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The status of
acupuncture needles in the United States has always been somewhat tenuous.
In 1973, the Food and Drug Administration classified acupuncture needles as
"experimental" and "investigational." This meant that if someone wanted to
use acupuncture needles, it could only be as part of a research study with
written protocols; further, every person participating in a study involving
acupuncture had to be advised in writing that acupuncture needles were
experimental.
Acupuncturists across the country have almost uniformly ignored these legal
requirements and have therefore placed themselves at risk whenever
malpractice actions are brought. A patient could claim that malpractice had
occurred simply because they had not received the appropriate disclosures
and warnings relating to the fact that acupuncture needles were
investigational and experimental. Much of this has now changed. The FDA has
now reclassified disposal acupuncture needles from Class III investigational
devices to Class II devices. Class II devices are those devices that the FDA
is satisfied are safe and effective.
There are some important limitations on this reclassification:
This reclassification only covers disposable needles. It does not apply to
reusable acupuncture needles. "If someone wanted to obtain reclassification
of reusable needles, they would need to submit a 501(K) application and
document how reusable needles would not constitute an additional risk of
infection," explained Ms. Melpomeni Jeffires, reclassification coordinator
for the FDA.
The reclassification of disposable acupuncture needles does not constitute a
decision by the FDA as to whether or not the practice of acupuncture is safe
and effective. The FDA does not have jurisdiction over the health care
professions, only the devices used on patients.
"This reclassification will substantially reduce the potential malpractice
exposure of acupuncturists from claims that acupuncture needles are
inherently unsafe," noted Michael Schroeder, vice president and general
council of the American Acupuncture Council, the largest malpractice
insurance carrier in the country for acupuncturists. He added: "This is only
part of the battle, however, because we still need to obtain the same
reclassification for reusable needles."
Information resource:
http://www.chiroweb.com/archives/14/17/01.html |
