Law Summary
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.