On the Asseswent of Risk to Ultrasound

ABSPRACT. A r e l i a b l e assessment of r i s k s and b e n e f i t s associated with exposure t o ultrasound is e s s e n t i a l because of the rapid development and increas ing u t i l i z a t i o n of ultrasound i n t h e hea l ing a r t s and i n i n d u s t r i a l and consmer appl ica t ions . has been d i rec ted t o the development of information on the b io logica l implicat ions of exposure t o ul t rasound. In te rac t ions between ul t rasound and b io logica l systems have been documented, and include degradat ion of b io logica l molecules, des t ruc t ion of cells and c e l l organel les , and formation of les ions i n t i s s u e s . Much ava i lab le information is based on inadequate dosimetry f o r purposes of r e a l i s t i c r i s k assessments. A uni f ied concept is e s s e n t i a l t o r e l a t e exposure t o energy d i s t r i b u t i o n and deposi t ion i n t i s s u e s . To develop this concept, i d e n t i f i c a t i o n of b i o l o g i c a l l y important physical parameters of exposure is necessary. s e n s i t i v e i n d i c a t o r s of damage. Dose-effect re la t ionships must be quant i ta ted . Substantive s t u d i e s are needed t o answer quest ions about poss ib le delayed, c m u l a t i v e , and s y n e r g i s t i c e f f e c t s . Proper epidemiologic designs must be employed t o eva lua te t h e impact of ultrasound exposure on hman development. I n f o m a t i o n from an e f f e c t i v e na t iona l research e f f o r t w i l l f a c i l i t a t e r i s k assessment a s an i n t e g r a l p a r t of t h e d e v e l o p e n t of r a d i a t i o n s a f e t y performance s tandards f o r ultrasound generat ing e l e c t r o n i c products, f o r which the Bureau has r e s p o n s i b i l i t y under Public Law 90-602. Disproport ionately low and i n s u f f i c i e n t a t t e n t i o n