The crucial role of fecal management systems in intensive care

ABSTRACT

Introduction

Patients in intensive care units (ICUs) frequently lose control over their fecal continence leading to fecal incontinence (FI). We provide an overview of existing medical devices, which are supposed to alleviate FI-related problems.

Areas covered

Fecal management systems (FMS) prevent infections and complications. They reduce the risk of pressure ulcers and fecal incontinence. The systems enhance patient comfort and mitigate emotional distress during illness. Furthermore, FMS facilitate nursing care by reducing the incontinence-related workload. Finally, these systems can help minimize treatment costs by preventing complications, and reduction of extended hospital stays and additional treatments. Several well accepted systems made of silicone are on the market. A polyurethane-based soft balloon FMS (hygh-tec® basic-plus) has also been introduced, offering more comfort to the patient, safer handling for the healthcare professionals, and provides reliable leakproof access to the patient’s colon. In addition to contamination-free fecal diversion, the trans-anal sealing mechanism of the device also allows for irrigation and delivery of medication into the colon.

Expert Opinion

FMS in ICUs are integral to patient care and dignity. Recognizing and prioritizing the importance of these systems is essential for providing the highest standard of care to critically ill patients in the ICU.

KEYWORDS:

• Intensive care
• fecal incontinence
• fecal management system
• polyurethane
• balloon

1. Introduction

The development of fecal management systems (FMS) in Intensive Care Units (ICUs) has evolved as a response to the critical need to manage fecal incontinence and its complications. Fecal incontinence in the ICU can be a significant problem, as it can lead to skin breakdown, infections, additional caregiver burden, and substantial economic burden [1–5]. Initially, traditional methods to manage fecal incontinence in ICUs included the use of indwelling rectal catheters and fecal incontinence pads. These methods were often uncomfortable for the patient and did not provide an adequate solution to the risks associated with fecal incontinence. Diapers and incontinence pads were also common, but they required frequent changes and could lead to pressure sores and skin breakdown [6,7]. The development of specialized rectal tubes that were designed to contain and divert fecal matter represented a significant advance. These included devices like the Flexi-Seal™ Fecal Management System, the ActiFlow^TM, or the DigniCare^TM device all introduced in the early 2000s, which provided a more effective and hygienic method to manage feces in bedridden patients [4,8–12], and they were quickly adopted into the guidelines and recommendations for critical care [13–20]. These systems typically involve a soft, silicone catheter inserted into the rectum, with an inflatable balloon to hold it in place and a collection bag to contain the waste. The introduction of systems with improved design features such as lumen for irrigation, odor control, and better securement methods describe today's standard of care, and more attention is paid to the comfort of the patient, ease of use for caregivers, and the prevention of complications such as pressure ulcers and infections [11,12]. The focus on patient dignity and quality of life continues to drive innovation in this area, with products that are less intrusive and more comfortable.

Intensive care units (ICUs) play a vital role in providing advanced medical care to critically ill patients. These units are equipped with cutting-edge technology and skilled healthcare professionals to manage complex medical conditions. While much attention is given to monitoring and treating primary medical issues, the importance of fecal management systems in ICU cannot be underestimated. Inability to control bowel movements can lead to infections, skin breakdown, and a host of complications [6,7]. Fecal management systems, such as rectal catheters and fecal containment devices, play a crucial role in preventing these complications by effectively managing fecal output. In this article, we will explore the significance of fecal management systems in the context of intensive care and their role in promoting patient comfort, preventing complications, and improving overall patient outcomes. We will also describe the currently available products including the most recently developed and introduced high-tec® basic-plus system.

1.1. Infection prevention

Fecal management systems are designed to prevent infections by effectively managing and containing fecal waste. They are intended to securely collect and contain fecal waste, which prevents feces from coming into contact with the patient’s skin, bedding, or surrounding medical equipment [11,12]. They ensure that fecal waste is isolated and contained within sealed systems and inhibits the growth of harmful bacteria that may be present in feces. This reduction in bacterial growth contributes to a cleaner and safer patient environment. Prolonged exposure of the skin to fecal matter can lead to skin breakdown and create an ideal environment for bacterial growth. Healthcare workers often need to change bedding and clothing when patients experience fecal incontinence [21,22]. Contamination can also lead to nosocomial catheter-associated infections like urinary tract infection or blood stream infection. Fecal management systems reduce the frequency of these changes, minimizing direct contact with contaminated materials [21]. This also reduces the risk of cross-contamination by healthcare workers inadvertently spreading infectious agents. Properly managing fecal waste is an essential part of infection control practices in healthcare facilities. Fecal management systems are designed to align with these practices and guidelines, ensuring that fecal waste is managed in a manner that minimizes the risk of infections.

1.2. Reducing the risk of skin maceration, dermatitis and pressure ulcers

Patients in the ICU are susceptible to pressure ulcers, commonly known as bedsores, due to prolonged bed rest and immobility [23–29]. Fecal incontinence can exacerbate this risk, as the skin becomes more vulnerable to damage when in contact with feces for extended periods. Fecal management systems help to keep the patient clean and dry and to significantly reduce the risk of pressure ulcers [30–32].

1.3. Enhancing patient comfort and dignity

The inability to control an important bodily process results in a loss of confidence, self-respect, modesty, and composure [33,34]. There is a significant correlation between symptom severity and quality of life in fecal incontinence [35,36]. Maintaining patient comfort and dignity is a fundamental aspect of healthcare, in particular at the ICU. Fecal management systems allow patients to maintain a sense of cleanliness and control over their bodily functions. They contribute to the overall well-being during a challenging period of illness. This can also help reduce the emotional distress associated with loss of bowel control [33].

1.4. Facilitating nursing care

ICU nurses and healthcare providers are constantly monitoring and treating patients’ critical conditions. Efficient fecal management systems alleviate some of the workload by minimizing the need for frequent bed changes and extensive cleaning due to fecal incontinence. This allows nurses to focus more on medical interventions and patient care [37,38].

1.5. Preventing cross-contamination

In a hospital setting, preventing cross-contamination is of paramount importance. The frequent use of antibiotics has increased the risk for nosocomial infections with difficult to treat bacterial strains, such as Clostridium difficile, vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus (MRSA), and others [39–44]. Fecal management systems are designed to contain waste securely, and to reduce the risk of contamination in the patient’s immediate environment and among healthcare staff. This added layer of protection is especially critical in the ICU, where patients may have compromised immune systems [4,9] and other hospital acquired infections are common.

1.6. Minimizing treatment costs

Fecal incontinence rarely occurs as an isolated condition and attributing costs to the appropriate disease state can be challenging. Complications arising from fecal incontinence, such as infections and pressure ulcers, can lead to extended hospital stays, increased healthcare costs, and additional treatments [45–47]. The economic burden of fecal incontinence includes, but is not limited to direct costs (personal hygiene products, diagnostic testing, medical and surgical management) and indirect costs (loss of productivity) costs. By effectively managing fecal output with dedicated systems, hospitals can potentially reduce treatment costs and improve resource allocation [5,17,34,48].

1.7. Risks associated with FMS use

Potential risk or adverse events associated with the use of FMS are primarily related to the potential impact of the FMS material (usually silicone, see below) on the patient anatomy including but not limited to drainage-induced pressure sores, bleeding, or skin lesions [49–56].

2. Available products

In the past decades, several fecal management systems have been developed to alleviate the burden and challenges, which fecal incontinence puts on patients and healthcare professionals in the ICU. A summary overview of the products characteristics is provided in Table 1.

Table 1. Commercially available fecal management systems.

Product	Flexi-Seal®	DigniShield®	ActiFlow®	Diarflex®	Qora®	hygh-tec® basic plus
Manufacturer	Convatec	Bard/BD	PROLIFE homecare GmbH	Primed	Concure Medical	Advanced Medical Balloons
Material	silicone	silicone	silicone	silicone	silicone	poly-urethane
Technology	balloon	balloon	balloon	balloon	stent	balloon
Filling medium	water	water	water	water	water	air
Sealing efficacy	30% [57]	30% [57]	No data	No data	No data	90%*
Observed anal lesions	12.757% [57]	12.757% [57]	No data	No data	No data	0.8%*

The Flexi-Seal® (Convatec) (Figure 1) stool management system consists of a single, ring-shaped retention balloon attached to the distal end of a single-layer, stool-diverting tubular component [4,7–10]. The tubing component is thick-walled and passes through the anal canal and from there to a replaceable stool collection bag. The entire drainage catheter is made of silicone. The drainage balloon is filled with water and inflated to a radially expanded state for anchoring in the rectum. The system is equipped with a supply line for the rectal infusion of fluids. The system also includes a pocket-like structure for insertion of a finger to facilitate rectal insertion of the retention balloon. Its indication is to treat fecal incontinence by collecting liquid to semi-liquid stool and to provide access for medication administration.

Figure 1. Commercially available silicone-based fecal management systems (Picture sources: manufacturer websites [58–62]).

The Diarflex® device (Primed, Halberstadt, Germany, Figure 1) consists of a single, ring-shaped retention balloon attached to the distal end of a single-layer, stool-diverting tubular component. The tubing component is thick-walled and passes through the anal canal and from there to a replaceable stool collection bag. The entire drainage catheter is made of silicone. The drainage balloon is filled with water and inflated to a radially expanded state for anchoring in the rectum. The system is equipped with a supply line for the rectal infusion of fluids. The system is largely identical to Convatec’s FlexiSeal® design and has a similar indication of use.

The Secco® Fecal Management System (Dahlhausen GmbH, Cologne, Germany, Figure 1) consists of a single, ring-shaped retention balloon attached to the distal end of a single-layer, stool-diverting tubular component. The tubing component is thick-walled and passes through the anal canal and from there to a replaceable stool collection bag. The entire drainage catheter is made of silicone. The drainage balloon is filled with water and inflated to a radially expanded state for anchoring in the rectum. The system is equipped with a supply line for the rectal infusion of fluids. The system is largely identical to Convatec’s FlexiSeal® design and has a similar medical indication.

The ActiFlow® Fecal Management System (PROLIFE Homecare GmbH, Figure 1) consists of a single, torus-shaped retention balloon that is connected to a single-layer tubing component at the distal end. The transanal part of the tubing component consists of a particularly thin-walled and soft segment silicone tube, while the extracorporeal segment is relatively thick-walled and has an odor-sealing coating. The catheter unit is made entirely of silicone components. The catheter is connected to a replaceable stool collection bag. The drainage balloon is filled with water and brought into an inflated, radially expanded state. The system is equipped with a supply line for the rectal infusion of fluids. The distal opening of the defecation tube can be closed by an inflatable balloon to facilitate anal insertion of the device and to intermittently close the drainage lumen. The catheter assembly also includes a belt-like component to hold the catheter in place around the patient’s waist. The medical indication is to drain feces to minimize contact with the patient’s skin, to facilitate collection of feces in patients requiring bowel management, to create access for colonic irrigation, and to administer enemas and medications.

The DigniShield® Fecal Management System (C.R. Bard Medical, Becton Dickinson, Providence, RI, Figure 1) consists of a single, torus-shaped retention balloon that is connected to a single-layer tubular component at the distal end. The tubing component is thick-walled and passes through the anal canal and from there to a replaceable stool collection bag. The entire drainage catheter is made of silicone. The drainage balloon is filled with water and brought into an expanded, radially expanded state. The system is equipped with a supply line for the rectal infusion of fluids. The system has a self-closing mechanism in the connection between the catheter unit and the stool collection bag unit, which prevents stool spillage when changing the collection bag. Its indication includes drainage and collection of liquid or semi-liquid stool to minimize skin contact and provide access for medication administration.

The Qora® device (Concure Medical, San Diego, CA, Figure 1) is retained by a wire mesh that spontaneously erects and presses against the lateral wall sections of the rectum, in the same way as a stent [63,64]. A transanal defecation tube is attached to the proximal end of the mesh structure. The tube element is connected to an extracorporeally replaceable collection bag. A supply line for fluids runs inside the tube. The device indication is to drain and collect liquid or semi-liquid stool to minimize skin contact and provide access for medication administration.

All the devices mentioned above are made of silicone and are filled with water when fixing them at the patient’s anus and sphincter muscle (except for the Qora device).

3. Recent innovations

The hygh-Tec® basic-plus fecal management system (Advanced Medical Balloons, Waghäusl, Germany) has been developed to address not only the practical concerns of fecal incontinence but also to manage the associated risks such as skin breakdown, transmission of infections, and the overall well-being of the patient. It is designed to be less invasive, more patient-friendly but to meet the rigorous demands of ICU care. The goal of the device is to manage fecal incontinence effectively without compromising patient comfort or dignity. It is composed of the biocompatible and more user-friendly material polyurethane (PU). This product (Figure 2) is indicated for continuous transanal drainage and collection of liquid or semi-liquid stool and provides separate access for cleaning and medication administration.

Figure 2. The hygh-tec® plus polyurethane-based fecal management system (pictures were kindly provided by the manufacturer, [65]).

The hygh-tec® basic-plus stool drainage system is particularly suitable for the tightly sealed drainage of thin to watery stools due to its special coaxial design in the trans-anal segment. The dumbbell-shaped design allows a perfect seal while minimizing pressure lesions. Stool modifications, such as watery stools or diarrhea, often occur in connection with the start of antibiotic therapy and/or the start of enteral nutrition and are a frequent complication in intensive care [66]. They are particularly problematic to care for and cannot be optimally treated with conventional silicone-based drainages.

Silicones cannot be molded with very thin walls and do not retain their shape when subjected to force. Therefore, silicone balloons must have a relatively thick wall thickness, and the balloon must always be completely filled, in order to expand during use. The use of polyurethane (PU) in the balloon of the hygh-tec® basic-plus device makes it possible to shape the balloon thinly and fill it loosely so that it can adapt completely to the patient’s anatomy. The special dumbbell shape ensures mechanical retention of the drainage head in the rectum and transanal sealing performance in and through the anal canal. The drainage head unit is in contact with intact skin and mucosa (see Figure 2)

The dumbbell-shaped balloon rests on an elastically deformable, transanal shaft element that runs through the inside of the drainage head and enables transanal drainage access to the patient’s rectum. The stool-diverting shaft element has a special wave-shaped (corrugated) profile that supports its elastic erection. When the sphincter muscle is in normal tone, the shaft element folds/invaginates radially. If the tone of the sphincter is released, the shaft element elastically straightens to its shaped, circular profile and thus gradually opens up the outflow pathways for bowel movements. The shaft is not in direct contact with the mucous membrane. During rectal irrigation, the rectally infused irrigation fluid collects inside the shaft element and thus enables indirect contact with the rectal mucosa. Therefore, if stool flows from the inside of the shaft element into the rectum, indirect contact of the shaft element with the rectal mucosa must be taken into consideration.

In contrast to silicone-based stool drainage systems, the PU balloon of the drainage head is not inflated with incompressible water, but with compressible air. The volume of air to be filled into the balloon is set to a discrete, binding value, which ensures that the balloon envelope assumes a tension-free, flaccid state. The partially filled, non-stretchable balloon adapts to the individual ano-rectal anatomy in a sealing manner. The distal, intra-rectal segment of the balloon absorbs the actual force in the rectum and converts it into a time-synchronized seal of the anal canal, whereby the trans-anal segment of the balloon sheath is pressed ‘pneumatically’ onto the anal mucosa. The transanal segment of the balloon thus maintains a continuous fecal seal that reacts adaptively to the tone and degree of opening of the anal sphincter. This dynamically adapting sealing performance is not only effective in immobile or immobilized patients, but can also be successfully employed in awake patients and patients undergoing a mobilization program.

It is to be expected that the use of the more convenient and comfortable PU material will also lead to higher tolerability and improvement in patient safety by reducing the risks associated the use of the previously introduced silicone-based FMS products. This is the subject of currently ongoing clinical studies.

4. Conclusion

In the complex world of intensive care, it is easy to overlook seemingly mundane aspects like fecal management. However, fecal management systems play a pivotal role in enhancing patient comfort, preventing complications, and ultimately improving patient outcomes. ICU patients deserve the highest standard of care, and integrating effective fecal management systems into their treatment plans are an essential step toward achieving that goal. Healthcare professionals and institutions must recognize and prioritize the importance of these systems to ensure the best possible care for their critically ill patients. Recent new designs and new materials have made fecal management systems to become more effective, safer, and more comfortable to wear than previous and older products. Further clinical studies are required to further investigate safety, efficacy, and economical aspects of FMS.

5. Expert opinion

Fecal incontinence (FI) is a frequent complication in patients admitted to an intensive care unit (ICU). Acute FI with diarrhea has been reported to affect up to 40% of ICU patients. The clinical challenges of this condition include the risk of perineal skin breakdown, skin infections, pressure ulcers, and cross-contamination with nosocomial infections. While it is a frequent reason for patient discomfort and prolongation of hospitalization, it is at the same time an unpopular research topic. Only a limited number of study reports or review articles are available in the international literature.

Over the past three decades, intra-rectal catheters with or without fecal collection bags (fecal management systems, FMS) have been developed to support ICU nurses in the attempt to maintain patient dignity and comfort, reduce incontinence-related medical risks, reduce the nursing workload, improve the overall care situation by avoiding incontinence-driven prolongation of hospitalization, and in consequence reduce the costs associated with ICU care. A first generation of FMS made of silicone material has been introduced since the beginning of the century and has meanwhile gained a broad level of acceptance in the field. Compared to the previous ways to handle the unpleasant FI condition (single-use patient pads, diapers, frequent patient cleaning, etc.), FMS have dramatically improved the caring situation and have helped to substantially reduce the prevalence of fecal incontinence-related complications. Still, there is a substantial incidence of such undesired events, and in particular with prolonged FMS use of up to a month, and further efforts should be undertaken to improve performance and usability of currently available devices.

A second-generation FMS, employing a different and softer material with a more flexible intra-rectal balloon design for better adjustment to the anatomical situation has recently been introduced in the EU and the US. It may offer an improved sealing efficiency and an even lower incidence of device-related adverse eventsin particular, when used for longer time periods and up to its approved usage time (30 days). This product is indicated for continuous trans-anal drainage and collection of liquid or semi-liquid stool and provides separate access for cleaning and medication administration. Unlike silicone-based stool drainage systems, this device has a drainage head made of polyurethane that positions the drainage system past the sphincter muscle and seals it. The balloon of the device head is dumbbell-shaped and has been molded to its fully working dimensions during production. Appropriately designed controlled clinical studies are required to elucidate whether the theoretical advantages of the softer material translate into improved patient outcome.

FMS in ICUs are integral to patient care and contribute to patient comfort and dignity. Different materials and designs have been employed in currently available devices. Recognizing and prioritizing the importance of these systems and assessing their sealing efficiency, safety, and user acceptance is essential for providing the highest standard of care to critically ill patients in the ICU.

In our opinion, future perspectives for fecal management in the ICU include but are not limited to the development of smart drainage systems, e.g. equipped with pressure sensors and capable to automatically adjust the air or water pressure in the drainage head to the lowest pressure needed for efficient sealing. Another addition can be moisture sensors with wireless data transfer for centralized leakage surveillance of all systems used in the ICU. New nanotechnologies may make the development of such smart FMS devices possible, and finally the devices may still be affordable even for routine ICU care.

Article highlights

• Fecal management systems (FMS) prevent infections and complications in intensive care. They help to:

  • Prevent infections

  • Reduce incidence of dermatitis and pressure ulcers

  • Maintain patient comfort and dignity

  • Facilitate nursing care

  • Prevent cross-contamination

  • Minimize treatment costs

• Six devices are currently available in the market. Five of them are made of silicone and sealing is done in four devices by balloons filled with water. One second generation device is made of polyurethane and filled with air. First observations indicate that the polyurethane device may provide better sealing efficacy and lower risk of anal lesions.

Declaration of interest

Tobias Gutting has received a research grant from Advanced Medical Balloons, the manufacturer of one of the products mentioned in this article. Andreas Pfützner has received consulting fees from Advanced Medical Balloons and Convatec, the manufacturers of two of the products mentioned in this article. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewers disclosure

Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.

Additional information

Funding

The publication costs for this manuscript will be covered by Advanced Medical Balloons GmbH, Waghäusl.