Evaluating New Innovations in Fecal Management Solutions

Editors Note: Correct Order of Authors is as follows:  Niall Wallace, Dr. Harsh Sheth, Dr. Michael Ackerman, Ashlee Garcia, WOCN

Abstract

Fecal incontinence is a debilitating condition that if not managed effectively can lead to nosocomial transmission. This can cause significant complications to the patient’s health and well-being while also being detrimental to healthcare workers (HCWs) and healthcare institutions. The risk of transmission of hospital acquired infections, such as Norovirus and Clostridium difficile (C. diff), in acute care environments is a persistent problem. New fecal management systems (FMSs) can significantly help decrease the risk of infection transmission by providing more effective containment. This containment prevents contact between the patient’s stool and HCWs, avoids environmental contamination of the patient area, and provides safe ongoing diversion of stool.

The potential financial benefits of better fecal management include reducing the cases of pressure injury (note to reader: ‘pressure injury’ replaces the more common term ‘pressure ulcer’ (The National Pressure Ulcer Advisory Panel, 2016), lowering the risk of nosocomial transmission, reducing costs related to consumables and nursing time, as well as decreasing the cost to address clinical complications. The provider may also avoid impacts related to the Centers for Medicare and Medicaid Services (CMS)/payer penalties associated with poor outcomes and patient satisfaction. With new and innovative FMS clinical devices available to hospitals and health providers, the evaluation for clinical adoption should consider better infection prevention, wider patient eligibility, improved clinical outcomes, and potential financial benefits and clinical preference for these new solutions among clinicians and HCWs.

Introduction

Fecal incontinence (FI), also referred to as bowel incontinence, presents a major challenge for safe and comprehensive nursing care of acute and critically ill patients. When manifested as diarrhea, the effects of fecal incontinence can range from mild skin irritation to more serious conditions including severe perineal dermatitis, altered water absorption in the intestinal tract, infection transmission, and sepsis (Beitz, J. M., 2006). Fecal incontinence can be a significant risk factor in the transmission of Clostridium difficile (C. diff) and Norovirus, which are commonly transmitted via the fecal-oral route.  This follows contamination of the hands of HCWs and patients as well as contamination across the patient care environment (Center for Disease Control, 2011, Robilotti, E., et al., 2015). The patient’s family and visitors are also at risk of cross contamination.

Effective fecal management systems (FMSs) provide for the containment and diversion of stool, which is either liquid or semi-liquid consistency. The FMS aid in keeping the skin clean, dry, and free from contaminants and moisture that contribute to skin breakdown, while also preventing contamination of the hands of healthcare workers(HCWs) and patient care environment.  The potential spread of infection is significantly minimized by keeping infectious body waste contained in a closed system during application and ongoing use (Whiteley, et al., 2014).

What causes FI?

FI is defined as the involuntary or unintentional loss of solid or liquid stool (MediceNet.com, 2017). This is a common problem, especially in the elderly. There are numerous potential causes and many patients typically have more than one reason that will cause loss of bowel control (MediceNet.com, 2017). Damage to the internal or external anal sphincter muscles, puborectalis muscle, and nerves may occur directly at the time of vaginal childbirth or after anal or rectal surgery (MediceNet.com, 2017). Neurologic diseases such as stroke, multiple sclerosis, spinal cord injury, and spina bifida can be potential causes of FI. Diabetic complications can also cause peripheral nerve damage leading to incontinence. Patients with inflammatory bowel disease (Crohn’s disease, ulcerative colitis) and irritable bowel disease may develop FI (MediceNet.com, 2017). Lastly, incontinence can also result in critical care environments following sedation or the use of certain medications. While there are numerous potential causes, it is not unusual to have FI unrelated to any specific factor (Robson, K. et al., 2009).

History of FI Solutions

In healthcare settings, FI was traditionally managed with the use of absorbent pads and adult diapers. Though inexpensive, these methods are time consuming, labor intensive while creating the possibility of secondary complications and increasing the risk of infection transmission (Langill M. et al., 2012). Before the development of intra-rectal catheters, clinicians trialed a variety of devices and methods including repurposing large urinary catheters, rigid rectal catheters, fecal collection bags, mushroom-tipped catheters, pharmacological and/or dietary interventions, incontinence pads, and the application of barrier creams to protect the skin. These devices and methods were not subject to rigorous evaluation and largely proved ineffective (Benoit RA Jr. et al., 2007). More importantly, these FI management options could result in costly complications with patients, such as incontinence associated dermatitis (IAD), facility-acquired pressure injuries, and certain nosocomial infections (Gray M. et al., 2012).

Intra-rectal balloon catheters, designed for the containment and diversion of stool, were originally created in the early 2000’s exclusively for patients in intensive care units (ICUs) to manage diarrhea and FI. These were able to prevent cross-infection from infective diarrhea and protect the perineal skin (Rees J, Sharpe A., 2009, Norton C., 2009, Woodward S., 2012). Intra-rectal catheters are inserted manually by a HCW into the patient’s rectum to channel loose stool into a collection bag. Traditionally, a balloon near the tip of the catheter (inside the body) can be inflated once the catheter is in position. The balloon is used as a retention device to prevent leakage of stool around the catheter and to prevent the tube from moving or being displaced during bowel movements (Langill, M et al., 2012).

Following the introduction of intra-rectal catheters as an FI solution into ICUs, clinicians recognized their value in preventing fecal contamination of burn injuries and other wounds. Consequently, intra-rectal catheters as an FI solution were introduced across various acute care departments in hospitals (Kowal-Vern A. et al., 2009). Intra-rectal catheters as FI solutions have now been widely adopted in acute care settings, and to a lesser degree, in long term care facilities, nursing homes, and assisted living facilities for immobilized patients.

Infection and Clinical Risk Factors Associated with Fecal Incontinence

Uncontrolled FI represents a major risk to patient care and outcomes, which can impact skin and wound integrity, the healing of perineal wounds or burns, and environmental contamination (Norton C., 2009). Skin breakdown can occur very quickly after the onset of unmanaged FI and can lead to pressure injuries (Faria D. et al., 1996). Patients with FI are 22 times more likely to develop pressure injuries – with the odds ratio increasing to 37.5 if the patient also has impaired mobility (Keller B. et al., 2002, Maklebust J., 1994, Langill, M et al., 2012).

Moreover, poor fecal management can directly contribute to infection transmission, hospital acquired pressure injuries, and the spread of C. diff (Langill, M et al., 2012). C. diff, which can be shed in feces, is the most common cause of hospital-acquired diarrhea and a significant cause of morbidity and mortality among hospitalized patients (Kyne, L. et al., 2002). It is frequently associated with diarrhea and creates a major cross-infection risk due to its resilience on surfaces. Any surface, device, or material (e.g., toilets, bathing tubs, and rectal thermometers) that are contaminated with feces may serve as a reservoir for the spores, which can transfer to patients primarily through hand transmission (CDC, 2017). The implications of other potential infection transmission risk from stool is also known. An example of a nosocomial transmission is vancomycin-resistant Enterococcus faecium (VRE), which causes bacteremia and bacteriuria, transmitted via rectal electronic thermometer probes (Livornese et al., 1992).

FMS generally include products that contain diarrhea (e.g., absorbent pads or diapers) or rely on a tube to drain feces away from the patient (i.e., external fecal collectors and indwelling retention drainage devices) (Brazzelli, M. et al., 2002). Absorptive products for fecal management are not a closed system and require frequent changing of dressings and soiled linens. In addition, these methods do not adequately remove fecal material from the perineal area, which may lead to skin breakdown and infection (Brazzelli, M. et al., 2002). Fecal collectors or pouches are considered a better option to contain diarrhea. These devices can be left in place for up to 29 days, but external fixation of the skin barrier can be problematic in cases of denuded skin or a lack of potential adherent surface (Beitz, JM., 2006).

Intra-rectal catheters as a FMS have been effective in addressing some existing issues by better containing the stool in a closed system, but they introduce new clinical risks. These include injury to the patient’s rectum from over-inflation of the balloon and prolonged insertion. Sphincter dysfunction may result due to the constant high pressure on the pressure sensitive anorectal junction and rectal mucosa (Whiteley I., et al., 2014). These issues can lead to leakage of a patient’s stool, which increases the risks associated with nosocomial infection transmission to patients or HCWs, and contamination of the patient environment (Whiteley I., et al., 2014).

There are cases, although rare, of rectal mucosal pressure necrosis resulting in life-threatening rectal bleeding following the use of intra-rectal catheters. One such case concludes that rectal bleeding resulted from FMS-induced rectal mucosal pressure necrosis. The authors noted that there were no definite cases of anorectal barotrauma with the use of indwelling FMS in the limited literature available (Bright, E. et al., 2008, Johnstone A., 2008, Padmanabhan A. et al., 2007). Another potential complication is rectal laceration following unintentional and forceful removal of the catheter, described in two cases. The bleeding in both cases only stopped after trans-anal suturing of the laceration (Sparks D., et al., 2010). The potential for necrosis remains a concern for health professionals in the comparative analysis and selection of a FMS, suggesting that the issue may be more common than confirmed in the literature.

Financial Impact of Poor Fecal Management

Many studies have illustrated that optimum FI management is a standard approach that can contribute to better clinical outcomes, whereas the effects of poor FI management has been increasingly shown to include significant financial impact (Beitz, J. M., 2006). With all approaches to managing FI, there are direct costs associated with absorbent and containment products. Depending on the approach and management options used, there could be an increased number of HCWs and use of environmental cleaning resources. In addition, direct costs include those associated with pressure injuries and nosocomial infections, which are increasingly not reimbursed by CMS/health payers, and are borne directly by the hospital. There is a financial and reputational impact to the healthcare institution based on quality and safety-based performance indicators. These are reported to the US state and federal authorities, which impact funding or increase potential penalties.

The incidence of diarrhea during the first 2 weeks among a mixed population of patients in a tertiary ICU is at least 14% (Thibault, R et al., 2013). In a single study conducted in 2009, the costs per ICU patient over a 5-day course of diarrhea, including nurse time and consumables, was an average of $423 for patients using an intra-rectal catheter vs. $763 for traditional approaches including pads, skin cleansers, and moisture barrier creams or pastes. In this 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 nursing time (Popovich-Durnal, A et al, 2009).

Nosocomial C. diff is the leading cause of infectious nosocomial diarrhea in the US. The incidence and severity of C. diff infection are increasing and is associated with significant morbidity and mortality. C. diff represents a large clinical burden because of the resultant diarrhea and potentially life-threatening complications (Shanshan, et al., 2016). It is widely acknowledged that C. diff places a significant financial burden on the US healthcare system. The development of nosocomial C. diff in hospitals has associated average costs of $29,000 per infection in New York State, with subsequent studies on a national level confirming costs ranging from $8,911 to $30,049 per patient (Lipp, M et al., 2012, Nanwa, N et al., 2015).

An outbreak of C. difficile sometimes requires hospitalization and the inevitable use of a FMS, which can lead to a pressure injury. Once a pressure injury has developed, immediate treatment is required (Bergstrom N et al., 1994). Treatment for pressure injuries is dependent on the stage of the wound and can include the use of special mattresses, dressings, ultrasonography, ultraviolet heat lamps, removal of necrotic tissue, and surgery (Medscape.com , 2017). The financial impact of pressure injuries includes costs related to the duration of intensive care, increased length of stay, and treatment costs (Spetz, J et al., 2010).The four stages of pressure injury treatment increase significantly by stage from Pressure Ulcer1 (PU1) to Pressure Ulcer4 (PU4). These costs start 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 (Spetz, J et al., 2010, Schaumberg, IL., 2010). In 2008, the CMS discontinued assigning supplemental payments to hospitals for stage three and four nosocomial pressure injuries, with the costs being borne by the hospital (Centers for Medicare and Medicaid Services, 2017). Changes to the reimbursement regulations have made preventing pressure injuries a priority for US hospitals (Centers for Medicare and Medicaid Services, 2008).

Through the Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey, patients rate their inpatient stay in 27 categories, including communication with doctors and nurses, pain management, facility cleanliness, and quietness. These scores may be affected by poor approaches to fecal management and/or the associated clinical complications and outcomes. Based in part on these scores, hospitals risk up to 2% of their Medicare payments, thereby further impacting the overall healthcare cost (Medicare.gov, 2017). In addition, health payers may also experience longer term financial impacts. Complications, including infections, that are acquired in hospitals or healthcare facilities result in patients with significant post-discharge insurance claims related to medications, primary care follow-up, lab work, rehab, and homecare. In some cases, this is drawn out for years, depending on the infection, severity, and patient health status (Wallace, N. et al., 2016). Therefore, the total healthcare burden due to poor FI management is significant to warrant new and innovative ways to manage FI and reduce the associated healthcare expenditure.

Use Cases for Intra-Rectal Catheter Fecal Management Solutions

There is one primary use case for intra-rectal FMS in Acute Care and LTC healthcare environments, with two emerging use cases that show early promise.

1. Fecal Management

The primary use case for FI solutions is fecal (stool) management. In acute care settings, FI is often associated with diarrhea, which is a challenging nursing problem. In this environment, it is essential that HCWs can provide high quality care. The assessment and management of FI are fundamental elements of practice. Through careful assessment, appropriate treatment options can provide optimum patient care (Rees J. et al., 2009).

As part of the appropriate patient care protocol, healthcare institutions can reduce the costly complications caused by patient and HCW exposure to fecal waste. In the US, CMS continues to increase in the scope of non-reimbursable costs to HCWs for those treatments they deem could be reasonably prevented through the application of evidence‑based guidelines – and in many cases, the lack of reimbursement due to complications from poor FI can be considerably higher than the increased cost of consumables (O’Brien JA et al. 2007, Zhan C et al. 2003).

Some hospitals have implemented and published guidelines for FMS for ICU patients, where they receive ongoing assessments and management of their bowels. In the presence of FI, the FMS is utilized to prevent pressure area complications, reduce infection transmission risk and promote patient comfort (Liverpool Hospital Guideline, 2015). Within Long Term Care, FI is a commonly encountered clinical issue that is associated with significant morbidity and utilization of healthcare resources. Constipation, fecal impaction, and overflow FI are common events in nursing home residents (Leung et al, 2008).

2. Medication and Fluid Administration

Medication intended for rectal administration traditionally comes in the form of a suppository or an enema. However, modern FMSs have incorporated irrigation and drug delivery ports that can be used for prescribed medication and fluid delivery via a syringe. The primary purpose of intra-rectal catheter medication administration is to provide an easy and rapid route for medication and fluid administration in non-critical situations when IV access is difficult, delayed, or unnecessary. Medication is often readily absorbed via rectal mucosa (Honasoge, A, et al., 2016). Use cases include treatment for dehydration, vomiting, fever, myocardial infarction, hyperthyroidism, and cardiac arrest with administration of a wide variety of medications or fluids (Honasoge, A, et al., 2016). Based on the observation of expected effects from the medication administrations, absorption is rapid (Honasoge, A, et al., 2016).

3. Fecal Microbiota Transplant

Fecal Microbiota Transplant (FMT) is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained, and placed in a patient (The Fecal Transplant Foundation, 2017). This is currently accomplished by colonoscopy, endoscopy, sigmoidoscopy, or enema. The purpose of fecal transplant is to replace the bad bacteria that have over-populated the colon, which results in often debilitating and sometimes fatal diarrhea, with good bacteria that were killed or suppressed (usually from the use of antibiotics) (The Fecal Transplant Foundation, 2017). FMT can be a low-cost, low-risk, highly effective treatment. It is not currently covered by most insurance companies because it is still classified as an experimental treatment (The Fecal Transplant Foundation, 2017).

New Innovations in FI

Typical features of FMSs include a long catheter with a balloon cuff, which relies on a large silicone retention balloon that anchors on the anorectal junction when inflated post-insertion to secure the catheter inside the rectum, a collection bag with a one-way valve, securing straps or tape, and ports within the catheter to irrigate or facilitate medication administration (Consure Medical, 2016a).

However, new closed-system stool management solutions are available that employ a simple design using a soft-stent technology, which have been more common in healthcare for use in angioplasty and vascular catheter surgery. Soft stents are positioned with a special applicator and secured in place by the stent’s radial pressure at a higher point in the colon. Soft-stent FMS systems offer a number of advantages over balloon-based intra-rectal catheters including:

1. Wider patient eligibility: Patients eligible for soft-stent systems do not require good sphincter tone to retain the catheter balloon, as the stent anchors the catheter securely higher in the rectum. Over 70% of incontinent patients have dysfunction of the external anal sphincter, internal anal sphincter, or both – putting them at risk for expulsion if managed with balloon cuff-based devices. Approximately ¹/₃ (29.6%) of FI patients, who exhibit the right sphincter tone, can support efficacious functioning of a balloon catheter (Consure Medical, 2016a). Patient eligibility using soft stent intra-rectal catheters can increase the eligible patient population by 3-fold because soft-stent catheters may be used in patients irrespective of sphincter (Consure Medical, 2016a).
2. Patient Safety: Stents offer a reduction in radial pressure compared to balloons – with up to 4 times less radial pressure on the rectal microvasculature. As a result, there are fewer complications with soft stents in insertion and withdrawal. The reduced pressure from soft-stent does not interfere with the normal physiological functioning of the ano-rectal anatomy – and there is no risk of ‘over-inflating’ the device, which is an issue with the balloon-based catheters. In contrast, the new devices with soft-stents conform to the rectal wall and moves with peristalsis, which mimics normal physiological function (Consure Medical, 2016a).
3. Increased diversion of stool and reduced leakage: Soft-stent catheters have superior stool diversion by maintaining a larger lumen during both resting and peristaltic states. Maintaining full lumen of the rectum is a significant difference over balloon-based catheters as the soft stent is imitating the natural movement of the rectum. The structure inherent to balloons of current fecal management catheters provides a substantially smaller cross-sectional area at the distal end of the catheter lumen as compared to the cross-sectional area of the rectum. This often causes high-pressure build up in the rectum, increasing risk of spontaneous device expulsion. Furthermore, normal peristaltic contractions may cause collapse or occlusion of the balloon cuff, especially if overinflated, compromising the integrity of the seal to the rectum that leads to peripheral leakage of stool (Consure Medical, 2016a).
4. Infection Prevention: The risk of infection transmission is reduced in 3 ways: 1) avoidance of manual insertion by the HCW using their finger, 2) reduced risk of peripheral leakage of stool from higher pressure buildup or poor sphincter tone, and 3) the unintended expulsion of the device. New systems come with an applicator that eliminates the need for a HCW to manually insert the catheter with their finger, reducing the HCW’s exposure to the patient’s stool, and reducing the amount of trauma or discomfort with insertion (Consure Medical, 2016a).

This innovation can reduce the risk of complications related to current stool management systems, such as pressure necrosis and rectal bleeding. At the same time, it increases the overall safety to patients and HCWs from environmental contamination and infection transmission, while contributing positively to the comfort and dignity of patients suffering from FI (Consure Medical, 2017).

Considerations for Evaluating Fecal Management Solutions

New FMS solutions offer promising outcomes to improving patient/workplace safety. An evaluation framework designed by quality and safety managers, in cooperation with clinical leadership, surgeons, and critical care nurses to review new FMS solutions need to be implemented. The following considerations can assist in presenting comparative analysis to a hospital’s value-based purchasing committees or other internal groups that review new clinical innovations.

1. Which FI solution provides evidence-based improvement of clinical outcomes that are recognized challenges within the healthcare institution? This includes increased eligible population of patients for FMS, reducing clinical complications resulting from the FMS, and maintaining patient dignity.
2. Does the FI solution improve current infection prevention and control strategies and initiatives to improve patient safety, and reduce infection transmission risks to patients, their families, and HCWs?
3. What is the financial impact for the FMS solution and is it able to provide a cost saving or cost-neutral outcome to the hospital? Return on investment from FMS can be measured in:
4. Cost comparison per device or an enterprise contract that covers all devices used.
5. Number of devices used, considering the replacement of devices due to unintentional expulsion.
6. Reduced direct costs associated with a reduction in infection cases and pressure injuries.
7. Following a service assessment, does the FMS represents a solution that will be adopted as the preferred clinical choice?

Conclusion

New fecal management systems can be an important clinical tool that impact patient safety and quality as well as HCW safety. As part of the ongoing efforts to prevent the risk of nosocomial infections, healthcare institutions should evaluate new innovations in FMSs that will improve current approaches to infection prevention and control. In addition, the use of closed FMS can be an important factor in reducing the FI related clinical complications such as incontinence associated dermatitis in hospital and long-term care patients. The clinical application of these new FMS solutions can positively impact healthcare outcomes, contribute significant financial savings, and play an important role in improving patient care and preserving patient dignity. Clinical adoption can be confirmed and driven by evidence from well-designed clinical trials and rigorous evaluation.

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