Radioactivity in Shielding Products

["Tupin, Edward A. 301-827-1230 Fax 594-4760" <EAT@CDRH.FDA.GOV>]

I received word that my post yesterday of the FDA notice had some 
extra characters in the text.  Here is another try.  Word 
processors are wonderful, except when you put a document through 
too many different kinds.

The following is an official FDA document.  Please share it with 
others who may be interested.

Ed Tupin
RSO, Center for Devices and Radiological Health
Food and Drug Administration
EAT@cdrh.fda.gov
(301) 827-1230
Fax:  (301) 594-4760

________________________________________________________________

                                          June 12, 1997


              FDA PUBLIC HEALTH NOTICE
      Radioactivity in Radiation Protection Devices

TO:	Health Care Professionals 
 
FDA is notifying you that some shielding products used for 
radiation protection contain lead contaminated with small amounts 
of naturally occurring radionuclides. The contaminants are 
lead-210 (Pb-210) and its daughter nuclides bismuth-210 
(Bi210) and polonium-210 (Po-210).  FDA and state evaluations 
have determined that the small amounts of radioactivity in the 
affected products do not constitute a significant health risk and 
the contaminants are not transferable to patients,  personnel or 
equipment by ordinary use. The products identified to date 
include medical devices used for radiation protection such as 
lead aprons, gonad shields, and thyroid shields manufactured 
after October 1, 1996.
 
Standard radiation safety practice is to avoid unnecessary 
exposure to radiation.  Therefore the use of contaminated 
products should be discontinued.  However, in cases where no 
alternative shielding is available, continued use of the 
contaminated products will be likely to provide greater 
protection during therapeutic and diagnostic procedures than 
using no shielding.  Facilities which have no alternative 
protective devices available should consider continued use of the 
contaminated items until replacements are obtained.

Investigations are underway to identify all firms that received 
contaminated lead.  FDA and state radiation control program 
officials have determined that a shipment of contaminated 
tin-lead alloy was imported from Brazil and then processed by 
MIDCO Industries of  St. Louis, MO. MIDCO sold contaminated lead 
to Taracorp Industries of Granite City, IL.  Taracorp then 
manufactured contaminated lead powder which was sold to 19 firms.  
Some of these 19 firms manufactured or distributed contaminated 
lead or lead products to a number of companies, including medical 
device manufacturers.  

Recalls are being initiated by medical device firms and 
distributors.   To date, E-Z-EM of Portchester, NY, and Picker 
Corporation of Cleveland, OH, are voluntarily recalling 
contaminated products. Other manufacturer recalls are likely to 
follow.  If you have purchased affected products, you should 
receive notice from your supplier.  The notice should provide 
instructions for disposition or return of the devices, and may 
include replacement information.  As affected product lists are 
available, they will be provided to the Conference of Radiation 
Program Control Directors and posted on the FDA internet site 
(http://www.fda.gov/cdrh/safety.html).
 
FDA recommends radiation protection medical devices containing 
lead purchased after October 1, 1996 be surveyed for radionuclide 
contamination.  This should be done by qualified personnel with a 
suitable survey meter, such as a thin window Geiger Mueller (G-M) 
instrument in contact with the product.  The 1.16 MeV beta from 
the Bi-210 is easily detected with this type of instrument. 
 
· If the survey results indicate contamination, contact your 
supplier for further instructions.  
 
· If you do not have the capability to survey, contact the 
supplier of your devices purchased after October 1, 1996, to 
determine if their products are affected by this problem.   
 
· If you receive a notice or a customer letter from a 
manufacturer or supplier concerning this matter, follow the 
instructions which should include information on disposition of 
affected products.

FDA is working with state radiation control program officials to 
identify all contaminated lead products that have been introduced 
into commercial distribution and to facilitate effective recalls 
of all contaminated devices.  As additional information becomes 
available, FDA will issue updated notices.

FDA requests users who discover shielding products with 
contaminated lead to report this information directly to 
MedWatch, the FDA voluntary reporting program.  Submit these 
reports to MedWatch by telephone at 1-800-FDA-1088, by FAX 
at 1-800-FDA-0178, or by mail to:

		MedWatch
		Food and Drug Administration, HF-2
		5600 Fishers Lane
		Rockville, MD 20857

Contact Sherry Purvis-Wynn of the FDA Center for Devices and 
Radiological Health by E-mail slp@cdrh.fda.gov or by 
fax 301-594-2968 if you have any questions about this notice.

				Sincerely yours,

				   /s/
			
				D. Bruce Burlington, M.D.
				Director
				Center for Devices and
				  Radiological Health