Flexi-Seal® Faecal Management System 

1.1 Background

The management of faecal incontinence has traditionally taken the form of meeting patients’ hygiene needs, changing bed linen and using incontinence pads ^[1].  Whilst this may be appropriate for some patients, it may be less effective for others. Faecal incontinence is a common denominator among hospitalized patients ^[2], and has a detrimental impact on psychological, social and physical functioning.

Faecal incontinence can cause extensive prolonged damage to the perineal skin due to bacteria and enzymes contained in faeces. It is a risk factor for pressure ulcers, leading to increased morbidity, mortality and length of stay. Faecal incontinence also increases the risk of cross-contamination and infection from pathogens such as Clostridium Difficile, where large numbers of spores are excreted in the liquid faeces contaminating the general environment ^[3].

There are at present no national guidelines available for the management of faecal incontinence ^[4]. The National Institute for Health and Clinical Excellence ^[5] recommends that health professionals should consider a faecal collection device for people in intensive care settings and people receiving palliative care with faecal incontinence and associated loose stools.

 A Faecal Management System (FMS) is a fully closed system that collects and contains liquid or semi-liquid stool, helping to preserve skin integrity and prevent environmental contamination ^[1]. Furthermore, better management and monitoring of faecal incontinence can enhance patient comfort and dignity, and allow more accurate fluid balance monitoring.  In 2007 FMS were awarded rapid review panel (RRP) recommendation 1 by the Department of Health’s ‘Technology Innovation Programme’, which identifies and supports the development of new initiatives for tackling health-care associated infections ^[6].

The indications, contraindications and possible adverse events of FMS must be considered before it is used, and the purpose of this guideline is to ensure the safe and appropriate use of such systems.

1.2 Aim/purpose

The faecal management system available within the Trust is the Flexi-Seal®SIGNAL Faecal Management System (Convatec Inc). These guidelines apply solely to the use of this product.

The Flexi-Seal® FMS is used in patients with little or no bowel control and liquid or semi-liquid stool.

 A soft silicone catheter is inserted into the rectum and retained by a low-pressure balloon. A non-drainable, single use collection bag is connected at the other end. The device contains and diverts faecal waste to protect the patient’s skin and prevent faecal contamination of the environment.

1.3 Patient/client group

The Flexi-Seal® FMS should be considered for those patients who are passing liquid to semi-liquid stools (type 6 – 7 as per Bristol Stool Chart; Appendix 5) AND exhibit one or more of the following:

• Are passing liquid to semi-liquid stools which is not overflow diarrhoea

• Are bed bound with little or no bowel control

• Are bed bound and cannot use a commode e.g. obese / at risk to move / sedated / ventilated

• Risk losing skin integrity caused by exposure to faecal incontinence / faecal leakage

• Have existing loss of skin integrity e.g. skin excoriation / incontinence-associated dermatitis caused by exposure to faecal incontinence / faecal leakage

• Have  wounds / skin grafts which require protection from faecal contamination

• Have infectious stools e.g clostridium difficile which pose an environmental risk (Discuss with Infection Control Team)

• Are unable to control bowel movements due to a specific condition e.g. malabsorption

Appropriate patients should be identified using these criteria, and an assessment carried out using the Pre-Insertion Checklist (Appendix 1). Both the patient’s consultant / registrar and the senior nurse on duty must agree the patient selection. Both must sign the Pre-Insertion Checklist.

1.3.1 Consent

It is essential that where possible the patient gives valid consent to the FMS before it is inserted. A Patient Information Leaflet produced by Flexi-Seal® is available (Appendix6)

• Information, including the reason for use of the FMS and potential complications, must be given to the patient and verbal consent should be obtained if the patient has capacity. If communication difficulties exist, the patient should be assisted to make and communicate their own decision. This consent must be documented in the patient’s healthcare record,  alongside information that was given to the patient and discussions that took place

• If the patient lacks capacity to give or withhold consent, staff must endeavour to establish if the patient has a nominated representative to make health related decisions on their behalf, i.e.  a Lasting Power of Attorney for Personal Welfare (LPAPW) or has a Court of Protection appointed Deputy. Consent  for FMS can sought from either.

• Where an adult patient lacks capacity to give or withhold consent, this fact should be documented in the patient’s healthcare record, along with the assessment of the patient’s capacity, why the health professional believes the treatment to be in the patient’s best interests, and details of consultation with people close to the patient (this may include LPAPW / Court of Protection Appointed Deputy / IMCA)

• If a patient who previously lacked capacity subsequently regains capacity, verbal consent should be sought and the discussion documented in the patients healthcare record

• The patient may ask for the FMS to be removed at any time

Refer to Trust Policy ‘Consent to examination or treatment’ for further guidance.

1.4 Exceptions/ contraindications

The Flexi-Seal® FMS should not be used on patients with the following:

• Are under 18 years of age

• Sensitivity or allergies to any of the materials used in the FMS i.e. silicone

• Solid or semi-formed stools

• Lower large bowel surgery or rectal surgery within the last 12 months

• Rectal or anal injury

• Severe rectal or anal stricture or stenosis

• Suspected or confirmed rectal mucosal impairment including lacerations or fissures, proctitis, ischaemic proctitis, radiation injury, scarring

• Suspected or confirmed rectal / anal tumour

• Severe haemorrhoids

• Bowel obstruction

• Faecal impaction / presence of impacted stools

• Any in-dwelling rectal or anal device e.g. thermometer or delivery mechanism in place e.g. suppositories or enemas

• Inadequate anal sphincter tone (unable to support the inflated balloon)

• Spinal Cord Lesion at T6 or above due to the risk of autonomic dysreflexia. Seek advice from Spinal Centre if considering FMS in any patient with a Spinal Cord Lesion at any level

1.4.1 Further considerations

• It must be remembered that FMS is not a treatment of diarrhoea, and the medical team must continue to consider the underlying cause(s) of the diarrhoea

• The FMS should not be used for longer than 29 consecutive days

• Caution should be exercised when considering use in patients who have inflammatory bowel conditions or thrombocytopaenia / clotting disorders. Seek advice from the patient’s consultant.

• Extreme caution should be exercised with patients at risk of developing toxic megacolon

• To avoid injury to the patient, do not insert anything into the anal canal whilst the FMS is in situ

• The FMS should not be used for patients who sit out in a chair / wheelchair due to the increased risk of pressure damage from the device. However, in some cases clinicians may consider whether it is required or beneficial to sit the patient out of bed even if she / he has a FMS insitu. If that is the case, the sitting position should avoid compressing or kinking the tubing and the sitting period should be no longer than 30 minutes. However, sitting a patient out in a chair / wheelchair whilst the FMS is insitu is outside the product license.

• Patients can be ambulant with the FMS

2.1 Staff & equipment

2.1.1 Staff and Training

• Insertion of the FMS must be preceeded by a digital rectal examination undertaken by a health professional who has been deemed competent within their area to perform this examination. Ideally this will be the nurse responsible for the insertion.

• The FMS must be inserted by a registered nurse or doctor who has been trained in the use of the Flexi-Seal® FMS, and has either completed the related competency (Appendix 7) or is under the direct supervision of a competent practitioner. Nurses must be able to demonstrate that they have received training to a level where they are deemed competent under the NMC Code of Professional Conduct (7), and are accountable and able to justify their actions and decisions.

• The ward leaders will be responsible for the delivery of training and competency assessments within their areas. Training will be provided in the following ways:

• At ward / departmental level by the Convatec Representative / Clinical Advisor (initially in the areas of highest use – Intensive Care Unit, Burns Unit, Laverstock Ward and then review according to need). Ward leaders will keep a register of staff who have received training.

• The three clinical areas named above will be expected to train a cohort of nurses within their area, to undertake the procedure and provide peer support

• Resource folders should be established in each clinical area

• Flexi-Seal reference guide posters should be displayed in staff only areas within the wards

• Competency assessment will be supervised by the ward leader in each area, and competent individuals will then be able to assess their peers and colleagues.

• Competency records will be maintained by ward leaders

• Ongoing assessment will be by means of self or peer assessment

• Ongoing support will be provided by the Clinical Advisor for Convatec, both by telephone and by clinical and training visits. Up to date contact details should be held locally within the resource folder

2.1.2 Equipment

The Flexi-Seal® FMS is latex free.

It is for single patient use; this means that it can be removed and reinserted e.g repositioning of the tube or in the unlikely event that the patient expels the device.

The kits (including 3 collection bags) and box of 10 collection bags are held in the following places:

• SDU (office hours)

• Radnor (out of hours)

• Burns Unit (out of hours)

SDU order the kits via procurement. Radnor and Burns ‘top-up’ their small stock from SDU.

Financial agreement to use a FMS must be given by the budget holder. If a system is taken from Radnor or Burns for use elsewhere, a budget transfer must be completed. FMS and collection bags obtained via SDU will be charged directly to the ward.

Each Flexi-Seal® SIGNAL FMS kit costs in the region of £267 and contains the following:

• 1 x soft silicone catheter tube assembly

• 1 x Luer-Lok syringe

• 3 x collection bags (non-drainable)

• Blank labels to record insertion details

In addition to the kit, disposable gloves and lubricant will be required.

2.2 Method/procedure

A digital rectal examination MUST be performed prior to insertion of the FMS, to confirm the patient’s rectum is empty. This must be undertaken by a health professional deemed competent within their area to perform this examination. Ideally this will be the nurse responsible for the insertion.

2.2.1 Guidelines

Use the following guidelines when using the FMS

• FMS pre-insertion checklist: Appendix 1

• Digital rectal examination and Insertion of the FMS: Appendix 2

• Maintenance of the FMS: Appendix 3

• Removal of the FMS: Appendix 4

2.2.2 Documentation

• FMS pre-insertion checklist must be completed and signed by the Senior Nurse on duty and the patient’s consultant / registrar, and filed in the patient’s healthcare records

• Maintenance of the FMS guideline must be commenced as soon as the FMS is inserted

• A fluid chart detailing patient input and output must be commenced (if not already in use)

2.2.3 Transfer of patients with FMS to another clinical area / ward

A full handover detailing rationale for FMS and all relevant information and documentation must be given to the registered nurse taking over the patient’s care

2.2.4 Removal of the FMS

The decision to remove the FMS must be a joint decision between the medical and nursing staff. Document the removal and rationale for removal in the patient’s healthcare record

2.3 Potential complications / Risk Management

• The FMS must not be used if any of the exceptions / contraindications is present

• The FMS must only be used when the ‘further considerations’ have been considered, further advice sought if appropriate and the benefits of using the FMS outweigh the risks

• There is a potential risk to confuse the ports of the FMS with other ‘lines’ in the vicinity e.g. femoral lines. However, the ports are clearly labeled, and staff training should identify this as a possibility

• Loss of anal sphincter tone could lead to temporary anal sphincter dysfunction

• Risk of pressure necrosis of rectal or anal mucosa. Remove FMS if evident and request medical review

• Infection

• Bowel obstruction

• Perforation of the bowel

2.3.1 Warnings

• Do not use if the packaging is open or damaged

• Do not place anything else in the anal canal whilst the FMS is insitu

• Use correct amounts and types of fluid

• Never use hot liquids

• Do not allow products with a petroleum base to contact the catheter as they may cause damage to the silicone and compromise the integrity of the product

• Patients with rectal tenesmus may not tolerate the FMS

• Notify the medical team if any of the following occur as these must be investigated:

• Persistent rectal pain
• Rectal bleeding
• Abdominal pain or distension

Information, including the reason for use of the FMS and potential complications, must be given to the patient and verbal consent should be obtained if the patient has capacity (See ‘Consent’ above). The patient must be offered a patient information leaflet about the FMS. These are produced by Flexi-Seal® (Appendix 6 ).

4.1 Audit Indicators

Any incidents arising from the use of the FMS must be reported and investigated through the adverse incident reporting system

5.1 Sources of information

1. Yates A (2011): Managing faecal incontinence: a joint approach to guideline development Nursing Times 107: 12

2. Wishin J, Gallagher T, McCann E (2008:) Emerging options for the management of faecal incontinence in hospitalized patients Journal of Wound Ostomy Continence Nursing 35 (1) 104-110

3. Ousey K, Gillibrand W, Lui S (2010): Effective management of acute faecal incontinence in hospital: review of continence management systems Frontline Gastroenterology 1: 94-97

4. Evans J, Price J, Yates A, Young T (2010): All Wales Guidelines for Faecal Management Systems MA Healthcare Ltd

5. National Institute for Health and Clinical Excellence (2007): Faecal Incontinence: The management of faecal incontinence in adults

6. Padmanabhan A, Stern M, Wishin J et al (2007):Clinical Evaluation of a flexible faecal incontinence system Americal Journal of Critical Care 16 (4): 384-393

7. Nursing and Midwifery Council (2008): Code of Professional Conduct. Nursing and Midwifery Council, London