CONTAMINATION OF MULTI-DOSE VIALS OF TECHNETIUM-99M-SESTAMIBI
(99M-Tc-S) WITH ACREMONIUM KILIENSE (A.K.).
M.Garcia, RN, CIC,* J. Burt, RN,
BA, R. Reilly, MSC PHM, R. Kaul, MD, I. Campbell, MD, R. Summerbell, PhD, J.M.
Conly, MD.
The Toronto Hospital, University of Toronto, Toronto, Ontario, Canada.
Background: Between August 16, 1993 and October 29, 1993, 7 samples of Technetium-99M-
Sestamibi (99M-Tc-S) injection prepared in Radiopharmacy were found to be contaminated with
A.K. 99M-Tc-S is a radioactive pharmaceutical used in Nuclear Medicine for cardiac imaging
A.K., a common soil fungus was identified as a result of a continuous quality assurance program
in Radiopharmacy. Sterility testing previous to this time period was negative for microbial
contamination for at least 5 years. Unit doses of this radioactive injectable product are
distributed to neighboring hospitals in leaded syringe containers. Each dose must be used with 6
hours of preparation to ensure potency.
Methods: Samples of the solution were stored for one week to allow for radioactive decay and
then sent to the hospital laboratory for sterility testing. Following the isolation of A.K. from
7/156 samples (4.4%) , an investigation was initiated by the Infection Control Unit. The
hospitals and clinics to which the contaminated 99M-Tc-S was sent were notified. The entire
preparation and distribution procedure was reviewed with the Radiopharmacy staff and multiple
environmental cultures were obtained in the Radiopharmacy laboratory.
Results: The foam packing material inside the lead pot used to hold the vial of 99M-Tc-S,. the
lid of the pot, the inside wall of the pot, and the rubber stopper of the vial were all positive for
A.K. The following steps were taken in an effort to control the contamination problem: 1) The
foam packing on the inside of the lead pot was removed, 2) Pots and lids were disinfected, and
3) Tap water used to boil the vial of 99M-Tc-S was replaced with sterile water and changed
daily. No patients were identified to have suffered any febrile morbidity or other adverse events
from the injection of contaminated material.
Discussion: The contamination may have been related to the preparation of the injectable
solution. We postulated that water from the wet vial of 99M-Tc-S penetrated the foam packing
material inside the lead pot and provided a moist hospitable environment for A.K. to grow. The
rubber top of the vial comes in contact with the foam packing material contaminated with the
fungus. The injectable solution in the vial becomes contaminated through multiple punctures in
the rubber top made during withdrawal of unit doses. Following the implementation
recommendations, no further samples have grown A.K.
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