Protecting People and the EnvironmentUNITED STATES NUCLEAR REGULATORY COMMISSION
UNITED STATES
NUCLEAR REGULATORY COMMISSION
OFFICE OF NUCLEAR MATERIAL SAFETY AND SAFEGUARDS
WASHINGTON, D.C. 20555
July 10, 1997
NRC INFORMATION NOTICE 97-50: CONTAMINATED LEAD PRODUCTS
Addressees
All U.S. Nuclear Regulatory Commission licensees.
Purpose
The U.S. Nuclear Regulatory Commission (NRC) is issuing this information
notice to alert addressees to the potential for some shielding products
containing lead to be contaminated with small amounts of naturally occurring
radioactive material. It is expected that recipients will review the
information for applicability to their facilities and consider actions, as
appropriate, to avoid unnecessary exposure to radioactive material. However,
suggestions contained in this information notice are not NRC requirements;
therefore, no specific action nor written response is required.
Description of Circumstances
NRC recently was notified of the distribution of contaminated lead and lead
products, including medical shielding devices. The contaminants are lead-210
and its daughter nuclides bismuth-210 and polonium-210. Based on current
information, it appears that the contaminated products were manufactured from
lead processed by one supplier between November 1996 and May 1997.
The contaminated lead was used to manufacture a variety of products consisting
of lead-vinyl or lead-plastic products used to make radiation shielding
materials for x-ray machine drapes, aprons, gonad shields, and sheet
shielding. The contaminated lead may also have been incorporated into other
commercially distributed products, such as brushes for electric motors,
bullets, lead shot, lead roof flashing, and galvanizing compounds. Radiation
from these products does not appear to represent a public health and safety
hazard and there is little possibility of persons being exposed to radiation
from any of these products except the radiation shielding products (vinyl-lead
and plastic-lead).
Although NRC does not regulate the radioactive contaminants and the products
do not appear to represent a threat to public health and safety, we are
issuing this notice because of the use of many of the contaminated lead
products as medical devices and temporary shielding and that users may not be
aware of the contamination.
9707030268. IN 97-50
July 10, 1997
Page 2 of 2
Discussion
This information has been coordinated with the Food and Drug Administration
(FDA), the U.S. Environmental Protection Agency (EPA), and the Conference of
Radiation Control Program Directors (CRCPD). The FDA has distributed a Public
Health Notice to health care professionals advising them of this issue and
requesting a report if any contaminated lead products are identified (see
attachment). Some medical device firms and distributors have initiated a
voluntary recall. The EPA and CRCPD have provided relevant information,
respectively, to regional offices and all members.
If you discover that you possess a product that contains this contaminated
lead, please contact the appropriate EPA regional office and State radiation
regulatory agency.
This information notice requires no specific action or written response. If
you have any questions about the information in this notice, please contact
the technical contact listed below or the appropriate regional office.
original signed by
Donald A. Cool, Director
Division of Industrial and
Medical Nuclear Safety
Office of Nuclear Material Safety
and Safeguards
Technical contact: Brian W. Smith, NMSS
301-415-5723
E-mail: [email protected]
Attachments:
1. FDA Public Health Notice
2. List of Recently Issued NMSS Information Notices
3. List of Recently Issued NRC Information Notices
. Attachment 1
IN 97-50
July 10, 1997
Page 1 of 2
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
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 polonium-210 (Po-210). Initial
FDA and state evaluation 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
(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. Attachment 1
IN 97-50
July 10, 1997
Page 2 of 2
2
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:
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 [email protected] or by fax 301-594-2968 if you have any
questions about this notice.
Sincerely yours,
Original signed by D B Burlington
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
