This article should serve as notification to dental health professionals of the potential for harmful lead exposure from dental
films stored in containers lined with unpainted lead. The FDA believes that there may be hundreds of these lead-lined boxes currently being used to store dental films. Some of them may have been in use for decades. Most of these boxes are the size and shape of shoe-boxes, made of wood, and lined with lead that has apparently not been painted or coated.
Dental films stored in these boxes have been found to be coated with a
whitish film that is about 80% lead. In many cases there are highly dangerous
levels of lead on the films, enough to potentially cause serious adverse health
effects in patients and health care professionals. These adverse health effects
include anemia and serious neurological damage.1
Intersted parties may obtain more information about public health concerns related to lead from the OSHA website: http://www.osha-slc.gov/SLTC/lead/index.html
1Hu Howard: Heavy
metal poisoning. In: Harrison’s Principles of Internal Medicine, 14th
edition, AS Fauci et al (eds) New York, McGraw Hill, 1998, pp 2565-2566.
What should be done:
- Discard any dental film that has been put in these boxes. None of
that film should be used. Wiping the film does not significantly
reduce the lead levels.
- Remove these boxes and dispose of them properly. THE OLD BOXES CANNOT BE
MADE SAFE by painting, coating or lining them. Scrap lead should be
discarded according to EPA regulations. You may call the EPA’s RCRA hotline
at 1 (800) 424-9346 and speak to a representative to find your State’s lead
- Make it a practice to store your dental film according to the manufacturer’s
Reporting adverse events to FDA
If you have experienced problems with dental devices or dental device
malfunctions, you can report this directly to the manufacturer. Alternatively,
you can report directly to MedWatch, the FDA’s voluntary reporting program.
You may submit reports to MedWatch four ways: online to http://www.accessdata.fda.gov/scripts/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.
Getting more information
If you have questions regarding this article, please contact, Marian Kroen,
Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville,
Maryland, 20850, by fax at 301-594-2968, or by e-mail at firstname.lastname@example.org.
Additionally, a voice mail message may be left at 301-594-0650 and your call
will be returned as soon as possible.
The picture below is an example of a shoe-box sized lead-lined wooden box
which may be a source of lead contamination: