Due to the COVID-19 pandemic, techniques in the diagnosis of persons with probable or suspected cases has been rapidly evolving. A review of statements and guidelines issued by international and local expert societies points to an increase in the use of radiation devices to augment such efforts. The American College of Radiology (ACR) issued recommendations last March 11, 2020 which pointed out that radiation devices should be used with caution and for justified clinical indications only. This has been reiterated by the Philippine College of Radiology (PCR) and its associate societies, the CT-MRI Society of the Philippines (CMSP) and the Ultrasound Society of the Philippines (LISP), through the issuance of separate guidelines and recommendations.
In view thereof, the FDA advises all medical radiation facilities to abide by the interim guidelines and protocols set by the Department of Health (DOH) in the diagnosis of COVID19 infections. Department Memorandum (DM) No. 2020-0138 or the “Adoption of PSMID Clinical Practice Guidelines on COVID-19″ states that real time polymerase chain reaction assay (RT-PCR assay) is the recommended test to confirm COVID-19 infection and chest imaging/radiological procedures are part of patient assessment, monitoring, and guidance to clinical treatment depending on epidemiological risk factors.
As such, diagnostic radiation devices (e.g. x-ray machines, CT Scans, MRIs, point-ofcare ultrasound machine, etc.) should not be used as first–line diagnostic tool for COVID19. No practice involving exposure to harmful radiation should be adopted without proper justification. These devices can instead be utilized to supplement the management of confirmed cases with infection control protocols set-up following the recommendations of the DOH.’
For more information and inquiries, you may contact the Center for Device Regulation, Radiation Health, and Research (CDRRHR) at (02) 8815-9600 or email us [email protected] or [email protected].
Attachment:-> FDA Advisory No.2020-1057