Colon Hydrotherapy (Colonic Irrigation) Guidelines Dubai Health Authority 2013 This guideline may be reproduced in whole or in part for reading or study purposes subject to the inclusion of an acknowledgement of the source. Reproduction for purposes other than those indicated above requires a written permission of the Dubai Health Authority. Colon Hydrotherapy Guidelines Page 2 of 14 HRD/HRS//FRU/023 Table of Contents I. Scope ........................................................................................................................................... 4 II. Purpose ....................................................................................................................................... 4 III. Definitions .................................................................................................................................. 4 IV. Acronyms: .................................................................................................................................. 4 Introduction ..................................................................................................................................... 5 1. Professional requirements: ....................................................................................................... 5 2. Training Course: ....................................................................................................................... 5 3. Application procedure: ............................................................................................................. 6 4. Facility requirements: ............................................................................................................... 6 5. The procedure/ treatment room: ............................................................................................. 8 6. Procedure Requirements .......................................................................................................... 8 7. Infection control....................................................................................................................... 10 8. Disposables ............................................................................................................................... 11 References: ..................................................................................................................................... 12 Appendix (1) - Contraindications to Colon Hydrotherapy........................................................ 13 Appendix (2) - Risks associated with Hydrotherapy .................................................................. 14 Colon Hydrotherapy Guidelines Page 3 of 14 HRD/HRS//FRU/023 I. Scope This guideline applies to any outpatient care facility that wishes to provide colon hydrotherapy services subject to licensure under the Dubai Health Authority (DHA) establishment law, including governmental and semi-governmental, private and health facilities operating in free zone areas. The DHA has the right to amend the guideline stipulated herein without prior notice; the latest version of the regulation shall be published in the DHA website www.dha.gov.ae II. Purpose The Dubai Health Authority is the sole responsible entity of ensuring that all health facilities and professionals in the Emirate of Dubai provide the highest level of safety and quality patient care at all times. This guideline outlines the basic mandatory requirements for a facility to be able to provide the colon hydrotherapy services. III. Definitions Colon hydrotherapy: also known as colonics, colonic lavage, colon irrigation, colonic irrigation or high colonic is the practice of cleansing the colon using filtered and temperature regulated water via a rectal catheter. IV. Acronyms: ARTG: Australian Register of Therapeutic Goods FDA: Food and Drug Administration CE: Conformité Européenne Colon Hydrotherapy Guidelines Page 4 of 14 HRD/HRS//FRU/023 Introduction Colon Hydrotherapy (also known as colonics, colonic lavage, colon irrigation, colonic irrigation or high colonic) is the practice of cleansing the colon using filtered and temperature regulated water via a rectal catheter. It is a method of removing waste from the large intestine, without the use of drugs. By introducing filtered and temperature regulated water into the colon, the waste is softened and loosened, resulting in evacuation through natural peristalsis. The process is repeated a few times during a session. 1. Professional requirements: Professional performing the Colon Hydrotherapy procedure must hold a valid Dubai Health Authority (DHA) license in one of the following categories: 1.1. Physician Licensed physician should be a General Practitioner or one of the following specialities: Internal medicine, Gastroenterology, Family medicine, or General surgery. 1.2. Registered nurse 1.3. Naturopathic professionals 2. Training Course: Interested healthcare professionals in performing Colon Hydrotherapy procedure (except Naturopathic professionals) shall attend a training program; such programs shall offer a full-time didactic curriculum with Educational program should include a clinical curriculum that offers both clinical instruction and direct patient contact. Such programs may consist of the following: 2.1. 100 hours of supervised theory training. 2.2. 50 to 55 hours of practice including being involved in a minimum of 20 to 25 colon hydrotherapy treatments performed during the training; records of each case study must be kept. Colon Hydrotherapy Guidelines Page 5 of 14 HRD/HRS//FRU/023 2.3. Verifiable satisfactory completion of the assignments, theory examinations and practical examinations. 2.4. Certifying schools of instruction shall be recognized by at least one of the following three organizations: 2.4.1. The International Register of Integrative Colon Therapists and Trainers (RICTAT) www.rictat.org 2.4.2. 2.4.2The Global Professional Association for Colon Therapy (GPACT) www.gpact.org 2.4.3. 2.4.3The International Association for Colon Therapy (I-ACT) www.iact.org 3. Application procedure: All applicants for colon hydrotherapy privilege must apply for “Add/upgrade” option in professional account in Sheryan system and submit the following: 3.1. Evidence of successful completion of an approved training program. 3.2. 3.2 Education program Transcript – the applicant must provide a full transcript clearly stating the breakdown of theory vs. clinical training hours. 3.3. Evidence of all clinical experience (including training period) 3.4. Malpractice insurance 3.5. Good standing certificate issued by the current licensing authority 3.6. A valid certificate of Basic Life support (BLS). 4. Facility requirements: 4.1 Colon hydrotherapy shall not be performed in an independent healthcare facility that provides this service only. 4.2 Colon hydrotherapy may be added to the services that an outpatient care facility ( specialty clinic or polyclinic) provides at least one of those specialties: gastroenterology, internal medicine or general surgery. The clinic needs to fulfill all the requirements stipulated in this guideline subject to inspection and approval of the Health Regulation Department. Colon Hydrotherapy Guidelines Page 6 of 14 HRD/HRS//FRU/023 4.3 The outpatient care facility providing Colon Hydrotherapy must abide with the facility regulation mentioned in the Outpatient Care Regulation on www.dha.gov.ae 4.4 Colon Hydrotherapy must be carried out in an outpatient care facility under the direct supervision of a physician , as mentioned in 1.1.1. 4.5 Equipment should be FDA, CE or ARTG approved and subject to approval from the Ministry of Health in the United Arab Emirates. 4.6 Specialized plumbing is required for the human waste released during the treatment so that it is flushed directly into the sewage water system of the facility. 4.7 There should be a sediment filter in addition to an activated carbon filter attached to the hot and cold water connection of the treatment room. 4.8 There should be a second filter system attached to the colon hydrotherapy device itself in accordance with the manufacturer specification. 4.9 The filters need to be changed in a timely manner (monthly is recommended) and a filter change record/log book needs to be maintained. 4.10 In some cases, specifically the closed pressure systems, the installation of an ultraviolet sterilizer at the main supply is required for water treatment. [UV sterilizer will sterilize water going into the client or patient; however when they go and wash their hands or face with “unsterilized” they would re-infect. The view here is that UV sterilized needs to be installed at the mains if the mains water could be contaminated; or in the situations of increased patient fragility, such as hospitals]. 4.11 Instructions of the equipment manufacturer must be followed always in performing the cleansing or priming procedure prior to commencing any treatments if the device is new or the filters have been changed. 4.12 Cleansing solution recommended by the manufacturer should be used. 4.13 Equipment must be maintained and all necessary parts should be changed as per the instructions contained in the equipment manual. Colon Hydrotherapy Guidelines Page 7 of 14 HRD/HRS//FRU/023 5. The procedure/ treatment room: 5.1. Consultation room and procedure/treatment rooms must be separate and their size abides by the outpatient care regulation available on www.dha.gov.ae . 5.2. The floors must be fully washable. Carpet floor are not allowed. 5.3. The room must have its own toilet and washing facilities. 5.4. The room must have an extraction system. 5.5. There must be a water fountain/supply of drinking water on the premises. 5.6. Separate hands free basin with hot and cold running water supplied through a single outlet with liquid soap and paper towels. 5.7. Have a toilet and shower for exclusive use of the client located in the procedure room or as an ensuite. 5.8. Have a paper towel on the client couch. 5.9. Have a paper towel for each client to clean themselves after the irrigation procedure. 5.10. The outpatient care facility must provide clean and comfortable facilities for the patient/ client to change. 5.11. Clean gowns, robes and towels should be provided. 5.12. Care must be taken so that the systems tubing does not get blocked during the procedure. 5.13. Crash cart trolley must be available in the procedure room and in accordance with the crash cart specification stipulated in the DHA Outpatient Care Regulation available on www.dha.gov.ae . 6. Procedure Requirements 6.1. Patient care: 6.1.1. Initially all patients must be clinically assessed by the specialist physician. 6.1.2. Pre-care and aftercare advice must be provided to the patients and recorded in their files. Colon Hydrotherapy Guidelines Page 8 of 14 HRD/HRS//FRU/023 6.1.3. Physician must ensure that all patients going through the procedure have an intravenous canulation. 6.1.4. Patients’ records must be kept in a lockable cabinet. In case the outpatient care facility utilizes electronic patient records the facility must ensure the records are kept safe and easily retrievable. 6.1.5. Patients undergoing the colon hydrotherapy must sign a “Consent Form” with information about the treatment, type of equipment used, contraindications and risks associated. For further information about the risks and contraindications of this treatment that must be on the consent form refer to ( Appendix 1& 2). 6.1.6. All patient details must be kept confidential. 6.1.7. Once treatment commences, controls should be placed such that the patient is unable to alter settings. 6.1.8. Operator should have clean clothes and no exposed cuts, abrasions or wounds. 6.1.9. Under no circumstances should the colonic irrigation equipment be connected directly to a drinking water supply system. This could result in serious, possibly fatal injury to the patient due to application of mains pressure. 6.2. Water pressure: 6.2.1. Manufacturer’s instructions must be followed always. 6.3. Water temperature: 6.3.1. Water temperature must be regulated to normal body temperature to prevent thermal shock or scalding. The minimum allowed temperature is 31°C and the maximum allowed temperature is 39°C with the average treatments temperature of 34°C to 37°C. It is unsafe to operate the equipment outside the recommended temperature levels Colon Hydrotherapy Guidelines Page 9 of 14 HRD/HRS//FRU/023 6.3.2. Any concern about the temperature should be discussed with the operator. 6.4. Treatment duration: 6.4.1. The average treatment duration is around 45 minutes; never exceed 60 minutes. 6.5. Lubricant: 6.5.1. Tubes of lubricant, single-use pouches or disposable spatulas should be used to avoid cross-contamination. Any contaminated lubricant MUST be discarded immediately. 7. Infection control Hygiene is of prime importance to avoid and protect both client and operator from disease transmission. The infection control procedures shall abide by those mentioned in the outpatient care regulation that can be accessed via www.dha.gov.ae in addition to the special precautions related to the procedure stated in this guideline. 7.1. Hygiene: 7.1.1. There must be disinfectant in the room at all times e.g. sterilizing alcohol or Milton solution . 7.1.2. All surfaces touched by the patient: the toilet, the door handles, the bed must be sanitized with a disinfectant solution between all treatments so as to prevent human cross-contamination. 7.1.3. The colon hydrotherapy device must to be cleaned and sterilized between all treatments. 7.1.4. Disposable gloves must be worn at all times during the treatment and the cleaning process. Any gloves smeared with bodily fluids must be immediately discarded and replaced. 7.1.5. Only tubes or single pouches of lubricant are allowed and any contaminated lubricant MUST be discarded immediately. Colon Hydrotherapy Guidelines Page 10 of 14 HRD/HRS//FRU/023 7.1.6. All disposable equipment used during the treatment must be discarded in a specialized medical waste bag. This must be collected by a medical waste collection service as it is classified as human bodily fluids and wastes. 7.1.7. Hands must be scrubbed between treatments. 8. Disposables 8.1. It is universally recommended to use only disposable kits. 8.2. A water based lubricant in a single use sachet is recommended to assist catheter insertion. 8.3. Single use gloves should be worn by the operator when assisting a patient/ client to insert a catheter or discard immediately after use. 8.4. No part of disposable kits (speculum, obturator, inlet or outlet pipe, disposable underpants or robe) must ever be re-used. 8.5. Speculum and obturator sealed packaging must not be opened until immediately prior to the commencement of the treatment and should be done so in full view of the patient. Colon Hydrotherapy Guidelines Page 11 of 14 HRD/HRS//FRU/023 References: 1. RICTAT - The International Register for Integrative Colon Therapists and Trainers www.rictat.org 2. GPACT - The Global Professional Association for Colon Therapy www.gpact.org 3. I-ACT - The International Association for Colon Therapy www.i-act.org Colon Hydrotherapy Guidelines Page 12 of 14 HRD/HRS//FRU/023 Appendix (1) - Contraindications to Colon Hydrotherapy a. Severe cardiac disease b. High blood pressure not controlled by a doctor c. Low blood pressure causing the person to pass out habitually and severe anaemia d. Aneurysm e. GI hemorrhage or perforation f. Severe internal hemorrhoids g. Cirrhosis of the liver h. Carcinoma of the colon i. Active fistulas and fissures j. Pregnancy k. Abdominal hernia l. Recent colorectal surgery m. Renal insufficiency (serious kidney problems) n. Inflammations (anything with a long name ending in “itis”, and acute form of such diseases as: Diverticulitis, Ulcerative colitis and Crohn’s disease. Colon Hydrotherapy Guidelines Page 13 of 14 HRD/HRS//FRU/023 Appendix (2) - Risks associated with Hydrotherapy People with acute or chronic illnesses, who are suffering from diarrhoea, or who are immune-compromised should seek medical advice prior to undertaking any colonic irrigation procedure. Potential risks for any client include: a. Infection due to unsterile equipment that permits backflow of faecal material to the water system. b. Injury to the colon, such as ulceration or perforation. c. Exacerbation of chronic bowel disease such as diverticulitis, Crohn’s Disease or hemorrhoids. d. Scalding if water temperature regulating controls fail. e. Reduced capacity to control bowel movements for a period of time after the procedure. f. Removal of normal intestinal flora may lead to gastrointestinal infections. If you develop an infection, feel weak, or have any other unusual symptoms following therapy, stop treatment and check with your doctor. You should also report these symptoms to the operator. Colon Hydrotherapy Guidelines Page 14 of 14 HRD/HRS//FRU/023