‘’Operation of e-LORA would be a big milestone for regulation of medical X-ray practice’’

In order to minimise unwanted radiation exposure to patients as well as technicians, the Atomic Energy Regulatory Board (AERB) this February embarked on a project that involves bringing thousands of unregistered medical X-ray facilities under its control in the next three years. Raelene Kambli seeks to know more on the available government regulations for diagnostic radiology in India, AERB’s role in setting them and its way forward in an interview with Dr Avinash U Sonawane, Head, Radiological Safety Division, AERB

What are the available government regulations for diagnostic radiology in India? What is the role of AERB in setting them?

Dr Avinash U Sonawane

The present regulatory framework for controlling safe use of ionising radiation sources, including medical X-rays, is based on the following:

• Atomic Energy Act, 1962
• Atomic Energy (Radiation Protection) Rules {AE(RP)R}, 2004
• Notification No. GSR 388 on, ‘The Radiation Surveillance Procedures for Medical Applications of Radiation, 1989’
• The Safety Code for Medical Diagnostic X-ray Equipment and Installations {No AERB /SC/MED-2 (Rev.1), 2001}.

The national regulatory authority, i.e., AERB was set up in November 1983 to carry out certain regulatory and safety functions envisaged under Sections 16, 17 and 23 of the Atomic Energy Act 1962. Chairman, AERB has been notified as the competent authority for the enforcement of radiation protection provisions in the country.

The mission of AERB is to ensure that the use of ionising radiation in India does not cause undue risk to the worker, public and the environment. Thus, AERB has put in place an effective regulatory mechanism based on scientific assessment of the magnitude of the hazard potential of different practices involving ionising radiation.

With respect to diagnostic radiology in particular, it is a statutory requirement that a licence for CT and interventional radiology practices (because of higher hazard potential) as well as registration for general X-ray diagnostic practice (because of low hazard potential) should be obtained from AERB for operation of equipment.

Proper safety principles and practices should be followed in medical X-ray installations – now for this we need to know how many X-ray installations are there in India? Is there any data available on that?

We have a fair idea about the number of all of the X-ray installations in the country, i.e. about 41, 000 based on data provided by major manufacturers/suppliers of X-ray equipment. Also, AERB has initiated a many-pronged approach towards radiation safety in the practice and building a firm database which involves:

1. Decentralisation by formation of regional regulatory centres (RRCs) and under state control, Directorate of Radiation Safety (DRS)
2. Commissioning of an eGovernance system by AERB. The software system named electronic Licensing of Applications of Radiation (eLORA) would regulate all radiation sources, including medical X-ray facilities in the country.
3. Bringing the manufacturers and suppliers of X-ray equipment under AERB control
4. Enhanced regulatory inspections
5. Bringing all utilities under AERB purview by simplifying regulatory requirements

We know that more than 70 per cent of X-ray utilities are general purpose X-ray equipment and dental-related equipment which are of low radiation hazard potential in diagnostic radiology. As CT and interventional radiology equipment are of a higher hazard potential, most regulatory efforts are directed towards bringing them under effective regulatory purview. This ensures radiation safety in the practice to a large extent.

Is it mandatory to get AERB certification after installing an X-ray machine? Is there any punishment/penalty for non-compliance or unregistered X-ray units?

It is mandatory to get an AERB license to operate any type of X-ray unit in the country. Our observation is that most of the institutions with high footfalls, such as government hospitals and private NABH-accredited hospitals do satisfy AERB requirements with respect to radiation safety, though some hospitals may not have obtained formal licenses from us. This is more due to lack of awareness on their part, rather than wilful non-compliance.

The sections 24, 25 and 26 of the Atomic Energy Act, 1962 stipulates that whoever contravenes any provisions of rules made under the Act and any of the terms and conditions of license/registration issued under the rules, shall be punishable with imprisonment or with a fine or with both. The Rule 10 of AE (RP) R, 2004 empowers the Competent Authority to suspend, modify or revoke license/registration issued for handling of radiation sources.

Are the AERB norms updated regularly to suit the changing healthcare environment in the country?

AERB has recently issued an amendment to its code AERB/SC/Med-2, 2001(Rev-1), bringing various facets of the changing scenario in diagnostic radiology, such as introduction of new modalities, new technologies etc. AERB is also in an advanced stage of issuing the revised safety code on medical diagnostic practice.

How does AERB create awareness on radiation safety among healthcare providers and patients?

AERB has taken full cognizance of the vital role that awareness plays in radiation safety. Hence, it has in its regulations roped in its stakeholders, such as suppliers, who interact with the utility and are best poised to percolate the safety information. Media is the other important channel.

On its part, AERB has conducted several awareness programmes on safety aspects in diagnostic radiology in major hospitals and medical institution. AERB experts also participate in such programmes organised by medical institutions, associations of medical professions, manufacturers of X-ray equipment, FICCI etc.

Has the AERB undertaken any special project on radiation safety recently?

Yes. AERB has made many landmark steps with respect to radiation safety in diagnostic radiology.

1. The signing of MoU with many states to form the Directorate of Radiation Safety.
2. AERB has also had policy level talks with Directorate General of Foreign Trade (DGFT) to ensure that no non-design approved equipment enter the country.
3. The existing requirements of national safety code on medical X-ray diagnostic installations have been revised to bring simplification in their implementation and to facilitate the registration/licensing process of medical X-ray facilities without compromising safety of patients, workers and the public.
4. AERB periodically publishes announcements (recently in July 2012 and on April 19, 2013) in all the leading national and local news papers in the country highlighting the need of AERB license/registration of medical X-ray facilities and the mandatory regulatory requirements to be complied with from radiological safety viewpoint.
5. It has been observed that a number of pre-owned/refurbished X-ray equipment are being procured and installed and their market is growing rapidly in the country mainly due to low cost and easy availability. AERB has therefore framed guidelines to bring such X-ray equipment under regulatory surveillance for ensuring their safe use.
6. Several research projects on radiation safety as well as quality assurance and dosimetric studies, mainly for the safety of patients, occupational workers and the public are being carried out in the country by various medical institution, with the support of AERB and involvement of its experts.

What can be done to resolve issues related to safety?

There are certain areas where additional efforts are necessary to ensure satisfactory radiation safety for medical X-ray installations in the country. Someof them include the necessity of good co-operation with regulatory body from the X-ray equipment manufacturers/suppliers/quality assurance (QA) service providers; establishment of effective regulatory control over all the stakeholders (i.e.manufacturers/ suppliers of new/pre-owned/ refurbished X-ray equipment, utilities and QA service providers); issuance of licenses/registrations to existing and upcoming X-ray installations; generation and appointment of adequate number of relevant medical professionals and X-ray technologists; provisions of personnel monitoring services to the operating staff; ensuring adequate number of QA kits; expediting the establishment of DRS in all the states and the RRCs of AERB in different parts of the country; organisation of more awareness programmes on radiation safety and QA in the field of diagnostic radiology. A special regulatory model is being established by AERB to deal with the above issues. This model would ensure radiation safety at every stage of the use of medical X-ray equipment

What are AERB’s plans for the coming year?

Operation of e-LORA would be a big milestone for regulation of medical X-ray practice and other applications of radiation sources like nuclear medicine, radiotherapy, industrial radiography, radiation processing facilities etc. However, few major action plans of AERB which are under implementation are summarised below:

1. Steps are being taken to decentralise the process though formation of state-level Directorate of Radiation Safety (DRS). The Department of Health and Family Welfare, Government of Kerala, has already set up Directorate of Radiation Safety) in 1996. The process of formation of DRS is underway in Mizoram, Madhya Pradesh, Chhattisgarh, Punjab, Tamil Nadu, Goa and Karnataka. AERB is following up with other States to set up similar DRSs.
2. AERB has established RRCs in the country to further strengthen the regulatory control over radiation sources including medical X-ray installations. RRCs have already been established at Chennai and Kolkata. One is planned in the northern region. DRS and RRCs are expected to cover the medical X-ray facilities of respective regions for getting X-ray units registered and contribute in increasing regulatory inspections.
3. The regulatory inspections, i.e., radiation safety audits of the medical X-ray installations are the most important part of the compliance assurance programme (CAP) of AERB. AERB conducts, under the relevant provisions of regulations, the periodic inspections on sample basis, of medical X-ray facilities
4. The Radiological Safety Officer (RSO) is responsible for maintaining periodic QA records of medical X-ray equipment. AERB is in the process of accrediting independent QA service providers, besides manufacturers/suppliers of X-ray equipment, to ensure satisfactory performance and radiation safety of X-ray equipment.

raelene.kambli@expressindia.com