All you need to know about AERB license and approvals

Wondering how to get an AERB license or operating license for your X-Ray machine? How to register in e-LORA? How to get a QA done for your machine? What if I dont get all these done? Who can help me with all AERB related approvals and licenses? Read on…

What is AERB?

AERB (Atomic Energy Regulatory Board) is a Government agency, constituted in 1983 to carry out the regulatory and safety functions identified under the Atomic Energy Act (33) 1962. The Atomic Energy Act envisages utilization of Atomic energy and Radiation technologies for the benefit of society, ensuring their safe deployment in line with well-established requirements and international benchmarks. AERB’s mission is to ensure that the use of ionizing radiation and nuclear energy in India does not cause undue risk to the health of people and the environment.

Why are X-Ray based medical equipment regulated by AERB?

Is radiation exposure from X-Ray equipment really a matter of concern?

Human body can cope with some minimal levels of radiation exposure without harm. We are all exposed to natural radiation of about 3mSv per year which is not harmful. Hence X-ray equipment is used because they serve a more useful purpose of diagnosing treatable diseases with minimal radiation. X-Radiation at controlled levels is useful for diagnosis of diseases. However, careless exposure to and excessive cumulative radiation over short periods of time can be very harmful to health. This is why AERB regulates use of radiology equipment.

What happens if a diagnostic radiology facility is operated without requisite AERB license?

AERB has taken serious note of unauthorized manufacture, supply and usage of medical diagnostic x-ray equipment without possessing statutory License from AERB and issued a ‘WARNING’ that facilities of the said stakeholders found operating in such contravention hereafter shall be sealed without further notice. Many such facilities have been sealed in the recent past.

What is meant by Diagnostic Radiology?

Diagnostic Radiology is a group of various modalities of medical imaging using X-rays. Common diagnostic radiology equipment requiring AERB license are:

X Ray Machine (Fixed & Mobile)
X Ray Machine (Fluoroscopy)
Portable X Ray Machines
Digital Radiography (DR)
C Arm / O-Arm
Dental X Ray Machines
Dental Orthopantogram (OPG)
Cone Beam Computed Tomography (CBCT)
Mammography
Bone Mineral Density (BMD)
Computerised Tomography (CT) Scan
Cath Lab

Check AERB site for full details regarding particulars related to Diagnostic Radiology

How do I get AERB operating license for my X-Ray equipment?

Following are the various steps to getting an Operating license:

Register your facility (Hospital/ Nursing Home/ Diagnostic Centre/ Clinic etc.) in e-LORA (e-Licensing of Radiation Applications) – Documents including Government issued registration document of the facility, employer photo ID with date of birth and employment document will be required for this step.
Complete all Pre-requisites for AERB license application
1. Declare all employees – Technician, Radiologists, other medical professionals, Radiation Professionals and non-radiation workers, if any. Each employee will need an ID in the e-LORA independently and they need to be associated with the facility under consideration, along with employment proof. A TLD Badge for the employee is mandatory for adding any radiation worker/ Professional.
2. Obtain RSO approval – Radiation Safety Officer (RSO) is mandatory for CT and Interventional Radiology.
3. Add Instruments- in case of X-Ray, it would be Safety tools like Lead Apron.
4. Prepare room layout as per AERB approved model layout plan.
Apply for Operating license
1. Apply for procurement license – If making a new purchase (whether new or pre-owned equipment)
2. Submit Installation report
  1. If new equipment – Supplier to submit installation report online
  2. If pre-owned – User should obtain installation report from service provider and upload the same along with a QA report.
  3. If you are newly registering into e-LORA, while the equipment already exists with a valid hardcopy operating license, declare the X-Ray equipment online in e-LORA along with a latest QA.
3. Once Installation report is accepted, apply for Operating license.

If you need help with going through the above processes – Call PrimedeQ on (+91)8971223957 or 7019759765.

For more details see e-LORA diagnostic radiology guidelines document.

What is e-LORA?

AERB has developed an electronic (web-based application) licensing system for radiation applications called e-LORA (e-Licensing of Radiation Applications) for helping users to file applications and associated documents online. There are guidelines available in this system for all types of facilities and activities involving radiation applications and corresponding requirements. Diagnostic Applications of Radiation (e.g., X-Ray machines, Computed Tomography machine, Cath Lab equipment, C-Arm, Mammography machines, general purpose Industrial radiography machines etc.) and therapeutic applications of radiation such as radiotherapy, nuclear medicine and RIA are all covered in this online system. Consenting process is explained in greater detail in e-LORA web portal. All the Manufacturers/Suppliers/Service Agencies/ X-ray institutions and all other stakeholders including Radiologist, Radiographer/ technicians etc. are required to obtain all the requisite consents from AERB through e-LORA. Detailed guidelines for all the stakeholders are available on homepage of e-LORA.

Why am I being asked to do a QA for my X-Ray equipment?

QA essentially involves testing of all the “exposure parameters” (e.g. kVp, mA and exposure time) to ensure accuracy of measurements as well as to check functional performance of X-ray equipment. As per AERB, Quality Assurance (QA) of medical diagnostic x-ray equipment means “systematic actions necessary to provide adequate confidence to the end-user(s) that, the medical diagnostic x-ray equipment will perform satisfactorily in compliance with safety standards specified by AERB”. Click here to read more about what is done in a QA test.

The main Objective of Quality Assurance for an X-Ray machine is to ensure that, with minimum possible radiation dose to the patient(s), optimum image quality of radiological procedures is achieved. Good quality of image is essential for an accurate diagnosis, but not at the cost of overdosing the patient with x-radiation. If the equipment has not undergone QA periodically, it may be performing sub-optimally, even if it is the best equipment and it was working well at the time of installation. To ensure that good quality image is obtained, the technician may end–up over-exposing the patient, either due to wrong settings or repeat exposure.

Quality Assurance (QA) is required for all X-Ray equipment every 2 years.

Who is responsible for getting AERB approvals and licenses?

As per AERB, the ‘prime responsibility’ for safety of patients, care-givers, staff and public within a medical facility, clearly and absolutely rests with the facility owner. Hence, the facility owner, at a minimum, shall have the responsibility to ensure all AERB registration, approval or licenses are in place and ensure adherence with the safety principles, requirements specified by AERB by everyone within their facility.

How long is AERB operating license valid?

Presently license is issued for 5-years therefore it needs to be renewed after that.

Do I need to inform AERB if I am selling my X-Ray equipment?

Yes, AERB needs to be intimated about de-commissioning of the X-Ray equipment through appropriate form submission.

NABH accreditation and AERB license

National Board for Accreditation of Hospitals (NABH) aims to ensure good quality of healthcare delivery, processes and patient safety within hospitals. An NABH accredited hospital / diagnostic facility ensures AERB licenses are in place for the sake of patient safety with regards to radiation exposure. This means that in an NABH accredited facility,

The medical equipment is ‘Type approved’ – which means the radiation exposure from the equipment is of acceptable safe level.
The room layout in which the equipment is installed is appropriate and safe and the room has adequate shielding.
The equipment has undergone periodic Quality Assurance (QA) to ensure it is well maintained / calibrated for continued radiation safety and not only at the time of installation.
Proper Standard Operating Procedures are in place, the staff is trained to follow these processes, including availability of lead apron/shields/TLD badges for their own personal safety.
Proper safety precautions are in place and caution signs are displayed so that even by accident public is not exposed to unnecessary radiation.

All in all, in an NABH accredited facility one is safe from unnecessary radiation exposure.

If you need any assistance on AERB approvals and licenses, contact PrimedeQ at 8971223957 / 7019759765 or write to us at [email protected]

Also read our Blog on – Myths & Facts about Radiation Safety and AERB approvals

Shanthi Mathur

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