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Advisory Committee Recommends Dropping Deferral Period
Prompted by dwindling blood supplies and a growing acceptance of alternative
medicine, federal health officials are considering rescinding a 10-year old
rule that currently prohibits acupuncture patients from giving blood. The
proposed change in policy comes on the heels of a recommendation from the
Food and Drug Administration's Blood Products Advisory Committee, which has
recommended unanimously that the FDA lift the current ban on donations from
acupuncture patients.
Under current regulations, people who have been treated with acupuncture in
the previous 12 months may be "deferred" from donating blood. The regulation
states that individuals "be deferred from donating whole blood, blood
components, source plasma or source leukocytes, who within one year of
donation have undergone acupuncture, ear piercing, ear piercing or tattooing
in which sterile procedures were not used."
The FDA's rule regarding acupuncture and blood donations was written in
1992, when concerns began to emerge about the safety of the nation's blood
supply and hepatitis C, a disease that can severely damage the liver. At the
time, hepatitis C was the leading cause of all hepatitis cases resulting
from blood transfusions, but because of improved screening procedures, the
risk from transfusions is now estimated at less than one in 10,000.
Long before the FDA's regulation was imposed, however, the acupuncture
profession identified the use of sterile needles as a top priority. In the
early 1980s, the National Certification Commission for Acupuncture and
Oriental Medicine developed the Clean Needle Technique Manual and mandated
that every national board-certified practitioner pass an approved clean
needle technique (CNT) course; in 1991, the commission added a clean needle
technique portion to its written exam. A CNT course is now administered by
the Council of Colleges of Acupuncture and Oriental Medicine and is a
requirement for licensure throughout the U.S.
The safety of the profession gained further credibility in 1996, when the
FDA reclassified disposable acupuncture needles as Class II devices. Under
the new classification, acupuncture needles were marketed as a single use
sterile product. Manufacturers of needles were required to label the
packages for single use only, and to provide information about device
sterility. Additionally, the classification stipulated that needles were to
be used only by licensed, registered or certified acupuncture practitioners.
On March 14, the FDA decided to reinvestigate the matter. It convened a
meeting of the Blood Products Advisory Committee (BPAC) to seek input on the
safety of the blood supply from donors who had a history of receiving
acupuncture, tattoos and skin or body piercing. The advisory committee
received oral and written testimony from several members of the health care
field, including licensed acupuncturists, registered nurses, medical doctors
and government disease specialists.
After a brief introduction, Dr. Miriam Alter of the Centers for Disease
Control began the discussion with an interactive slide show that evaluated
the risk of contracting hepatitis from acupuncture, tattooing or body
piercing. She cited two studies, one conducted in Taiwan, the other in
Japan, which showed an association between acupuncture and hepatitis.
However, she added that the association was "highly dependent on where the
study was done," and that "the risk where there is one could very well
substantially vary depending on the circumstances and the setting."
Among those who testified in favor of having the deferral removed was
Tierney Tully, the executive director of the Acupuncture and Oriental
Medicine Alliance. In a letter submitted to the committee, Ms. Tully
highlighted acupuncture's safety record as it pertains to the transmission
of communicable diseases:
"Communication of disease through acupuncture has not been an issue in the
U.S., a record few other health care professions can claim. There is no
known transmission of AIDS through acupuncture and, according to the
National Acupuncture Foundation's memo on the Safety Record of Acupuncture,
only one documented incidence of transmission of hepatitis by an individual
licensed without examination or education in national clean needle technique
over 12 years ago. In over 17 years of national board certification, the
NCCAOM has received no complaint of transmission of disease through
acupuncture, nor to our knowledge has any state board.
" ¡¤ The use of excellent national standards in the U.S. and the emphasis on
clean needle technique have created an outstanding safety record for our
profession," she added. "We ask that you support the removal of acupuncture
from the blood donor questionnaire where its categorization with non-medical
activities such as tattooing and ear and skin piercing discredits our
profession and may discourage consumers from qualified acupuncture
services."
Although Ms. Tully was not in attendance at the meeting, another member of
the Alliance, Alexandra Knox, was. Knox reiterated many of the claims made
by Ms. Tully in her letter, and provided further information on the cost and
use of acupuncture needles.
"We really have some good statistics in our profession" regarding the
transmission of diseases through acupuncture, Knox said. "Whether it's
possible for somebody to be very sloppy, absolutely. But I think that's true
with any medical device that's going to enter the skin."
"¡¤ An acupuncture needle costs four cents," she continued. "There is no
reason to reuse your needles. I mean, there's no economic incentive,
certainly, and there is a lot of reason not to. As a practitioner you will
also know that if you try to use the same needle on the same person twice,
it dulls and you can't get it in and it hurts. There's a lot of reasons you
don't do it apart from safety."
Also speaking before the committee was Margaret Hoffman, a registered nurse
and licensed acupuncturist from Maryland. A member of the Maryland
Acupuncture Society, she began her testimony by stating simply, "I'm not
here representing any particular organization per se; however, I am
representing acupuncture."
In addition to the deferral for blood donors, Ms. Hoffman took issue with
the fact that acupuncture was grouped together with body piercing and
tattooing. She believed that such an association gives the impression that
acupuncture is not a professional form of health care, and that acupuncture
treatment - even if it is received from a licensed, registered or certified
acupuncturist - could place a patient at unnecessary risk for transmission
of blood-borne diseases.
"I believe this is an uninformed understanding that potentially sheds a
damaging view on acupuncture," Ms. Hoffman said. "¡¤ Based on the current
donation guidelines, a certain portion of the population may be totally
excluded from donating blood. With an increase in demand to build the blood
supply, it seems that the decision to defer or exclude because of
acupuncture treatment is an inappropriate one."
Following her speech, Ms. Hoffman was asked several questions by the
committee about the practice of acupuncture and the use of disposable
acupuncture needles. She also described the clean needle technique to the
committee to give them a better idea of the sterility procedures used by
licensed acupuncturists.
Dr. Louis Katz, a medical doctor representing the American Association of
Blood Banks, also appeared supportive of having the acupuncture deferral
removed.
"The science, the medicine has changed," Dr. Katz said in an interview with
the Richmond Times-Dispatch. "We're deferring people who are probably not at
risk for the things we've been deferring them for."
At the conclusion of the meeting, committee members were asked to
individually vote on whether blood donors should be deferred for tattooing,
body piercing or acupuncture. The committee voted 14-3 to continue the
deferral period for both piercing and tattooing, but voted unanimously to
remove acupuncture as a consideration for deferral of blood donation,
reasoning that the practice is a regulated medical procedure with an
outstanding safety record. Three committee members added a clarification to
their votes, requesting that removing the deferral be limited only to states
that currently regulate the practice of acupuncture. The committee also
agreed that a state or locally licensed practice could be used as evidence
of sterility.
A final decision on the blood donor policy is expected by the FDA later this
year. Stay tuned to Acupuncture Today for more updates in an upcoming issue.
References
Hostetler AJ. Acupuncture patients - safe blood donors? FDA may drop their
deferral. Richmond Times-Dispatch, April 3, 2002.
Letter from Tierney Tully, MSOM, Dipl.Ac., to Linda Smallwood, PhD, Center
for Biological Evaluation & Research, Food and Drug Administration, March 5,
2002.
Transcript of the 72nd meeting of the Blood Products Advisory Committee,
Center for Biological Evaluation & Research, Food and Drug Administration,
March 14, 2002. Available online at www.fda.gov.
Information resource:
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