FDA Approved Use

In 2004, the Food and Drug Administration (FDA) issued Indications For Use of the Hirudo medicinalis; "An adjunct to the healing of graft tissue when problems of venous congestion may delay healing, or to overcome problems of venous congestion by creating prolonged localized bleeding."

The FDA states that the bite of the medical leech "produces a small amount of bleeding which mimics venous circulation in areas of compromised tissue it is of value in healing following plastic and reconstructive surgery. A leech bite produces anticoagulant and vasodilator substances which allow continued bleeding and improved venous circulation even after the animal has been removed from the patient."

FDA approval cites historical use and documented value in various post surgical situations as the reason for recognizing Hirudo medicinalis, as a medical device. In addition, they determined that the use of Hirudo medicinalis requires prescriptive authority. Finally, they noted that the animal is an endangered species and subject to additional regulation by the U.S. Fish and Wildlife Service.

A medical device, by FDA standards, is an “article intended to diagnose, cure, treat, prevent, or mitigate a disease or condition, or to affect a function or structure of the body, that does not achieve its primary effect through a chemical action and is not metabolized.”

FDA approval makes it more likely that leech therapy will be covered by insurance and more readily accepted. FDA approval may also stimulate commercial interested in selling leeches for medical use. At $7 to $10 per leech, this is one medical device that's a bargain.

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