A comparison of current regulations and regulatory guide governing quality control of dose calibrators

The U.S. Nuclear Regulatory Commission recently amended its regulation governing the calibration of dose calibrators. The changes include (1) the radioactivity of radiopharmaceutical dosages that contain photon-emitting radionuclides has to be measured by a dose calibrator prior to administration to patients and human research subjects; (2) the lower end of the radioactivity limits for linearity testing has been raised to 1.1 MBq (30 microCi) to be consistent with the Nuclear Regulatory Commission Quality Management Program Requirements; and (3) the requirement for signature of the Radiation Safety Officer on the records for accuracy, linearity, and geometry dependence tests has been removed. Although these are practical amendments, further clarification of the new Nuclear Regulatory Commission regulation is required for the following issues: (1) inconsistency in individual's identification requirement for the record keeping (i.e., initials of the individual who performed the constancy check and identity of the operator for the accuracy, linearity, and geometry dependence tests); (2) whether the use of 99mTc is adequate for linearity testing when other radionuclides are being measured in the dose calibrator; and (3) lack of provision for dose calibrator adjustment when conducting the accuracy test. In addition, Nuclear Regulatory Commission Regulatory Guide 10.8 should be revised to become consistent with the Nuclear Regulatory Commission's regulation in order to assist licensees with full compliance of the requirements or recommendations.