You may not think that the topic of fecal incontinence (FI) and management sounds very lucrative or interesting, and within demanding and stressful healthcare environments it is usually last to receive attention. Even if healthcare workers do think about these issues, they often do not have as much time as they would like to invest in fecal management, and they have had few options to choose from until now.
Consure Medical has developed Qora, a novel stool management kit, that not only improves management, patient care, and provides ease of use with no compromise of patient safety, but it also greatly reduces overall hospital stay and associated costs. Qora can greatly reduce the incidence, occurrence, and the costs associated with hospital acquired conditions (HACs), including nosocomial infections such as C. diff, Catheter-Associated Urinary Tract Infections (CAUTI), Central Line-Associated Bloodstream Infection (CLABSI), and hospital-acquired pressure injury (HAPI), in comparison to the traditional practices of FI management.
Qora features a hygienic applicator which contains a stringently tested, flexible indwelling diverter that is designed to complement physiological rectal anatomy. Once deployed, the diverter conforms to all sides of the rectal wall, providing a pathway for stool diversion with minimal leakage. The diverted stool is collected into a malodor containment collection bag through a transit sheath. The withdrawal port allows the user to collapse the indwelling diverter and ensure safe removal of the device after usage is complete.
The inventors and engineers of this device have also tested and accounted for patient comfort and safety, with a largely decreased radial pressure, thus minimizing the pressure exerted on the rectal wall, internal sphincter, and thereby avoiding complications like rectal necrosis, hematoma and sphincter dysfunction or injury.
Effective fecal management systems provide for the containment and diversion of exudate, which is either liquid or semi-liquid consistency. If not managed effectively, fecal incontinence can lead to nosocomial (hospital-acquired) transmission and cause significant complications to a patient’s health and well-being, in addition to being detrimental to healthcare workers.
Therefore, issues involving bowel management and incontinence represent a major challenge for safe and comprehensive nursing care of acute and critically ill patients. Fecal incontinence (FI) also represents an economically significant subsection of patient healthcare, with an average annual total cost of $4110 per person1 with steadily increasing cost trends seen each year. Even more significant are the downstream costs associated with patient healthcare after complications and infections that occur because of FI. In one study, it was reported that improved FI management could lead to annual savings greater than $75,000 per ICU – with savings mainly attributed to reduced
More than 100 million bedridden patients suffer from fecal incontinence and diarrhea across the globe, and 36-50% of critical care patients with FI develop incontinence-associated dermatitis and are 22-37.5 times at higher odds of developing hospital-acquired pressure injuries.3,4 The leading cause of infectious nosocomial diarrhea in the United States remains C. difficile, which affects up to 20% of hospitalized patients per year and leads to almost 3 million cases of infectious diarrhea and colitis per year.5
In a study performed in New York, the development of nosocomial C. diff in hospitals has associated average costs of $29,000 per infection, with subsequent studies on a national level confirming costs ranging from $8,911 to $30,049 per patient.2 Subsequent to the treatment of C.difficile infection, pressure injury of the sacral region is a common clinical sequlae of liquid stool incontinence. Pressure injuries incur costs related to the duration of intensive care, increased length of stay, and treatments that begin at $21,410, with the overall average incremental cost of these estimated to be at $10,700 per patient based on increasing levels of severity.2
Per annual cost reduction projections performed by Consure Medical, adoption of Qora™ SMK has shown to decrease the average direct cost of managing fecal incontinence in bedridden patients by almost 85%. The efficacy of Qora™ SMK both as an effective infection control device and a wound care solution in bedridden patients has shown a US hospital to save between $50,000 to $300,000 per year.
The bottom line is that FI management affects millions of patients annually and the cost of management quickly amplifies with concurrent complications and infections. To answer some questions about this product, I had the pleasure of speaking with Amit Sharma, Co-Founder of Consure Medical, and inventor of the Qora stool management kit, and the head of US Market Development and Operations for Consure Medical, Emily Reichart.
Alice Ferng, Medgadget: How did you become interested in this topic and how did that lead to the founding of this company and development of a stool management product?
Amit Sharma, Consure Medical: This isn’t a glamorous topic so not many people want to work in this area, but once you have a family member or someone close to you suffer from this condition, it is just not possible not to think about it.
A reputed senior cardiologist from our team had been tending to his mother who was sick. After her recovery, he light-heartedly expressed that even with his kind of expertise the only thing he could not take care of was her fecal incontinence. We have all seen FI become a big problem during patient care and management, even with our own family members. Many of the other conditions have a method of management or a solution, but FI is something where an effective management method just did not seem to exist. It struck us that FI is a condition that is widely prevalent but is over-looked by most of the experts and technology providers.
This product emerged from the Stanford Biodesign program, and Consure Medical was formed to address this latent clinical condition and be a pioneer in a multi-billion dollar global opportunity. Containment of diarrhea has been largely an overlooked opportunity for about 40 years by the industry, however industrious care providers have tried many jerry-rigged solutions to help their patients. What has emerged has been intrarectal balloon catheters, which is an adaptation of the Foley catheter and not really designed for the anatomy of the rectum. There were various aspects to consider when creating this product, such as peristalsis, stool consistency, location of nerve endings, etc. from a clinical perspective. Hygiene, 100% malodor containment, and patient comfort were by far the biggest demand from the care provider’s perspective.
After over 2-3 years of rigorous development and clinical trials, Qora™ SMK meets the needs of the hospitals, care providers and patient’s family members. We are establishing a new standard of care for containment of diarrhea, which we hope will make Qora™ as synonymous as Foley’s and Ryle’s.
Emily Reichart, Consure Medical: A lot of the motivation of Consure Medical lies with preventative medicine, where we are interested in creating products that impact both acute and long-term management of patient healthcare. Consure Medical strives to be a value based provider for hospitals and aims to provide solutions that address the unmet and latent needs of the user.
Our product is called Qora™ stool management kit. Qora™ has significant advantages and key differences when compared to other products available on the market, specifically the way in which the product is used. Typically, fecal incontinence and diarrhea are managed by diapers and pads, or by intrarectal balloon catheters. For patients who already have skin break down, burns, or other critical conditions, there is an important need to keep fecal matter contained and separate such that no further infections or complications result. Qora™ stands out given its novel design and safety features that differentiate it as a premier solution compared to other products available in the market.
The intrarectal catheters on the market right now often require the sphincter to anchor, and can lead to internal trauma such as sphincter dysfunction or tissue necrosis. Qora™ anchors above the sphincter thus eliminates the potential of sphincter dysfunction and increases patient eligibility. Moreover, intrarectal balloon catheters have to be manually inserted. A hallmark feature of this device is it’s applicator which allows for a safe and hygienic deployment. Once deployed, the gentle indwelling diverter conforms to the rectal wall ensuring maximum comfort to the patient. Some of our conscious patients have reported that they do not feel the presence of the device placed inside. The indwelling diverter is designed in a way that any involuntary pull on the device by patient or healthcare provider allows the device to be safely expelled without causing any harm to the patient.
I also want to reiterate the 100% malodor containment aspect of our product, including the sheath and collection bag– more often than you would imagine, I have nurses come and share how much they appreciate this singular feature.
Medgadget: What is the longest amount of time that this device has been left in a patient?
Amit Sharma, Consure Medical: Our device is FDA cleared for use up to 29 days, and therefore the device can be left in, with the sample collection bag replaced as often as necessary. Usually we observe an average of 7-10 days of use. The longest period of time that we have utilized the device was 27 days. Since this particular patient had previously developed necrosis due to an alternate management plan and was in an extremely critical condition, he would not have survived without our device and thankfully with the use of Qora™, he was able to make a full recovery.
Medgadget: Are there issues with the comfort level of the patient with use of your device?
Emily Reichart, Consure Medical: We have had conscious patients that had used both the balloon catheters and also been managed by our device. Because of the area where our device is deployed, the profile diameter of our trans-sphinteric sheath, these patients often verbally comment that either they don’t feel the device at all, or that our product is more comfortable compared to other solutions. Again, when we decided to reimagine containment of diarrhea in bedridden patients, we started with an unmet need and designed the product with patient comfort in mind.
Medgadget: What are the big advantages of using your device over traditional management approaches (pads, skin cleansers, diapers, etc.)?
Amit Sharma, Consure Medical: Our is product is not only about convenience, but also patient safety. Consure Medical is the only product in this category that has conducted a safety, efficacy study that included a pre and post device use colonoscopic examination. Qora™ is proven to not cause any injury, trauma, or even erythema. Our health-economic evidence enables a hospital administration to project the potential improvement to their quality metrics and associated cost savings. Lastly, over 70% of the nurses that have used the Qora™, agreed that they would recommend our product to their colleagues, which has led to groundswell of support for our novel technology.
Medgadget: How does Qora comparatively decrease undesired leakage outcomes over balloon cuff-based anchoring?
Amit Sharma, Consure Medical: Our design features a thoughtfully engineered indwelling diverter that not only decreases pressure exerted on the rectal wall, but also conforms to the rectal wall to maintain a larger lumen during both resting and peristaltic contractions, which is something that can be uncomfortable for a patient when using balloon cuff-based anchoring. Our diverter conforms to the rectal anatomy irrespective of physiological functioning or patient position, thereby providing an optimal rectal seal and reducing instances of peripheral leakage.
Product page: Qora…
- Economic cost of fecal incontinence
- Evaluating New Innovations in Fecal Management Solutions
- Gray M, Beeckman D, Bliss DZ, et al. (2012). Incontinence-associated dermatitis: A comprehensive review and update. J Wound Ostomy Continence Nurs 39(1):61-74.
- Maklebust J, Magnan MA. (1994). Risk factors associated with having a pressure ulcer: a secondary data analysis. Adv Wound Care 7(6):25 -34.
- Jones S, Towers V, Welsby S, et al. (2011). C. diff containment properties of a fecal management system: an in vitro investigation. Ostomy Wound Manage 57(10):38-49.