Earlier this year, Medgadget reported on the FDA’s clearance of the SEM Scanner, a device created by Los Angeles-based Bruin Biometrics (BBI). The SEM Scanner is a wireless, handheld device that detects changes in sub-epidermal moisture as an indicator of risk for developing a pressure ulcer. Moisture can indicate the presence of localized edema and tissue fluid-related inflammation well before visual and tactile tests that represent the diagnostic standard of care today. To learn more about the challenges of pressure ulcers, their impact on the healthcare system, and how the SEM Scanner is making an impact improving standards of care for pressure injuries, Medgadget heard from BBI’s CEO Martin Burns.
Medgadget: Martin, thank you for taking the time to speak with us. First off, help us understand the challenges posed by pressure injuries and their impact on the U.S. healthcare system?
Martin Burns: First, it’s important to know how many people are affected by pressure injuries (PIs). They are among the most commonly reported injury among hospitalized Americans, affecting upwards of 2.5 million patients each year, with more than 60,000 deaths reported annually as a result of the injury itself or its complications. Sixty thousand deaths are comparable to the number of deaths from the opioid crisis. Furthermore, in a report from the Agency for Healthcare Research and Quality (AHRQ), although the rate of most hospital-acquired conditions dropped between 2014 and 2017, the rate of PIs—which are often classified as “never events”—actually increased by six percent over the same period, the only hospital-acquired condition to do so.
For healthcare providers (HCPs), PIs are costly in the extreme. PIs occurring post-admission in the care of a facility are seen to be reportable “never events” for which the facility pays for all of the screening, prevention, and treatment. Our economic models, submitted for publication, show that a 300-bed facility with a 2.5 percent incidence rate spends approximately $14M per year on PI screening, prevention, and treatment, of which approximately 90 percent is treatment.
At a population level, in 2017, the overall cost to treat these injuries in the U.S. was estimated in Congressional testimony at more than $25 billion. Separately, the AHRQ has estimated that the annual U.S. treatment cost lay between $9.1 billion to $11.6 billion per year, with the cost of individual patient care ranging from $20,900 to $151,000 per pressure injury. Additionally, the cost of treatment for hospitalized veteran patients with PIs in VHA facilities is estimated to be in the billions. More than 17,000 lawsuits related to pressure injuries are filed every year and they represent the second-most-common claim for medical malpractice after wrongful death—and even a greater number of claims than falls.
Medgadget: What are the risk factors that lead to the occurrence of a pressure injury? Are certain types of patients more susceptible to experiencing a pressure injury than others?
Burns: PIs form because of prolonged pressure on the skin and tissue of a force sufficient to exceed an individual’s “damage threshold,” a point at which a PI is likely to occur. Sheer and friction further compromise skin and tissue. They occur in people of all ages, from the very young to the very old, and in a variety of settings including hospitals, residential care, and people’s own homes. Risk factors have been well-studied and are understood to include those who have an existing PI, or have had one in the past, and individuals with diabetes, poor blood flow, and of course, those who are severely limited in their ability to move. Particularly striking is the statistic that dark skin-toned patients are four times more likely to die from complications of a PI, the diagnostic latency problem being particularly acute for that population cohort.
In order to best prevent serious pressure injuries from occurring, it is not just identifying who might be at risk but where on the body each patient who is at risk might develop an injury, and doing so before the damage manifests at the skin’s surface.
Medgadget: What happens today when a patient presents with a pressure injury?
Burns: Currently, patients are screened on admission into two PI groups: patients who have already developed PIs, or those without PIs who may or may not be at risk of developing one or more. A patient presenting with a PI formed prior to admission will undergo a variety of treatments, each dependent on the condition of the patient’s skin and tissue, the clinical goals being, healing, pain management and of course, avoidance of the chronic wound cascade, and infection.
Those without an existing PI are further assessed, typically using validated risk-assessment tools. Depending on assessed risk, patients will receive a bundle of “universal preventions” designed to reduce PI risk for the whole patient. This is supplemented by a skin assessment—visual and palpation tests—intended to diagnose a developed PI. If the skin assessment diagnoses a PI, then anatomy-specific interventions (e.g., at the left heel) are initiated.
A subtle insight of consequence is that the diagnostic standard currently in use has a
chronic “latency problem” in
one of two forms:
- Diagnostic latency: This is the gap between the time when the damage actually begins and the time, under the current standard of care, at which it is detected and confirmed. Risk assessment tools tell nurses that a patient is at risk; the question of where that patient is at risk goes unanswered. Diagnosis by skin assessment occurs too long after the wound has developed.
- Anatomical latency: Prevention, keeping the patient’s skin intact, rescuing and reversing the damage, requires knowing where on the body to intervene, when and how intensively, not only that the patient is at risk. Skin assessments only achieve that diagnostic threshold required to trigger anatomy-specific interventions once the wound has developed, too late to achieve prevention at scale.
Medgadget: What are some of the limitations of current standards of care?
Burns: The understanding of PI etiology has significantly advanced over the past few years. Researchers around the world—USA (Bates-Jensen), UK (Bader), Ireland (Moore), the Netherlands (Oomens), and Israel (Gefen)—have now definitively demonstrated in the lab and in patients that tissue damage starts at the cellular level, invisible to the naked eye, and often it starts from the inside out; this again is the source of the latency problem.
Yet unfortunately, the current standard of care in PI prevention still depends to a large degree on assessing risk by sight and by touch on areas of the skin that are most likely to form PIs. HCPs still depend on evaluating patients this way to confirm that the wound is present; this strong reliance on visible and tactile signs of damage, as reported in 2017 by Moore in International Wound Journal, is a major contributing factor to the latency problem. But again, this approach brings several significant challenges. The current approach to risk assessment is very subjective, and concerns have rightly been raised as to how reliable they are. By the time someone actually sees something, a lot of tissue damage has likely already taken place. Assessing PIs by sight can also be subjective and unreliable because it depends on how experienced the clinician is.
A more data-driven method of detecting the early warning signs of PIs backed by years of scientific research—which would allow for early invention and better prevention—is urgently needed. In safety-engineering terms, this current standard of care is a system that is fully optimized in its efficiency. Without technology, this is as good as it gets.
Medgadget: Shifting to Bruin Biometrics, what is the SEM Scanner, how does it work, and how does it aid in the prevention of pressure injuries?
Burns: The SEM Scanner is the first device to provide practitioners the information they need to assess the risk of an anatomy developing a PI. It augments the intelligence of nurses and their assistants in being able to know when, where, and how to intervene.
The SEM Scanner is a wireless handheld device that is indicated for use as an adjunct to the standard of care when assessing patients who are at increased risk for PIs. The SEM Scanner is the world’s first FDA-authorized device to objectively alert clinicians to specific anatomical areas of a patient’s body at increased risk for developing pressure damage. These data facilitate earlier, and anatomically specific, interventions designed to reverse the damaging effects of pressure and shear, and prevent PIs from breaking through the skin. Patient risk assessments are performed with the SEM Scanner before visible damage manifests at the skin surface.
Medgadget: What differentiates the SEM Scanner?
Burns: The Scanner differentiates itself from the current standards of care by moving:
- From subjective skin assessment to objective measures;
- From acting on visually manifest PIs to acting on the biomarker, earlier;
- From whole body to anatomy specific; and,
- From treating broken skin ulcers to keeping skin intact.
Early identification of risk can benefit patients by leading to the potential reversal of tissue damage and by allowing HCPs to manage the tissue damage while the skin is still intact. No new or dedicated staff are needed to operate the device and existing staff and intervention resources are used once anatomy-specific risk is identified using the Scanner. Because the care-pathway is already well defined, the Scanner readily fits into existing protocols.
All of our health economic models show the Scanner implementation as a cost-saving, “dominant” quality intervention that “subordinates” all other PI prevention initiatives based on well-established health economic thresholds of willingness-to-pay.
Medgadget: Why has no one taken this approach to tackling pressure injury prevention?
Burns: Development of these new-to-the-world types of devices is complex, costly, time-consuming and, in the early stages, highly risky. The challenge we faced was not knowing at the outset if the biomarker—subepidermal moisture—was credible and whether it could be reliably measured. That is not terribly appealing to investors and, understandably, was met with initial skepticism from the scientific community. Remarkably, for a clinical challenge the size of PIs, until the SEM Scanner, no technology has been successfully applied to addressing the latency or anatomy problems. It’s remarkable in comparison to other, lesser-scale and less fatal conditions, which have hundreds of millions of research dollars applied to the problems every year.
PIs, by contrast, have lagged that kind of investment in innovation. PI research has been highly clinically focused on well-defined clinical questions and has not benefitted from inputs from translational science and engineering. The researchers named in an earlier answer, along with BBI changed that.
We believe that we have been able to “see the future” of PI treatment in a way that the healthcare community had previously not been able to do. We have taken steps to share what we’ve learned—both with regard to the fundamental science of PIs as well as the application of our technology—with the appropriate stakeholders so they can share our vision of where the state of care is heading.
Medgadget: Can you share some of the outcomes that the SEM Scanner has achieved?
Burns: The outcomes practitioners have achieved are published in studies showing 100 percent reductions in “hospital-acquired pressure injuries” being achieved. Most of the sites of service are publicly reporting their results as more than 80 percent reductions.
Of particular pride for me is a conference report by a palliative care chief nurse in the UK, Gillian Raine at Marie Curie, who cares for end-of-life patients. Even in that chronically compromised oncological population, Gillian reported a more than 40 percent reduction in PI incidence. Gillian frequently talks about wanting her patients to “live well and die well”; not suffering from a PI at the end of life helps.
Medgadget: What’s next for BBI in tackling the challenge of pressure injuries in addition to other conditions?
Burns: Success for us is an SEM Scanner being used on every at-risk patient in every care setting at admission, during the stay and at discharge so that prevention is achieved and sustained. We will then address patients at risk of PIs who are not in active care; think mobility-compromised people at home.
We know that the journey is not short. Now that we have resolved all of our development and commercialization “formulas” of receiving regulatory authorization, having the data, customers, users, and a movement behind prevention using this modernized care pathway, we are focused on accelerating growth toward being the new, modern standard of care; of making PI prevention at scale a reality.
Concurrently, we have started work in Europe toward expanding the use of the SEM biomarker and our device on detecting changes in diabetic foot conditions. Research into other skin conditions follow.
Medgadget: Thank you again for your time Martin, is there anything else you’d like to share?
Burns: Once decision-makers understand this new insight into why PIs are still occurring (latency) and the message that PIs can be prevented without more staff while saving operating expenses and reducing provider risk, I believe the standard of care will pivot rapidly. A provider institution that is turning over $11 billion a year is, by our models, spending about half a billion on PI screening, prevention, and treatment. By preventing just half of the PIs and taking out variable costs, then these organizations end up saving about $100 million a year by simply not incurring the treatment cost; those savings instead going directly to operating earnings. That’s $1.3 billion of added corporate value. I am unaware of any quality interventions, in any area of care, that can add so much value as preventing PIs.
Flashback: First Device for Predicting Risk of Pressure Ulcers FDA Cleared
Product page: SEM Scanner…
Anupam Ghose, a physician by training, was diagnosed with Type 2 Diabetes Mellitus (T2DM) in 2017. After the diagnosis of T2DM, he followed a low carbohydrate high fat diet and reversed his T2DM within a year. Now he has one main goal in life and that is to make people understand that the conventional method of treating T2DM is not beneficial. Type 2 diabetes is reversible and the best way to reverse T2DM is through diet and lifestyle modifications. He now decided to help people with type 2 diabetes by offering online coaching to reverse their diabetes.