June 13, 1997
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 (Bi-210) and polonium-210 (Po-210). Initial FDA and state evaluations indicate that there is only a very small exposure to radioactivity from the affected products, 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's Internet site.
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 don't 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's 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:
Food and Drug Administration, HF-2
5600 Fishers Lane
Rockville, MD 20857
Contact Sherry Purvis-Wynn of FDA's Center for Devices and Radiological Health by E-mail firstname.lastname@example.org or by fax 301-594-2968 if you have any questions about this notice.
D. Bruce Burlington, M.D.
Center for Devices and Radiological Health
Food and Drug Administration