From:	Pomije, Brian D. (LCDR)
Sent:	Monday, August 08, 2005 1:12 PM
To:	LaFontaine, Richard L CT; Giel, Daniel T. (CIV); Saylor, Tillman K (NNMC Contractor); Hecht, Sheila C , LCDR; Maher, John M CDR; Fong, Raynard K   CAPT; Van Way, Rick L (LCDR)
Cc:	Pomije, Brian D. (LCDR); Ely, Karen D. (CIV); Clark, Dorothy M. (CIV); Earles, Marvin R LCDR ; Glennon, Brendan K. CDR BUMED; Lino CDR Fragoso (E-mail) (Lino.Fragoso@navy.mil)
Subject:	NRMP - Shifting of Cs-137 Sources in Wang Vaginal Applicators
Shifting of Cs-137 Sources in Wang Vaginal Applicators

To all Radiation Therapy Physicists and RSOs:

The Nuclear Regulatory Commission (NRC) has recently reported that there have been several significant Medical Events regarding the use of "Wang" vaginal applicators during intercavitary brachytherapy.  Apparently, the applicators are designed to hold C-137 tube sources made by specific manufacturers, and the sources may shift within the applicator if from a different manufacturer.  The excerpt from the NRC is pasted at the end of this message.

Note that paragraph (a)(2) in 10 CFR 35.432 requires that before the first medical use of a brachytherapy source on or after October 24, 2002, a licensee shall have determined source positioning accuracy within applicators.

Each command shall ensure that their "active" sources as well as "dummy" sources are compatible with all applicators (i.e., Wang, Tandem and Ovoid, Fletcher Suite, etc.) and that the sources do not shift within the applicators during simulation or during patient treatment.

Please respond to confirm that you have received, read and understand the contents of this message.

V/R,

LCDR Pomije

Brian D. Pomije, MS, DABR
Lieutenant Commander, Medical Service Corps, USN
Radiation Health Team Leader
Navy Environmental Health Center
620 John Paul Jones Circle (Suite 1100)
Portsmouth, VA 23708-2103

W: (757) 953-0766; DSN: 377-0766
Cell: (757) 651-2814
Fax: (757) 953-0685

---------------------------------------------------------------

SIGNIFICANT MEDICAL EVENT

Medical Event at St. Joseph Regional Medical Center
Date and Place: February 23, 2004, South Bend, Indiana

Nature and Probable Causes:  The licensee reported that five patients who received brachytherapy treatments for endometrial cancer, received radiation doses to the wrong location.  The first patient was treated in January 2004; the second and third patients in February 2004; and the fourth and fifth patients in March 2004.

A new Wang vaginal applicator was used during the procedures.  The tandem device was loaded with Cesium-137 sources, and the sources were manufactured by Amersham.  The tandem device was designed to use 3M brachytherapy sources; however, Amersham sources were used.  The Amersham sources were too small for use in the tandem device, causing the sources to slide out of position and irradiate the inner thigh, whenever the patients moved into a more up-right position.  Approximately 2 weeks after treatment, the third, fourth and fifth patients developed ulcerations on the skin of the inner thigh.  The licensee's initial calculations estimated the skin doses to be below 50 cSv (50 rem).  However, the third patient exhibited recurring skin ulcerations, prompting the licensee to reevaluate the calculated doses.  The licensee's revised calculations determined that the third patient received an unintended dose to a small area of the skin on the upper thigh of approximately 2000 cGy (rad).  The fourth patient received an unintended dose to a similar area of the thigh of approximately 1500 to 2000 cGy (rad).  Despite the unintended doses to the inner thigh, the licensee believed that the patients received the respective prescribed doses to the treatment areas, based on clinical observations.  All patients were notified of the error.  A NRC Region III inspection will review the circumstances surrounding the event and an NRC medical consultant will provide an independent medical evaluation of the probable deterministic effects of the radiation exposures.

Actions Taken to Prevent Recurrence:  The licensee retrained personnel and replaced the applicator with one that will accept both source sizes.

---------------------------------------------------------------