17
definition of drug, denotes a broad category that contrasts with the list of specific types
of products that are “devices.” Except for implants and in vitro reagents, most items
included in the definition of a device are mechanical products generally constructed of
solid materials such as metal or plastic. Pursuant to the latter part of the definition for
medical devices, FDA may not regulate as a medical device an article that achieves any of
its principal intended medical purposes through chemical action or by being metabolized.
Congress did not insert any counterpart clause into the definition of a drug that would
make chemical or metabolic action a prerequisite to a product being regulated as a drug.
Neither did Congress, in its 1976 revision of the definition of device, substitute the broader
term “article” for the listing of narrower categories of products to be regulated as devices
found in the act since 1938.
In light of this background information, questions naturally arise about the rationale
used by FDA in its decision to classify leeches and maggots as medical devices. It is inter-
esting to speculate on how the late Senator Clark would have reacted to this decision. As
will be seen in the following descriptions, both organisms secrete substances that clearly
have a chemical action within or on the body. We will look at maggots first.
Maggots and Leeches: A History of Therapeutic Use
Maggots
Maggots are fly larvae, and there are literally thousands of species of flies, each with
distinct habits and lifecycles. Currently, Phaenicia sericata (green blow fly) larvae are used
clinically. This species has been used successfully for many decades.
Although just recognized officially by FDA in 2004, maggots were used therapeuti-
cally by Mayan Indians a thousand years ago.4 As early as the 16th century, European
physicians recognized that soldiers with maggot-infested wounds healed well. Maggots
were used extensively during World War I, when an American physician noticed that
two soldiers with abdominal wounds infested with maggots recovered better than did
wounded men treated in a military hospital. In the 1930s, before the age of sulfa drugs
and antibiotics, hundreds of hospitals used maggot therapy. In the late 1930s, two phar-
maceutical houses began to mass produce germ-free maggots for clinical use. The use of
this therapy rapidly declined during the antibiotic era in the 1950s and beyond. For almost
50 years, the only reminder of maggot therapy was research on the activity of larval
secretions and infrequent notice by a few physicians of the results of natural wound infes-
tation.5 Now we know that antibiotics have their limitations, and patients are increasingly
developing resistant infections. Thus, alternative therapies are needed when antibiotics
prove powerless to treat festering wounds.
Rediscovery and Regulatory Issues
The use of maggots was in some respects rediscovered in 1984, when an 88-year-old
woman entered the emergency room of San Francisco’s General Medical Center with a
cheek wound filled with maggots. The physicians there allowed the maggots to finish the
job of cleaning the area, after which they surgically closed the wound. The patient recov-
ered without further incident.6
This accident piqued the curiosity of Drs. Edward Pechter and Ronald Sherman at
the University of California Los Angeles Medical Center,7 who began using maggots to
treat other wounds. Sherman, an entomologist, has become an advocate of the use of
maggots. In fact, he single-handedly worked through the administrative process to gain
510(k) clearance by interacting with FDA’s Center for Devices and Radiological Health
and Center for Biologics Evaluation and Research, as well as the FDA ombudsman. The
process required about 18 months and several appeals.8 Maggots were finally classified
Maggots and Leeches—Are They Medical Devices?
definition of drug, denotes a broad category that contrasts with the list of specific types
of products that are “devices.” Except for implants and in vitro reagents, most items
included in the definition of a device are mechanical products generally constructed of
solid materials such as metal or plastic. Pursuant to the latter part of the definition for
medical devices, FDA may not regulate as a medical device an article that achieves any of
its principal intended medical purposes through chemical action or by being metabolized.
Congress did not insert any counterpart clause into the definition of a drug that would
make chemical or metabolic action a prerequisite to a product being regulated as a drug.
Neither did Congress, in its 1976 revision of the definition of device, substitute the broader
term “article” for the listing of narrower categories of products to be regulated as devices
found in the act since 1938.
In light of this background information, questions naturally arise about the rationale
used by FDA in its decision to classify leeches and maggots as medical devices. It is inter-
esting to speculate on how the late Senator Clark would have reacted to this decision. As
will be seen in the following descriptions, both organisms secrete substances that clearly
have a chemical action within or on the body. We will look at maggots first.
Maggots and Leeches: A History of Therapeutic Use
Maggots
Maggots are fly larvae, and there are literally thousands of species of flies, each with
distinct habits and lifecycles. Currently, Phaenicia sericata (green blow fly) larvae are used
clinically. This species has been used successfully for many decades.
Although just recognized officially by FDA in 2004, maggots were used therapeuti-
cally by Mayan Indians a thousand years ago.4 As early as the 16th century, European
physicians recognized that soldiers with maggot-infested wounds healed well. Maggots
were used extensively during World War I, when an American physician noticed that
two soldiers with abdominal wounds infested with maggots recovered better than did
wounded men treated in a military hospital. In the 1930s, before the age of sulfa drugs
and antibiotics, hundreds of hospitals used maggot therapy. In the late 1930s, two phar-
maceutical houses began to mass produce germ-free maggots for clinical use. The use of
this therapy rapidly declined during the antibiotic era in the 1950s and beyond. For almost
50 years, the only reminder of maggot therapy was research on the activity of larval
secretions and infrequent notice by a few physicians of the results of natural wound infes-
tation.5 Now we know that antibiotics have their limitations, and patients are increasingly
developing resistant infections. Thus, alternative therapies are needed when antibiotics
prove powerless to treat festering wounds.
Rediscovery and Regulatory Issues
The use of maggots was in some respects rediscovered in 1984, when an 88-year-old
woman entered the emergency room of San Francisco’s General Medical Center with a
cheek wound filled with maggots. The physicians there allowed the maggots to finish the
job of cleaning the area, after which they surgically closed the wound. The patient recov-
ered without further incident.6
This accident piqued the curiosity of Drs. Edward Pechter and Ronald Sherman at
the University of California Los Angeles Medical Center,7 who began using maggots to
treat other wounds. Sherman, an entomologist, has become an advocate of the use of
maggots. In fact, he single-handedly worked through the administrative process to gain
510(k) clearance by interacting with FDA’s Center for Devices and Radiological Health
and Center for Biologics Evaluation and Research, as well as the FDA ombudsman. The
process required about 18 months and several appeals.8 Maggots were finally classified
Maggots and Leeches—Are They Medical Devices?