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AEC Requirements for authorisation to use Radiation Sources for Medical purposes in Uganda

Practices regulated by Atomic Energy Council in Uganda

c) Nuclear medicine, where radiopharmaceuticals are used for diagnosis or treatment of various diseases using Single Photon Emission Computed Tomography (SPECT) Scanners and Therapeutic Nuclear Medicines such as Iodine-131 (I-131), Lutetium-177 (Lu-177) and Radium-223 Dichloride.

Practices regulated by Atomic Energy Council in Uganda

In general, AEC has registered a total of 703 active medical facilities with 1133 radiation sources in the medical field.

Requirements for authorisation to use Radiation Sources for Medical purposes in Uganda

Atomic Energy Council is responsible for overseeing the safe and secure use of radiation sources in all facilities with the aim of protecting people, workers, and the environment from the dangers that may result from adverse or harmful effects of ionising radiation. Hence, medical facilities intending to utilize radiation sources must adhere to AEC’s licensing and authorization requirements as highlighted below.

a) Notify the Council about the practice

Any person intending to conduct a practice or possess a radiation source must notify the Council in advance, as stipulated under Section 33 of the Atomic Energy Act, Cap. 154. This requires completing the Notification Form for practices involving radioactive materials and radiation-generating equipment (FORM 1A), available on the AEC website at www.atomiccouncil.go.ug. This process ensures that both the Regulator and Operator are adequately prepared with the necessary documentation and resources for the intended practice.

b) Apply for authorisation to Possess and use radiation sources

According to Regulation 9(1)(b) of the Atomic Energy Regulations (AER), 2012, the Atomic Energy Council (AEC) is mandated to issue authorizations and grant exemptions for the possession and use of radiation sources. Facilities intending to use radiation sources must obtain authorization by submitting the relevant application forms basing on the practice to be undertaken for review and assessment. These forms can be downloaded from the AEC website at www.atomiccouncil.go.ug and may include;

i. Application for authorisation to possess and use a source(s) for medical application (FORM 2B)

ii. Application for authorisation to import or export device(s) or radioactive materials (FORM 4)

iii. Application for authorisation to sell, transfer, loan or lease a radiation source (FORM 7)

iv. Application for authorisation to transport radioactive materials (FORM 8)

v. Application for authorisation to decommission a facility with radioactive materials (FORM 9)

These applications must be submitted with copies of the relevant attachments and proof of payment as highlighted in the subsequent requirements for medical use of radiation sources in Uganda.

c) Seek approvals of the facility layout and designs for the practice from AEC

As part of the application to possess and use radiation sources for medical purposes, Facilities must submit their designs and layouts of the premises where they intend to carry out medical practices in order to get the necessary approvals from Atomic Energy Council. Such designs should meet the national standards for imaging rooms that are to house radiation sources to ensure adequate shielding from radiation with the overall aim of ensuring radiation safety and security at the facility premises.

d) Use qualified personnel to operate equipment that generate radiation sources

Operators of medical equipment that generate radiation should be qualified to do so. Such medical practitioners should be registered by health professional bodies and may include; radiographers, radiologists, medical physicists, oncologists, and radiation safety officers, based on the practice type. Additional training for operators training in radiation protection and safety is required. Qualification documents are part of the attachments to application form for authorisation to possess and use the radiation sources for medical purposes.

e) Appoint a Radiation Safety Officer

Facilities are required to appoint a suitably qualified person as a Radiation Safety Officer whose obligations are defined under Section 36(4) of the Atomic Energy Act, Cap. 154, who shall among others advise his or her employer in relation to all matters pertaining to the safety of workers, the public and the environment from radiation; and security of radiation sources.

f) Constitute a Radiation Safety Committee

For complex facilities/practices, such as those with more than one practice/radiation source, authorised persons are required to constitute a Radiation Safety Committee for each premise comprising of a representative from management, a qualified expert, a representative of workers and a Radiation Safety Officer. Such a Committee shall oversee the implementation of the Radiation Safety Programme for the facility.

g) Document a quality assurance program for the practice

Facilities should document and implement a quality assurance (QA) program for the practice to ensure radiation equipment operate correctly for patient protection, safety of the workers and the members public, and regulatory compliance and other applicable standards. Such records shall be kept on facility file and periodically reviewed by the Radiation Safety Officer/Radiation Safety Committee.

h) Conduct a safety assessment for the practice

Facilities are required to carry out a safety assessment to evaluate radiation risks, shielding, equipment, and procedures, ensuring that exposure to staff, patients, and the public are within regulatory limits. A safety assessment report is to be documented and submitted to AEC together with the authorization application. Guidelines for preparing a safety assessment report are available on the AEC website.

Introduction

i) Document an emergency plan for the practice. Facilities should document an emergency response plan commensurate with the radiological risks associated with the practice. The plan is meant to address radiological incidents, detailing hazards, roles, responsibilities, and risk mitigation actions. Staff must be taken through the plan by the Radiation Safety Officer (RSO) and should conduct periodic drills/exercises which need to be documented. A copy of the plan must be submitted together with the authorization application.

j) Documentation of Local rules for the practice

Facilities are required to define specific roles and responsibilities of persons involved in the process of using the radiation sources at their premises. Such rules may include; access control, safe handling of radiation sources, monitoring, quality assurance and emergency preparedness and response, ensuring they are clear and communicated to all personnel. A copy of the local rules must be submitted together with the authorization application.

Recommendations to the operators

i. Adhere to the Atomic Energy Act Cap. 154, Atomic Energy Regulations, 2008, and Atomic Energy (Security of Radioactive Materials) Regulations, 2021. Submit timely licensing and renewal applications to ensure uninterrupted operations.

ii. Employ, train and retain qualified staff, including Radiation Safety Officers, to oversee radiation source operations and ensure adherence to safety protocols.

iii. Design and maintain facilities to meet shielding and operational safety requirements.

iv. Conduct regular inspections to ensure equipment performs safely and effectively.

v. Provide and enforce the proper use of appropriate Personal Protective Equipment (PPE), such as lead aprons and gloves, ensuring equipment meets safety standards and is regularly maintained.

vi. Develop, train for, and routinely test response plans for radiation-related emergencies.

vii. Implement strong controls to prevent unauthorized access, loss, or theft of radiation sources, and report incidents promptly to the Atomic Energy Council (AEC).

viii. Participate in AEC inspections and audits, and address recommendations or required corrective actions without delay.

Recommendations for members of the public

i. Seek medical diagnostic and therapeutic services using radiation sources from licensed facilities, as these are largely compliant with safety standards. ii. Immediately report any unauthorized use or handling of radiation sources to the AEC or local authorities to prevent potential harm or misuse.. iii. Adhere to safety precautions in facilities using radiation and avoid tampering with equipment or warning signs. iv. In case of a radiation incident, follow instructions from authorities, stay away from affected areas, and avoid handling unknown materials. v. Employers using radiation in their operations must hire qualified personnel. vi. Get to know about radiation benefits, risks, and safety measures within your community to promote awareness and informed decisions.

The Atomic Energy Council’s Commitment to Radiation Safety

Atomic Energy Council is dedicated to ensuring the safe and beneficial use of radiation in Uganda’s healthcare sector by authorising facilities with radiation sources who meet the set requirements for the protection of people and the environment from harmful effects of radiation.

 

Practices regulated by Atomic Energy Council in Uganda

b) Radiotherapy, where equipment is used in the treatment of cancer using Linear Accelerator (LINAC) machines, Cobalt-60 Teletherapy and Brachytherapy machines.

Practices regulated by Atomic Energy Council in Uganda

c) Nuclear medicine, where radiopharmaceuticals are used for diagnosis or treatment of various diseases using Single Photon Emission Computed Tomography (SPECT) Scanners and Therapeutic Nuclear Medicines such as Iodine-131 (I-131), Lutetium-177 (Lu-177) and Radium-223 Dichloride.

Practices regulated by Atomic Energy Council in Uganda

In general, AEC has registered a total of 703 active medical facilities with 1133 radiation sources in the medical field.

Requirements for authorisation to use Radiation Sources for Medical purposes in Uganda

Atomic Energy Council is responsible for overseeing the safe and secure use of radiation sources in all facilities with the aim of protecting people, workers, and the environment from the dangers that may result from adverse or harmful effects of ionising radiation. Hence, medical facilities intending to utilize radiation sources must adhere to AEC’s licensing and authorization requirements as highlighted below.

a) Notify the Council about the practice

Any person intending to conduct a practice or possess a radiation source must notify the Council in advance, as stipulated under Section 33 of the Atomic Energy Act, Cap. 154. This requires completing the Notification Form for practices involving radioactive materials and radiation-generating equipment (FORM 1A), available on the AEC website at www.atomiccouncil.go.ug. This process ensures that both the Regulator and Operator are adequately prepared with the necessary documentation and resources for the intended practice.

b) Apply for authorisation to Possess and use radiation sources

According to Regulation 9(1)(b) of the Atomic Energy Regulations (AER), 2012, the Atomic Energy Council (AEC) is mandated to issue authorizations and grant exemptions for the possession and use of radiation sources. Facilities intending to use radiation sources must obtain authorization by submitting the relevant application forms basing on the practice to be undertaken for review and assessment. These forms can be downloaded from the AEC website at www.atomiccouncil.go.ug and may include;

i. Application for authorisation to possess and use a source(s) for medical application (FORM 2B)

ii. Application for authorisation to import or export device(s) or radioactive materials (FORM 4)

iii. Application for authorisation to sell, transfer, loan or lease a radiation source (FORM 7)

iv. Application for authorisation to transport radioactive materials (FORM 8)

v. Application for authorisation to decommission a facility with radioactive materials (FORM 9)

These applications must be submitted with copies of the relevant attachments and proof of payment as highlighted in the subsequent requirements for medical use of radiation sources in Uganda.

c) Seek approvals of the facility layout and designs for the practice from AEC

As part of the application to possess and use radiation sources for medical purposes, Facilities must submit their designs and layouts of the premises where they intend to carry out medical practices in order to get the necessary approvals from Atomic Energy Council. Such designs should meet the national standards for imaging rooms that are to house radiation sources to ensure adequate shielding from radiation with the overall aim of ensuring radiation safety and security at the facility premises.

d) Use qualified personnel to operate equipment that generate radiation sources

Operators of medical equipment that generate radiation should be qualified to do so. Such medical practitioners should be registered by health professional bodies and may include; radiographers, radiologists, medical physicists, oncologists, and radiation safety officers, based on the practice type. Additional training for operators training in radiation protection and safety is required. Qualification documents are part of the attachments to application form for authorisation to possess and use the radiation sources for medical purposes.

e) Appoint a Radiation Safety Officer

Facilities are required to appoint a suitably qualified person as a Radiation Safety Officer whose obligations are defined under Section 36(4) of the Atomic Energy Act, Cap. 154, who shall among others advise his or her employer in relation to all matters pertaining to the safety of workers, the public and the environment from radiation; and security of radiation sources.

f) Constitute a Radiation Safety Committee

For complex facilities/practices, such as those with more than one practice/radiation source, authorised persons are required to constitute a Radiation Safety Committee for each premise comprising of a representative from management, a qualified expert, a representative of workers and a Radiation Safety Officer. Such a Committee shall oversee the implementation of the Radiation Safety Programme for the facility.

g) Document a quality assurance program for the practice

Facilities should document and implement a quality assurance (QA) program for the practice to ensure radiation equipment operate correctly for patient protection, safety of the workers and the members public, and regulatory compliance and other applicable standards. Such records shall be kept on facility file and periodically reviewed by the Radiation Safety Officer/Radiation Safety Committee.

h) Conduct a safety assessment for the practice

Facilities are required to carry out a safety assessment to evaluate radiation risks, shielding, equipment, and procedures, ensuring that exposure to staff, patients, and the public are within regulatory limits. A safety assessment report is to be documented and submitted to AEC together with the authorization application. Guidelines for preparing a safety assessment report are available on the AEC website.

Introduction

i) Document an emergency plan for the practice. Facilities should document an emergency response plan commensurate with the radiological risks associated with the practice. The plan is meant to address radiological incidents, detailing hazards, roles, responsibilities, and risk mitigation actions. Staff must be taken through the plan by the Radiation Safety Officer (RSO) and should conduct periodic drills/exercises which need to be documented. A copy of the plan must be submitted together with the authorization application.

j) Documentation of Local rules for the practice

Facilities are required to define specific roles and responsibilities of persons involved in the process of using the radiation sources at their premises. Such rules may include; access control, safe handling of radiation sources, monitoring, quality assurance and emergency preparedness and response, ensuring they are clear and communicated to all personnel. A copy of the local rules must be submitted together with the authorization application.

Recommendations to the operators

i. Adhere to the Atomic Energy Act Cap. 154, Atomic Energy Regulations, 2008, and Atomic Energy (Security of Radioactive Materials) Regulations, 2021. Submit timely licensing and renewal applications to ensure uninterrupted operations.

ii. Employ, train and retain qualified staff, including Radiation Safety Officers, to oversee radiation source operations and ensure adherence to safety protocols.

iii. Design and maintain facilities to meet shielding and operational safety requirements.

iv. Conduct regular inspections to ensure equipment performs safely and effectively.

v. Provide and enforce the proper use of appropriate Personal Protective Equipment (PPE), such as lead aprons and gloves, ensuring equipment meets safety standards and is regularly maintained.

vi. Develop, train for, and routinely test response plans for radiation-related emergencies.

vii. Implement strong controls to prevent unauthorized access, loss, or theft of radiation sources, and report incidents promptly to the Atomic Energy Council (AEC).

viii. Participate in AEC inspections and audits, and address recommendations or required corrective actions without delay.

Recommendations for members of the public

i. Seek medical diagnostic and therapeutic services using radiation sources from licensed facilities, as these are largely compliant with safety standards. ii. Immediately report any unauthorized use or handling of radiation sources to the AEC or local authorities to prevent potential harm or misuse.. iii. Adhere to safety precautions in facilities using radiation and avoid tampering with equipment or warning signs. iv. In case of a radiation incident, follow instructions from authorities, stay away from affected areas, and avoid handling unknown materials. v. Employers using radiation in their operations must hire qualified personnel. vi. Get to know about radiation benefits, risks, and safety measures within your community to promote awareness and informed decisions.

The Atomic Energy Council’s Commitment to Radiation Safety

Atomic Energy Council is dedicated to ensuring the safe and beneficial use of radiation in Uganda’s healthcare sector by authorising facilities with radiation sources who meet the set requirements for the protection of people and the environment from harmful effects of radiation.

 

No person shall acquire, own, possess, operate, import, export, hire, loan, receive, use, install, commission, decommission, transport, store, sell, distribute, dispose of, transfer, modify, upgrade, process, manufacture or undertake any practice related to the application of atomic energy…

Introduction

As part of the ongoing efforts to ensure the safe use, handling, storage, and disposal of radiation sources used for medical diagnosis and treatment, Atomic Energy Council (AEC) has in place requirements for authorisation to possess and use radiation sources in the medical sector. These requirements are intended to ensure the safety of patients, radiation workers and members of the public as well as the safe management of radioactive sources used in medical facilities.

Radiation sources are used in diagnosing, treating, and managing various medical conditions. However, they also present significant safety risks, especially if mishandled. The potential risks range from unnecessary exposure to harmful radiation, which could lead to deterministic effects (short-term) such as skin reddening, skin burns, cataracts, death and stochastic effect (long-term) such as cancer and genetic mutations to misuse of radioactive materials for malicious purposes.

Section 31 of the Atomic Energy Act Cap. 154. requires that no person shall acquire, own, possess, operate, import, export, hire, loan, receive, use, install, commission, decommission, transport, store, sell, distribute, dispose of, transfer, modify, upgrade, process, manufacture or undertake any practice related to the application of atomic energy and regulated by the Act unless permitted by an authorization issued by Atomic Energy Council.

Medical practices regulated by Atomic Energy Council

In Uganda, the applications of atomic energy for medical use include.

a) Diagnostic Radiology where equipment is used in disease diagnosis and monitoring using Plane X-ray machines, Dental X-ray machines, Fluoroscopy X-ray machines. Computed Tomography X-ray machines, C-arm X-ray machines, Bone Densitometers and Mammography X-ray machines.

Practices regulated by Atomic Energy Council in Uganda

b) Radiotherapy, where equipment is used in the treatment of cancer using Linear Accelerator (LINAC) machines, Cobalt-60 Teletherapy and Brachytherapy machines.

Practices regulated by Atomic Energy Council in Uganda

c) Nuclear medicine, where radiopharmaceuticals are used for diagnosis or treatment of various diseases using Single Photon Emission Computed Tomography (SPECT) Scanners and Therapeutic Nuclear Medicines such as Iodine-131 (I-131), Lutetium-177 (Lu-177) and Radium-223 Dichloride.

Practices regulated by Atomic Energy Council in Uganda

In general, AEC has registered a total of 703 active medical facilities with 1133 radiation sources in the medical field.

Requirements for authorisation to use Radiation Sources for Medical purposes in Uganda

Atomic Energy Council is responsible for overseeing the safe and secure use of radiation sources in all facilities with the aim of protecting people, workers, and the environment from the dangers that may result from adverse or harmful effects of ionising radiation. Hence, medical facilities intending to utilize radiation sources must adhere to AEC’s licensing and authorization requirements as highlighted below.

a) Notify the Council about the practice

Any person intending to conduct a practice or possess a radiation source must notify the Council in advance, as stipulated under Section 33 of the Atomic Energy Act, Cap. 154. This requires completing the Notification Form for practices involving radioactive materials and radiation-generating equipment (FORM 1A), available on the AEC website at www.atomiccouncil.go.ug. This process ensures that both the Regulator and Operator are adequately prepared with the necessary documentation and resources for the intended practice.

b) Apply for authorisation to Possess and use radiation sources

According to Regulation 9(1)(b) of the Atomic Energy Regulations (AER), 2012, the Atomic Energy Council (AEC) is mandated to issue authorizations and grant exemptions for the possession and use of radiation sources. Facilities intending to use radiation sources must obtain authorization by submitting the relevant application forms basing on the practice to be undertaken for review and assessment. These forms can be downloaded from the AEC website at www.atomiccouncil.go.ug and may include;

i. Application for authorisation to possess and use a source(s) for medical application (FORM 2B)

ii. Application for authorisation to import or export device(s) or radioactive materials (FORM 4)

iii. Application for authorisation to sell, transfer, loan or lease a radiation source (FORM 7)

iv. Application for authorisation to transport radioactive materials (FORM 8)

v. Application for authorisation to decommission a facility with radioactive materials (FORM 9)

These applications must be submitted with copies of the relevant attachments and proof of payment as highlighted in the subsequent requirements for medical use of radiation sources in Uganda.

c) Seek approvals of the facility layout and designs for the practice from AEC

As part of the application to possess and use radiation sources for medical purposes, Facilities must submit their designs and layouts of the premises where they intend to carry out medical practices in order to get the necessary approvals from Atomic Energy Council. Such designs should meet the national standards for imaging rooms that are to house radiation sources to ensure adequate shielding from radiation with the overall aim of ensuring radiation safety and security at the facility premises.

d) Use qualified personnel to operate equipment that generate radiation sources

Operators of medical equipment that generate radiation should be qualified to do so. Such medical practitioners should be registered by health professional bodies and may include; radiographers, radiologists, medical physicists, oncologists, and radiation safety officers, based on the practice type. Additional training for operators training in radiation protection and safety is required. Qualification documents are part of the attachments to application form for authorisation to possess and use the radiation sources for medical purposes.

e) Appoint a Radiation Safety Officer

Facilities are required to appoint a suitably qualified person as a Radiation Safety Officer whose obligations are defined under Section 36(4) of the Atomic Energy Act, Cap. 154, who shall among others advise his or her employer in relation to all matters pertaining to the safety of workers, the public and the environment from radiation; and security of radiation sources.

f) Constitute a Radiation Safety Committee

For complex facilities/practices, such as those with more than one practice/radiation source, authorised persons are required to constitute a Radiation Safety Committee for each premise comprising of a representative from management, a qualified expert, a representative of workers and a Radiation Safety Officer. Such a Committee shall oversee the implementation of the Radiation Safety Programme for the facility.

g) Document a quality assurance program for the practice

Facilities should document and implement a quality assurance (QA) program for the practice to ensure radiation equipment operate correctly for patient protection, safety of the workers and the members public, and regulatory compliance and other applicable standards. Such records shall be kept on facility file and periodically reviewed by the Radiation Safety Officer/Radiation Safety Committee.

h) Conduct a safety assessment for the practice

Facilities are required to carry out a safety assessment to evaluate radiation risks, shielding, equipment, and procedures, ensuring that exposure to staff, patients, and the public are within regulatory limits. A safety assessment report is to be documented and submitted to AEC together with the authorization application. Guidelines for preparing a safety assessment report are available on the AEC website.

Introduction

i) Document an emergency plan for the practice. Facilities should document an emergency response plan commensurate with the radiological risks associated with the practice. The plan is meant to address radiological incidents, detailing hazards, roles, responsibilities, and risk mitigation actions. Staff must be taken through the plan by the Radiation Safety Officer (RSO) and should conduct periodic drills/exercises which need to be documented. A copy of the plan must be submitted together with the authorization application.

j) Documentation of Local rules for the practice

Facilities are required to define specific roles and responsibilities of persons involved in the process of using the radiation sources at their premises. Such rules may include; access control, safe handling of radiation sources, monitoring, quality assurance and emergency preparedness and response, ensuring they are clear and communicated to all personnel. A copy of the local rules must be submitted together with the authorization application.

Recommendations to the operators

i. Adhere to the Atomic Energy Act Cap. 154, Atomic Energy Regulations, 2008, and Atomic Energy (Security of Radioactive Materials) Regulations, 2021. Submit timely licensing and renewal applications to ensure uninterrupted operations.

ii. Employ, train and retain qualified staff, including Radiation Safety Officers, to oversee radiation source operations and ensure adherence to safety protocols.

iii. Design and maintain facilities to meet shielding and operational safety requirements.

iv. Conduct regular inspections to ensure equipment performs safely and effectively.

v. Provide and enforce the proper use of appropriate Personal Protective Equipment (PPE), such as lead aprons and gloves, ensuring equipment meets safety standards and is regularly maintained.

vi. Develop, train for, and routinely test response plans for radiation-related emergencies.

vii. Implement strong controls to prevent unauthorized access, loss, or theft of radiation sources, and report incidents promptly to the Atomic Energy Council (AEC).

viii. Participate in AEC inspections and audits, and address recommendations or required corrective actions without delay.

Recommendations for members of the public

i. Seek medical diagnostic and therapeutic services using radiation sources from licensed facilities, as these are largely compliant with safety standards. ii. Immediately report any unauthorized use or handling of radiation sources to the AEC or local authorities to prevent potential harm or misuse.. iii. Adhere to safety precautions in facilities using radiation and avoid tampering with equipment or warning signs. iv. In case of a radiation incident, follow instructions from authorities, stay away from affected areas, and avoid handling unknown materials. v. Employers using radiation in their operations must hire qualified personnel. vi. Get to know about radiation benefits, risks, and safety measures within your community to promote awareness and informed decisions.

The Atomic Energy Council’s Commitment to Radiation Safety

Atomic Energy Council is dedicated to ensuring the safe and beneficial use of radiation in Uganda’s healthcare sector by authorising facilities with radiation sources who meet the set requirements for the protection of people and the environment from harmful effects of radiation.

 

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