Only One Advanced Assessment Technology Earned a Recommendation in the International Pressure Injury Guideline
On August 7, 2026, the NPIAP/EPUAP/PPPIA International Pressure Injury Guideline published its Advanced Technologies for Skin and Tissue Assessment chapter; the first update to the guideline since 2019.
Clinical practice guidelines are intended to give clinicians clear guidance on how to practice, using the best available evidence. Recommendations, when practiced, are intended to help clinicians meet expected standards of care in specific areas of medical care. Understanding guidelines can still take some work; here is our analysis on what was written in the technology section of the pressure injury guideline.
The guideline describes using technologies for early detection of pressure injuries as “an innovative and promising field of research and practice with a high potential to improve clinical decision making and PI prevention planning and implementation.” (emphasis added) After years of review and analysis of the clinical evidence in pressure injury prevention, the guideline came to sharp conclusions about four different technology categories in this guideline. The differences can be easy to miss, so it’s important to understand that only one of the technology categories in the guideline earned designation as an evidence-based practice recommendation (that’s practice, not research).
Focal edema measurement, also known as sub-epidermal moisture (SEM) measurement, is the only advanced skin and tissue assessment technology in the guideline to receive a graded recommendation.
For nurses and nursing leaders evaluating pressure injury prevention technology, four important points follow from these guidelines and the regulatory status of the technologies assessed:
- Recommendations and good practice statements are not two degrees of the same thing. They have entirely different evidence bases.
- The panel reached the focal edema recommendation by following the published evidence all the way to patient outcomes.
- The focal edema recommendation carries information clinicians can act on: a location, a threshold, and a “window of opportunity for enhanced prevention”.
- While not addressed in the guideline, it’s important to understand that focal edema measurement is the only category in the guideline with technology FDA-cleared for pressure injury management. No other technology in the guideline has this recognition.
Each of these topics is explored in more detail below.
1. Recommendations and good practice statements have entirely different evidence bases. It’s the difference between evidence and opinion.
You can think about this like the inspection grades you see at restaurants. A restaurant with an inspection grade displayed means an inspector showed up, evaluated the latest evidence of cleanliness, and scored that kitchen according to a rigorous guideline. However, without that grade the restaurant may “look clean” from the street or even the dining room and you might get by with that…or you may end up with food poisoning. If you don’t follow the grade, you’re putting yourself at risk.
Now looking at the guideline recommendation for focal edema, it reads:
“We suggest using results from a device that detects and measures focal edema as an adjunct to a visual and tactile skin and tissue assessment in individuals at risk of pressure injuries, where the technology is available and feasible to use.” STA3 — conditional recommendation, very low certainty of evidence
A conditional recommendation is a graded recommendation. That means a clinical question goes through the guideline’s full GRADE pipeline: a systematic search for evidence, an assessment of risk of bias, meta-analysis where possible, a certainty rating, and an Evidence-to-Decision framework. The 2026 edition of the guideline was developed using that methodology. The 2019 edition was not.
Other technology approaches in the chapter were determined to be good practice statements, including skin and tissue temperature assessment, because the available evidence was insufficient to support a GRADE review or recommendation. To quote the Guideline directly regarding skin and tissue temperature assessment, “There was only a very small volume of very low certainty evidence across the full chain of linked evidence. The Guideline Governance Group considered this body of evidence to be insufficient to establish a clear link demonstrating that use of advanced technologies to evaluate skin and tissue temperature leads to a reduction in PI occurrence.”
2. The panel followed the evidence all the way to patient outcomes
The chapter does not evaluate categories on technology alone. It applies a four-step chain of linked evidence, and the final link is the one that decides the outcome:
| The panel’s question | What the guideline reports for focal edema |
| 1. Does the technology measure the pathology? | Biocapacitance distinguishes normal tissue from tissue with focal edema. Porcine model showed a statistically significant difference (p=0.0052) with a dose-response relationship. |
| 2. Can it be reliably administered? | Trained testers achieve good inter-rater reliability (ICC 0.848–0.961), which the guideline says suggests translatability to practice. See the caveat below. |
| 3. Does the test result change prevention? | In all eight studies a delta cutoff ≥0.6 triggered enhanced prevention — SSKIN, support surface change, repositioning, heel offloading, barrier cream, preventive dressings, more frequent assessment, nutrition care planning, patient education. |
| 4. Does test-informed care reduce PI occurrence? | Meta-analysis: Relative Risk 0.36 (95% CI 0.245–0.53, p<0.001); 16 fewer per 1,000. A further pre-post study, excluded from the analysis, reported a 93% reduction. |
This is what separates the statements in the chapter. Focal edema measurement is the ONLY technology in the chapter whose evidence extends across all four steps of the guideline’s own chain.
3. The recommendation clinicians can act on
Pressure-induced tissue damage can begin beneath the skin before there is anything obvious to see or feel. One early response to that pressure damage is focal edema.
Focal edema measurement gives clinicians information about changes beneath the skin at a specific anatomical location. This gives clinicians an objective, validated biomarker to act on.
It does not diagnose a pressure injury. Technologies detect, clinicians diagnose. The guideline states directly that detection of focal edema should not be considered diagnostic of a PI. It adds a source of information to the visual and tactile skin assessment nurses already perform, and the guideline is explicit that it should be used as an adjunct to that assessment rather than a replacement for it.
That information is valuable at the bedside for five primary reasons:
- A specific body location, not just a risk score. Risk assessment identifies who is at risk. Focal edema measurement identifies where an early pressure-induced tissue response has already occurred. The guideline states that “focal edema detection is specific to an anatomical site and can be used to prompt the immediate enhancement of anatomically targeted interventions.”
- A defined biomarker and single threshold. In all the studies the guideline reviewed, “a delta cutoff score of ≥ 0.6 was considered a measurement indicating a potential requirement for increased preventive PI care.” A Delta ≥0.6 is not a diagnosis, it indicates developing tissue damage that requires intervention. It is information to be used alongside clinical judgment in deciding when and where to enhance prevention.
- A window of opportunity before visible damage. The guideline notes that “the time lag between detection of focal edema and visually detectable and diagnosable PIs provides a window of opportunity for enhanced prevention,” and quantifies it: a meta-analytic mean of 4.61 days (95% CI 3.94–5.28, p=0.0001), with a second meta-analysis at 4.08 days.
- Assessment of dark skin toned patients. The panel identified this as part of its own reasoning: “An important consideration in making a conditional recommendation for using a device to measure focal edema to augment a visual and tactile skin and tissue assessment is the potential to enhance assessment of dark toned skin.”
- 64% safer care. The guideline reported that persistent focal edema measured by biocapacitance showed differences between healthy and pressure damaged tissue, can be reliably used at the bedside, prompts intervention earlier and more than skin and tissue assessments alone, and results in patient care which is almost two-thirds safer for patients than without it.
4. Always understand FDA clearance and indications for use
The clinical guideline tells you what a panel concluded the evidence supports. A device’s FDA clearance tells you what that specific device is cleared to be used for, and therefore what the manufacturer is allowed to claim in its marketing and use instructions. The guideline evaluates a method. FDA clears a device for a stated use in words printed on the label. Both records are public and they do not always line up.
What focal edema measurement is cleared for. In December 2018, FDA granted a De Novo request (DEN170021) for the Provizio SEM scanner measuring sub-epidermal moisture, cleared as “an adjunct to standard of care when assessing the heels and sacrum of patients who are at increased risk for pressure ulcers.” Because it was a De Novo, FDA created the category rather than matching an existing one: 21 CFR 876.2100, “Pressure ulcer management tool.” CMS followed with a dedicated procedure code, ICD-10-PCS XX2KXP9, effective April 2024.
What a thermal imaging camera is cleared for. The long-wave infrared device most often referenced in pressure injury discussions is not cleared for pressure injury management. It was cleared in 2013 (K131596) under the classification for surgical cameras and accessories, with a wound measurement camera as its predicate. Its indication is to capture images and “measure the thermal intensity data of a part of the body or two body surfaces.” The words pressure injury, risk, prevention, and early detection do not appear in it.
Why that matters to you. Off-label use of a device or technology is typically allowed in investigational studies with specific “Investigational Device Exemption (IDE)” requirements. The liability exposure arrives when off-label use stops being an individual clinical judgment and becomes policy and documented instructions applied to every at-risk patient. If a pressure injury later becomes a claim, litigation rests on what the device was cleared to do and what the protocol asked it to do. Present-on-admission and HAC Reduction Program determinations rest on that same record for CMS reporting.
Make sure you and your team fully understand the FDA clearance and indications for use when evaluating any new technology, including pressure injury prevention solutions.
A note about “very low certainty”
The focal edema conditional recommendation is rated very low certainty of evidence, and those words understandably catch a reader’s attention. Read on its own, the phrase sounds like a caution about focal edema measurement specifically. It is not. Among all the statements and levels of evidence in this guideline, it is simply the standard of this field.
Measuring focal edema is now in the same category as offloading heels, 30-degree lateral positioning, 2–3-hour repositioning, and protein supplementation, which have been relied on for decades in pressure injury prevention and management.
Across the published guideline:
| Statement types and evaluations in the guideline | 94 |
| Of those, graded recommendations | 28 (30%) |
| Graded recommendations rated very low certainty of evidence | 23 (82%) |
| Rated moderate certainty of evidence | 1 (seating support surfaces) |
| Rated high certainty of evidence | 0 |
| Strong recommendations resting on very low certainty evidence | 2 of 4 |
Across the published guideline, only three statements moved from “no specific recommendation” in 2019 to a “recommended practice” in 2026. Focal edema measurement is one of those three, and the only technology category among them.
What this means for evaluating technology
When several technologies appear in the same guideline chapter, it is easy to come away with the impression that the guideline supports all of them in broadly the same way. It doesn’t.
So “Is this technology in the guideline?” is not the best question to ask. It misses most of what the guideline is actually telling you. A better question is “What does the guideline say about it?” And in practice, that means looking at the type of statement attached to the technology and asking:
- Is it a graded recommendation or a good practice statement?
- Has the evidence been through the full GRADE process?
- How far along the chain of linked evidence does it reach and does it show positive changes in patient outcomes?
- Is there a defined threshold clinicians can act on?
- Can that information guide care at a specific anatomical site?
- Does the technology in question have the regulatory clearance and indications for use for pressure injury prevention?
For focal edema measurements, the only technology that is FDA-cleared for pressure injury management, the evidence answers all 4-steps of the evidence-to-decision framework, including reduced pressure injury occurrence and positive patient outcomes. It has a defined ≥0.6 threshold. And it flags a change at a named body site in a window the guideline puts at a meta-analytic mean of 4.61 days before a pressure injury becomes visible and diagnosable.
When evaluating advanced skin and tissue assessment technology, being included in a guideline and being recommended by a guideline are two entirely different levels of evidence. Understanding that difference between recommendations and good practice statements can help nurses and nursing leaders make better-informed decisions about the technologies they bring into clinical practice in their facilities.