Under the auspices of the CTNF, this code permits the practice
of colon hydrotherapy. Each individual practitioner needs to
comply with state and local regulations as they relate to colon
hydrotherapy. CTNF has developed protocols which we believe
are safe but the physician providing medical oversight to your
practice will determine what are safe operating standards. Colon
hydrotherapy aims to restore, strengthen and maintain the proper
function of the colon via water irrigation of the large intestine
that eliminates waste and stimulates the natural contractions
(peristalsis) of the colon.
Colon irrigation – also referred to as a colonic, colon
lavage, high colonic or colon hydrotherapy – introduces
water into the patient’s large intestines through a plastic
tube (speculum) inserted < 2 inches (50mm) into the patient’s
rectum. For 30-45 minutes the patient’s large intestines
are filled with water, and then released to excrete possible
obstructions or impaction. Typically, the procedure’s
administrator will massage the patient’s lower abdomen
to loosen any hardened obstructions or impaction.
There are two types of colonic devices available: referred
to as open systems and closed systems. Open systems deliver
a constant, low-pressure stream of water through a small pencil
sized speculum. In open systems, the patient naturally controls
the filling and release of water from their colon as they would
when going to the bathroom. During an open system procedure
the need for oversight is minimized, and patient privacy is
increased.
Unlike open systems, closed system colonic devices utilize
a large speculum, are administered and controlled by the professional
and do not allow for privacy. A closed system’s speculum
is the diameter of a cigar and used by the professional to deliver
water and remove waste. The professional regulates the pressure,
fill and release timing during a closed system procedure. Since
the device does not run by itself, no privacy is afforded to
the patient.
Colonic practices can place patients at risk of disease and
infection. As such, practices should adhere to strict, regimented
cleaning and sterilizing procedures for all equipment and patient-used
environments. Professionals not exercising a reasonable level
of care can expose their patients to bowel infections like Hepatitis
A and blood borne viruses like Hepatitis B, C and HIV. Patients
could be harmed and sue claiming negligence, likely putting
the practitioner out of business.
CLASSIFICATION OF COLON THERAPIST PRACTITIONERS
Level one: Physicians / Nurse Practitioners
/ Physician Assistants- can operate independently.
Level two: Registered Nurses-
Must operate under STANDING ORDERS or direct supervision
from physician or nurse practitioner.
Level three: Licensed Practical Nurses-
LPN’s must operate under delegation of Registered
Nurses.
Level four: Certified Nursing Assistants-
CAN’s must operate under delegation of Registered
Nurses.
Level five: Emergency Medical Technicians:
EMT’s must currently be registered with either the
state they work in or the NREMT. EMT’s must operate
under delegation of Registered Nurses.
Level six: Student Nurses- Must
operate under supervision of Registered Nurses with Master's
degree (see state Nurse Practice Act for local guidelines).
Level seven: Layperson- Must operate
under supervision of a physician that acts as medical oversight.
All practioners must receive certification or probationary
status from the Colon Therapist Nursing Foundation to operate
under the auspices of the CTNF. Generally, they will already
be qualified doctors, nurses or complementary medicine practitioners.
All persons must be able to demonstrate competency. Full records
must be kept on the premises of all qualifications, courses
attended (with dates, and the titles of the courses, and awarding
bodies) of all practitioners. These details must be available
for inspection at all times.
TREATMENT SESSION:
Procedure space should include:
• Attention to patient privacy and comfort
• Regularly sterilized surfaces and equipment to prevent
spread of infection and disease to client and practitioner
• A hands-free sink with running water, paper towels and
liquid soap
• Toilet and shower close to colonic device for exclusive
use by client
• Paper towels by colonic device and seating area
• Changing area that includes clean gowns, robes and towels
• Regular device cleaning and maintenance to insure against
system clogs during procedure
• Single use lubrication packets for speculum
• Single use gloves for practitioner’s insertion
of speculum; or single use wipes for patient insertion
• Water temperature regulation – to avoid shock
or scalding water for treatment must be kept between 34 and
40 degrees C, never to exceed 40 degrees. Normal body temperature,
37.6 C, should be the guide.
• Controls should not be available for patient to alter
once procedure has begun.
• Practitioner should be clean and sanitary – clean
clothes and no exposed cuts, abrasions or wounds. Hands should
be washed and dried thoroughly before putting on new gloves.
• Colonic equipment should be registered and inspected
by appropriate government agency, i.e. FDA. Procedures for safe
operation, manufacturer’s maintenance guidelines and specifications
should be strictly followed.
• Colonic device water supply should not be connected
to a drinking or main water supply – changes in pressure
or temperature could result in injury.
• All tubing and catheters should be single use
• All questions about equipment prior to the procedure
should be directed to the manufacturer prior to treatment.
DISEASE PREVENTION BY SPREAD OF CONTAMINANTS
Personal Protective Devices: When there is a chance of contamination
to the hydrotherapist protective devices to prevent injury to
therapist should be prevented by the use of gowns, masks, goggles
and gloves as is appropriate. Single-use, non sterile latex
examination gloves should be used for treatments. Latex finger
cots should be used over these for rectal examinations and discarded.
Sterilization of equipment between sessions:
A suitable lubricant should be used for insertion of the speculum
or finger, with extra care given to prevent cross-contamination.
All hard surfaces shall be cleaned and disinfected before and
after each client, especially surfaces subject to soiling, such
as door knobs and toilet handles. Disposable specula, obturators
(a device serving to close an opening in the body) and any piping
should be cleaned of any obvious soiling and disposed of safely
as clinical waste (see Waste Collection). Non-disposable specula
and obturators must be cleaned thoroughly of gross contamination,
rinsed and disinfected before re-use with a disinfectant, at
the correct concentration, according to the manufacturer’s
instructions. All gowns, wraps or other protective clothing,
paper or other covering, towel, cloth or other such articles
used in treatment shall be clean, in good repair, and so far
as is appropriate, sterile. The finish on all surfaces within
the treatment area should be made of materials that are easily
cleaned. Fittings in the treatment area such as benches should
be cleaned between each client and/ or a clean covering placed
over the treatment surface. Adequate lighting is recommended.
Personal Hygiene:
Any therapist that has an open boil, sore, cut or other open
wound must be sure that it is effectively covered by an impermeable
dressing. Shall not carry out any treatment if they are suffering
from an acute respiratory infection. Hands are kept clean and
are washed immediately prior to carrying out any treatment.
They shall refrain from smoking or consuming food and drink
during the course of the treatment. They shall not carry out
any treatment if there is a likelihood that they will contaminate
colonic irrigation equipment, supplies or working surfaces with
body fluids or pathogenic organisms.
Disinfectants:
Disinfectants do not sterilize, they only reduce the number
of some microbes. Disinfectants are needed for: Cleansing the
colonic unit, Wiping down the treatment couch, Table tops and
general surfaces in the treatment area, including door knobs
and toilet handles. Recommended disinfectants are as follows:
Bleach for dealing with spillages of body fluids, Detergent
and water for general cleaning and wiping down.
ASSESSMENT OF PATIENT CONDITION
Patient condition (Blood Pressure, Temperature, Pulse, Abdomen,
Lungs, SPO2 and Mental Status) must be assessed before, during
and after treatment session. Additionally, prior to each session
the therapist should conduct an stool occult blood test to determine
the possible presence of damage to the intestinal digestive
tract (NO COLON IRRIGATION SHOULD BE COMMENCE WHEN THERE IS
A POSITIVE READING). History of Patient’s prior medical
treatment must be reviewed with patient prior to commencement
of a session. Review Standing Orders as per medical oversight
prior to beginning treatment with ALL patients. Be careful to
question patients in relation to any contraindications that
may make Colon Irrigation a danger to the patient.(SEE CTNF
training manual for template).
COMPLETION OF TREATMENT
• Dispose of all single use materials: gloves,
gowns, speculums, tubing
• All equipment and patient-contact areas must be cleaned
• All linens must be cleaned after treatment
• Any equipment that comes in contact with blood or bodily
fluids must be sterilized before it is reused
• Details of sterilization procedures should be recorded
• All waster should be bagged and disposed of properly
PATIENT EDUCATION (SEE CTNF training manual
for template).
Prior to commencement of a colon irrigation session the patient
shall demonstrate or verbalize understanding of:
a) The basic digestive process?
b) What to expect from a colon irrigation session?
c) What are risks and benefits of colon irrigation?
d) What to do if the colon irrigation session feels wrong (pain,
nausea, vomiting, dizziness)?
Potential risks for any client include:
• Infection from un-sterilized equipment or back flow
of fecal matter into water system
• Colon perforation or ulceration
• Worsening of current digestive diseases or disorders
such as diverticulitis, Chron’s disease or hemorrhoids.
• Scalding in the absence of proper temperature regulation
• Reduced ability to control bowel movements following
procedure
• Changes in normal intestinal floral resulting in infection
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 therapist.
PATIENT FOLLOW UP (SEE CTNF training manual
for template).
All patients should be provided follow up dietary, exercise
and cleansing follow up based on the particulars of their session
tolerance, history and physical assessment.
PATIENT CONSENT
Each patient will be provided education sufficient to understand
the risks and benefits of Colon Hydrotherapy so that they can
provide informed consent. (SEE CTNF training manual for template).
CONTRAINDICATIONS (SEE CTNF training manual
for template).
Severe abdominal pain in area of sigmoid colon YES / NO
Noticeable blood in feces YES / NO
Congestive heart failure YES / NO
Diverticulitis YES / NO
Ulcerative colitis YES / NO
Crohn's disease YES / NO
Severe or internal hemorrhoids YES / NO
Tumors in the rectum or colon YES / NO
Intestinal perforation YES / NO
Carcinoma of the rectum YES / NO
Fissures or fistula YES / NO
Severe hemorrhoids YES / NO
Abdominal hernia YES / NO
Renal insufficiency YES / NO
Recent colon or rectal surgery YES / NO
Cirrhosis of the liver YES / NO
First and last trimester of pregnancy YES / NO
ALL CURRENT CONDITIONS SHOULD GIVE RISE TO CONCERN & PATIENT
SHOULD HAVE PHYSICIAN APPROVAL TO HAVE COLON IRRIGATION TREATMENT-
STANDING ORDERS DO NOT APPLY AND CAN NOT BE USED TO AUTHORIZE
COLON IRRIGATION IN THESE INSTANCES
STANDING ORDERS
No registered nurse shall perform a Colon Irrigation with out
first receiving medical authorization from a physician or nurse
practitioner licensed in the state of the Colon Irrigation practice.
Such authorization shall be received via individual patient
or through the use of standing orders; which shall specifically
detail the necessity of colon irrigation and the contraindication
which prohibit colon irrigation. (See CTNF training manual for
template)
CHARTING THE COLON HYDROTHERAPY TREATMENT SESSION
Each practioner is required to chart the complete hydrotherapy
treatment session as outlined in the COLON THERAPY Tx PROTOCOL
(See CTNF training manual for COLON THERAPY Tx PROTOCOL template).
The chart shall include regular assessments as well as follow
up instructions.
FIRST-AID / ADVERSE EVENTS
Equipment: to include all that is necessary to monitor patient
condition during session as well as: defibrillator if such is
required by local regulations, bag valve mask, O2 canister with
100% flow mask, airway adjuncts.
Supplies: disinfectant supplies according to equipment manufacturer’s
specifications.
Reporting: All adverse events involving a colon irrigation shall
be promptly reported to the FDA or appropriate foreign governmental
body that monitors Colon Irrigation Medical Equipment.
WATER TEMPERATURE
The temperature of the water delivered through the speculum
should normally be between 33-40°C (92° F -104°F).
It should never exceed 40°C (104°F).
PERMISSABLE DEVICES / COLONIC EQUIPMENT
A suitable water filter should be fitted to all colonic irrigation
systems, and should be capable of reducing/removing particulate
matter, dissolved organic and inorganic matter from irrigation
water before it enters the client’s colon. The filter
element must be replaced at the manufacturer’s recommended
intervals. Colonic machines should not have pumps or other pressure
enhancing devices, but should be equipped with non-return (to
protect the water supply) and pressure-reducing valves. There
should be a mechanical break between the mains water supply
and the client.
For all countries recognizing and accepting FDA registered
devices all colonic equipment used must be Class II FDA Registered
equipment receiving current updates and support from the manufacturer.
Use of unregistered or equipment from a defunct manufacturer
where no support and recall communications are being communicated
are prohibited. When operating outside the USA other countries
regulations must be adhered to to comply with this CODE OF PRACTICE.
CONDUCT OF THE BUSINESS
The business operator shall ensure full compliance with this
code of practice.
The business operator shall ensure that:
• A ‘responsible person’ is in charge of the
premises at all times
• He/she is familiar with, and implements, the requirements
of the relevant codes of practice
Responsible persons should be nominated in writing by the business
operator. This notification should be continuously available
for inspection on the premises.
The responsible person shall:
• Be in charge of premises and on site during operating
hours, or any time the public is on site
• Be assisted as necessary by suitable adult persons to
ensure adequate supervision
• Not be engaged in any other duties which would prevent
him/her from exercising general supervision
PREMISES
• All internal walls, doors, windows, partitions, floors
and floor coverings, and ceilings shall be kept clean and in
such good repair to enable effective cleaning.
• Treatment area must only be used for treatment and
kept completely separated from all other rooms by full height
walls or partitions.
• Effective pest control measures, such as pest proofing,
and appropriate treatments shall be carried out, as necessary,
and proper records kept.
• The floor of the treatment area must be a smooth, impervious
surface.
• There must be a minimum of 5m2 (45 square feet) of
floor space for each practitioner in the establishment.
• No animals of any kind can be allowed in the establishment,
except assistance animals used by persons with disabilities,
eg: guide dog for the blind.
• All furniture and surfaces in the premises must be
kept clean.
• Furniture in the treatment area (such as tables, couches
and seats) should be covered with a smooth, impervious surface
for effective cleaning.
• There must be an adequate, constant supply of clean
hot and cold water at a sink, sanitizing soap or detergent,
nailbrush, and disposable towels, conveniently accessible to
the practitioner for his sole use.
• A substantial sink with hot and cold water supply for
washing of soiled instruments, etc, with adjacent work surfaces
must be provided.
• There must be suitable and sufficient sanitary accommodation
for practitioners.
• There must be adequate clean and suitable storage for
all items, so as to avoid, as far as possible, the risk of contamination.
• Suitable and sufficient means of heating to a reasonable
room temperature, appropriate to the treatment provided must
be provided.
• Suitable screening to provide privacy must be provided.
• Adequate artificial lighting must be provided and maintained.
A suitable overall standard of lighting would be 500 lux.
• The premises must be adequately ventilated.
TOILET FACILITIES
A toilet should be very conveniently located near the treatment
room and reserved exclusively for the client’s use during
working hours. A waste bin, for the disposal of sanitary towels
and soiled articles should be provided. It is essential that
the toilet facilities are regularly cleaned and disinfected
. A bidet, while not essential, is desirable; wet wipes should
otherwise be provided.
RECORD KEEPING/INFORMATION
A record shall be kept of every practitioner, as follows:
Full names and exact duties
Date of birth
Gender
Home address
Home/work telephone numbers
Patient Records & HIPPA Compliance
HIPPA FORMS (if you store patient information electronically).
Every client shall read and sign a consent form, which contains
details of name, address, age, medical history etc. These forms
shall be kept for a period of at least 7 years, after the cessation
of current treatment and be available for review by patient
or their representative (on presentation of written consent
from the client), at all times. This is so that alleged cases
of infection can be epidemiologically studied. Records including
name, address, date and type of treatment received shall be
confidentially kept for all treatments, for a period of at least
7 years after the treatment has finished. They shall be made
available to an appropriate governmental body upon request,
and with the written consent of the client.
All infections, complications or diseases resulting from any
colonic irrigation procedure that become known to the business
operator shall be reported to the local Health Department within
24 hours.
PEOPLE WITH DISABILITIES
Access should be provided for disabled people at the premises.
FIRE PRECAUTIONS
All fire exits, staircases and other means of escape shall be
kept unobstructed, immediately available, and clearly signed,
in accordance with the council’s requirements, and any
requirements of the Fire Authority. All fire-resisting and smoke
stop doors shall be maintained self closing, and shall not be
secured open. All exit doors shall be available for access and
egress whilst the public are on the premises. A notice or notices
reading “No Smoking” shall be prominently displayed
within the treatment area.
INSURANCE
All Registered Nurses must be covered by Malpractice Insurance.
The business shall have third party liability insurance, to
cover claims for damages or negligence, as well as employer’s
liability insurance where appropriate.
CERTIFICATION STATUS
The certification certificate / sticker shall be conspicuously
exhibited at all times in a conspicuous place at entrance of
facilities. It must be clearly visible by all persons using
the premises. It shall be adequately protected against theft,
vandalism or defacement.
MAINTENANCE
All systems, eg: fire safety equipment, boilers, electrical
equipment etc. provided in the premises shall be maintained
regularly by competent persons, and records kept.
All equipment used in connection with special treatments shall
be serviced/maintained in accordance with the manufacturers/suppliers
recommendations, and records kept.
WASTE COLLECTION
Refuse should be stored in covered receptacles and suitable
arrangements should be made for its regular collection.
A copy of the current contract for the removal of such waste,
including any clinical waste, together with a copy of the contractor’s
licence and transfer notes, shall be available for inspection
on the premises at all times.
EMPLOYEE RECORDS
A record shall be kept of every practitioner, including:
Name
Address
Home telephone number
Mobile telephone number
Name and address of establishment
Telephone number of establishment
Attached current passport photo