3 Weird Things the FDA Regulates or Recognizes

JUNE 09, 2016
Meghan Ross, Senior Associate Editor
Medical treatment doesn’t always entail a pill, injection, or surgery.
 
In some cases, patients might be prescribed a “medical device” that lives and breathes on its own.
 
Here are 3 kinds of creatures the FDA either regulates or recognizes as a medical treatment.
 
1. Maggots
Maggot therapy involves a controlled maggot infestation on a wound for debridement.
 
“The maggots macerate their food with their mouth hooks, release their digestive enzymes into the local environment, and ingest the liquefying and semi-solid tissue,” the FDA explained.
 
Before being placed on a wound, the fly eggs are disinfected and placed in a sterile vial.
 
Medical Maggots is a trademarked, prescription-only medical device approved by the FDA. The device is applied via confinement dressings, and it’s left on the wound for a cycle of 48 hours. Typically, 2 to 6 cycles are needed for complete debridement.
 
Some common complaints related to maggot therapy include late or lost shipments, viability problems from extreme temperatures, and lack of access to the right kind of dressings.
 
“The substitutions they have made has resulted in dressings that break down at the bedside and could potentially lead to escaping maggots,” the FDA stated.
 
Maggots are most likely to escape during the first few minutes after administration, “when the maggots are still small and exploring the wound,” according to the FDA. Maggot escape incidents may also go underreported because of the small size of the species.
 
The safety and efficacy of maggots was examined in the early 1990s, but the earliest 501(k) premarket notification related to the use of maggots dates back to 2004. A man named Ronald A. Sherman from Irvine, California, received the FDA’s approval to market Medical Maggots. The indications were for “debriding nonhealing necrotic skin and soft tissue wounds, including pressure ulcers, venous statis ulcers, neuropathic foot ulcers, and nonhealing traumatic or post-surgical wounds,” according to the FDA.
 
The FDA also approved a preassembled version of a hydrocolloid-netting cage in 2007 that aimed to simplify the use of medical maggots and reduce user error.
 
“The accessory should increase safety by decreasing the opportunity for escaping maggots,” the FDA’s 501(k) premarket notification statement read.
 
In 2011, an accessory called LeSoc was approved to reduce the chances of maggots escaping.
 
All licensed physicians can prescribe maggot therapy. Around 50,000 maggot therapy treatments were administered in 2011, according to Monarch Labs, which is the company Sherman cofounded.  



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