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Regarding contamination of lead aprons...
Probably you might have already read about the possible contamination of
some lead aprons manufactured after Oct 1996. We found five of our aprons
purchased in April 1997 to be contaminated. These were manufactured by Lite
Tech Inc.. I am enclosing the FDA notice and other notices I received in
this regard, and will look forward to any comments in this regard. Even
though the dose to personnel is said to be minimal, how about dose to
thyroid from contaminated thyroid shields. Comments can be sent directly to
my email address at
"mmmahesh@rad.jhu.edu"
Thankyou in advance.
Mahesh
-------------->
June 3, 1997
NOTICE
POSSIBLE CONTAMINATION OF LEAD PRODUCTS
The Illinois Department of Nuclear Safety recently become aware of a problem
with contamination of certain lead products used for shielding. Lead
aprons, gonad shields, thyroid shields and other lead vinyl products
manufactured after November 1996, may be
contaminated with a small amount of non-removable contamination.
Although radiation surveys of the contaminated items do not demonstrate a
threat to health and safety, the department recommends the following:
Persons in possession of lead vinyl products purchased after November 1996,
should discontinue using these products.
Several manufacturers of lead aprons and other products are voluntarily
recalling affected products. Please contact your supplier for further
instructions concerning return of the current
product and obtaining a suitable replacement.
If you are unable to contact your supplier or have additional questions or
concerns, please contact the department at (217) 785-9947.
The department is attempting to identify where contaminated lead products
may have been distributed. Our information indicates that the companies
listed below may manufacture
lead vinyl aprons or materials used therein. They include, but may not be
limited to:
Bar Ray Products Kennedy Company Lite Tech
Tillotson
When contacting your supplier or distributor, please mention these
manufacturers. We will update you with additional information as it becomes
available.
June 4, 1997
This information is a followup to the notice distributed by the Illinois
Department of Nuclear Safety (IDNS) or the Conference of Radiation Control
Program Directors, Inc.
(CRCPD) that was sent to you within the last 24 hours. If you have further
questions, please contact Steve Collins at 217-785-9935 or fax 217- 782-1328
or at collins@idns.state.il.us.
Based on results of analyses from the IDNS Radiochemistry Laboratory for
five samples, the radionuclides are lead-210 and its daughters bismuth-210
and polonium- 210. The half-life
of lead-210 is approximately 22 years, bismuth-210 is approximately 5 days,
and polonium-210 is approximately 138 days.
The total activity is approximately 4 + 2 nanocuries per gram of lead
material. The bismuth 1.16 MeV beta is the primary contributor to dose
followed by the k-shell x-rays. The energy of the x-rays is 88 keV or less
with most less than 50 keV.
The estimated dose rate is approximately 0.6 to 3 millirad per hour at
contact. If a film badge/tld is near an apron made of the contaminated
material for a long period of time with the window of the film badge/tld
holder toward the source of radiation, there may be a reading that is
significantly above the actual dose received by the individual assigned the
personnel dosimeter.
The IDNS has notified each state Radiation Control Program in which there is
a company that received contaminated lead (Pb) material from the Illinois
supplier of lead. Each state agreed
to support the effort to track the distribution of the products. Each of
the companies has also been requested to provide a description of the
company's process for use of the lead, a description of the company's
products made with the lead, and a distribution list for the company's
potentially contaminated products.
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 evaluations indicate 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 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.
o If the survey results indicate contamination, contact your supplier for
further instructions.
o 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.
o 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,
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
---------------->
Mahadevappa Mahesh, Ph.D., DABR.
Chief Clinical Radiology Physicist
P.O.Box. 0811,
601, N. Caroline Street
Baltimore, MD 21287-0811
(410) 955-5115 (o)
(410) 614-1977 (fax)
(410) 668-7948 (h)