Saudi National diagnostic reference levels (NDRLs)

Background Saudi Food and Drug Authority (SFDA) has led the first governmental initiative to establish Saudi National Diagnostic Reference Levels (NDRLs) for various imaging modalities. NDRLs provide benchmarks for radiation dose levels in medical imaging procedures, ensuring that these doses are optimized and kept as low as reasonably achievable while maintaining diagnostic image quality. Methods The NDRLs established in adherence to international guidelines for the common routine examinations, which include Computed Tomography (CT) (adults and pediatrics) that cover 54 hospitals, General X-ray that cover 22 hospitals, and Mammography that cover 7 hospitals across the Kingdom of Saudi Arabia (KSA), including a total of 29,672 cases. Results The established NDRLs encompass a range of doses for various imaging modalities ensuring diagnostic efficacy while maintaining safety. The dose ranges for adult CT procedures were as follows: Head CT showed a CTDIvol of 24–95 mGy and a DLP of 495–1435 mGy-cm; Abdomen & Pelvis CT had a CTDIvol of 5–17 mGy and a DLP of 269–996 mGy-cm; Chest CT reported a CTDIvol of 6–16 mGy and a DLP of 160–578 mGy-cm. For pediatric CT, the Head CT for ages 0–5 years had a CTDIvol of 15–32 mGy and a DLP of 289–652 mGy-cm, while for ages 6–15, the CTDIvol was 23–44 mGy and the DLP was 389–866 mGy-cm. The abdomen X-ray DAP ranged from 0.04 to 6.71 (Gy.cm2), while Chest X-ray DAP ranged from 0.05 to 0.9 (Gy.cm2), and the Mammogram 2D MGD for a thickness of 40–53 cm was between 0.92 and 1.64 mGy. Conclusion The establishment of the NDRLs aligns with the strategic objectives of the SFDA aiming to ensure safety, efficacy and performance of medical devices. This initiative addresses a significant advancement in the regulatory framework for medical imaging in the kingdom and setting a procedure for future quality assurance measures.