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Despite the increased demand to utilize innovations in diagnostic x-ray devices brought about by the COVID-19 pandemic, the Food and Drug Administration (FDA) reminds the general public and all radiation facilities to refrain from using portable/handheld diagnostic xray machines pursuant to Section 5.3.25 of DOH Administrative Order (AO) No. 35 s. 1994 or the “Requirements for the Control of Radiation Hazards from Clinical Diagnostic X-ray Facilities”. These handheld x-ray devices are configured to have a single peak kilovoltage (kVp) and low tube current (mA) settings insufficient for x-ray procedures of varying body dimensions. Basic radiation protection and safety principles are compromised with the use of such devices because of the increased probability of committing errors caused by the following:

The FDA fervently supports measures that will help in the prevention and diagnosis of COVID-19 and other communicable diseases without compromising other aspects of the public health. For questions, clarifications and/or reports regarding this matter, please contact the Center for Device Regulation, Radiation Health, and Research (CDRRHR) through the hotline (02) 8815-9600 or email at cdrrhr@fda.gov.ph or cdrrhr.rrd@fda.gov.ph.

For strict compliance.

Attachment:-> FDA Advisory No.2020-793