	Epidural catheter	7 (4.4)
	ET tube	1 (0.6)
	Tracheostomy cannula	3 (1.9)
	Oxygen mask	23 (14.4)
	PEG/PEJ	4 (2.5)
	Ostomy bag	12 (7.5)
	CPAP/BiPAP	3 (1.9)
	Drain	38 (23.8)
	Brace/Sling	4 (2.5)
	Anti‐embolic stockings	29 (18.1)
	VAC	2 (1.3)
	SCD	4 (2.5)
	Pulse oximetry probe	11 (6.9)
	BP cuff	10 (6.3)
	ECG electrodes	7 (4.4)
	Restraints	1 (0.6)
	Incontinence pad	10 (6.3)
MDRPI development	Yes	17 (10.6)
	No	143 (89.4)
Device associated with MDRPI (n = 17)	Urinary catheter	5 (29.4)
	Anti‐embolic stockings	3 (17.6)
	CVC	2 (11.8)
	NG tube	3 (17.6)
	Oxygen mask	2 (11.8)
	Incontinence pad	1 (5.9)
	IV catheter	1 (5.9)
Location of MDRPI (n = 17)	Ankle	3 (17.6)
	Inner leg/genital area	6 (35.3)
	Ear	2 (11.8)
	Neck	2 (11.8)
	Nose	3 (17.6)
	Arm	1 (5.9)

Abbreviations: AF, Atrial fibrillation; BP, Blood Pressure; CAD, Coronary artery disease; COPD, Chronic obstructive pulmonary disease; CPAP/BiPAP, Continuous/Bilevel Positive Airway Pressure; CVC, Central Venous Catheter; ECG, Electrocardiogram; ET, Endotracheal; HF, Heart failure; ICU, Intensive Care Unit; IV, Intravenous; M, Mean; MDRPI, Medical Device Related Pressure Injury; NG, Nasogastric; PEG/PEJ, Percutaneous Endoscopic Gastrostomy/Jejunostomy; SCD, Smart Compression Device; SD, Standard Deviation; VAC, Vacuum‐Assisted Closure.

^a Multiple devices per patient.

^b Rheumatoid arthritis, Vasculitis, Hyperlipidemia, Benign prostatic hyperplasia, Diverticular disease, Chronic gastritis, Anaemia, Rosacea.

The most commonly used devices among the patients were intravenous catheters (78.8%) and urinary catheters (31.9%), followed by drains (23.8%), central venous catheters (20.6%), and anti‐embolic stockings (18.1%). Overall, 17 patients (10.6%) developed MDRPIs. Among patients who developed MDRPIs, the most frequently implicated devices were urinary catheters (n = 5, 29.4%), anti‐embolic stockings (n = 3, 17.6%), nasogastric tubes (n = 3, 17.6%), central venous catheters (n = 2, 11.8%), and oxygen masks (n = 2, 11.8%). The most common anatomical locations of MDRPIs were the inner leg/genital area (n = 6, 35.3%), ankle (n = 3, 17.6%), and nose (n = 3, 17.6%) (Table 1).

5.2. Evaluation of the Preliminary Version of the MedRAS and Final Revisions

Table 2 summarizes the results of univariate binary logistic regression analyses examining the associations between items in the preliminary version of the MedRAS and MDRPI development. The binary logistic regression analyses revealed that several items of the preliminary version of the scale were significantly associated with the development of MDRPIs. Specifically, the number of medical devices (Item 1), device stability and safety (Item 2), use of protective materials (Item 6), friction and/or shear forces (Item 8), anatomical compatibility (Item 10), placement site (Item 11), condition of contact tissue (Item 12), moisture accumulation (Item 13), and overall PI risk score (Item 14) were found to be significant predictors of MDRPI development (p < 0.05). No significant associations were identified for hardness of material (Item 3), biocompatibility (Item 4), duration of device use (Item 5), device removability/repositionability (Item 7), or device surface area (Item 9) (p > 0.05). Accordingly, these non‐significant items were excluded from the final version of the scale.

TABLE 2.

Associations between items in the preliminary version of the scale and MDRPI development, based on binary logistic regression analyses.

Items of the scale	n (%)	OR	95% CI	p‐value
Item 1. Number of Medical Devices
3 points: The patient has only one device in place.	53 (33.1)
2 points: The patient has two or three devices in place.	70 (43.8)	10.78	2.22–52.32	0.003
1 point: The patient has four or more devices in place.	37 (23.1)	1.54	0.27–8.77	0.623
Item 2. Device Stability and Safety
2 points: All devices are stable and safe.	122 (76.3)
1 point: At least one device is not sufficiently stable and safe, but still usable.	38 (23.7)	4.42	1.56–12.46	0.005
Item 3. Hardness of the Material
2 points: All devices are made of soft material with pressure‐redistributing properties.	6 (3.8)
1 point: At least one device is made of hard material and exerts direct pressure on the skin.	154 (96.3)	0.74	0.24–2.27	0.610
Item 4. Biocompatibility
2 points: All devices are biocompatible, non‐allergenic, and non‐irritant.	147 (91.9)
1 point: At least one device has allergenic or irritant properties on the skin.	13 (8.1)	1.60	0.32–7.91	0.564
Item 5. Duration of Device Use
2 points: At least one device is in use for a moderate duration (2–4 h).	3 (1.9)
1 point: At least one device is in use for a long duration (≥ 4 h).	157 (98.1)	0.22	0.02–2.64	0.237
Item 6. Use of Protective Materials
3 points: All devices are covered with protective materials that are scientifically recommended as effective.	134 (83.8)
2 points: At least one device is covered with a protective material not reported to be scientifically effective.	5 (3.1)	6.94	2.23–21.53	0.001
1 point: At least one device is not covered with any protective material.	21 (13.1)	3.47	0.35–34.40	0.287
Item 7. Device Removability/Repositionability
2 points: At least one device is removable or repositionable within a defined time frame or under specific conditions.	68 (42.5)
1 point: At least one device is neither removable nor repositionable.	92 (57.5)	2.63	0.81–8.46	0.104
Item 8. Friction and/or Shear Forces
2 points: All devices are stable and do not generate friction or shear forces.	105 (65.6)
1 point: At least one device is unstable and generates friction or shear forces.	55 (34.4)	3.11	1.11–8.70	0.031
Item 9. Device Surface Area
4 points: Only a peripheral intravenous (IV) catheter is in place.	45 (28.1)
3 points: At least one device has a large surface area (≥ 10 cm).	9 (5.6)	2.68	0.53–13.59	0.232
2 points: At least one device has a moderate surface area (6–10 cm).	12 (7.5)	4.88	0.87–27.24	0.070
1 point: At least one device has a small surface area (≤ 5 cm).	94 (58.8)	2.93	0.45–18.86	0.257
Item 10. Anatomical Compatibility
2 points: All devices are anatomically compatible with the patient.	151 (94.4)
1 point: At least one device is not anatomically compatible with the patient.	9 (5.6)	25.45	5.59–115.88	0.001
Item 11. Placement Site
2 points: The device is placed only on the skin.	94 (58.8)
1 point: The device is placed on both the skin and mucosal surfaces.	66 (41.2)	13.52	2.97–61.52	0.001
Item 12. Condition of Contact Tissue
2 points: All devices are in contact with intact skin and tissue with preserved integrity.	110 (68.8)
1 point: At least one device is in contact with tissue of impaired tolerance (e.g., macerated, excessively dry).	50 (31.2)	4.88	1.69–14.12	0.003
Item 13. Moisture Accumulation
2 points: No moisture is accumulated beneath the device.	117 (73.1)
1 point: Moisture accumulation beneath the device is within a tolerable level.	43 (26.9)	4.76	1.68–13.49	0.003
Item 14. Overall Pressure Injury Risk Score (e.g., Braden Scale)
3 points: Low Risk	62 (38.8)
2 points: Moderate Risk	71 (44.3)	12.63	2.46–64.67	0.002
1 point: High Risk	27 (16.9)	3.28	0.65–16.43	0.148

Note: The bold p‐values indicate a statistical significance of less than 0.05.

Abbreviations: CI, Confidence Intervals; OR, Odds Ratio.

In the present study, the mean score according to the final version of the MDRPI risk scale was 17.39 (SD = 2.97, range = 9–21). Higher MDRPI risk scale scores were significantly associated with lower odds of MDRPI development (OR = 0.60, 95% CI = 0.47–0.74, p < 0.001).

The ROC curve analysis (Figure 2) demonstrated a strong discriminative ability of the final version of the scale, with an AUC of 0.844 (95% CI: 0.728–0.961, p < 0.001). According to the Youden's Index, the optimal cut‐off score was determined as 14.5, corresponding to a sensitivity of 70.6% and a specificity of 88.8% (Table 3). Based on the diagnostic balance between sensitivity and specificity obtained from ROC analysis, total scale scores were categorized into three levels: high risk (9–14 points), moderate risk (15–18 points), and low risk (19–21 points). This classification was statistically supported by a significant difference in the incidence of MDRPIs across the three groups (χ² = 37.267, p < 0.001) (Table 4).

FIGURE 2.

ROC curve illustrating the discriminative ability of the scale for predicting MDRPI development.

TABLE 3.

Youden's Index–based cut‐off score analysis for the Medical Device–Related Pressure Injury Risk Assessment Scale.

Cut‐off	Sensitivity	1−Specificity	Specificity	Youden's index
9	0	0	1	0
10.5	0.176	0.007	0.993	0.169
11.5	0.235	0.007	0.993	0.228
12.5	0.412	0.028	0.972	0.384
13.5	0.529	0.07	0.93	0.459
14.5	0.706	0.112	0.888	0.594
15.5	0.765	0.238	0.762	0.527
16.5	0.882	0.308	0.692	0.574
17.5	0.882	0.413	0.587	0.469
18.5	0.882	0.524	0.476	0.358
19.5	0.941	0.65	0.35	0.291
20.5	0.941	0.804	0.196	0.137
22	1	1	0	0

Note: Bold values indicate the optimal cut‐off point based on the highest Youden’s index.

TABLE 4.

Comparison of MDRPI risk levels between two groups of patients (N = 160).

Risk level	Patients with MDRPI, N (%)	Patients without MDRPI, N (%)	χ 2	p‐value
High risk (9–14 points)	12 (70.6)	16 (11.12)	37.267	< 0.001
Medium risk (15–18 points)	3 (17.6)	59 (41.3)
Low risk (19–21 points)	2 (11.8)	68 (47.5)

Additionally, EFA was conducted on the final nine‐item version of the MedRAS to examine its underlying factor structure. The KMO measure of sampling adequacy was 0.792, indicating that the sample was adequate for factor analysis. Bartlett's test of sphericity was statistically significant (χ² = 397.887, p < 0.001), confirming that the correlation matrix was appropriate for factoring. The analysis revealed a two‐factor structure explaining 50.92% of the total variance. Factor 1 (eigenvalue = 3.492, 38.80% variance) was labelled “Device and Mechanical Factors” and included items related to device stability and safety (0.777), placement site (0.666), number of medical devices (0.661), use of protective materials (0.657), and friction and/or shear forces (0.614). Factor 2 (eigenvalue = 1.090, 12.11% variance) was labelled “Patient and Tissue Factors” and comprised items related to overall PI risk score (0.723), condition of contact tissue (0.707), moisture accumulation (0.566), and anatomical compatibility (0.475) (Table 5).

TABLE 5.

Exploratory factor analysis results for the MedRAS.

Items	Factor 1 device and mechanical factors	Factor 2 patient and tissue factors
Device stability and safety	0.777
Placement site	0.666
Number of devices	0.661
Use of protective materials	0.657
Friction/shear	0.614
Overall PI risk score		0.723
Skin/tissue condition		0.707
Moisture		0.566
Anatomical compatibility		0.475
Eigenvalue	3.492	1.090
Variance explained (%)	38.80	12.11
Cumulative variance (%)	38.80	50.92

Note: KMO = 0.792; Bartlett's test of sphericity: χ² = 397.887, p < 0.001. Factor correlation: r = 0.311.

Reliability analyses demonstrated satisfactory results. The internal consistency of the scale was good, with a Cronbach's alpha coefficient of 0.80. The inter‐rater reliability assessed by Cohen's kappa coefficient was 0.806 (p < 0.001), indicating a very good level of agreement between the two raters (Table 6).

TABLE 6.

Inter‐rater reliability results for the Medical Device–Related Pressure Injury Risk Assessment Scale.

Raters	M ± SD	Kappa coefficient	p‐value
Rater 1	16.46 ± 2.76	0.806	< 0.001
Rater 2	16.50 ± 2.89

Abbreviations: M, Mean; SD, Standard Deviation.

6. Discussion

This methodological study developed the MedRAS to identify MDRPI risk in hospitalized adult patients by focusing on the device–skin/mucosa interface mechanisms that differentiate MDRPIs from conventional pressure injuries. The findings provide evidence that MedRAS is a psychometrically sound instrument, demonstrating acceptable validity and reliability for bedside use in adult inpatient settings. By incorporating clinically observable and modifiable device‐related and tissue‐related risk cues, MedRAS aims to support early risk recognition and promote more targeted preventive nursing actions within routine clinical workflows.

The content of MedRAS was shaped to reflect practical risk cues that can guide prevention at the point of care. The retained items capture device burden and device–interface risk in a way that supports structured nursing interventions. For example, the number of devices reflects cumulative mechanical load and more opportunities for unnoticed high‐pressure zones, while device stability/safety and friction/shear highlight a key MDRPI pathway in which repetitive micro‐movements intensify tissue deformation [31, 32]. Likewise, anatomical compatibility and placement site emphasize the vulnerability of fragile contours, bony prominences, and mucosal surfaces, whereas contact tissue condition and moisture accumulation address reduced tolerance and microclimate‐related susceptibility [2, 7, 33]. Collectively, these domains were selected to ensure that MedRAS not only identifies risk but also indicates modifiable targets such as stabilization, optimizing device positioning, protective interfaces, and moisture management [9, 31].

In addition to clarifying what MedRAS includes, the preliminary items that were not retained provide important clinical insight. Factors such as device material hardness (i.e., the rigidity or stiffness of the device material, which affects pressure distribution at the skin–device interface), biocompatibility, surface area, removability/repositionability, and duration of device exposure may be theoretically relevant, yet they may not consistently differentiate MDRPI risk in routine adult care. One plausible explanation is limited real‐world variability, as many devices share standardized materials and are inherently designed to be biocompatible, reducing contrast across patients ([34]; Mateu‐Sanz et al. [35]). Likewise, duration of exposure may be less discriminative due to ceiling effects in inpatient settings where devices often remain in place for prolonged periods. This is plausible because the association between wear time and MDRPI is not uniform across studies; in some settings (e.g., NIV masks in pulmonary ICU), duration shows no direct relationship with injury [36], and in others MDRPIs can develop quickly, indicating that time alone may be insufficient to distinguish risk [37, 38]. Moreover, device‐related characteristics such as repositionability/removability and interface contact extent may not always reflect modifiable care processes, because many devices are clinically indispensable and repositioning can be limited by patient condition and workflow constraints; consequently, their relationship with MDRPI development may be less detectable in single‐center settings [31, 39]. Importantly, excluding these items does not suggest clinical irrelevance; instead, it highlights that MedRAS prioritizes bedside‐observable and operationally actionable determinants to support prevention‐focused assessment.

From a validity perspective, MedRAS demonstrated strong evidence of content‐ and criterion‐related validity, supporting its use as a focused MDRPI risk assessment tool in adult inpatient care. First, the expert review process indicated excellent content relevance (overall CVI = 0.96), suggesting that the retained items comprehensively represent the MDRPI risk construct and reflect clinically meaningful device–tissue interface mechanisms. This strong content foundation was further supported by the scale's criterion‐related validity, as ROC curve analysis showed high discriminative ability in identifying patients who developed MDRPIs, and the cut‐off score derived from Youden's Index offered a clinically interpretable balance of sensitivity and specificity. The two‐factor structure identified through EFA provides further support for the construct validity of MedRAS. Factor 1 (Device and Mechanical Factors) captured items related to external device characteristics and mechanical forces, while Factor 2 (Patient and Tissue Factors) reflected intrinsic patient‐related vulnerability. This distinction aligns with the theoretical understanding of MDRPI aetiology, which recognizes both extrinsic device‐related mechanisms and intrinsic tissue susceptibility as key determinants of injury risk ([31]; NPIAP, 2025). In the other MDRPI Scale developed by Aydin Kahraman & Ipek Çoban [20], validity was supported through content and construct analyses. Their scale reported a CVI of 0.87 and yielded an 8‐item, two‐factor structure with adequate sampling adequacy (KMO = 0.726) and acceptable CFA fit indices; however, the model explained 47.063% of the total variance, which suggests that additional MDRPI‐relevant dimensions may remain unaccounted for in adult clinical settings. Notably, the factor structure of MedRAS differs conceptually from that of Aydin Kahraman & Ipek Çoban [20], whose factors were labelled “General Condition of the Patient” (including consciousness status, tissue perfusion, and general PI risk) and “Effect of the Medical Device on the Contact Area” (including skin/mucosal integrity, device position, and use of pressure‐reducing materials). In contrast, MedRAS organizes risk determinants by distinguishing between device/mechanical factors and patient/tissue factors, which may offer a more clinically actionable framework by explicitly separating modifiable device‐related risks from patient‐specific tissue vulnerabilities.

While this study makes a valuable contribution, MedRAS appears to strengthen the validity argument by offering broader, prevention‐oriented coverage of bedside‐observable and modifiable interface‐related determinants, which may enhance clinical interpretability and support action‐guiding risk stratification in adult workflows. Moreover, MedRAS' criterion performance compares favorably with instruments that incorporate device‐related factors more indirectly; for example, in an adult ICU study, the Braden QD showed only moderate predictive ability for MDRPI outcomes (AUC = 0.6897), underscoring the potential advantage of an instrument specifically structured around MDRPI‐related mechanisms [18]. Nonetheless, regardless of the risk assessment tool employed, performing a baseline skin assessment prior to device placement remains a fundamental step in MDRPI prevention.

Regarding reliability, MedRAS demonstrated strong internal consistency and rater agreement, indicating that the scale yields stable and consistent scores when applied in routine clinical practice. The internal consistency of MedRAS was good (Cronbach's α = 0.80), suggesting that the retained items measure a coherent MDRPI risk construct while maintaining sufficient clinical breadth. In addition, MedRAS showed very good inter‐rater reliability (Cohen's κ = 0.806), supporting the scale's usability as a bedside tool that can be applied consistently by different clinicians. These reliability findings compare favourably with the only other MDRPI‐specific adult scale currently available. Aydin Kahraman & Ipek Çoban [20] reported an overall internal consistency of α = 0.738 for their 8‐item instrument, indicating acceptable reliability but relatively lower internal consistency compared with MedRAS.

7. Strengths and Limitations

This study has several strengths that should be highlighted. First, MedRAS was developed through a systematic and theory‐informed process, ensuring that item generation and selection were grounded in clinically relevant MDRPI mechanisms and aligned with current guideline recommendations. In addition, the scale was designed to emphasize bedside‐observable and modifiable device–tissue interface determinants, supporting its potential feasibility and usefulness within routine nursing workflows. Finally, the study provides comprehensive initial evidence supporting the validity and reliability of MedRAS, indicating that it may serve as a practical tool for structured MDRPI risk assessment in hospitalized adult patients.

Several limitations should also be considered when interpreting the findings. First, the study was conducted in a single center, which may limit the generalizability of the results to healthcare settings with different patient characteristics, device utilization patterns, and care processes. Second, the use of a non‐probability convenience sampling approach may have introduced selection bias. Third, the relatively small number of patients who developed MDRPIs (n = 17), combined with unbalanced participant distribution across clinical settings (ICU n = 10 vs. surgical clinics n = 90), reduced statistical power and precluded reliable subgroup analyses by clinical context; future studies with larger, balanced samples are needed to examine setting‐specific performance of MedRAS. Fourth, item selection relied on univariate logistic regression; future studies using multivariable approaches may further strengthen and refine the predictive structure of the scale. Finally, the predictive validity of MedRAS across longer follow‐up periods and in more diverse clinical settings (e.g., multicenter cohorts and different hospital units) was not evaluated in the present study. Further external validation studies are therefore warranted.

8. Implications for Policy and Practice

While MedRAS requires further validation and refinement through multicenter studies before widespread implementation, the current findings suggest several potential implications for clinical practice. With additional validation, MedRAS may offer nurses and clinical teams a structured approach to bedside MDRPI risk assessment. For nurses and clinicians, the scale can function as a standardized decision‐support aid during key moments such as initial device placement, shift handovers, daily skin/mucosa checks, patient transfers, and changes in treatment intensity. Using a shared MDRPI‐specific risk language may also strengthen communication between nurses, physicians, and allied health staff (e.g., respiratory therapy), enabling earlier escalation when high‐risk interface conditions are identified and improving coordination of preventive actions around device stabilization, protective interface selection, and follow‐up monitoring. Additionally, incorporating MedRAS into nursing documentation systems could improve continuity across shifts and support unit‐level tracking of MDRPI prevention performance.

9. Recommendations for Further Research

Further research should evaluate MedRAS across broader care contexts to strengthen its generalizability and implementation feasibility. Multicenter studies involving different inpatient units and device profiles are needed to examine consistency of performance and applicability across adult populations. Future studies may also test whether MedRAS‐guided prevention protocols improve nursing workflow efficiency and reduce MDRPI incidence compared with standard care, particularly when combined with structured staff training and routine reassessment schedules. Longitudinal research could explore how MedRAS scores evolve over hospitalization and whether repeated scoring enhances early detection. Finally, implementation studies focusing on nurse usability, interprofessional uptake, and digital integration (e.g., electronic prompts or automated risk flags) would clarify how MedRAS can be adopted sustainably in real‐world clinical practice.

10. Conclusion

This study developed MedRAS as an MDRPI‐specific risk assessment tool for hospitalized adults and demonstrated that the instrument has appropriate validity and reliability to support structured bedside evaluation of MDRPI risk. The overall psychometric profile indicates that MedRAS can produce consistent and clinically meaningful risk scores, strengthening confidence in its use for routine prevention planning. Further multicenter validation and implementation studies are warranted to confirm its performance across diverse patient populations and to evaluate its contribution to MDRPI prevention outcomes in real‐world practice.

Funding

The authors have nothing to report.

Ethics Statement

Ethical approval was obtained from the Koç University Clinical Research Ethics Committee (Decision No: 2024.331.IRB3.140).

Conflicts of Interest

The authors declare no conflicts of interest.

Supporting information

Data S1: Supporting Information.

Data Availability Statement

The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available due to privacy or ethical restrictions.