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The investigation involved 327 patients
who attended the Wellness Centre in
2000, 2001 and/or 2002.
TPH did not require that they be notified
of the results of testing and therefore likely has
incomplete information with respect to the extent of the
outbreak. Nevertheless, results for 64 individuals did
ultimately come to the attention of TPH. While there was no
evidence of recent hepatitis B, C, or HIV infection linked
to the Wellness Centre, 32 cases of M. abscessus were
reported (50% of the sample population; 10% of the patient
population).
The Claim
A lawsuit was
launched in early 2003 seeking compensation for the
victims of the outbreak.
The legal team
has hired two experts in the field of acupuncture. Both
experts indicate that only pre-sterilized single-use
disposable needles should be used in the practice of
acupuncture. Needles should be used only once and discarded
in a sharps container directly. This applies to needles of
every type in the acupuncture practice. In addition, a
“universal precautions” approach to infection control should
have been employed, including hand washing and the use of
gloves. The evidence gathered to date indicates that
disposable needles were not used.
The re-use of
inexpensive needles designed (or labeled) for single use is
fraught with risk and reflects poorly on the judgment of the
practitioner.
Sandra
Testaguzza
As the individual
performing the acupuncture, it is alleged that Sandra
Testaguzza is primarily responsible for the outbreak of M.
abscessus at the Wellness Centre. The risk of
spreading infectious disease through the use of re-usable
acupuncture needles is well known. The outbreak itself is
clear evidence that improperly sterilized, re-usable needles
were used in the acupuncture treatments at the Wellness Centre as well as Ms. Testaguzza's
home clinic.
M. abscessus
M. abscessus, is a rapidly growing
atypical non-tuberculous mycobacteria. It may take from 2 to
30 days for primary isolation. M. abscessus causes human
infections ranging from abscesses and lung disease to very
serious illness.
M. abscessus is not usually transmitted
from one person to another. This bacterium is relatively
common in the environment and individuals are frequently
exposed to it with no ill effect. M. abscessus is most
likely to cause disease when it gets into a wound or when
contaminated medical devices are placed under the skin. M.
abscessus is known to grow in disinfectants, notably
glutaraldehyde. While there have been no reported outbreaks
associated with acupuncture needles, several disease
clusters have been associated with contaminated surgical
instruments and other invasive medical equipment.
The incubation period varies with the
individual. Although most people get sick within one month
of exposure, some individuals will not get sick for many
months. Incubation periods may be as long as one year.
The effects of M. abscessus may become
much more severe in persons who are immunosuppressed. Skin
and soft tissue infections are often acquired by inoculation
or injection and may resemble pyogenic (pus filled)
abscesses. Most occur within one month after exposure and
are manifested as acute inflammatory reactions with
suppuration. Chronic inflammation and ulceration may also
occur.
Sores or abscesses must be drained to cure
infections with M. abscessus. Surgery may be necessary.
Since the rapidly growing mycobacteria vary widely in their
antibiotic susceptibilities, antibiotic therapy is not
always effective. Long-term antibiotic therapy is often
necessary. Many cases will require antibiotic therapy for 3
to 6 months or longer. Prolonged antibiotic therapy and
removal of all infected material may be required in cases of
deep-seated infections or in immunocompromised patients.
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