United States Nuclear Regulatory Commission - Protecting People and the Environment

Information Notice No. 88-52: Failure of Intrauterine Tandem of Fletcher Suit Applicator Brachytherapy Devices During Patient Treatment

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

                                  July 27, 1988


Information Notice No. 88-52:  FAILURE OF INTRAUTERINE TANDEM OF FLETCHER 
                                   SUIT APPLICATOR BRACHYTHERAPY DEVICES 
                                   DURING PATIENT TREATMENT 


Addressees: 

Medical licensees. 

Purpose: 

This information notice is intended to provide information on the inspection 
of intrauterine tandem of Fletcher Suit Applicator brachytherapy devices for 
applicator weld corrosion and the proper sterilization procedures.  It is ex-
pected that licensees will review this information for applicability to their 
brachytherapy activities and distribute this notice to responsible medical 
staff.  Suggestions contained in this information notice do not constitute new 
NRC requirements, and no written response is required. 

Description of Circumstances: 

The U.S. Food and Drug Administration (FDA) Center for Devices and 
Radiological Health received eight reports since 1983 of incidents with 
Fletcher Suit Applicator intrauterine tandems.  In each incident, the 
radioactive capsules were removed, but the closed end of the tandems separated 
from the applicator and remained in the patient during applicator removal.  
Additional radiographic and operating procedures were required to locate and 
remove the broken pieces.  The failure is caused by weld joint corrosion.  The 
corrosion may be due to improper cleaning before sterilization. 

Discussion: 

The Fletcher Suit Applicators can be used with either byproduct material or 
radium brachytherapy sources.  The FDA believes that all Fletcher Suit Ap-
plicators should be inspected before each use, to ensure that the closed ends 
of the intrauterine tandem are secure.  If they are not secure, the device 
should not be used.  Cleaning the applicators with hydrogen peroxide or 
glutaraldehyde (Cydex) before autoclaving or cold sterilization may corrode 
the applicators' welds.  The FDA recommends that the applicators be cleaned 
using only mild detergent and water, and then thoroughly rinsed with water 
before sterilization.  The FDA also recommends that all applicators of similar 
design be checked, and the same cleaning instructions followed. 



8807210218
.                                                            IN 88-52 
                                                            July 27, 1988 
                                                            Page 2 of 2 


No specific action or written response is required by this information notice.
If you have any questions about this matter, please contact the person listed 
below or the appropriate NRC regional office. 



                                    
                                    Richard E. Cunningham, Director 
                                    Division of Industrial and 
                                      Medical Nuclear Safety 
                                    Office of Nuclear Material Safety 
                                      and Safeguards 

Technical Contact:  Donna-Beth Howe, NMSS 
                    (301) 492-0636 


Attachment:  List of Recently Issued NRC Information Notices 

.                                                            Attachment
                                                            IN 88-52 
                                                            July 27, 1988 
                                                            Page 1 of 1

                             LIST OF RECENTLY ISSUED
                            NRC INFORMATION NOTICES 
_____________________________________________________________________________
Information                                  Date of 
Notice No._____Subject_______________________Issuance_______Issued to________

88-46,         Licensee Report of            7/26/88        All holders of OLs
Supplement 1   Defective Refurbished                        or CPs for nuclear
               Circuit Breakers                             power reactors. 

88-51          Failures of Main Steam        7/21/88        All holders of OLs
               Isolation Valves                             or CPs for nuclear
                                                            power reactors. 

88-50          Effect of Circuit             7/18/88        All holders of OLs
               Breaker Capacitance                          or CPs for nuclear
               on Availability of                           power reactors. 
               Emergency Power 

88-49          Marking, Handling,            7/18/88        All holders of OLs
               Control, Storage and                         or CPs for nuclear
               Destruction of Safe-                         power reactors and
               guards Information                           all other licensed
                                                            activities 
                                                            involving a 
                                                            formula quantity 
                                                            of special nuclear
                                                            material. 

88-48          Licensee Report of            7/12/88        All holders of OLs
               Defective Refurbished                        or CPs for nuclear
               Valves                                       power reactors. 

88-47          Slower-Than-Expected          7/14/88        All holders of OLs
               Rod-Drop Times                               or CPs for PWRs. 

88-46          Licensee Report of            7/8/88         All holders of OLs
               Defective Refurbished                        or CPs for nuclear
               Circuit Breakers                             power reactors. 

88-45          Problems In Protective        7/7/88         All holders of OLs
               Relay and Circuit                            or CPs for nuclear
               Breaker Coordination                         power reactors. 

88-44          Mechanical Binding of         6/24/88        All holders of OLs
               Spring Release Device                        or CPs for nuclear
               in Westinghouse Type                         power reactors. 
               DS-416 Circuit Breakers 
_____________________________________________________________________________
OL = Operating License
CP = Construction Permit 
Page Last Reviewed/Updated Tuesday, November 12, 2013