without their input:
WASHINGTON - Flesh-eating maggots and blood-sucking
leeches were once the tools of quack doctors and shamans. But they have
experienced a quiet renaissance among high-tech surgeons, and for two days
beginning today a federal advisory board will discuss how to regulate them.
Leeches, it turns out, are
particularly good at draining excess blood from surgically reattached or
transplanted appendages. As micro- surgeons tackle feats such as re-attaching
hands, scalps and even faces, leeches have become indispensable.
Maggots clean festering wounds that
fail to heal, as happens among diabetics, better than almost anything in use,
although the use of maggots in the United States has been slight, in part
because of squeamishness.
But neither leeches nor maggots, despite
their long histories of use, have ever been subject to thorough regulation by
the Food and Drug Administration.....
Since 1976, the agency has required
that makers of medical devices prove that their products are safe and effective.
Those already on the market had to prove their worth; those invented later had
to get approval before marketing.