EVALUATION OF POTENTIAL GENOTOXICITY OF PULSED ELECTRIC AND ELECTROMAGNETIC-FIELDS USED FOR BONE-GROWTH STIMULATION

Medical devices emitting pulsed electric and electromagnetic fields ha ve been found to be effective for a number of clinical applications in cluding stimulation of bone and tissue growth. To determine whether pu lsed fields of the type used in these clinical applications present a mutagenic hazard, electric and electromagnetic fields at two exposure levels were tested in the Ames test, CHO cell chromosomal aberration a ssay, BALB/3T3 cell transformation assay and unscheduled DNA synthesis assay in primary rat hepatocytes. For both field types, initial and i ndependent repeat studies were performed for each assay at both clinic al and supra clinical doses. In all assays, the results show a lack of cytotoxic, transforming and mutagenic activity. The data suggest that pulsed electric and electromagnetic fields of the type and dose level s used in bone growth stimulation lack mutagenic and transforming acti vity.