CAUTION FOR FLETCHER-SUIT APPLICATORS

“The U.S. Food and Drug Administration (FDA) has received reports of eight incidents in which the closed end of the intrauterine colpostats of a Fletcher Suit applicator separated from the applicator and remained in the uterus after the applicator had been removed, necessitating an additional removal procedure. Clearly this can cause undesirable complications for patients and holds the potential for the loss radioactive sources within the patient’s uterus.  The reasons for these separations is unknown. However, cleaning the applicator with hydrogen peroxide or glutaraldehyde (Cidex) prior to autoclaving or cold sterilization can result in corrosion of the applicator’s welds.

FDA is using this notice to alert users of Fletcher Suit applicators of this potential problem.  FDA believes that all Fletcher Suit applicators  should  be  inspected to determine whether or not the closed end of the colpostats or the colpostats themselves are adequately secured, and that any applicators that are questionable should not be used. Until recently, manufacturers guidance on cleaning and sterilization may not have been clear. The applicators should be cleaned using only a mild detergent and water, and then thoroughly rinsed with water before sterilization.

Although, to date, FDA has only received reports of the problems with Fletcher Suit applicators, it is also recommending that all applicators of similar design be checked, and that the same cleaning instructions be followed.”

The above article appears in the American Association of Physicists in Medicine. Volume 14 No. 3, May/June 1988, Pages 7 and 8.

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