Radiopharmaceutical Safety Alert

[GKRAMER@hpb.hwc.ca]

                                      November 30, 1993



           RADIOPHARMACEUTICAL SAFETY ALERT

     Special consideration must be given to those
radiopharmaceutical kits which require a boiling step in the
reconstitution procedure.
 
     Recently, it was reported to the Radiation Protection Bureau
that 7 out of 152 batches of a kit which were prepared using a boiling
step in a Canadian nuclear medicine department were found to be
contaminated by a fungus.  This problem was identified through the
department's retrospective sterility testing program.  Following
radiolabelling the product was placed in a lead pot which contained a
cushion of sponge material attached to the lid and bottom of the lead
pot.  The cushion became wet from contact with the outer surface of
the vial that had just been removed from the boiling water bath.  Tests
showed that the sponge was contaminated with a fungus and because
the sponge was in intimate contact with the rubber septum of the vial,
the radiopharmaceutical became contaminated.

     It is recommended that when a boiling step is required to
radiolabel a kit, that the following precautions be taken.

     1.   Ensure that the vials are not totally submerged in
the water bath.  The rubber septum should never be below the
surface of the water.

     2.   It is preferable to use a high quality water for
boiling vials, such as Water for Injection.  Tap water often
contains enough dissolved nutrients to sustain growth of several
species of microorganisms.

     3.   Do not use a water bath which is cloudy and filthy. 
Change the water regularly, preferably daily.

     4.   Ensure that the exterior surface of the vial is dry
before it is inserted into the lead dispensing pot.

     5.   Do not use any packaging or cushioning material in
pots which may come in contact with the vial rubber septum.

     Injection of a contaminated parenteral may have severe
deleterious effects on the patient.  The patient response will be
dependent on the nature of the contaminant and the resistance of the
patient at the time of exposure.  The situation becomes serious when
the resistance of the patient is significantly impaired or when circulating
microorganisms reach vulnerable exposed tissue.

     This incident re-emphasize the importance of a good
retrospective sterility test programme in Canadian Nuclear Medicine
Departments.

     This Bureau welcomes comments concerning the above safety
issue.

              Radiation Protection Bureau
                   775 Brookfield Rd
                    OTTAWA, Ontario
                        K1A 1C1                   
                         Telephone: (613) 954-6704,
952-1385, 954-6688
                  Fax: (613) 941-1734