Wound Care Treatment by RN Using the Anodyne® Therapy Professional System 480

A request was received for an opinion as to whether wound care treatment,  as prescribed, using the Anodyne® Therapy Professional System 480, is within the  scope of RN practice.  The Anodyne® Therapy Professional System 480 was described as a non-invasive, drug-free device that delivers Monochromatic InfraRed Energy (MIRE) through infrared light-emitting diodes, with a wave length of 890nm that is mounted in flexible therapy pads.

Following discussion of the question posed, statutes governing nursing practice, and the Scope of Practice Determination Guidelines, it was the advisory opinion of the Board that the performance of Anodyne® Therapy, as described above for wound care, is within the scope of RN practice when the nurse possesses the educational preparation and current clinical skills to perform the therapy in a safe and effective manner.  Nursing practice should be consistent with the Kentucky Nursing Laws, established standards of practice, and be evidenced based.

The use of Anodyne® Therapy for treatment of wounds is being prescribed for a non-FDA approved use.  In a FDA Information Sheet (1998 Update) on Off-Label Use of Marketed Drugs, Biologics, and Medical Devices, the FDA advises:  Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics, and devices according to their best knowledge and judgments.  If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.   Use of a marketed product in this manner, when the intent is  
the “practice of medicine,” does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE), or review by an Institutional Review Board (IRB).  However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.