Information Notice No. 95-07: Radiopharmaceutical Vial Breakage During Preparation

                          UNITED STATES
                  NUCLEAR REGULATORY COMMISSION
        OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
                     WASHINGTON, D.C.  20555

                        January 27, 1995


Information Notice No. 95-07:  RADIOPHARMACEUTICAL VIAL                    
                                   BREAKAGE DURING PREPARATION


Addressees

All U.S. Nuclear Regulatory Commission medical licensees authorized to use
byproduct material for diagnostic procedures. 

Purpose

The U.S. Nuclear Regulatory Commission (NRC) is issuing this information
notice to alert addressees to a potential problem that can occur when heating
radiopharmaceuticals.

Although the incidents we describe involve the preparation and subsequent
cracking of Cardiolite (Kit for the Preparation of Technetium-99m (Tc-99m)
Sestamibi) vials, the potential for cracking and significant contamination
exists whenever vials containing radioactive material are heated.
 
It is expected that recipients will review this information for applicability
to their operation and consider action, as appropriate.  However, information
contained in this notice does not constitute new NRC requirements; therefore,
no specific action nor written response is required.

Description of Circumstances

NRC was recently notified of 20 separate incidents in which a Cardiolite� vial
had cracked during the heating process.  The events occurred between     
November 3 and January 11, 1995, and included vials from three lots:  3593M,
3594M, and 3595M.  Eighteen of the vials that fractured came from lot No.
3594M (Kit lot 3594MK).  

Contamination occurred when the contents of the cracked vial either leaked
into the boiling water or came in contact with the hot heating block.  In each
case, the Tc-99m labeled Cardiolite� became airborne as steam.  The level of
radioactive contamination at each of the facilities varied depending on the
activity in the vial, the preparation site, and emergency procedures employed. 

9501230260.                                                  IN 95-07
                                                  January 27, 1995
                                                  Page 2 of 3


The maximum personnel exposure reported, a total effective dose equivalent 
(TEDE) of 80 millirem, occurred at a facility that prepared the Cardiolite� on
an open bench, rather than in a fume hood.

In a letter to Cardiolite� customers dated December 15, 1994, the Dupont Merck
Pharmaceutical Company offered to replace any unused vials of Cardiolite� lot
No. 3594M with vials from another lot.

Discussion

Two different methods were used to heat the Cardiolite� vials.  The
manufacturer's recommended method involved immersion of the vial in a boiling
water bath for a specified time.  The other method involved the use of a
"heating block" (i.e., a block of heated lead containing wells into which the
vial is placed and heated).  Although the manufacturer has stated that it
believes that the breakage may be related to the combined effects of low
incidents of vial abrasion and a particularly stressful means of heating, it
has not been unequivocally verified that these are the causes of the vials'
cracking.  Additionally, the volume of liquid within the 5 milliliter (ml)
vials varied from less than the 3 ml maximum recommended by the manufacturer
to 4.6 ml.  However, it should be noted that each of the affected licensees
had prepared many other Cardiolite� vials in the same way, using the same
heating process and vial volume, with no problems.  Therefore, the root cause
for the vial breakage remains unknown.  However, the manufacturer plans to
continue its investigation which may lead to further information in the
future. 

In the cases described above, the licensees responded promptly, and thereby
avoided overexposing personnel and spreading contamination.  Licensees who
prepare radiopharmaceuticals that may volatilize (e.g., such as by heating)
should be aware of the possibility of vials cracking or breaking. 
Consequently, licensees are reminded of the importance of having emergency
procedures to respond to unforeseen exposure events, and to ensure that all
supervised individuals are trained in the procedures.  Licensees may wish to
review their procedures to ensure that they include controls and actions to
address unexpected airborne activity when radiopharmaceuticals are heated.

.                                                  IN 95-07
                                                  January 27, 1995
                                                  Page 3 of 3


This information notice requires no specific action nor written response.  If
you have questions about the information in this notice, please contact the
technical contact listed below or the appropriate regional office.


                              /S/'D BY CJPAPERIELLO

                              Carl J. Paperiello, Director
                              Division of Industrial and 
                                Medical Nuclear Safety
                              Office of Nuclear Material Safety
                                and Safeguards


Technical contact:  Sally L. Merchant, NMSS
                    (301) 415-7874
Attachments:
1.  List of Recently Issued NMSS Information Notices
2.  List of Recently Issued NRC Information Notices