Repair Services for the 3M #6586 Fletcher-Suit Delclos Shields Afterloading Applicators

Radiation Products Design does fiber optic inspection of tungsten shielding inside of the ovoid. We can detect if the tungsten shields are mounted at the top and the bottom of the ovoid.

The following tests can be conducted at Radiation Products Design or within your organization:

Separate the Fletcher-Suit-Delclos (FSD) Applicator  into two halves and conduct Tests A, B, C and D on each half as follows:

Mechanical Test A
Gently manipulate each ovoid with one hand while holding the ovoid handle with the other.  Each ovoid should be solidly attached to the handle. If the ovoid is loose, Test A fails and unit may be repaired, no other tests need to be done. If test A passes, continue to Test B.

Visual Test B
Visually inspect each half of the FSD for hairline cracks at the top and bottom of the ovoid and the ovoid handle joint. Inspect silver-brazed joints where center pivots and the locking brackets attach to the ovoid handles. If cracks are seen, Test B fails and unit may be repaired, no other tests need to be done.  If Test B passes, continue to Test C.

Pressure Test C
Conduct the following test on each half of the FSD:
Test 1: Remove the ovoid handle cap from the end of the ovoid handle
Test 2: Remove the bucket carrier
Test 3: Stand the ovoid in a cup of water to a depth above the ovoid handle joint
Test 4: Apply slight air pressure on the open end of the FSD handle (using for example, a 20 cc syringe connected to surgical tubing connected to the FSD handle), and look for air bubbles escaping from the ovoid or ovoid handle joint. If bubbles are seen, Test C fails and unit may be repaired.  If Test C passes, the ovoid is solidly attached to the ovoid handle and no immediate action is necessary.

Fiber Optics or Radiograph Test D
Use fiber optic inspection for tungsten placement or radiograph using film.

If Tests A, B, C or D fails stop using the FSD for patient therapy.

Send complete units in for repair, including the bucket carriers, to Radiation Products Design.  When sending in an applicator the following information is needed: contact name, phone number and address.  Other repairs are also available, if not listed below, please call for more information.

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.

Radiation Products Design, Inc                 www.rpdinc.com                     sales@rpdinc.com
 763-497-2071    Fax 763-497-2295     5218 Barthel Industrial Drive  Albertville, MN 55301