FDA
Targets Recycled Medical Devices
It’s a growing practice but very few patients
realise: Medical devices like cardiac catheters and angioplasty
balloons that were intended to be used once and thrown in the trash,
instead are resterilised and used again in other patients.
This controversial recycling
largely has gone unregulated, but hospitals and resterilising
companies soon will have to meet strict new standards to prove that it
is safe for patients, the Food and Drug Administration told Congress.
A Kansas woman is living with
a piece of metal lodged inside her heart after a reused catheter broke
during surgery last year. Some studies have concluded that a few
patients caught tuberculosis, hepatitis or pneumonia from improperly
resterilised devices. But the FDA insists it has no evidence that
reusing disposable devices is much riskier than using other medical
equipment. Brand new heart catheters can break the first time they are
used, says FDA medical device chief Dr. David Feigal.
Also lots of medical devices
are made to be used over and over - yet they too, commonly cause
infections whenever hospitals do not properly resterilise them. Still,
the FDA has decided "this growing practice needs increased
scrutiny", Feigal told Congress. So the agency proposed forcing
hospitals and resterilising companies to prove they can safely reclean
and reuse disposable medical devices - and whether it’s safe to
reuse such devices only two or three times, or if 10 times is OK.
The proposal would make
hospitals and resterilising companies called "reprocessors"
meet the same FDA safety standards as medical device manufacturers
must meet before they can sell equipment.
(Ref: EPP dt. 17/2/2000)
