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The deleterious effects of ionizing
radiation are well documented and include both stochastic and
deterministic effects.(1) In the past, the primary
concern during diagnostic x-ray procedures has been for stochastic
long-term effects such as carcinogenesis.
Recently, there has been increasing
concern for the short-term acute effects resultant from high doses
of radiation associated with long interventional procedures which
use fluoroscopic guidance. These acute effects are deterministic
and generally have a threshold below which the effect is not observed.
Effects which have been documented include epilation and serious
skin injuries such as moist desquamation and tissue necrosis.
(2)
To make the medical community aware
of this potential for severe acute effects, the FDA has issued
several advisories which recommend the determination of radiation
dose, (3-5) explaining that “the patient’s
medical record should contain an unambiguous identification of
those areas of the patient’s skin that received an absorbed
dose that may approach or exceed the selected threshold.”
References:
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Wagner LK, Eifel PJ and Geise RA.: Potential biological
effects following high x-ray dose interventional procedures.
J of Vascular and Interventional Radiology 5: 71-84, 1994
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Shope TB: Radiation
induced skin injuries from fluoroscopy. Radiology Vol. 197(P)
Supplement, p 449 and Radiographics September 1996.
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FDA Avoidance
of serious x-ray induced skin injuries to patients during
fluoroscopically-guided procedures. US Food and Drug Administration,
Rockville, MD. September 1994.
-
FDA Public Health
Advisory: Avoidance of serious x-ray induced skin injuries
to patients during fluoroscopically-guided procedures. US
Food and Drug Administration, Rockville, MD, September 30,
1994.
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FDA Recording
information in the patient's medical record that identifies
the potential for serious x-ray induced skin injuries following
fluoroscopically-guided procedures US Food and Drug Administration,
Rockville, MD, March 1995.
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