The
Illinois Department of Nuclear Safety (IDNS) and the Center for Devices
and Radiological Health of the Food and Drug Administration (FDA) have
brought to our attention that some lead used in shielding is contaminated
with radionuclides and that products containing this lead were widely
distributed throughout the country.
IDNS coordinated with FDA
regarding the nature of the contamination. FDA on June 13, 1997 issued a
public health notice entitled "Radioactivity in Radiation Protection
Devices" to health care professionals. All compliance and consultative
personnel should be aware that certain lead aprons, gonad shields, thyroid
shields and other lead devices used by health care employees could be
contaminated. FDA health notice is attached for your use and it includes
background information and recommendations.
Please distribute this
bulletin to all Area Offices, State Plan States, Consultation Project
Offices, and appropriate labor and industry groups.
Attachment
June 13, 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 (Bi-210) and
poloniurn-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 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 l, 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 identity 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:
MedWatch
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 slp@cdrh.fda.gov or by fax 301-594-2968 if
you have any questions about this notice.
Sincerely,
D.
Bruce Burlington, M.D.
Director
Center for Devices and Radiological
Health
Footenote(1).
The Directorate of Technical Support issues Hazard Information
Bulletins (HlBs) in accordance with OSHA Instruction CPL 2.65 to
provide relevant information regarding unrecognized or misunderstood
health hazards, inadequacies of materials, devices, techniques, and
engineering safety controls. HlBs are initiated based on information
provided by the field staff, studies, reports and concerns expressed by
safety and health professionals, employers, and the public. Information is
compiled based on a through evaluation of available facts, literature and
in coordination with appropriate parties. (Back to
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