Alerta De Seguridad O Notificaciones De Seguridad para Peristeen Anal Irrigation System

Safety alert / Field Safety Notice

MDA/2011/002

CON105651

2011-01-06

2011-01-06

United Kingdom

MHRA

https://webarchive.nationalarchives.gov.uk/20150113054913/http://www.mhra.gov.uk/PrintPreview/MedicalDeviceAlertSP/CON105651?tabName=allTabs

Bowel perforation is an extremely rare (less than one in 100,000 uses) complication to anal irrigation.Recently, there have been some incidents of bowel perforation following insertion of the rectal catheter, which is part of the anal irrigation system.Bowel perforation is a rare but serious complication of anal irrigation, which often requires surgery to close the perforation or, if necessary, to form a temporary or permanent colostomy. complications of bowel perforation such as peritonitis or sepsis can be fatal.The risk of bowel perforation can be reduced by ensuring that patients are clinically assessed for suitability prior to treatment. patients and carers should receive comprehensive training to ensure that they are competent in the use of the peristeen anal irrigation system before using it unsupervised. the residual risk of perforation should be balanced against the improvement in bowel function and quality of life for each patient.The risk of bowel perforation has been highlighted in the manufacturer’s revised instructions for use. the mhra is issuing this medical device alert to bring this issue to wider attention. for information the warnings, contra-indications, precautions and intended use which appear in the most recent ifu for the peristeen anal irrigation system (in packs manufactured after 3 december 2010) are reproduced below: warnings anal irrigation procedure should always be carried out with care. bowel perforation is an extremely rare, but serious and potentially lethal complication to anal irrigation and will require immediate admission to hospital, often requiring surgery. contact your doctor immediately, if you during or after anal irrigation experience following: severe and sustained abdominal pain or back pain, especially if combined with fever sustained anal bleeding this product contains phthalates and should not be used by either children or pregnant or nursing women without consulting a physician. contains or presence of phthalate: dibutyl phthalate (dbp)reuse of the single use rectal catheter may create a potential risk to the user. reprocessing, cleaning, disinfection and sterilization may compromise product characteristics which in turn create an additional risk of physical harm to or infection of the patient. contra-indications peristeen anal irrigation must not be used in the following situations: known obstruction of the large bowel due to strictures or tumours. acute inflammatory bowel disease. diverticulitis. complex diverticular disease recent abdominal or anal surgery. precautions always consult a physician before starting up the irrigation procedure. if you are heavily constipated an initial and thorough clean-out of your bowels is advisable before starting up the irrigation procedure. please consult your health care professional.Peristeen anal irrigation is not recommended for: children under 3 years of age. pregnant or nursing women.Special caution must be shown if you have or have had any of the following: inflammatory bowel disease (e.G. crohn’s disease or ulcerative colitis). any anorectal condition, which may cause pain or bleeding e.G. anal fissure, severe haemorrhoids (third or fourth degree haemorrhoids). irradiation therapy in the abdominal or pelvic region. diverticular disease. abdominal or anal surgery. recent colonic biopsy. spinal cord shock phase. autonomic dysreflexia. cancer in the abdominal or pelvic region. long term steroid therapy. anticoagulant therapy. changed stool pattern like sudden diarrhea of unknown origin. the cause for diarrhea must be identified. rectal medication for other diseases. the effect of such medication may be diluted by the anal irrigation. risk factors for ischaemic colitis (atrial fibrillation, coronary artery disease, hypercholesterolaemia). onset of any the above mentioned conditions. blood in faeces, weight loss, abdominal pain. changes in the frequency, colour and consistency of the stools.For hygienic reasons the peristeen anal irrigation system must only be used by the same person. do not share with others. intended use peristeen anal irrigation is for people who suffer from faecal incontinence, chronic constipation or have to spend a long time on bowel management procedures. please read the whole instruction including warnings, contra-indications and precautions before carrying out the anal irrigation procedure. it is vital for your safety that you consult a physician before starting up the irrigation procedure. we also require that you receive thoroughly instruction from a health care professional before using this product. your first irrigation must be supervised by a health care professional. before starting the irrigation procedure, please ensure you have identified which catheter size you are using. the product codes can be found on the catheter packaging. small catheter – product code 29128 regular catheter – product code 29123 for health care professionalsto receive further information as well as training material for peristeen anal irrigation, please access www.Coloplast.Com for contact information.

Familiarise yourself with the instructions for use (IFU), which have recently been updated.Ensure that patients (and where appropriate carers): have received comprehensive training and are competent in the use of the system before using it unsupervised are aware of the risk of bowel perforation, how to recognise the symptoms and actions to be taken.Before starting Peristeen Anal Irrigation, Coloplast instruct that patients should undergo a medical evaluation by a doctor with appropriate expertise to ensure that they have no conditions that preclude its use or require further investigation.