TRAINING AND CERTIFICATION

Colon Lavage is a unique profession in healthcare, as it does not specifically require a degree to treat patients (i.e. R.N., L.P.N., M.D. or an N.D.). However, as these units are a class II medical device they do require a prescription to purchase. Various states impose different standards for what sort of qualifications are required to operate a class II medical device but a universal standard is that such a device requires medical oversight to operate. Unless the particular state (such as Florida) designates specific training standards for use of a class II medical device the standards are set by the physician authorizing use. A prudent physician would require specific guidelines for which to operate such equipment with standards that include patient assessment guidelines and operation guidelines. If such guidelines require the practioner to perform a physical assessment or interventions which require advanced training by state statute such individuals should be licensed as statute requires (RN, LPN, CNA etc.). Additionally, the FDA typically requires class II medical device manufacturers to publish administrator guidelines detailing proper use and maintenance of such equipment.

The colon irrigation has faced controversy in recent years with many manufacturers ignoring FDA guidelines for distributing class II equipment and coupled with non professional colonic practioners unqualified to perform physical assessment and medical histories on patients to determine feasibility for safe colon irrigation.

In the case, STATE OF TEXAS v. COLON THERPEUTICS, INC. & JIMMY JOHN GIROUARD, the state of Texas sued makers of the Jimmy John colonic device when its improper use led to the perforation of a patient’s colon. Investigations relating to the case uncovered the following violations regarding use of a Class II medical device: the therapist performing the colonic was not a licensed healthcare professional, the therapist had no licensed medical oversight during the procedure, and the therapist performed the treatment without obtaining a prescription. The therapists’ violations were traced to improper training and marketing for the device provided by the manufacturer and thus resulted in the death of a patient.

In order to avoid expensive lawsuits that could threaten your business, or worse, proper training and certification are a must. For certification there are two organizations available – International Association of Colon Therapists (I-ACT) or the Colon Therapists Nursing Foundation (CTNF). Following the Jimmy John case, I-ACT came under scrutiny for certifying and improperly training the therapist responsible for the perforation. Proper training and certification should include thorough understanding of the anatomy & physiology of the digestive tract and the pathophysiology of the various diseases which affect digestion to insure proper use of a Class II medical device. Such training is available through the CTNF whose founding was in response to the difficulties colon therapists faced from both medical and legal communities. CTNF has employed specific standards, protocols and educational parameters to ensure that colon therapists are prepared to safely and effective practice colon irrigation.

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