Title
Prohibition of X-ray below 100 mA operation
Law
Fda Circular No. 2014-005
Decision Date
Feb 20, 2014
A Philippine law prohibits the operation of radiographic x-ray machines with tube currents below 100 mA in diagnostic radiology, based on the recommendation of the World Health Organization, due to findings of excessive dose levels in selected chest x-ray clinics.

Context and Rationale

  • In 1993, WHO reviewed and set specifications under the World Health Imaging System for Radiography (WHIS-RAD).
  • WHO's guidelines emphasize radiation safety and adequate tube current for image quality and reduced radiation exposure.
  • Local Radiation Protection Survey and Evaluation revealed that some facilities exceeded guidance dose levels set by the Philippine Department of Health (DOH).

Scope and Exceptions

  • Dental, veterinary, industrial, anti-crime, and research radiographic x-ray machines are exempted if their use conforms to their licensed purposes.
  • Mobile C-arm units and specialized x-ray equipment such as mammography, bone densitometry, and lithotripsy devices are not affected by this circular.

Procedures for Compliance

  • New license to operate (LTO) applications for x-ray facilities using radiographic machines below 100 mA tube current will not be accepted.
  • Facilities previously licensed using machines below 100 mA were given until December 31, 2014, to upgrade their equipment to at least 100 mA.
  • Renewals of affected LTOs issued for 2014 will only be valid until December 31, 2014.
  • Applications for renewal of LTOs for 2015 and onwards will be rejected unless the equipment is upgraded accordingly.

Enforcement and Penalties

  • Facilities operating prohibited machines beyond the December 31, 2014 deadline will face sanctions under the Implementing Rules and Regulations of Republic Act No. 9711.

Effective Date and Administration

  • The Circular took effect immediately upon issuance.
  • The FDA's Center for Device Regulation, Radiation Health, and Research (CDRRHR), along with Regional Field Offices, are responsible for enforcement.

Key Legal Concepts

  • Emphasis on radiation protection standards based on international best practices.
  • Licensing as a control mechanism for compliance with safety standards.
  • Time-bound phase-out for non-compliant machines to ensure public health and safety.
  • Coordination between national health agencies and regulatory bodies for effective regulation of medical devices.

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