- Subject: Radioactivity in Radiation Prot Device
- Date: Thu, 12 Jun 1997 16:42:12 EDT
- A1-type: DOCUMENT
- Importance: normal
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