Occupational hazards in radiology



1.14: Occupational hazards in radiology


Pankaj Tandon, Krishan Kumar Jain, Chander Mohan, Rengarajan Rajagopal


1.14.1

RADIATION PROTECTION IN DIAGNOSTIC IMAGING


Dr. Krishan Kumar Jain



Radiation risks


Absorbed dose is defined as the amount of energy absorbed per unit mass and is measured in Gray (Gy), i.e., J/Kg. The energy deposition of 1 J/kg tissue is the equivalent of 1 Gy. There are different types of radiation and all types do not produce the same biological effect; therefore, the term equivalent dose is often used instead of the absorbed dose. The equivalent dose is the product of the absorbed dose and a radiation weighting factor (earlier termed as quality factor) and is expressed in Sieverts (Sv). Because the radiation weighting factor for X-rays and gamma rays is same, i.e., 1.0; thus, 1 Gy is equivalent to 1 Sv in medical imaging. Radiation doses in medical imaging are typically expressed in millisieverts (mSv).


In our routine life, we are getting exposed due to small doses of radiation from the natural sources all the time, i.e., from cosmic radiation, rock, building material and by food like banana we eat. Usually, the average estimated dose received per year due to natural background is of the order of 3 millisieverts (mSv) per year. Unless you are exposed to high doses of radiation during cancer treatment at young age, any increase in risk for you developing cancer due to medical radiation appears to be quite low as the effects of radiation damage typically take many years to appear.


There are many ways to diagnose ailments in the patient which may involve ionizing radiation used in diagnostic radiology by conventional X-ray, CT scan or by administering radiopharmaceuticals to patients in nuclear medicine. It is always preferable to use non-ionizing radiation like MRI and USG for the desired information required by the referring physician. There is always a risk of developing cancer, if the person is exposed to radiation more than the background level. Moreover, the risk to an individual exposed to ionizing radiation is not the same as it depends upon age, sex and many other parameters. As it is a well-known fact that in children the cells are dividing rapidly, they are more sensitive and also have longer life expectancy; thus, it becomes visible. It is seen that the risk is small in diagnostic imaging rather not treating the diseases. It is always better that there should be awareness amongst public that as and when they are referred for CT scan or any other examination in nuclear medicine, they need to discuss the benefit and risk with the referring physician.


The very purpose of using any diagnostic modality is to provide the relevant information to the referring physician so that future mode of treatment can be decided based on the information obtained after the study. It is a proven fact that the there are advantages of using X-ray for getting information as it is a noninvasive technique and has low risk and at the same time provides accurate information instantaneously. Since all the imaging modalities more or less provide the relevant information about the specific diseases, however, it is always preferred to use nonionizing modalities like MRI and USG, w.r.t the other modalities using ionizing radiation, if it can be.


During radiation exposure, due to the damage of the cell structure, either stochastic effect takes place or deterministic effect takes place. But the likelihood of stochastic effect increases with the increase of dose received. The evidence available on radiation-induced cancer risk is available from the data available from the atomic bomb survivors. It has been noted that the cancer risk is more prevalent for doses above 100 mSv, which is very unlikely in diagnostic radiology until multiple CT examinations take place as a single CT examination of abdomen is likely to deliver a dose of around 10 mSv. It is also observed that no epidemiological effect is noted at the dose levels below 10 mSv which are usually the doses received in general radiography or nuclear medicine imaging.


International Commission on Radiological Protection (ICRP) uses the concept of effective doses to assess the health risk. In order to reduce the radiation dose to the patient, either the alternative modality is to be used or the examination is carried out by imparting less dose to get the desired clinical information. It is always better that clinician explains the radiation risk and benefit of the radiological procedures to the patients who express concern about this issue. It is the mere responsibility of the medical practitioner to perform the scan, if no alternative modality is available to get the desired information.


Legislation and principles of radiation protection


Legal framework


Medical uses of ionizing radiation are amongst the longest established applications of ionizing radiation. According to UNSCEAR 2008, the estimated worldwide annual number of diagnostic and interventional radiological procedures (including dental) was 3.6 billion, the estimated number of nuclear medicine procedures was over 30 million and the estimated number of radiation therapy procedures was over 5 million. The number of such procedures has continued to increase since then.


Though, medical use of X-rays for diagnosis and treatment has proven to be immensely beneficial to the society at large, however, unsafe use of X-ray radiation has health risks associated with it, and hence, it is required that proper care is exercised throughout the useful life of the equipment, i.e., from manufacture, supply, installation, operation, maintenance, servicing and ultimately decommissioning.


The Atomic Energy (Radiation Protection) Rules, 2004 [AE (RP) R-2004], promulgated under the Atomic Energy Act, 1962, provides the legal framework for the safe handling of radiation generating equipment (in this context – X-ray equipment).


Atomic energy regulatory board


The Atomic Energy Regulatory Board (AERB) is constituted by the president of India under Section 27 of the Atomic Energy Act, 1962 (33 of 1962) to carry out certain regulatory and safety functions envisaged under Section 16, 17 and 23 of the Act. According to Rule 16 of Atomic Energy (Radiation Protection) Rules, 2004 (AE (RP) R-2004), the Competent Authority (i.e., Chairman, AERB) may issue safety codes and safety standards, from time to time, prescribing the requirements for radiation installation, sealed sources, radiation generating equipment and equipment containing radioactive sources and transport of radioactive material and the licensee shall ensure compliance with the same.


AERB has published Safety Code ‘Radiation Safety in Manufacture, Supply and Use of Medical Diagnostic X-ray Equipment’ (No. AERB/RF-MED/SC-3 (Rev. 2), 2016), issued under Rule 16 of AE (RP) R-2004, which specifies the licensing requirements for manufacturers, suppliers and users for entire lifecycle of diagnostic X-ray equipment from radiological safety view point.


Licensing activities


A wide range of medical devices are utilized in the society to harness their benefit to mankind. The hazard potential in these devices differs vastly; therefore, prerequisites for license also differ widely. Accordingly, the license is granted in various forms based on hazard associated with the facility/activity. The objective of licensing is to ensure that only such practices are permitted which are justified in terms of their societal and/or individual benefits; radiation protection is duly optimized in the radiation facilities, radiation doses to the personnel in these facilities and to the members of the public in their vicinity do not exceed dose limits prescribed by the Competent Authority and potential for accidental exposures from the facilities remains acceptably low. This involves approval of equipment for radiation applications after necessary design safety checks followed by approval of facility using approved equipment after compliance check of the layout and shielding adequacy etc.




  • Dose limits given for occupational worker are applicable for female workers also. However, once pregnancy is declared, the equivalent dose limit to embryo/fetus shall be 1 mSv for the remainder of the pregnancy.
  • Dose limit for apprentices and trainees between 16 and 18 years of age shall not exceed 6 mSv in a year.

Licensing of medical diagnostic X-ray equipment


Following types of licenses are issued by AERB for diagnostic X-ray equipment:




  1. A. License


    • For operation of Computed Tomography (CT) unit
    • For operation of Interventional Radiology (IR) X-ray unit
    • Facilities engaged in commercial production of diagnostic X-ray equipment

  2. B. Authorization


    • Facilities engaged in supply of diagnostic X-ray equipment

  3. C. Registration


    • For the operation of diagnostic X-ray equipment other than CT and IR equipment

  4. D. Approval


    • Type Approval of diagnostic X-ray equipment for the purposes of manufacture and supply

Licensing requirements for facilities engaged in commercial production of diagnostic X-ray equipment:




  • The facility (manufacturer) engaged in commercial production of diagnostic X-ray equipment and X-ray tubes is required to obtain license from the Competent Authority under Rule (3) of AE (RP) R-2004. The Competent Authority issues license from radiological safety stand point. The facility (manufacturer) is required to obtain all other approvals/clearances required under applicable laws from respective statutory authorities.
  • This facility is required to obtain type approval of every new model of diagnostic X-ray equipment from the Competent Authority for the purposes of manufacture and supply in the country under Rule (3) of AE (RP) R-2004.
  • The prerequisites of obtaining license for the facility (manufacturer) are availability of radiation test facility, radiation protection devices, quality assurance (QA) and radiation monitoring equipment, qualified and trained service engineers and availability of personnel monitoring services to radiation workers (service engineers).
  • The shielding and space requirements for radiation test facility shall be such that the radiation doses to radiation workers and members of public are As Low As Reasonably Achievable and do not exceed the dose limits prescribed by the Competent Authority. A warning placard shall be displayed outside the radiation test facility.


TABLE 1.14.1.1


Dose Limits (AERB Directive No. 01/2011 Issued Under Rule 15 of the AE (RP) R-2004)





































Sr. No. Part of the Body Occupational Worker Apprentices and Trainees Members of Public
1 Whole body (effective Dose) 20 mSv in a year averaged over five consecutive years 6 mSv in a year 1 mSv in a year


30 mSv in any year
2 Lens of eye (equivalent Dose) 150 mSv in a year 50 mSv in a year 15 mSv in a year
3 Skin (equivalent Dose) 500 mSv in a year 150 mSv in a year 50 mSv in a year
4 Extremities (equivalent Dose) 500 mSv in a year 150 mSv in a year 50 mSv in a year

Radiological safety officer


The facility is required to designate one of its qualified and trained service engineers as RSO, with written approval of the Competent Authority. The qualification requirements for personnel in Medical X-ray Installation are prescribed by the Competent Authority.


Licensing requirements for facilities engaged in supply of diagnostic X-ray equipment:




  • The facility (supplier) engaged in supply of diagnostic X-ray equipment and X-ray tubes is required to obtain authorization from AERB under clause 4.1 of AERB/RF-MED/SC-3 (Rev. 2). Authorization is issued by AERB from radiological safety stand point only. The facility (supplier) is required to obtain all other approvals/clearances required under applicable laws from respective authorities.
  • This facility is required to obtain type approval of every new model of diagnostic X-ray equipment from the Competent Authority for the purposes of supply in the country under Rule (3) of AE (RP) R-2004.
  • The prerequisites of obtaining authorization of the facility (supplier) are availability of Quality Assurance (QA) and radiation monitoring equipment, qualified and trained service engineers and availability of personnel monitoring services to radiation workers (service engineers). The availability of radiation test facility and radiation protection devices is a desirable requirement.

Licensing requirements for users of diagnostic X-ray equipment


The users are required to obtain license for operation of their diagnostic X-ray equipment from the Competent Authority under Rule (3) of AE (RP) R-2004. The Competent Authority issues license from radiological safety view point. Users are required to obtain all other approvals/clearances required under applicable laws from respective statutory authorities.


Prerequisites for obtaining license for operation of X-ray equipment:




  1. (a) The user is required to procure with validated NOC/Type Approved X-ray equipment from authorized suppliers after obtaining permission for procurement from AERB.
  2. (b) X-ray room layout and shielding requirement

The user is required to install his X-ray equipment in a room complying with following requirements:




  • The room housing X-ray equipment shall have an appropriate area to facilitate easy movement of staff and proper patient positioning. Appropriate structural shielding shall be provided for walls, doors, ceiling and floor of the room housing the X-ray equipment so that radiation exposures received by radiation workers and the members of the public are kept to the minimum and shall not exceed the respective limits for annual effective doses as per directives issued by the Competent Authority. Appropriate overlap of shielding materials shall be provided at the joints or discontinuities.
  • The control console of computed tomography equipment shall be installed in a separate room located outside but adjoining to computed tomography room and provided with appropriate shielding, direct viewing and oral communication facilities between the operator and the patient. The gantry and couch shall be placed such that it enables the operator to have the complete view of the patient from the control room viewing window.
  • Interventional radiology equipment room shall have an adjoining control room with appropriate facilities for shielding, direct viewing and oral communication.
  • In case of room housing radiography equipment, chest stand shall be located in X-ray room such that no significant stray radiation reaches at control console/entrance door/areas of full time occupancy such that the dose limits to radiation workers and members of public are not exceeded.
  • Mobile X-ray equipment, when used as fixed X-ray equipment, shall comply with all the requirements of those of fixed X-ray installation. Movement of mobile X-ray equipment shall be restricted within the institution for which it is registered.
  • A permanent radiation warning symbol and instructions for pregnant/likely to be pregnant women shall be displayed on the entrance door of the X-ray installation, illustrating that the equipment emits X-radiation.
  • The vehicle wherein the installation of X-ray equipment is to be done shall have appropriate shielding all around to ensure adequate built in protection not only for occupational worker but for general public all around. Radiation warning symbol shall (4) be displayed on the vehicle.
  • (c) Staffing Requirements:


    • There is a requirement of operator for operating X-ray equipment in every X-ray facility. Radiologist/related medical practitioner/X-ray technologist with adequate knowledge of radiation protection can operate the X-ray equipment.
    • The employees involved in these activities are considered as radiation workers. The responsibilities of radiation workers are prescribed in safety code. The qualification requirements for personnel in medical X-ray installation are prescribed by the Competent Authority.

  • (d) Radiological Safety Officer (RSO)


    • All the imaging centres using X-rays or CT scan shall have RSO approved by the Competent Authority. The approved RSO may be employer himself/herself or an employee who can fulfil the responsibility of radiation safety. The qualification requirements for personnel in Medical X-ray Installation are prescribed by the Competent Authority.

  • (e) Radiation Protection Devices


    • Appropriate radiation protection devices such as protective barrier, lead apron, ceiling-suspended protective glass, couch-hanging protective flaps are made available in X-ray installation and shall be used by X-ray technologists and medical practitioners during operation of X-ray equipment. These devices shall be verified periodically for their shielding adequacy.

  • (f) Personnel Monitoring


    • In context of diagnostic radiology, personnel monitoring (Thermoluminiscent Detector (TLD) badges) is mandatory, i.e., the user is required to provide personnel monitoring (TLD badges) to the radiation workers who are operating X-ray equipment or working in close proximity of X-ray equipment during ‘X-ray On’ condition.
    • In context of dental radiology, personnel monitoring (TLD badges) has been made recommendatory for the operators of dental X-ray equipment [dental (intraoral) and dental extraoral equipment], i.e., dental orthopan tomography (OPG) and dental cone beam computed tomography (CBCT). However, it may be provided to the operators of dental X-ray equipment in institutions (such as academic institutions) having high workload.

  • (g) Quality Assurance (QA)


    • In the context of diagnostic radiology, the user is required to arrange quality assurance (QA) of X-ray equipment by National Accreditation Board for Calibration and Testing Laboratory (NABL) accredited agency at the time of installation of X-ray equipment, in case of major repair including tube replacement, at the time of applying renewal of license with a frequency of once in 2 years.
    • In context of dental radiology, the user is required to arrange quality assurance (QA) of dental (intraoral/hand-held/OPG/CBCT) equipment by NABL accredited agency at the time of installation of X-ray equipment, in case of major repair including tube replacement and at the time of applying renewal of registration of dental X-ray equipment. In addition, the user is required to arrange periodic QA of Dental (OPG)/Dental (CBCT) equipment with a frequency of once in 5 years.


TABLE 1.14.1.2


The Radiation Protection Devices Required for Different Types of X-Ray Equipment



































Sr. No. Type of Equipment Radiation Protection Devices Required
1.

Interventional radiology




  • Couch-hanging protective rubber flaps
  • Ceiling-suspended protective glass
  • Protective apron
2.

Computed tomography




  • Protective apron
3.

Radiography and Fluoroscopy




  • Mobile protective barrier with lead equivalent viewing window
  • Protective rubber flaps
  • Protective apron
4.

Radiography (fixed)




  • Mobile protective barrier with lead equivalent viewing window
  • Protective apron
5.

Dental (OPG)


Dental (CBCT)




  • Mobile protective barrier with lead equivalent viewing window
  • Protective apron
6.

Mammography




  • Protective barrier with lead equivalent viewing window
  • Protective apron
7.

Radiography (Mobile)


Radiography (portable)


C-arm


O-Arm


Dental (intraoral)


Dental (hand-held)




  • Protective apron


TABLE 1.14.1.3


The Lead Equivalence of Radiation Protection Devices is Mentioned























Sr. No. Radiation Protection Devices Lead Equivalence
1.


  • Mobile protective barrier with lead equivalent viewing window
1.5 mm lead equivalence
2.


  • Couch-hanging protective rubber flaps
  • Ceiling-suspended protective glass
0.5 mm lead equivalence
3.


  • Protective barrier with lead equivalent viewing window for mammography unit
0.25 mm lead equivalence
4.


  • Lead Aprons/Gloves/goggles
0.25 mm lead equivalence

Common regulatory requirements for manufacturer/supplier/user





  • The facility/user is required to obtain renewal of license from the Competent Authority before its expiry.
  • The facility/user is required to submit periodic safety reports in the format as specified by AERB.
  • The user is required to decommission the diagnostic X-ray equipment with the services of authorized suppliers/approved agencies. The user himself may perform decommissioning of dental (intraoral/hand-held/OPG/CBCT) equipment and required to intimate decommissioning status of X-ray equipment to AERB.
  • The facility (manufacturer) is required to obtain requisite approval from the Competent Authority for decommissioning of the manufacturing facility.
  • The facility (supplier) is required to intimate the Competent Authority in case he decided to cease functioning as supplier.

Electronic licensing of radiation applications


AERB developed a web-based electronic licensing system for radiation applications called e-LORA in 2013 for helping users to submit their applications and supporting documents on-line. All types of regulatory approvals and licenses can be obtained through the e-LORA system. The guidelines for submitting applications in e-LORA system are available at AERB website for helping the users. The following are the practical tips for ensuring radiation safety during X-ray imaging.


Radiography (fixed) installation





  • Always wear TLD badge at chest level.
  • Always work behind the protective barrier.
  • Provide lead aprons to the patient’s relative for holding the patient during X-ray imaging, if needed.
  • Use collimator (diaphragm) to limit the X-ray field size to the area of interest.
  • Ensure X-ray room door(s) remains closed during X-ray imaging.

Radiography (Mobile):




  • Always wear TLD badge at chest level below lead apron
  • Operate the mobile X-ray equipment by extending the control cable.

Computed tomography installation





  • Always wear TLD badge at chest level.
  • Ensure CT room door(s) remains closed during CT imaging.
  • Provide lead aprons to the patient’s relative for holding the patient during CT scanning, if needed.
  • Use paediatric protocols for paediatric patients.

Interventional radiology installation





  • Always wear TLD badge at chest level.
  • Use ceiling suspended screens and lead rubbers flaps during IR procedures.
  • Use X-ray tube under couch and image intensifier over couch during IR procedures.
  • In oblique orientation, always stand adjacent to detector/image intensifier side.
  • Ensure IR room door(s) remains closed during IR procedures.

Mammography installation





  • Always wear TLD badge at chest level.
  • Always work behind the protective barrier.
  • Ensure mammography room door(s) remains closed during mammography.

Dental imaging





  • Operate dental X-ray equipment from a location as far away as possible from the patient and equipment.
  • Always operate dental (intraoral) equipment by extending the control cable.
  • Always operate dental (OPG)/dental (CBCT) by standing behind the protective barrier.
  • For intraoral radiography, the angle of emission of X-rays should be so adjusted by the operator that the patient’s eye/thyroid should not come in primary X-ray beam.
  • In intraoral radiographic examination, patient’s film should be held by patient, himself.
  • Provide lead aprons to the patient’s relative for holding the patient during X-ray imaging, if needed.
  • Ensure dental X-ray room door(s) remains closed during dental X-ray examinations.

Patient doses in diagnostic imaging


When radiation passes through the body, majority of radiation get absorbed, some of it get scattered and some of it get transmitted. The X-rays that are transmitted from the patient are used to create the radiographic image. The amount that is absorbed contributes to the patient’s radiation dose.


Medical practitioners always use the term effective dose when estimating the risk to the patient whilst using ionizing radiation for diagnosis or treatment of diseases, as the risk takes into account the possible side effects during the diagnosis/treatment later in life. ICRP Report-133 also states that as and when the term effective dose is used; it is to be noted that whether the organ and tissue has received whole body exposure, partial body exposure or heterogeneous exposure which is usually the case in diagnostic radiology, where the beam is collimated only to the organ of choice.




  1. (A) General Radiography:


    • It is expected that the radiology report of patients of CT scan and interventional radiology (IR) procedures should include data necessary to calculate the patient dose in Gray. Using the effective dose, it is possible to compare it with other source of radiation exposure. Simple formulas, taking into account for different anatomical regions, derived from dose-area product (fluoroscopy procedures) or dose-length product (CT) are provided to calculate the effective dose in Sievert. For CT, the effective dose corresponds to 1–10 years of yearly background radiation.

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Mar 25, 2024 | Posted by in CARDIOVASCULAR IMAGING | Comments Off on Occupational hazards in radiology

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