FDA panel seeks to classify 2 wound therapies
Since the passage of the Medical Device Amendments of 1976, which amended the Food, Drug, and Cosmetic Act, the Food and Drug Administration (FDA) has regulated the safety and efficacy of medical devices. However, some undefined areas remain, including use of wound dressings that contain drugs (such as silver) and the sale of maggots for wound debridement (although the FDA did clear medical maggots for marketing as the first "live" medical device in 2004). During a 2-day hearing in late August, the FDA's General and Plastic Surgery Devices Panel met to discuss how to classify and regulate these 2 types of wound devices, as well as 3 other preamendment medical devices (bone wax, medicinal leeches, and tissue expanders).
Recent literature has included much discussion in support of the use of dressings containing silver for their antimicrobial properties and the use of maggot debridement therapy to assist in healing of complex wounds. In this issue of Advances in Skin & Wound Care, in fact, Steenvoorde et al report on the results of their study, Maggot Debridement Therapy: Free-Range or Contained? An In Vivo Study (page 430). In addition, Warriner and Burrell summarize research on silver dressings in a supplement to this issue, Infection and the Chronic Wound: A Focus on Silver.
Documents sent to the panel members recommend classifying wound dressings with a drug and medical maggots as class II devices. This means "special controls" will be needed to ensure safety and efficacy of the devices. Special controls can include guidance documents, performance standards, postmarket surveillance, clinical data, and specific labeling recommendations. At press time, no further information was available on the special controls that would regulate these devices.
The BioTherapeutics, Education and Research (BTER) Foundation in Irvine, CA, produces support and educational programs for maggot and leech therapy. Its director, Ronald Sherman, MD, MSc, also an Assistant Researcher at the University of California in Irvine, and producer of medicinal maggots, told Advances in Skin & Wound Care that BTER welcomes the FDA's increased scrutiny of the medical maggot market.
"This represents a formalization of the process by which marketing clearance was recently granted to one producer of maggots," he said. "As such, the marketing requirements will become standardized, and more suppliers will be able to know and achieve those high standards.
"The BTER Foundation supports this constructive effort to ensure that patients are provided with the best quality maggots possible, and at an affordable cost."