ML20042A223
| ML20042A223 | |
| Person / Time | |
|---|---|
| Site: | 07001500 |
| Issue date: | 02/11/1982 |
| From: | Mcdaniel J WASHINGTON HOSP. CENTER, WASHINGTON, DC |
| To: | Kinneman J NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION I) |
| Shared Package | |
| ML20042A218 | List: |
| References | |
| NUDOCS 8203230220 | |
| Download: ML20042A223 (2) | |
Text
<
5
'h 1'
Il0 Irving Street.NW Washington.DC 20010 February 11, 1982 Nuclear Regulatory Commission Region I 631 Park Avenue King of Prussia PA 19406 Attn:
Mr. John D. Kinneman
Dear Sirs:
This is in reference to your letter of January 12, 1982, Docket No.
70-01500, concerning a special safety inspection of these facilities conducted on September 1, 1981.
The following explanations are in answer to the items listed in Ap-pendix A of your letter:
The Washington liospital Center has a strict protocol concerning the ordering and receipt of radioactive materials. The four Coratomic Model C-101P nuclear powered pacemakers in question were ordered directly by -
and delivered directly to - an individual. physician investigator. This was not in accord with Institutional policy.
In consequence, the mechan-isms for registration and logging-in were bypassed inadvertently.
Upon our being notified that the C-101P pacemakers were being used in this liospital, we applied for an amendment to license SNM-1446 to receive such devices.
An amendment was obtained for 5 specific pacemakers, liow-ever, an amendment to receive further C-101P's was denied until further information could be obtained by the Radioisotopes Licensing Branch, NRC.
To avoid further violations of this type, all users of radioactive mat-erlais will be notified again, that the ordering and receipt of these materials must be processed through the Nuclear Medicine Department.
Each vendor will be sent the same information in writing. This action will be completed by February 19, 1982.
An amendment request was submitted to the Radioisotopes Licensing Branch on February 8, 1982 to include Coratomic Model C-101 and/or C-101P pace-makers for clinical evaluation in accordance with the C-101P IDE.
We found the NRC inspection of September 1, 1982 to be an informative contribution to our radiation safety program. It is hoped that this con-8203230220 820315 PDR ADOCK 07001500 C
~
v.
\\
Page 2 stitutes a satisfactory reply to you: recent letter.
Sincerely yours,
-(> vy.
.s w John P. McDat,el President cc: Chairman, Radiation Safety Committcc Radiation Safety Officer Nicholas P. D. Smyth, M.D.
Harold llawfield, M.D.
NRC Document Management Branch