19
removing pooled blood. It would seem logical that maggots were used as predicate
devices to clear leeches, but what about concerns for a chemical action? Both leeches and
maggots secrete substances that are responsible for their therapeutic actions. Maggots
clean wounds by dissolving necrotic, infected tissue killing bacteria and stimulating heal-
ing. Leeches, as mentioned earlier, secrete a number of valuable compounds. FDA did not
justify its decision on the device classification to say that the effects of leeches were due to
mechanical effects of “chewing.” The effect in this instance could be “swallowing.”
Conclusion
It would appear that the clearance of leeches and maggots as medical devices attests to the
versatility of the FD&C Act and to the creativity of officials at the agency. More surprises
may be on the way. The BioTherapeutics Education &Research Foundation is an organiza-
tion involved with all forms of symbiotic medicine.20 This group has been quite active in
supporting additional research. Symbiotic medicine or biotherapy includes diagnosing
and treating diseases with live animals, such as maggots, leeches, honey bees and even
wound-eating fish. Two of the four are already medical devices—do not be surprised if
other aquatic species are next at least two species of fish are known to cure skin diseases
such as psoriasis and abscesses.
References
1. US Food and Drug Administration. FDA Clears Medicinal Leeches for Marketing. 28 June 2004. Available at:
http://findarticles.com/p/articles/mi_m0BPC/is_8_28/ai_n6156523/. Accessed 23 January 2012.
2. Hutt PB. A history of government regulation of adulteration and misbranding of medical devices. Food Drug
Cosmet Law J. 1989 44:99–117.
3. Pub L. No. 75-717, 52 Stat 1040 (1938).
4. Zimmer C. The healing power of maggots. Discover. 1993 14:22.
5. Root-Bernstein R, Root-Bernstein M. Honey, Mud, Maggots and Other Medical Marvels. Boston, Mass: Houghton
Mifflin 1997 21–30.
6. Ibid.
7. Ibid.
8. Sherman R. Email communication, August 2004.
9. Maggot Therapy Project, University of California at Irvine.
10. Sherman RA, Tran JM, Sullivan R. Maggot therapy for venous stasis ulcers. Arch Dermatol. 1996 132:254–256.
11. Sherman RA. A new dressing design for use with maggot therapy. Plast Reconstr Surg. 1997 100:451–456.
12. BioPharm Leeches Online. The Biting Edge of Science. Available at: http://www.biopharm-leeches.com.
Accessed 23 January 2012.
13. Op cit 5.
14. Bates M, Kneer K, Logan C. Medicinal leech therapy: an overview. Orthop Nurs. 8(2):12–17.
15. Ibid.
16. Op cit 5.
17. Ibid.
18. Adams SL. The medicinal leech. A page from the annelids of internal medicine. Ann Intern Med.
1988 109:399–405.
19. Op cit 1
20. BioTherapeutics Education &Research Foundation website. Available at: www.bterfoundation.org. Accessed
23 January 2012.
Published in Regulatory Affairs Focus, November 2004. Copyright © 2004 Regulatory Affairs Professionals Society.
Maggots and Leeches—Are They Medical Devices?
removing pooled blood. It would seem logical that maggots were used as predicate
devices to clear leeches, but what about concerns for a chemical action? Both leeches and
maggots secrete substances that are responsible for their therapeutic actions. Maggots
clean wounds by dissolving necrotic, infected tissue killing bacteria and stimulating heal-
ing. Leeches, as mentioned earlier, secrete a number of valuable compounds. FDA did not
justify its decision on the device classification to say that the effects of leeches were due to
mechanical effects of “chewing.” The effect in this instance could be “swallowing.”
Conclusion
It would appear that the clearance of leeches and maggots as medical devices attests to the
versatility of the FD&C Act and to the creativity of officials at the agency. More surprises
may be on the way. The BioTherapeutics Education &Research Foundation is an organiza-
tion involved with all forms of symbiotic medicine.20 This group has been quite active in
supporting additional research. Symbiotic medicine or biotherapy includes diagnosing
and treating diseases with live animals, such as maggots, leeches, honey bees and even
wound-eating fish. Two of the four are already medical devices—do not be surprised if
other aquatic species are next at least two species of fish are known to cure skin diseases
such as psoriasis and abscesses.
References
1. US Food and Drug Administration. FDA Clears Medicinal Leeches for Marketing. 28 June 2004. Available at:
http://findarticles.com/p/articles/mi_m0BPC/is_8_28/ai_n6156523/. Accessed 23 January 2012.
2. Hutt PB. A history of government regulation of adulteration and misbranding of medical devices. Food Drug
Cosmet Law J. 1989 44:99–117.
3. Pub L. No. 75-717, 52 Stat 1040 (1938).
4. Zimmer C. The healing power of maggots. Discover. 1993 14:22.
5. Root-Bernstein R, Root-Bernstein M. Honey, Mud, Maggots and Other Medical Marvels. Boston, Mass: Houghton
Mifflin 1997 21–30.
6. Ibid.
7. Ibid.
8. Sherman R. Email communication, August 2004.
9. Maggot Therapy Project, University of California at Irvine.
10. Sherman RA, Tran JM, Sullivan R. Maggot therapy for venous stasis ulcers. Arch Dermatol. 1996 132:254–256.
11. Sherman RA. A new dressing design for use with maggot therapy. Plast Reconstr Surg. 1997 100:451–456.
12. BioPharm Leeches Online. The Biting Edge of Science. Available at: http://www.biopharm-leeches.com.
Accessed 23 January 2012.
13. Op cit 5.
14. Bates M, Kneer K, Logan C. Medicinal leech therapy: an overview. Orthop Nurs. 8(2):12–17.
15. Ibid.
16. Op cit 5.
17. Ibid.
18. Adams SL. The medicinal leech. A page from the annelids of internal medicine. Ann Intern Med.
1988 109:399–405.
19. Op cit 1
20. BioTherapeutics Education &Research Foundation website. Available at: www.bterfoundation.org. Accessed
23 January 2012.
Published in Regulatory Affairs Focus, November 2004. Copyright © 2004 Regulatory Affairs Professionals Society.
Maggots and Leeches—Are They Medical Devices?