Circular No. 13/2018/TT-BKHCN Amending and supplementing certain Articles of Joint Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014 of the Minister of Science and Technology and the Minister of Health on ensuring radiation safety in healthcare

CIRCULAR

Amending and supplementing certain provisions of the Joint Circular

No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014

of the Minister of Science and Technology and the Minister of Health

on ensuring radiation safety in healthcare

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Pursuant to the Atomic Energy Law on June 3, 2008;

Pursuant to Decree No. 07/2010/NĐ-CP dated January 25, 2010 of the Government detailing and guiding the implementation of certain provisions of the Atomic Energy Law;

Pursuant to Decree No. 95/2017/NĐ-CP dated August 16, 2017, of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Science and Technology;

At the proposal of the Director of the Radiation and Nuclear Safety Agency and the Head of the Legal Department,

the Minister of Science and Technology issues this Circular amending and supplementing certain provisions of the Joint Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014 of the Minister of Science and Technology and the Minister of Health on ensuring radiation safety in healthcare.

Article 1. Amending and supplementing certain provisions of the Joint Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014 of the Minister of Science and Technology and the Minister of Health on ensuring radiation safety in healthcare

1. Amending and supplementing Clause 1 of Article 1 as follows:

"1. This joint circular stipulates requirements for ensuring radiation safety for radiation equipment, radioactive sources, radiopharmaceuticals used in healthcare, and equipment used in nuclear medicine; requirements for rooms housing radiation equipment, working with radioactive sources and radiopharmaceuticals, patient rooms treated with radiopharmaceuticals (injection, infusion, oral intake of radiopharmaceuticals or implantation of radioactive sources), and storage areas for radioactive sources or radioactive waste; requirements for installation and operation of radiation equipment; requirements for occupational radiation exposure control, public radiation exposure control, and medical radiation exposure control; requirements for emergency response to radiation incidents and responsibilities of organizations and individuals related to ensuring radiation safety in healthcare."

2. Amending and supplementing Clause 4 of Article 2 as follows:

"4. Medical radiation workers are doctors, nurses, medical technicians, nursing assistants, pharmacists, pharmacy technicians, engineers, technical staff, midwives at healthcare facilities who work directly with radiation equipment or sealed radioactive sources, unsealed radioactive sources, or care for patients treated with radioactive isotopes or must work in areas with potential radiation exposure exceeding 1 mSv/year or in areas at risk of radioactive contamination."

3. Amending and supplementing Clause 6 of Article 2 as follows:

"6. Medical X-ray diagnostic equipment includes X-ray devices used for imaging and diagnosis, including dental X-ray machines (panoramic dental X-rays, skull X-rays, intraoral dental X-rays using film placed behind the tooth socket, cone-beam computed tomography), mammography X-ray machines, mobile X-ray machines, bone density measurement X-ray machines, general X-ray fluoroscopy machines, X-ray television systems, computed tomography machines, and veterinary X-ray machines."

4. Amending and supplementing Clause 7 of Article 2 as follows:

"7. Radiotherapy equipment includes devices that emit ionizing radiation used in healthcare for treating diseases, such as radiotherapy X-ray machines, linear accelerators, teletherapy machines using radioactive sources, brachytherapy machines, Gamma Knife, Cyber Knife, X Knife, Tomotherapy, proton therapy machines, and other similar devices."

5. Amending and supplementing Clause 8 of Article 2 as follows:

"8. Equipment used in nuclear medicine includes devices or systems used in the field of nuclear medicine to image from inside the body through radiation emitted from radiopharmaceuticals administered to patients, or to measure radioactivity levels, such as rectilinear scanners, gamma cameras, single-photon emission computed tomography (SPECT), SPECT/CT, positron emission tomography (PET), PET/CT, PET/magnetic resonance imaging (MRI), radioactivity calibration machines, scintillation counters, radioactivity concentration measuring machines, and other similar devices."

6. Supplementing Clause 9 in Article 2 as follows:

"9. Investigation level refers to the effective dose or radiation dose rate at work locations of medical radiation workers, around rooms housing radiation equipment, radioactive source storage areas, radioactive waste storage areas; contamination levels or surface contamination levels per unit area or volume in areas at risk of radioactive contamination within nuclear medicine facilities. These values are established based on actual assessment data from the facility or good practices from similar facilities and when exceeded during operations, an investigation must be conducted to determine the cause and corrective measures taken."

7. Amending and supplementing Point c of Clause 3 of Article 10 as follows:

"c) In the control room or location of the control cabinet of medical X-ray diagnostic equipment (except for mobile X-ray machines and X-ray television systems for interventional procedures/angiography) shall not exceed 10 µSv/h;"

8. Amending and supplementing Clause 2 of Article 13 as follows:

"2. Healthcare facilities shall not employ persons under 18 years old to operate radiation equipment, work with radioactive sources, care for patients treated with radioactive isotopes, or work in areas with potential radiation exposure exceeding 1 mSv/year or in areas at risk of radioactive contamination."

9. Amending and supplementing Clause 3 of Article 21 as follows:

"3. Patients treated with I-131 radiopharmaceuticals may only be discharged from the hospital when their residual radioactivity level does not exceed 1100 MBq. When discharging I-131 treated patients, the treating physician must provide direct counseling and written guidance to the patient regarding radiation safety requirements for family members, colleagues, and the community."

10. Amending and supplementing Point d of Clause 3 of Article 25 as follows:

"d. Creating conditions for inspection teams, inspectors to perform their duties in inspecting and supervising radiation safety and nuclear safety; providing necessary information upon request;"

11. Amending and supplementing Point c of Clause 1 of Article 29 as follows:

"c. Inspecting and handling violations; taking the lead and coordinating with relevant units of the Ministry of Health to check compliance with laws and regulations on ensuring radiation safety in healthcare;"

12. Amending and supplementing Point c of Clause 2 of Article 29 as follows:

"c. Inspecting and handling violations; taking the lead and coordinating with the Department of Health to check compliance with laws and regulations on ensuring radiation safety in healthcare for healthcare facilities under their jurisdiction;"

13. Replace Appendix III issued together with Circular Joint Circular No. 13/2014/TTLT-BKHCN-BYT dated June 9, 2014, of the Minister of Science and Technology and the Minister of Health, concerning radiation safety in healthcare, with the Appendix issued together with this Circular.

Article 2. Implementation clause

1. This Circular takes effect from November 1, 2018.

2. In the course of implementation, if there are any difficulties, agencies, organizations, and individuals are requested to promptly report them to the Ministry of Science and Technology for consideration and resolution./.