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35 AERB Annual Report - 2016 SAFETY SURVEILLANCE OF RADIATION FACILITIES 2 Chapter 2.1 INTRODUCTION Radiation sources are being used in multifarious and ingenious ways to achieve overall societal health and prosperity. The radiation source implies radioisotopes (such as 192 Ir, 60 Co, 137 Cs, 170 Tm, 75 Se etc.) and radiation generating equipment like X-rays and Accelerators. The radiation sources have a wide range of applications in the industries, medicine, agriculture and research institutions and the Atomic Energy Regulatory Board (AERB) regulates these facilities/institutions. These sources have the radiation hazard potential ranging from high to very low. Proper design, handling and disposal methodologies are required for ensuring safe and intended use of radiation sources. Regulation of these sources is in accordance with the radiation hazard potential involved and the extent of use in the public domain. A glimpse on the various applications of these sources and their licensing status is as given below. INDUSTRIAL APPLICATIONS OF RADIATION SOURCES Description No. of Facilities / Equipment Licensed as on December 31, 2016 RPF Radiation Processing Facilities (RPF) including Gamma Irradiators and Electron Beam Accelerators are used mainly for radiation processing of food, sterilisation of healthcare products and crosslinking of polymers in cable industries. Radiation processing of food items includes inhibiting sprouting, delay in ripening, microbial decontamination, insect disinfestation, shelf life extension etc. The activity range is about few PBq (10 15 ). They are of high radiation hazard potential. 19 (Gamma Irradiators)+ 6 (Accelerator) facilities IRED Industrial Radiography using Industrial Radiography Exposure Device (IRED), is one of the important non-destructive (NDT) methods used for study of weld joints, castings etc. Radioisotopes like 192 Ir, 60 Co, 170 Tm, 75 Se and different energies of X-rays are used in the field of industrial radiography. The activity range is from few TBq to few tens of TBq. The X-ray energy range is from few hundreds of keV to few MeV. They are of high to moderate radiation hazard potential. 519 facilities with 2507 equipment

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35PBAERB Annual Report - 2016

SAFETY SURVEILLANCE OF RADIATION FACILITIES2

Chap

ter

2.1 INTRODUCTION

Radiation sources are being used in multifarious and ingenious ways to achieve overall societal health and prosperity. The radiation source implies radioisotopes (such as 192Ir, 60Co, 137Cs, 170Tm, 75Se etc.) and radiation generating equipment like X-rays and Accelerators. The radiation sources have a wide range of applications in the industries, medicine, agriculture and research institutions and the Atomic Energy Regulatory Board (AERB)

regulates these facilities/institutions. These sources have the radiation hazard potential ranging from high to very low. Proper design, handling and disposal methodologies are required for ensuring safe and intended use of radiation sources. Regulation of these sources is in accordance with the radiation hazard potential involved and the extent of use in the public domain.

A glimpse on the various applications of these sources and their licensing status is as given below.

INDUSTRIAL APPLICATIONS OF RADIATION SOURCESDescription No. of Facilities

/ Equipment Licensed as on December 31, 2016

RPF Radiation Processing Facilities (RPF) including Gamma Irradiators and Electron Beam Accelerators are used mainly for radiation processing of food, sterilisation of healthcare products and crosslinking of polymers in cable industries. Radiation processing of food items includes inhibiting sprouting, delay in ripening, microbial decontamination, insect disinfestation, shelf life extension etc. The activity range is about few PBq (1015). They are of high radiation hazard potential.

19 (Gamma Irradiators)+

6 (Accelerator) facilities

IRED Industrial Radiography using Industrial Radiography Exposure Device (IRED), is one of the important non-destructive (NDT) methods used for study of weld joints, castings etc. Radioisotopes like 192Ir, 60Co, 170Tm, 75Se and differentenergiesofX-raysareusedinthefieldofindustrial radiography. The activity range is from few TBq to few tens of TBq. The X-ray energy range is from few hundreds of keV to few MeV. They are of high to moderate radiation hazard potential.

519 facilities with 2507 equipment

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3736AERB Annual Report - 2016

GIC Gamma Irradiation Chambers (GIC) are basically used for research and development and also in blood banks for irradiation of blood and its components. Usually 60Co and 137Cs radioisotope are used in this application. The activity range from few tens of TBq to few hundreds of TBq. They are of high to moderate radiation hazard potential.

Irradaitor based on X-ray generator are also used in blood banks.

100 facilities with 122 devices

Nucleonic Gauges Nucleonic Gauges also know as Ionizing Radiation Gauging Devices (IRGD) are used for online monitoring of quality control parameters such as thickness, level, density, coating thickness, elemental analysis etc. Sources used for nucleonic gauges consist of gamma sources such as 60Co, 137Cs, 241Am etc., beta sources such as 85Kr, 90Sr, 147Pm, 204Tl, etc., and neutron sources such as 241Am-Be. The activity range is from MBq to GBq. They are of low radiation hazard potential.

1920 facilities

Well Logging Radioactive sources are used in well logging application for exploration of oil, coal, geophysical logging etc. The sources used are mainly 137Cs, 241Am-Be, some calibration sources such as 60Co, 226Ra, 232Th etc. and neutron generators e.g. Deuterium-Tritium (DT) generators. The activity range is from kBq to GBq. They are of moderate to low radiation hazard potential.

48 facilities

1520 sources

MEDICAL APPLICATIONS OF RADIATION SOURCESTeletherapy In teletherapy (branch of Radiotherapy), radiation

is used to treat malignancy. The radioisotopes like 60Co and radiation generators such as Linear Accelerators are used. They are of high radiation hazard potential.

416 facilities with 608 teletherapy units

Brachytherapy In brachytherapy (branch of radiotherapy in which the source is kept very near to the lesion) the isotopes used are 192Ir, 137Cs, 90Sr, 106Ru, 125I with activity range from MBq to GBq. They are of moderate radiation hazard potential.

260 Remote After loading and

60 Manual After loading equipment

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3736AERB Annual Report - 2016

Cath Lab X-rays are used in medicine as an important diagnostic tool. Diagnostic Radiology using X-rays are:

•¾Interventional Radiology equipment (Cath-Lab and C-Arm):

These equipment are used in operation theatres for various interventional procedures and pose moderate radiation hazard to patients and medical professionals involved in operation of the equipment. The C-Arm equipment is of low to moderate hazard potential.

•¾Computed Tomography (CT):

These equipment are of moderate radiation hazard potential to both worker and patient.

•¾General purpose radiography and fluoroscopy equipment and dental equipment:

These constitute around 70-80% of all X-ray equipment that are used, and are of low to very low radiation hazard potential, to both worker and patients.

•¾Mammography, Bone Mineral Densitometer:

These equipment are of very low radiation hazard potential.

•¾1029 Cath lab equipment

•¾2465 CT equipment

•¾30,620 other medical X-ray equipment

Computed Tomography

Radiography and Fluroscopy

Nuclear Medicine Facilities In Nuclear Medicine, radio-pharmaceuticals, such as 99mTc, 131I, 201Tl and 18F are used for diagnosis and treatment. 18F Radiopharmaceuticals are routinely used in PET-CT facilities, while 131I is used for diagnosis and treatment of thyroid cancers. The facilities using pharmaceuticals are of moderate-low radiation hazard.

240 facilities. (PET-CT, SPECT and Gamma Camera)

Medical Cyclotron Radio-isotopes that are used in Nuclear Medicine are generally produced in Medical Cyclotron facilities. Cyclotrons are utilized for the production of 18F labelled radiopharmaceuticals. The medical cyclotron facilities are of moderate-high radiation hazard potential.

15 facilities

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3938AERB Annual Report - 2016

Consumer Goods Manufacturing

Facilities

Consumer products such as smoke detectors, thorium gas mantles and starters, gaseous tritium luminescence devices use exempt quantity of radioactive sources. They are of very low hazard potential. However, regulatory control exists on the manufacturing facilities of these devices.

15 facilities

Facilities using sealed sources

Though, sealed radioactive sources are used in various industrial and medical applications, but under this heading, sealed source means those used in education, research and calibration purposes. The activity range is from kBq to GBq. They are of low to moderate radiation hazard potential.

257 facilities

Facilities using unsealed sources

Unsealed sources are used in various research and academic institutions, such as agriculture, veterinary science etc. They are of low radiation hazard potential.

213 facilities

2.2 SAFETY REVIEW MECHANISM OF RADIATION FACILITIES

2.2.1 Issuance of Consents

Consenting process involves the issuance of consent, in the form License, Authorisation or Registration (in the order of decreasing hazard potential), to operate the equipment/ facility. Type Approvals are issued to manufacturer/ supplier for equipment conforming to the regulatory standards. Approvals are also issued as an interim consent towards the respective Licenses. No Objection Certificates (NOC) are issued to the stakeholdersto import either equipment or radioactive source, after which the stakeholders need to obtain either

a Type Approval or the respective consent for use. AERB has a system of multi-tier review process (i.e. review by AERB and its Safety committees) for various consents depending on the hazard potential involved. The process of issuance of various consents is as per AERB Safety Guide on ‘Consenting Process for Radiation Facilities’ (AERB/RF/SG/G-3).

The transportation of radioactive material (including that of nuclear material from nuclear facilities) is governed by regulations specifiedby AERB in Safety Code for the ‘Safe Transport of Radioactive Materials’ and is in line with the international requirements specified by IAEA forsafe transport of radioactive material.

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3938AERB Annual Report - 2016

The number of licenses and other consents issued during the period (i.e. April to December 2016) are as follows:

Consent Practice Equipment/ Facility/Activity Number Issued

License/Renewal

Radiotherapy Linear Acceleratorand Tele-cobalt

446

Nuclear Medicine Medical Cyclotron Facility 6PET-CT and SPECT-CT 23

Diagnostic X-ray Interventional Radiology 301Computed Tomography 765Manufacturing facilities of diagnostic X-ray equipment

8

Radiation Processing Facilities (RPF) 2Industrial Radiography 139Research Accelerators -

Authorisation Radiotherapy HDR Brachytherapy 187Gamma Irradiation Chamber (GIC) 22Well logging 8Nuclear Medicine Facilities 112Diagnostic X-ray Facilities Suppliers 15

Service Agencies 20

Registration Diagnostic X-ray 9139Self-shielded X-ray unit and PCB analyser 21Ionising Radiation Gauging Devices (IRGD) (Nucleonic Gauges) 23Facilities using radio-isotopes for research

Unsealed sources 33Sealed sources 14

Consumer products manufacturing facilities 17

Type Approval/ Renewal

Radiotherapy 11Interventional Radiology 1Computed Tomography -Diagnostic Radiology 17Industrial Gamma Radiography Exposure Device (IGRED) 7

Gamma Irradiation Chamber 8Ionising Radiation Gauging Devices (Nucleonic Gauges) 63X-ray baggage Inspection System 15

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4140AERB Annual Report - 2016

NOC’s Issued for Import of Equipment

Medical Linear Accelerator 43

Tele-cobalt 6

PET-CT/SPECT-CT 17

RAL Brachytherapy Unit 25

Diagnostic Radiology 68

Computed Tomography 4

Interventional Radiology 1

Industrial Electron Beam Accelerator (RPF) 1

Industrial Radiography Exposure Devices (IRED) 314

Nucleonic Gauges (IRGD) 223

Permission for Procurement of Radioactive Sources

Practice Indigenous Imported

Industrial Radiography (sources)

750 176

Well logging (sources) - 119

Nucleonic Gauges 187

GIC 6 -

Thorium Nitrate - 10

Consumer Products 6 201

Tele-cobalt source 11 4

HDR Brachytherapy sources - 264

Brachytherapy sources 13 2

Nuclear Medicine 741

Radioisotopes used in Research Facilities 123

Disposal of Radioactive Sources (permission for transportation of radioactive material for safe disposal)

Exported to the original supplier 614

Disposal in authorised waste management facility within the country

638

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4140AERB Annual Report - 2016

Intermediate Approvals leading to issuance of Licence:

Consent Equipment / Facility Number Issued

Other Approvals

Site approval Medical Cyclotron 2

Gamma Radiation Processing Facility 4

Industrial Accelerator Radiation Processing Facility

1

Layout plan

Radiotherapy 224

Nuclear Medicine Centres 50

Medical Cyclotron -

Research Centres 50

Research Accelerator -

Sources Storage Pit (well logging) 5

Source Storage Facility (Industrial Radiography)

201

Industrial Radiography Enclosure 93

Calibration Facilities 2

Gamma Irradiation Chamber 4

Design and construction

Nuclear Medicine 13

Research Accelerator 3

Radiation Processing Facility 4

Commissioning

Medical Linear Accelerator (Radiotherapy) 33

Tele-cobalt 5

RAL Brachytherapy Facilities (HDR) 22

Medical Cyclotron 2

Radiation Processing Facility 1

Industrial Radiography Enclosure 85

Well Logging Source Storage Facility 41

Decommissioning

Tele-cobalt units 14

Remote after loading (RAL) brachytherapy unit 10

Medical Linear Accelerator 9

MAL Brachytherapy 6

Industrial Radiography 1

Gamma Irradiation Chamber (GIC) 6

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4342AERB Annual Report - 2016

Consent Equipment / Facility Number Issued

Other Approvals

Source Movement Well logging 553

IGRED 1039

IRGD 13

Source replacement / replenishment

Gamma Radiation Processing Facility 9

2.2.2 Safety Committees for Radiation Facilities

The safety committees review the radiation safety aspects of medical, industrial and research institutions which use radioactive sources/radiation generating equipment.

The committees also recommend issuance of license for operation or issuance of Type Approval, based on their review. The committees consist of experts inthefieldfromtheindustry,medicineandacademicinstitutions apart from the experts from Bhabha Atomic Research Centre (BARC), BRIT and AERB.

Name of Committee Abbreviations Number of meetings

Safety Review Committee for Applications of Radiation SARCAR 3

Safety Review Committee of Medical and Research Accelerators SRCMRA 2

Safety Review Committee for Radiation Processing Plants SRC-RPP 1

Committee on Safe Transport of Radioactive Material COSTRAM 2

Committee on Safe Management of Disused Sources originating from Radiation Facilities

COSMDS 2

Committee to Review Security Aspects of Radiation Facilities and Transport of Radioactive Material

CRSA-RF&T 1

Committee for Recognition of Calibration Laboratories for Radiation Monitoring Instruments

CRCL 2

Committee to Review functioning and accreditation of Environmental Survey Laboratories (ESL) at NPPs and other Radio Analytical Laboratories (RAL)

CORFAL 1

Committee for Accreditation of Personnel Monitoring Laboratories CAPML 2

Excessive Exposure Investigation Committee EEIC 9

2.2.3ApprovalofRadiologicalSafetyOfficers While the built-in safety of the equipment and institution’s operational preparedness towards safety are ensured by adhering to requirements specified by AERB, the implementation ofradiation safety is carried out by the AERB

approvedRadiologicalSafetyOfficers(RSO).TheRSO are thus not only acting as extended arms of the regulatory body at every radiation facility, but are also the pivotal interface between the radiation facility and the regulatory body.

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4342AERB Annual Report - 2016

The number of RSO’s approved for different practices during this period are as follows:

Type of Practice Number Type of Practice Number

Industrial Radiography 192 Radiotherapy Facilities 124

Calibration Facilities 8 Nuclear Medicine Facilities 71

Radiation Processing Facilities 16 Research Centres 61Well Logging Operations 8 CT and Cath-lab Centres 990Ionising Radiation Gauging Devices 210 Gamma Irradiation Chambers 33

2.3 REGULATORY INSPECTIONS One of the important means to ensure effective regulatory control in the use of radiation sources is through a structured regulatory inspection programme. AERB carries out inspections as laid down in its safety manual on “Regulatory Inspection and Enforcement in Radiation Facilities” (AERB/RF/SM/G-3).

Apart from the headquarters, its regional regulatory centres (RRC) i.e. the Eastern Regional Regulatory Centre (ERRC), Northern Regional

Regulatory Centre (NRRC) and the Southern Regional Regulatory Centre (SRRC) are mandated to carry out extensive regulatory inspections, covering the region. In addition, Directorate of Radiation Safety (DRS)/ Radiation Safety Agency (RSA) at Kerala, Mizoram, Chhattisgarh, Tripura, Punjab and Arunachal Pradesh are authorised to carry out regulatory inspections for ensuring radiation safety of diagnostic radiology equipment installed in the respective states. The following are the inspections carried out by AERB including the RRC, DRS and RSA.

Radiation Facility Type of InspectionNo. of

Facilities/ Institutes Inspected

No. of Equipment Inspected

Radiotherapy Periodic 41 147

Medical Cyclotron Includes Site, Pre-commissioning and Periodic

06 06

Nuclear Medicine Includes Site, Pre-commissioning and Periodic

38 ---

Radiation Processing Facilities

Includes Site, Pre-commissioning, Periodic and Special

01 01

Gamma Irradaition Chamber

Periodic 05 06

Industrial Radiography Periodic and Special 80 130

Well Logging Periodic 07 50

IRGD On sample basis 28 111

Research On sample basis 01 01

Manufacturer of Gas Mantles

Periodic 10 10

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4544AERB Annual Report - 2016

Radiation Facility Type of InspectionNo. of

Facilities/ Institutes Inspected

No. of Equipment Inspected

Diagnostic Radiology On sample basis

By AERB 85 646

Directorate of Radiation Safety, Kerala

62 131

Radiation Safety Agency, Mizoram 54 73

Directorate of Radiation Safety, Arunachal Pradesh

15 18

Total 433 1330

Regulatory Inspection of Industrial Radiography Site

Regulatory Inspection of Nucleonic Gauge Installations

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4544AERB Annual Report - 2016

2.4 UNUSUAL OCCURRENCES AND ENFORCEMENT ACTIONS

(i) Radiation Injury to an Untrained Employee carrying out Industrial Radiography

Radiation injury on the right hand of untrained and unmonitored personnel, who had been engaged for radiography work by a radiography agency at Ahmedabad was reported to AERB on December 22, 2016. Based on the information received, a surprise regulatory inspection was carried out by AERB on December 26, 2016 at the incident site. During the investigation, it was noted that the incident occurred in April 2016. The source pigtail with radioactive source (30Ci of 192Ir) got decoupled from the driving cable and remained in the guide tube during operation of Industrial Gamma Radiation Exposure Device (IGRED). The said person continued the radiography job without knowing that the source was in exposed condition, since he was not provided with a radiation survey meter. Later he found that pigtail was in the guide tube. Without knowing the repercussion, he lifted the source by hand and put the source back into the IGRED. After 8-10 days, radiation injury was observedinhisrighthand’sfingers.

At present he is under treatment, which is being facilitated by the employer of the radiography institution. The person was neither a trainee nor had undergone any radiation safety program and was not provided personal monitoring device (TLD badge) and radiation survey meter for handling radiography device.

Enforcement Actions by AERB:

AERB issued show-cause notice on December 30, 2016 to the institute owing to violation of safe radiography work practice and their failure in reporting the incident to AERB within a stipulated time, with a directive to stop radiography work at the site, where the incident took place till further orders. The institute responded to the show-cause notice on January 31, 2017 and the same was discussed in an AERB Apex Committee. The decision on the enforcement action is pending.

(ii) Radiation injury to Patient undergoing Interventional Radiology Procedure

An incident of excessive exposure to a patient undergoing Interventional Radiology (IR) procedure leading to severe skin injuries was reported to AERB on August 23, 2016. The patient had undergone an interventional radiology procedure on November 14, 2015 at one of the centre in Coimbatore. Subsequently, the patient had developed discoloration of skin and intense pain within two weeks of IR procedures. Peeling of skin occurred within a month of IR procedure on both gluteal region and middle third region of right forearm of the patient.

Based on reported incident, regulatory inspectionwas carried out byAERB officials onAugust 30-31, 2016 for investigating the incident. It was noted that lack of training about the proper use of safety features of the Cath-lab unit for optimisation of radiation dose(s) of patients was one of the reasons for the occurrence.

AERB had directed the institution to arrange Chromosomal Aberration Analysis (CAA) of the patient and concerned interventional radiologist(s) as well as other associated staff (four persons) involved in IR procedures of patients during October-December 2015 for estimation of their absorbed radiation doses. CAA result of interventional radiologist(s) and associated staff was reported negative (no radiation dose assigned), while dose estimated of the patient was 165 mGy, as reported by an accredited bio-dosimetry laboratory at Chennai.

The institution has initiated following measures to prevent recurrence of such incidents:

• Mechanism for monitoring radiation doses during procedures such as display and recording of doses with pre-set alarm levels were implemented in the IR unit.

• Consent form is modified incorporating theinformation on the possibility of radiation induced skin reactions to the patients undergoing such procedures.

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4746AERB Annual Report - 2016

♦ AERB initiative toward Safety Awareness in Interventional Radiology (IR) Practice

AERB has taken a serious note on this incident and opined that there is a pressing need to enhance and strengthen radiation safety awareness among medical professionals and other staff associated with those engaged in IR practices. In view of the above, AERB would be carrying out some major remedial measures for enhancing radiation safety awareness among medical professionals. Few of them are listed below;• Dissemination of the information and lessons

to be learnt from this incident to all diagnostic X-ray facilities of the country operating IR equipment.

• Making available an e-learning module on Radiation Safety for Diagnostic Radiology Practice on AERB website/e-Licensing for Radiation Applications (e-LORA) portal.

• Instructions to suppliers of IR equipment to enable display of dose related information with appropriate warnings at higher doses, as per the requirement in revised Safety Code on Diagnostic Radiology [AERB/RF-MED/SC-3 (Rev.2)]

• Instructions to facilities for recording and maintaining patient doses in IR procedures within the institution(s).

• Approaching concerned Authorities/Ministries for inclusion of radiation safety related syllabi in the course curriculum of Graduate and PG Degree/Diploma of the medical professionals dealing with radiation sources/generators.

• Targeted radiation safety awareness campaign among medical professionals dealing with IR equipment.

• Communicating to all diagnostic X-ray facilities operating IR equipment for updating the details of medical professionals with their qualificationsthroughe-LORA.

(iii) Source Stuck Incident in Radiotherapy Institution

Tele-cobalt (Theratron 780E unit) radioactive

source got struck in the machine during patient treatment in the transit position of the source. Rotary Union and Hose pipe assembly of the unit was repaired by the service engineer. While source not retracting to shielded position, does not normally occur, the institutions are well-prepared to handle such accidental situations.

(iv) Theft of FDG Consignment

OnJune14,2016,avehiclecarryingfluoro-deoxy-glucose (FDG) consignment from one of the institution in Bangalore was stolen on its way to a hospital in Kerala. However, soon after the FDG consignment was retrieved safely with no damage. The incident reported to Incident andTraffickingDatabase (ITDB), IAEA.

Initiative taken by AERB

1) Actions taken to Secure Disused Sources in the Country

Any radioactive source or equipment containing radioactive source which is lying in an unused condition for more than one year without any reasonable possibility of using it in the near future is considered a “disused source”. This situation sometimes arises in certain hospitals, industries and research centres due to bankruptcy, non-availability of requisite manpower leading to non-utilisation of the equipment etc.

Such sources, especially if they are of high activity, become a safety concern owing to their possible neglect and likelihood of disposal of source in an unauthorised manner. Keeping in view of public safety, these institutions are identifiedby AERB and are immediately directed to initiate process for decommissioning of equipment housing the source and its safe disposal by obtaining requisite consents for:

a) Decommissioning of the equipment

b) Transport of the source for safe disposal.

With persistent efforts of AERB, the number of institutions possessing disused sources has come down.

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4746AERB Annual Report - 2016

AERB continues to reinforce its regulatory inspections at institutions possessing disused sources, to ensure the safety of source while at the same time ensuring that the security arrangements at the institutions remain appropriate.

2) Enforcement Actions against Errant Medical Diagnostic X-Ray Facilities

As a part of the nation-wide campaign to ensure increased compliance and regulatory coverage of Medical diagnostic X-ray equipment, AERB carried out surprise inspection of these facilities in major cities/towns in the country viz. Nashik, Amravati, Panvel, Lucknow, Jammu, Bhopal, Indore, and Ujjain. About 14 such inspections of medical diagnostic facilities where 36 X-ray equipment were sealed and warning for

seal was issued to 22 X-ray equipment in view of theirnon-compliancewiththespecifiedregulatoryand radiation safety requirements.

Before start of the campaign, AERB had given notices in various leading national dailies, directing utilities who have not yet obtained License/Registration to come forward and first declaretheir X-ray equipment in the e-governance portal (e-LORA) of AERB and within 6 months obtain the requisite License/Registration. The surprise inspections carried out at various cities/towns in the country, revealed that certain diagnostic X-ray facilities have still not complied with the regulatory requirements of AERB and accordingly requisite enforcement actions were taken against such facilities. The above actions taken by AERB received wide media attention.

LucknowJammuBhopalIndoreUjjain

NashikAmravati

PanvelSealed

Sealed

Sealed

Newspaper clips on AERB’s Enforcement Actions against Medical Diagnostic X-ray Facilities/Equipment

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4948AERB Annual Report - 2016

Though the X-ray equipment are of low radiation hazard potential, it is important that they are installed and operated in accordance with the radiological safety requirements specifiedby AERB. AERB issues the requisite License/Registration after ensuring that they conform to the specifiedsafetyrequirements.

3) Initiatives on Patient Dose Monitoring

The monitoring of radiation doses of patient undergoing medical diagnosis or treatment procedures is required for alerting the medical practitioner(s) on medical dose history of the patients. This will facilitate taking an informed judgment on the medical exposure or repeated radiological procedures. Analysis of patient doses would also be helpful for establishing national level ‘Referral Criteria’ on the appropriate use of radiological examinations.

A Technical Discussion for evolving the mechanism of monitoring patient doses in Computed Tomography (CT) and Interventional Radiology (IR) procedures in the country was held. Representatives of all the manufacturers/suppliers of computed tomography & interventional radiology equipment and faculty members of diagnostic radiology and nuclear medicine department of Tata Memorial Hospital (TMH), Mumbai and Dept. of Radiology, BARC Hospital, Mumbai attended the discussions. The objective of the meet was to develop an Action Plan for linking of patient doses in CT and IR procedures with their AadhaarNumber(s)issuedbyUniqueIdentificationAuthority of India (UIDAI) to track their radiation doses in the country.

After discussion held with suppliers, one of the supplier (M/s. General Electric) deployed their dose monitoring software (Dose Watch) at TMH, Mumbai. During demonstration, it was noted that dose monitoring software is capable of recording effective doses received by the patient during diagnostic radiology procedures.

4) Initiatives for Increased Regulatory Control in X-ray Facilities

Owing to e-LORA, AERB has now a database of nearly all radiation facilities in the country.

Thus, AERB has spread information on increased regulatory control and radiation safety by way of diverse action points.

a) Letters were sent to 36 State Government(s) (Department of Health & Family Welfare) regarding compliance of medical diagnostic X-ray facilities with regulatory requirements.

b) Advertisement published in leading newspaper on ‘Licensing requirement for Diagnostic X-ray Equipment’. Similar advertisement was published in monthly magazine ALARA published by ISRT (Indian Society of Radiographers and Technologists).

c) Periodic emails were sent to utility for obtaining License for their X-ray equipment declared in eLORA.

d) Authorised suppliers were informed about the AERB requirements for procurement of X-ray equipment by end user. Show-cause notices were issued to suppliers for non- compliance of AERB requirements.

e) Created awareness on proper usages of TLD badges among radiation workers of diagnostic radiology facilities to avoid the excessive exposure case.

f) Recognition issued to training courses in Diagnostic Radiology [B.Sc. & M.Sc. Medical Imaging Technology (MIT)] incorporating AERB prescribed syllabi on radiation safety.

g) Circulated the radiation protection guidelines for fluoroscopy procedures in diagnosticradiology practice to radiation professionals/workers.

5) Advisory to Dental X-ray Facilities An advisory circular was issued for compliance of Dental X-ray facilities with regulatory requirements stipulated in the Atomic Energy (Radiation Protection) Rules, 2004 to 85 members including President, Dental Council of India (DCI); Executive Committe Members and Council Members of DCI, and Secretary, Indian Dental Association (IDA)

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4948AERB Annual Report - 2016

LeafletsonRadiationSafetyinFluoroscopyCirculatedtoRadiationprofessionals/workersinDiagnosticRadiology

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PB50AERB Annual Report - 2016