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Dental Practice Radiation File

The Dental Practice Radiation File


Contents

Page

1 Introduction - Background 6

- Purpose of the guidance 6

- Scope of the guidance 7

- Radiation protection in dental practices 7

- Disclaimer 9

2 Regulation of Medical Ionising Radiation Usage - Legislative framework for radiation protection 10

- National arrangements for patient radiation protection 12

- Publications relating to patient radiation protection 13

- Protection of workers and the public 13

- National arrangements for implementing SI 125 (2000) 13

3 Framework for Demonstrating Compliance with Regulations - The ORPEM licence 14

- Radiation safety procedures (‘local rules’) 14

- Radiation safety committee 14

- Dosimetry in dental practices 15

- Licensing requirements 15

- New installations 16

- Licence renewal 17

4 Radiation Safety Incidents - Recording of incidents in a Dental Practice Radiography File 18

- Equipment related safety incidents 20

- Content of the incident report 20

5 Protocols for Promoting Radiation Safety in a Dental Practice - Radiation safety protocols 21

- Personal protective equipment 21

- Referral criteria 22

- Justification 23

- Optimisation 24

- Dose limitation/constraint 24


- Consent 25

- Biomedical and medical research 25

- Health screening 26

6 Clinical Audit in Dental Radiography - Clinical audit 27

- Clinical audit cycle 28

- Criteria for clinical audit in dental radiology 28

7 AppendixA. NRSC Guidance to Holders on their responsibilities 2010 31

B. Radiation protection legislation 40

C. Publications relevant to radiation safety 41

D. ORPEM Guidance notes for the compilation of radiation safety procedures/Local Rules 42

E. MERU incident reporting template for dental practices 43

F. Sample Terms of Reference for a Dental Radiation Safety Committee 45

8 References 47


DENTAL PRACTICE RADIATION FILEGuidelines for Radiation Protection in a Dental Practice

First edition.Published 2017.

Dr. Andrew Bolas BDS FFDRCSI FDSRCS(Ed) MSc Oral Surgeon/ Principal Dental Surgeon,

HSE West Dental Department, Markievicz House, Sligo.

[email protected]

Medical Exposure Radiation Unit,Quality Assurance and Verification Division,

Health Service Executive,Stewarts Hospital,

Palmerstown,Dublin 20.

[email protected]


Abbreviations

BSS Basic Safety Standard

CT Computed Tomography

EURATOM European Atomic Energy Community Treaty

HPRA Health Products Regulatory Authority

HSE Health Service Executive

ICRP International Commission for Radiological Protection

MED Medical Exposure Directive

MERU Medical Exposure Radiation Unit

MPE Medical Physics Expert

mSv Millisevert

NRSC National Radiation Safety Committee

ORPEM Office of Radiation Protection and Environmental Monitoring

OPG Orthopantomogram

RPA Radiation Protection Adviser

RCSI Royal College of Surgeons Ireland

SI Statutory Instrument


• Background

• Purpose of the guidance document

• Scope of the guidance document

• Radiation protection in dental practices

• Disclaimer

Background

The National Radiation Safety Committee (NRSC), a statutory committee established under statutory instrument (SI) 478 (2002), is tasked with providing expert advice to the Director General of the Health Service Executive (HSE) on the safe and optimal use of ionising radiation. In 2010, the NRSC recommended that all radiological licence holders in dentistry should keep a “Dental Practice Radiation File”.

A similar document entitled the “Patient Radiation Protection Manual” (http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/RP%20Manual%202013.pdf ) has been developed for medical practice and should be used in conjunction with this document.

This national guidance document has been developed by the National Dental Radiation Safety Committee of the HSE.

Purpose of the guidance document

The purpose of the guidance document is to support dentists in developing a central repository to store all relevant information relating to the safe use and custody of diagnostic equipment held on their premises. Whilst the concept for this document originated from SI 478 (2002), it also encompasses other legislation and best practise guidance to ensure protection of patients, staff and the public from the potential detrimental effects of ionising radiation.

By using this document, a dentist will have an understanding of their legislative responsibilities and an assurance that they have arrangements in place to promote the safety of the patients they treat and their employees.

The objectives of this guidance document are as follows:

• Keep staff informed of their responsibilities under the relevant regulatory requirements to protect patients.

• Provide guidance and support from the available information to reduce the risk to patients undergoing radiographic examination.

1. Introduction


• Provide a central repository for local and national guidance documents.

• Provide assurance that regulatory requirements are being adhered to when an installation is inspected.

• Support the training and education of new and existing employees within the dental practice.

Scope of the guidance document

This guidance document applies to all dental locations that administer medical ionising radiation to patients. It is intended to provide a framework upon which a practitioner can add to, or adapt, to suit local practice. It should be considered a working document rather than a finished and complete piece of work, and it is recommended that the Holder seeks other relevant documents in order to build up this file to its full potential.

The advice and guidance contained within this document have been sourced from the HSE Medical Exposure Radiation Unit (MERU), the Office of Radiation Protection and Environmental Monitoring (ORPEM), and from international publications detailing best practice in radiation safety for dentists.

Within a dental practice, the future upkeep of the guidance document should be carried out by the Practitioner in Charge, or the Holder1, or a designated person employed within the practice.The Practitioner in Charge is responsible for ensuring that the guidance document is made available to all employees and is used to support the staff induction programme.

Documentary evidence that all staff have read and understood the guidance outlined herein should be made available when required.

Radiation protection in dental practices

In 2010, the NRSC issued guidance to Holders of medical ionising radiological equipment on their responsibilities (See Appendix A). The information specific to dental practitioners is as follows:

Dental radiography differs from medical radiography in that, in the majority of cases, the dentist, acting in a single handed capacity, is defacto the prescriber, radiographer and radiologist when a radiographic examination is required. The dentist may also, by way of being a single handed practitioner, automatically be the “Practitioner in

1 “Holder” in SI 478 (2002) is defined as any natural or legal person who has the legal responsibility under national law for a radiological installation.


Charge” for the purposes of the legislation.

Outside of large organisations, such as the HSE dental and orthodontic services and the Dental Schools, the majority of dental practitioners operate in a general dental practice setting, with some practitioners in specialist or limited practice.

As private dental practices will often be staffed by the dental practitioner, occasionally an associate and support staff, it would be impractical to have a Radiation Safety Committee. Instead, dentists who are ORPEM licence holders are required to hold a file of compliance on site.

The ORPEM recommends that the Dental Practice Radiation File, or “compliance file”, should contain the following:

• A copy of the current x-ray licence including schedules 1, 2, 3 and 4.

• Personnel Dosimetry reports - to be held for 7 years.

• Commissioning reports - to be held for the life time of the equipment.

• Service reports – to be held for the life time of the equipment.

• Maintenance reports – to be held for the life time of the equipment.

• Reports from the Radiation Protection Advisor (RPA).

• Reports from the Medical Physics Expert (MPE), including a record of the annual number of exposure per machine type, where possible.

• Copy of the safety operating procedures (local rules).

• Clinical audit reports and associated data.

• Details of radiation Incidents, investigation reports and any subsequent quality improvement initiatives.

• Quality assurance program data to be held for the lifetime of the machine and a record of the replacement review date for each machine.

• Staff training and induction records.

• Evidence of safe disposal of developer chemistry and lead foil.

• Any correspondence relating to the radiographic practice at that location.

Note: This is not an exhaustive list and additional documents may be considered necessary for inclusion.


Disclaimer

This document does not purport to be comprehensive or to be a legal interpretation of medical ionising radiation legislation but offers professional guidance to Holders, dental practitioners and all employees involved with medical ionising radiation


• Legislative framework for radiation protection

• National arrangements for patient radiation protection

• Publications relating to patient radiation protection

• Protection of workers and the public

• National framework for implementing SI 125 (2000)

Legislative framework for radiation protection

The system of radiation protection used in Ireland and throughout Europe is based on the recommendations of the International Commission for Radiological Protection (ICRP). The core principles of radiation protection are justification, optimisation and dose limitation.

These principles are embodied in various European directives, most notably the Basic Safety Standard (BSS) 96/29/EURATOM and the Medical Exposure Directive (MED) 97/43/EURATOM. The BSS was transposed into Irish legislation by SI 125 (2000) to protect workers and the public; whereas the MED 97/43 EURATOM was transposed by SI 478 (2002), with associated amendments SI 303 (2007) and SI 459 (2010), to protect patients.

The MED 97/43 EURATOM deals with the protection of individuals against the dangers of ionising radiation in relation to medical exposure. This directive is the main legal instrument for the protection of patients undergoing diagnostic and therapeutic procedures using ionising radiation. One of the fundamental aims of the MED is to eliminate unnecessary medical exposures and to this end, the principles of justification and optimisation, in a context where dose limits are not applied to medical procedures, are central.

Currently, SI 478 (2002), amended by SI 303 (2007) and SI 459 (2010), gives effect to the MED in Ireland. Its scope includes the exposure of patients as part of their medical diagnosis and treatment. However, the MED has been incorporated into the revised BSS 2013/59/EURATOM which will be transposed into Irish law in 2018. Once transposed, this guidance document will be updated accordingly.

Overleaf is a description of the current legislative framework for radiation protection in Ireland.

2. Regulation of Medical Ionising Radiation Usage


Figure 1: Legislative Framework for Radiation Protection in Ireland

MEDICAL EXPOSURE DIRECTIVE

MED 97/43/EURATOM

BASIC SAFETY STANDARD DIRECTIVE

BSS 96/26/EURATOM

Transposed into Irish legislation

OFFICE OF RADIATION PROTECTION AND

ENVIRONMENTAL MONITORING

SI 125 (2000)

DEPARTMENT OF HEALTH

HSE / MERU

SI 478 (2002), SI 303 (2007)

SI 459 (2010)

RADIATION SAFETY PROCEDURES

GUIDANCE DOCUMENTATION

INSPECTION AND ENFORCEMENT

PATIENT RADIATION PROTECTION MANUAL

DENTAL PRACTICE RADIATION FILE

INTERNATIONAL COMMISSION FOR RADIOLOGICAL PROTECTION

(ICRP)

EUROPEAN ATOMIC ENERGY COMMUNITY TREATY

(EURATOM)

RADIATION SAFETY FOR WORKERS AND THE PUBLIC

RADIATION SAFETY FOR PATIENTS


National arrangements for patient radiation protection

SI 478 (2002) allows for the Director General of the HSE to introduce additional guidelines with respect to radiation protection of patients, as appropriate.

In this regard, the NRSC was established in 2007 to advise the HSE on issues pertaining to medical ionising radiation exposure.

The NRSC is a statutory committee tasked with:

• Providing advice to the Director General of the HSE on measures that are necessary to protect patients in both public and private facilities from the unnecessary harmful effects of ionising radiation.

• Producing an annual report which includes a report on population dose from medical exposure to ionising radiation.

• Receiving reports of audits, incidents and inspections.

• Gathering lifetime data on equipment and an assurance that each piece of equipment is recorded as being maintained.

• Monitoring diagnostic reference levels.

• Advising on guidance and direction to Holders, practitioners, other staff and statutory bodies on relevant matters.

MERU is the executive, administrative and advisory unit for the NRSC and regulates patient radiation protection practices in both public and private radiological facilities.

MERU is tasked with:

• Supporting and managing the work of the NRSC and its three subcommittees:

- National Radiotherapy Committee

- National Population Dose and Optimisation Committee

- National Dental Radiation Safety Committee

• Commissioning and supporting audits of radiological facilities using medical ionising radiation.

• Managing the mandatory incident reporting system.

• Developing and providing guidance and direction to Holders, practitioners, other staff and statutory bodies on relevant matters as guided by the NRSC.

• Ensuring quality assurance programmes are in place in radiological facilities which administer medical ionising radiation to patients.

• Maintaining a register of installations.


Publications Relating to Patient Radiation Protection

See Appendix B for a list of pertinent radiation protection legislation.

In addition, a number of key documents and reports have been published to assist with the interpretation and implementation of legislative requirements. Some of these documents are listed in Appendix C. It must be noted, however, that this list is not exhaustive.

Protection of workers and the public

The BSS 96/26/EURATOM lays down the requirements for protection of workers and the public against the dangers of exposure to ionising radiation. It encapsulates the principles of justification, optimisation and dose limitation, articulated by the ICRP, and gives legal authority to the regulatory framework for monitoring those practices involving ionising radiation which impact on public and workers’ safety.

SI 125 (2000) gives effect to the BSS directive in Ireland.

National arrangements for implementing SI 125 (2000)

Under SI 125 (2000), the ORPEM is assigned the role of Competent Authority and, as such, is responsible for ensuring that both workers and members of the public, as well as the environment, are adequately protected from the harmful effects of ionising radiation.

The ORPEM fulfils this statutory responsibility through a system of regulatory control and inspections which includes the following:

• Providing advice to members of the public and government agencies

• Monitoring the exposure of individuals to radiation

• Providing technical support to the national emergency plan for managing radiation exposure incidents

• Co-operating with similar regulatory bodies, both within Ireland and internationally.

SI 125 (2000) requires all locations which use radioactive sources and/or irradiating apparatus (such as an X-ray unit) to hold a valid licence from the ORPEM, unless they have been exempted. Licensees must also adhere to the conditions the ORPEM attaches to each licence.

Inspections undertaken by the ORPEM are designed to assess compliance with the legislative requirements of SI 125 (2000) and the individual conditions set out in each license. Inspectors also assess the level of radiation protection in place at each licensed facility to ensure licensees are striving to attain best practice in relation to radiation protection.


3. Framework for Demonstrating Compliance with Regulations

• The ORPEM licence

• Radiation safety procedures (‘local rules’)

• Radiation safety committee

• Dosimetry in dental practices

• Licensing requirements

• New premises

• Licence renewal

The ORPEM licence

All users of ionising radiation are required to hold a valid license, issued by the ORPEM. The licensee is responsible for ensuring that high standards of radiation protection are maintained in order to promote a robust safety culture, and that all license requirements are met.

This chapter outlines the obligations of licensees. It is a condition of each licence that a copy of the licence front cover must be displayed in a prominent public location, on each of the premises listed on the licence, where radiological equipment is held.

Radiation Safety Procedures (also referred to as “Local Rules”)

All licensees in the dental sector must comply with the ORPEM Code of Practice for Radiological Protection in Dentistry (RPII, 1996).

Where work practices involve local arrangements that are not covered in the Code of Practice, these should be documented in the Dental Radiation Safety File, prepared in consultation with the Radiation Protection Advisor (RPA).

See Appendix D for ORPEM guidance notes for compiling a radiation safety procedures / local rules file.

Radiation Safety Committee

As mentioned previously, it would be impractical for an individual dentist to establish a radiation safety committee. However, dental licensees holding large numbers of x-ray units, or based across several locations, such as the HSE or teaching hospitals, are required to establish a radiation safety committee which must meet twice a year. This committee is responsible for overseeing radiation safety throughout the practice. Appendix F is a sample set of “Terms of Reference” for a Dental Radiation Safety Committee. In situations where a number of dentists work in the same premises, a Radiation Safety


Committee can still be set up to review incidents, equipment issues and audit results as a peer review environment is often beneficial in quality improvement initiatives.

Dosimetry in Dental Radiology

Prior to 2011, it was mandatory that all users of dental x-ray equipment wear personal dosimeters which were to be replaced every eight weeks. In 2011, the ORPEM, then entitled the Radiation Protection Institute of Ireland, reviewed the available evidence regarding the use of personal dosimeters in dentistry, in order to determine whether this practice was still necessary. (RPII, 2011)

The findings from this review are summarised below:

• The standard of dental x-ray equipment had greatly improved since this requirement was introduced.

• Since 2008, all licence holders are required to appoint and consult with an approved RPA to ensure best practice in regards radiation safety.

• European and international guidelines do not support a requirement for personal dosimetry.

• A review of available dose records for Irish licensees demonstrated that, over a ten year period, there was only one reportable dose recorded.

The review concluded that the mandatory wearing of personal dosimeters in dentistry is not warranted where a risk assessment, carried out by the RPA, indicates that operators of dental x-ray equipment are not expected to receive doses in excess of 1millisievert (mSv) per year.

This risk assessment should take into consideration the annual workloads and the type of equipment being used, with special attention being given to panoramic equipment and cone beam computed tomography (CBCT) equipment. Whilst it is unlikely that a dentist or a member of staff could expect to be exposed to a dose exceeding 1mSv per year, if the risk assessment indicates otherwise, then continuous personal dose monitoring should be used, in accordance with the requirements of SI 125 (2000).

Licensing Requirements

A licence is required for the custody, use or distribution of dental x-ray equipment in Ireland.

All undertakings (sole traders, partnerships, limited companies, government agencies etc) must apply to the ORPEM for a licence. The ORPEM has classified dental licences into three separate categories which reflect the sector in which they apply:


Figure 1: Dental x-ray licence categories

CATEGORY DESCRIPTION

Dental Level 1 Dentists in private practice

(no limit on number of x-ray units)

Dental Level 2 Government departments (Defence and Justice)

Academic teaching hospitals

Dental Level 3 HSE Dental clinics

The possession of an ORPEM licence is a legal requirement under SI 125 (2000).

New Installations

When setting up a practice or moving premises, a number of steps must be followed.

1. The room in which the x-ray equipment is to be located should be reviewed by the appointed RPA to ascertain if any additional shielding is required. The RPA may also advise on the location of the x-ray equipment within the room so as to prevent the primary beam passing into adjacent public or occupied areas.

2. Before a practice can take custody of a new x-ray unit, they must first be issued a licence by the ORPEM. The licence will initially restrict the use of the x-ray unit “for commissioning purposes only”. This will allow the RPA to carry out the necessary tests to ensure that it can be used safely on patients. At this stage, the x-ray unit may not be used on patients.

3. Following installation by a qualified engineer, the equipment must be tested to see if it meets requirements under the terms of a dental x-ray licence. This test must be carried out by the RPA and their report submitted to the ORPEM. Once the ORPEM is satisfied with the RPAs commissioning report, the licence restriction will be removed and the equipment can then be used clinically.

4. It is a condition of licensing that the licence holder:

- Keep records of all x-ray equipment held.

- Inform the ORPEM of any changes to the inventory of licensed items.

- As appropriate, keep records of dose monitoring, disposals, incidents, servicing or any other relevant information relating to the items on the inventory.

- Ensure that any changes or proposed changes to the licensed facilities (e.g. new equipment, relocation of equipment) are approved by the RPA.

- Develop and maintain a radiation safety manual or radiation safety procedures


(Local Rules) where routine activities are not covered by the Dental Code of Practice, and these should be updated on a regular basis.

- Inform the ORPEM of any loses or thefts of any licensed equipment.

- Display a copy of the front cover of the licence in a public place.

- Ensure that all licensed equipment is subject to regular maintenance.

- Obtain authorisation from the ORPEM when disposing of any licensed equipment and ensure such equipment is put out of commission.

- Ensure the x-ray equipment on the licence is tested at least every two years by the RPA.

Licence Renewal

A valid x-ray licence for dental surgeries normally covers a four year period. Licences should be renewed at least 30 days prior to the expiry of the current licence.

Licences can now be renewed and applied for electronically at www.edenireland.ie . Licence holders can create an account through this portal and renew or amend their licence as needed. Documents such as RPA reports can also be uploaded to the account and reviewed by the ORP/EPA.


4. Radiation Safety Incidents

• Recording of incidents in a Dental Practice Radiation File

• Equipment related safety incidents

• Content of the incident report

Enhancing patient safety and reducing risks to employees are the aims of all risk management frameworks. In this regard, promoting an open, transparent culture where incidents are reported and managed in a well structured, timely fashion is essential. Learning from incidents and near miss events should be shared to prevent recurrence.

The MERU Patient Radiation Protection Manual (HSE, 2017) highlights the need to record and report incidents that involve the exposure of the patient to radiation, and the importance of identifying trends in near miss events. A radiation safety incident occurs when medical ionising radiation is administered to the wrong patient or when the delivery of radiation during a therapeutic or diagnostic procedure is different to that intended. Near miss events are potential errors identified outside the routine checking procedures.

As with any procedure in dentistry, adverse incidents can occur in radiography. Dental radiography will expose the patient to very low doses of ionising radiation but nevertheless, any exposure carries with it a potential risk.

All incidents should be reported, reviewed and where necessary, investigated, through the local risk management framework within the dental practice. It is good practice to use the HSE Safety Incident Management Policy (HSE, 2014a) and the HSE Guidelines for System Analysis Investigation of Incidents and Complaints (HSE, 2012) when investigating and reporting on radiation safety incidents. Also, the HSE Open Disclosure Policy (HSE, 2013b) should be activated, where indicated.

Recording of Incidents in the Dental Practice Radiation File

Details of all incidents, investigations, outcomes and quality improvement plans should be documented in the Dental Practice Radiation File.

Incidents that exceed the parameters below should be notified to MERU using the reporting template in Appendix E. However, this list is not exhaustive and any radiation incident considered to have serious patient safety implications should be reported to MERU.

If in doubt, the incident can be reported verbally or by email to MERU and advice will be given as to the requirement for a formal report.


2 OPG – Orthopanthomogram, a panoramic or wide view x-ray of the lower face, which displays all the teeth of the upper and lower jaw on a single film.

Figure 1: Notifiable incidents in dentistry

Exposure much greater than intended

Exposure where none intended

Any other relevant radiation incident considered to have serious patient safety implications.

Diagnostic overexposure of adult as a result of more than twice the exposure intended that leads to an overexposure of > 10mSv or 20 times the dose intended, regardless of the dose level.

As dental exposures are in the range of μSv up to 1mSv, unless there is equipment failure, this dose level is unlikely to be reached. For example, 10 CBCT procedures could result in > 10mSv.

Diagnostic overexposure of a child as a result of more than twice the exposure intended that leads to an overexposure of > 3mSv or 15 times the dose intended, regardless of the dose level.

Dose given to carers without consent that is greater than Medical Council guidelines of 3 mSv for adults under 60 years of age, and 15mSv for adults 60 years or over. Such a dose is unlikely to be delivered in dental practice.

Inadvertent Dose to foetus over 1 mSv

Incorrect patient exposed to over 1mSv.

For example, a CBCT or more than one OPG2 could result in delivery of a dose > 1mSv.

Any other relevant radiation incident involving the safety of a patient, or a patient incident that has been reported to the RPA and the ORP/EPA, should be notified to MERU.

A near miss under any of the above headings


A radiation incident that did not reach a level where notification to MERU was required, but where the patient received an unnecessary exposure to ionising radiation, should be recorded in the Dental Practice Radiation File.

For example, a diagnostic exposure “greater than intended”:

Diagnostic Procedure Dose Multiples Greater Than Intended

Peri-apical, Bitewing, OPG 5

Dental CBCT 3

Exposure where none intended, for example:

• Incorrect Patient

• Incorrect Procedure

• Incorrect Anatomy

• Equipment failure, accident, error or mishap causing patient exposure.

Equipment Related Safety Incidents

All equipment related safety incidents should be notified to the Health Products Regulatory Authority (HPRA). The HPRA works to drive quality improvement in medical device safety by focusing on three inter-related areas - the dissemination of safety information, the development of the role of ‘designated person / vigilance officer’ and the encouragement of user reporting. As the national competent authority for medical devices, the HPRA publishes notices relating to the safety and/or quality of medical devices on its website www.hpra.ie.

Content of the incident report

All incident reports should include the following information:

• Name and contact details of practitioner

• Date and time of incident

• Nature of incident

• Assessment of dose and immediate clinical outcome for patient

• Details of discussion with the patient

• Action taken to avoid recurrence

• Details of discussion with Holder, practitioner and RPA/ Medical Physics Expert (MPE)

Practitioners will be informed of further details required in the case of a formal report being requested.

www.hpra.ie.


• Radiation safety protocols

• Personal protective equipment

• Referral criteria

• Justification

• Optimisation

• Dose limitation/constraint

• Consent

• Biomedical and medical research

• Health screening

Radiation safety protocols

Delivering care that is appropriate, evidence based and standardised is in the best interest of the patient and staff. Developing and implementing patient care protocols for common dental radiology procedures will help to reduce errors and promote a culture of safety.

The purposes of dental protocols are to:

• Provide instructions and guidance on the most appropriate actions to be undertaken in specific circumstances

• Promote best evidence based practice

• Standardise practice and service delivery

• Reduce duplication

• Ensure that legislative and regulatory requirements are met

• Ensure employees and line managers are clear on their roles and responsibilities

• Facilitate effective staff induction

• Act as educational tools

• Act as a basis for audit, evaluation and continuous improvement

• Ensure standards are met

Personal Protective Equipment

For many years the use of lead aprons in dental radiography was mandatory to protect patients and the unborn foetus (considered a member of the public in Irish law) during a radiographic exposure.

5. Protocols for Promoting Radiation Safety


In 2011, both the ORPEM and the HSE jointly reviewed the evidence to support this practice and their findings are summarised below:

• There is no justification for the routine use of a lead apron in dental radiography.

• A lead apron is required when a member of staff or a relative is required to hold the patient during exposure, and should be used for the protection of the staff member or the relative.

• Practices must adhere to safe radiological practice whereby staff should remain at least two meters from the patient’s head and not in the path of the primary beam.

• There is no requirement to use a lead apron for pregnant patients.

• The use of thyroid collars should be considered when the thyroid gland is likely to be in the primary beam and the use of the collar will not interfere with the image.

• Thyroid collars should not be used in panoramic radiography.

• Where cephalometric radiography includes the thyroid gland, a protective collar should be used.

• Where a round collimator for intra-oral radiography is being used, and the patient is aged below 30 years, the use of a thyroid collar should be considered.

Lead aprons must be kept hygienically clean and stored in an appropriate manner, usually on a hanger, to prevent cracking of the lead.

Referral Criteria

Within medical radiography, it is frequently the case that the prescriber and the practitioner are different people. Dentistry, however, is somewhat unique in that the prescriber (the dentist treating the patient) and the practitioner (the person taking the radiograph) are, in the majority of cases, the same individual.

In some cases, a dental practice may receive referrals from other dental practitioners requesting that a radiograph is taken of a patient; or a dentist may refer a patient to a suitably trained and qualified member of staff within the same practice to have the radiograph taken.

SI 478 (2002) states that, in cases such as these, referral criteria should be drawn up to assist in the justification process in order to establish when it is appropriate to take certain exposures.

Article 14.2: “The Practitioner in Charge of an installation shall recommend, having regard to these regulations and subject to the approval of the Holder, the referral criteria for prescribers when referring patients for a radiological procedure.”

Referral criteria are often interchangeable with selection criteria. Selection criteria


are a set of best practice guidelines developed using available scientific evidence and approved by the Faculty of General Dental Practitioners, that make recommendations as to what the most appropriate radiographs for a given clinical condition are. Selection criteria have been developed and published by many international organisations, for example the EURATOM (RP 136), and other documents which can be downloaded from the respective organisations:

European Guidelines on Radiation Protection in Dental Radiology.https://ec.europa.eu/energy/sites/ener/files/documents/136_0.pdf

Selection Criteria for Dental Radiography FGDP(UK) (for purchase)http://www.fgdp.org.uk/content/publications/selection-criteria-for-dental-radiography.ashx

Dental radiographic Examinations – American Dental Associationhttp://www.ada.org/~/media/ADA/Member%20Center/FIles/Dental_Radiographic_Examinations_2012.pdf

Selection of Patients for dental radiographic examination – FDAhttps://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm116505.pdf

EAPD Guidelines for use of radiographs in children.http://www.eapd.eu/dat/590A99C0/file.pdf

Guideline on prescribing dental radiographs in infants, children, adolescents, and persons with special health care needs.http://www.aapd.org/media/policies_guidelines/e_radiographs.pdf

Justification

Justification is a process whereby the clinician must balance the potential harm to the patient with the potential benefits from the radiographic exposure. This weighing up of options should be carried out for every exposure, no matter how large or small the radiation dose might be. In practice, this involves the dentist deciding what information is likely to be gained from the exposure that will add to the diagnosis or treatment planning for the patient.

SI 478 (2002) Article 7.1: “Medical exposure referred to in regulation 4.1 shall show a sufficient net benefit, weighing the total potential diagnostic or therapeutic benefit it produces, including the direct health benefits to an individual and the benefits to society,

https://ec.europa.eu/energy/sites/ener/files/documents/136_0.pdf

http://www.fgdp.co.uk/shop

http://www.ada.org/~/media/ADA/Member%20Center/FIles/Dental_Radiographic_Examinations_2012.pdf

https://www.fda.gov/downloads/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/MedicalImaging/MedicalX-Rays/ucm116505.pdf

http://www.eapd.eu/uploads/590A99C0_file.pdf

http://www.aapd.org/media/policies_guidelines/e_radiographs.pdf


against the individual detriment that the exposure might cause, taking into account the efficacy, benefits and risks of available alternative techniques having the same objective but involving no or less exposure to ionizing radiation.”

The above definition indicates that, as part of the clinical justification process, the dentist must also consider what type of radiograph should be used. For example, bitewings may give better diagnostic value when investigating caries or periodontal disease rather than a panoramic radiograph which will expose the patient to a higher dose of radiation and irradiate a greater area of tissue.

Once the radiographic exposure has been clinically justified, the reason for justification should be included as part of the radiographic prescription. It is a statutory requirement that all radiographic exposures have a written prescription.

SI 478 (2002) Article 7.11 “A prescriber shall state in writing on each individual prescription his or her reason for requesting the particular procedure and the practitioner shall make arrangements to satisfy himself or herself that the procedure as prescribed is justified.”

Optimisation

SI 478 (2002) Article 7 defines optimisation as:

7.5 (a) “All doses due to medical exposure for radiological purposes except radiotherapeutic procedures referred to in Regulation 4.1 shall be kept as low as reasonably achievable consistent with obtaining the required diagnostic information, taking into account economic and social factors.”

Thus, all dentist practices must have optimisation protocols in place to ensure that doses due to medical exposure are kept as low as reasonably achievable. As part of the licensing requirements, dental x-ray apparatus must be inspected and tested biennially by the RPA.

As part of SI 478 (2002), a practitioner must engage with a Medical Physics Expert (MPE). Most MPEs are also RPAs and the dental practitioner should consult with the RPA at the time of inspection to identify methods by which the radiation dose to the patient can be reduced. For example, this might include matching the exposure settings to the receptor used; and comparison of the machine’s dose reference level to the nationally accepted limits.

Dose limitation/constraint

SI 125 (2000) defines dose constraint as “a restriction on the prospective doses to


individuals which may result from a defined source, for use at the planning stage in radiation protection whenever optimisation is involved.”

In practical terms, in dentistry, this means that suitable methods to reduce the radiation exposure to the patient should be used, where possible. For example, the use of a rectangular collimator can reduce the dose to the patient by up to 60%; also many panoramic machines allow the practitioner to restrict the exposed area to that of interest.

Consent

All dental facilities must have an appropriate protocol in place for obtaining consent for imaging procedures.

Consent is only considered valid if the patient, or guardian, is given verbal and written information on the risks and benefits of exposure to radiation so that an informed decision about treatment can be made. All information must be presented in a way the patient understands and time must be given for answering questions and repeating explanations, when required.

Patient information should include the potential benefits, risks and the likelihood of success of any proposed intervention, as well as that of any available alternative. The amount of information given should take into consideration the urgency, complexity, nature and level of risk associated with the procedure.

It is recommended that the HSE National Consent Policy 2014 (HSE, 2014b) is consulted when acquiring consent and that the person obtaining the consent is suitably trained and qualified. Whilst the consent obtained for dental radiography need not necessarily be in writing, any imaging requirements should form part of the treatment plan documented for the patient.

Bio-medical and Medical Research

SI 478 (2002) gives explanation to the use of ionising radiation when used for research purposes. Though research incorporating the use of ionising radiation in dentistry would be rare and most likely to be restricted to the Dental Schools, it is important that any such projects are planned in accordance with current legislation.

SI 478 (2002) Article 10 states:

10.1. “Medical exposure for bio-medical and medical research shall not be permitted, save in accordance with such criteria as may be directed by the Medical or Dental Councils and approved by the local medical ethics committee”.


10.2. “Without prejudice to the generality of paragraph 10.1, the practitioner shall ensure that for each biomedical and medical research project, each participating individual shall participate voluntarily, the practitioner shall seek where practicable to obtain previous diagnostic information or medical records relevant to the individual, that the individual is informed about the risks of this exposure and that he or she gives his or her informed consent in writing and that a dose constraint is established for that individual”.

10.3. “In the case of patients who voluntarily accept to undergo an experimental diagnostic or therapeutic practice and who are expected to receive a diagnostic or therapeutic benefit from this practice, the target levels of doses shall be planned on an individual basis by the practitioner”.

Health Screening

Population screening programmes are designed to identify diseases before symptoms become apparent to the individual, thereby allowing for early intervention and improving prognosis. SI 478 (2002) defines health screening as “a procedure using radiological installations for early diagnosis in population groups at risk”.

SI 459 (2010) outlines the procedure to be followed when providing a health screening programme which involves medical ionising radiation exposure.This SI dictates that all programs, or use of radiographs for health screening, must be notified to the Minister of Health three months prior to any activity, and permission for this screening must be given by the Minister.

Whilst health screening is not routinely carried out as part of dental practice, there may be instances where a patient may request a radiographic examination as part of an application for employment, visa applications etc.

The case could also be made where new patients to a practice routinely receive a panoramic radiograph that this would constitute a screening exposure.


• Clinical audit

• Clinical audit cycle

• Criteria for clinical audit in dental radiography

Clinical audit

Conducting clinical audit ensures the delivery of an effective and efficient service by identifying good practice and highlighting areas for improvement. Practitioners should use clinical audit as a means to ensure practice remains evidence based, to demonstrate quality assurance and to always act in the best interest of the patient.

Clinical audit is a statutory requirement under SI 478 (2002) for all dental practices which use medical ionising radiation. Clinical audit is defined by the HSE as the systematic review and evaluation of current practice against research based standards with a view to improving clinical care (HSE, 2013a).

The relevant articles of SI 478 (2002) are as follows:

Article 15.1: “The Medical and Dental Councils shall, within two years of the making of these regulations and in consultation with the Faculty of Radiologists of the Royal College of Surgeons of Ireland (RCSI) adopt criteria for clinical audit.”

Article 15.2: “The chief executive officer shall maintain a register of all installations in his or her functional area and he or she shall appoint a person who is for the time being a member of the Faculty of Radiologists, RCSI or other comparable faculty or body, to conduct clinical audits in accordance with the criteria established under paragraph 15.1 of these regulations, and the costs associated with that audit shall be borne by the holder.”

Article 15.3: “Each holder shall ensure that the clinical practice conducted in his or her installation or installations, is audited in accordance with the criteria adopted under paragraph 15.1 at least once every five years and the first audit under these regulations shall be undertaken not later than three years from the date of adoption of the criteria for clinical audit specified in paragraph 15.1.”

Article 15.4: “Notwithstanding the provisions of paragraphs 15.3 a person appointed under paragraph 15.2 may, with the approval of the chief executive officer and without notice, attend at any installation for the purposes of conducting a clinical audit and the holder and practitioner shall co-operate with that clinical audit.”

Article 15.5: “A copy of the auditor’s report shall be sent to the holder, to the practitioner in charge and to the chief executive officer who appointed him or her.”

It can be seen from these articles that the onus is on the Holder, the practitioner and the practice employees involved in dental radiography, to carry out clinical audit. Also, that provision has been made for these audits to be inspected by an external auditor.

6. Clinical Audit in Dental Radiography


Clinical Audit Cycle

Below is an example of a typical clinical audit cycle, taken from Wikipedia (www.en.wikipedia.org).

Figure 1: Clinical audit cycle

Criteria for clinical audit in dental radiology

Under the provisions of SI 478 (2002) Article 15.1, the Dental Council of Ireland, in consultation with the Faculty of Radiologists, RCSI, issued the following criteria in 2008 for clinical audit in dental radiology, based on The European Communities (Medical Ionising Radiation) Regulations:

Clinical Audit -

Clinical audit is a quality improvement process that seeks to improve patient care and outcome through systematic review of care and comparison with explicit criteria followed by implementation of change.

In a clinical audit, aspects of the structure, processes and outcomes of care are selected and systematically reviewed against explicit criteria. Improvements are then instituted and the process re-evaluated, thus completing the audit cycle.

The primary rationale for audit is to determine that the dental radiographic practice under review meets a reasonable standard.

www.en.wikipedia.org

www.en.wikipedia.org


An audit of a dental practice should encompass all radiological procedures including:

• Selection Criteria

• Technique selection

• X-ray Equipment

• Patient Dose

• Processing

• Image Quality

• Image Interpretation

• Records

• Training

• Internal Audit

The audit process should be undertaken by a dental practitioner engaged in full time practice similar to the practice being audited and should include a report from the RPA attached to the practice. The advice of a MPE / RPA may also be considered when deciding on a suitable audit.

It must be noted that dentistry is dramatically different in many ways from practice in a medical radiological installation. The dental practitioner is typically the prescriber, practitioner and operator. The dentist may also work alone, with no team support.

Thus, in a typical dental practice, the dentist, as prescriber, would not write a prescription for a radiographic exposure if this procedure is going to be undertaken onsite by them, where they are also considered the practitioner who accepts the prescription and the operator who undertakes the procedure.

The criteria outlined above by the Dental Council cover all stages and aspects of the dental radiographic process. At the time of issuing these criteria, a number of organisations developed and published guidance documents and audit tools to support the audit process in a dental practice, and several training events were staged nationwide to support the guidance.

Audit templates from the Irish Dental Association and the Dental Radiation Safety Committee of the HSE in Dublin were developed at the time. Practitioners and Holders are, of course, free to design their own audit tools or use other tools from different jurisdictions, however, these tools should satisfy the criteria outlined by the Dental Council.


7. Appendix

A. NRSC Guidance to Holders on their Responsibilities 2010

B. Radiation Protection Legislation

C. Publications Relevant to Radiation Safety

D. ORPEM Guidance Notes for the Compilation of Radiation Safety Procedures/Local Rules

E. MERU Incident Reporting Template for Dental Practices

F. Sample Terms of Reference for a Dental Radiation Safety Committee (Taken from HSE West Radiation Safety Committee)


Appendix A: NRSC Guidance to Holders on their Responsibilities 2010

To: Holders of Medical Ionising Radiation Equipment

From: National Radiation Safety Committee, HSE

Date: 04 March 2010.

RE: Guidance on Responsibilities in European Communities (Medical Ionising Radiation Protection) Regulations (SI 478 (2002), as amended by the European Communities (Medical Ionizing Radiation Protection) (Amendment) Regulations (SI 303 (2007).

These regulations are intended to protect the patient from harmful effects of exposure to ionising medical/dental radiation.

The National Baseline Audits conducted in 2008 in Radiology, Nuclear Medicine, Dentistry and Radiotherapy in 2008 recommended that “The HSE and the National Radiation Safety Committee should clarify and promote the requirements of SI 478 and ensure that all Holders of ionising radiation equipment are aware of these”.

This document is an initial guidance from the National Radiation Safety Committee to Holders of Medical/Dental Ionising Radiation Equipment in Ireland. It addresses some of the key responsibilities of Holders to assist them to comply with the relative provisions of the regulations. It also provides some advice on implementation issues, such as governance structures.

Disclaimer

This document is intended to act as a guideline to the regulations. It must be read in conjunction with the regulations referred to above and other laws, regulations or other responsibilities attaching to these roles. It does not purport to be comprehensive or to be a legal interpretation or to constitute legal or professional advice. Further guidance documents and changes in the regulations can be expected in the future that will necessitate the update of this guidance in due course. The advice given is wide-ranging and does not undermine an employer’s legal responsibilities for implementing compliant local procedures.

This regulation concerns important issues of quality and patient safety. Currently, a national review is being undertaken to implement the recommendations from the Report of the Commission on Patient Safety and Quality Assurance, 2008. This and other national developments will have consequences for the implementation of SI 478 (2002) in the future. The National Radiation Safety Committee may issue further guidance in this regard.


Holders’ Responsibilities - Guidelines

Significant responsibility for the protection of patients from the harmful effects of ionising radiation rests with the Holder who must ensure that appropriate provisions are put in place to meet the requirements of the regulations. The Holder means “any natural or legal person who has the legal responsibility under national law for a radiological installation”. In almost all cases the Holder will also be the undertaking [licensee with the Radiological Protection Institute of Ireland] as defined under SI 125 (2000) and will have additional responsibilities set out in that statutory instrument. Practitioners in Charge, Practitioners, Radiographers, Medical Physics Experts and Prescribers and each person involved in the use of ionising radiation for the purpose of medical/dental exposures to patients also have the duty to comply with the provisions of the regulations.

1. Governance and Structures

The regulations state that a holder may establish a local radiation safety committee in respect of a particular installation and that committee shall have regard to the advice of the National Radiation Safety Committee. A number of other responsibilities are required of Holders. The National Radiation Safety Committee has reviewed these and recommended the following to assist Holders in fulfilling their legal requirements.

National Radiation Safety Committee Recommendations

The National Radiation Safety Committee has made the following recommendations to assist Holders in fulfilling their legal requirements and has provided advice on a local governance framework.

(a) Radiation Safety Committees.

Radiation Safety Committees are recommended to be in place in organisations that have a large volume of procedures and/or higher risk practices. This does not generally apply to smaller practices, for example a dental practice or DEXA scanning practice.

Many Holders have established Radiation Safety Committees to meet the licence requirements of the Radiological Protection Institute of Ireland, under SI 125 (2000). Where these committees exist, it is recommended that their terms of reference are expanded to additionally advise the Holder on the following:

• Ensure and monitor compliance with SI 478/303

• Monitor risks and incidents

• Monitor quality assurance programme

• Review and prioritise clinical audit

• Monitor equipment, maintenance and replacement criteria


• Monitor staff education and training

• Monitor patient dose levels

• Other responsibilities as may be delegated by the National Radiation Safety Committee or the Competent Authority

Note:

Arrangements similar or additional to above, such as risk or clinical audit committees, particularly in radiotherapy, that achieve the same aims within the quality, safety and risk framework of the facility may also be considered to be appropriate. These would need to demonstrate good governance and have an integrated approach to ensure the above agenda is delivered on.

It is recommended that committees meet at minimum twice per year (4 times per year in radiotherapy) and be integrated in to the governance, risk and safety framework of the organisation.

It is recommended that membership includes, at a minimum:

• The CEO/ Hospital Manager*, or their representative, should ideally chair the Committee

• Risk Manager

• Practitioner in Charge at a minimum and the possibility for an additional Consultant Radiologist and/or Consultant Radiation Oncologist as appropriate

• Radiography Services Manager and/or Radiation Therapy Services Manager as appropriate

• Radiation Protection Adviser** / Medical Physics Expert

• A representative from each department using ionising radiation for patients

• Nurse, where nurses are prescribers/operators

• Representation from satellite hospitals/clinics, as appropriate

• Consultant in Public Health Medicine

• Dental Practitioner, where applicable

Note

* The CEO/hospital manager has the corporate responsibility and should ideally chair the committee but may nominate a suitable person to chair.

** The responsibilities of the Radiation Protection Adviser are set out in SI 125 (2000) and in the conditions that the Radiological Protection Institute of Ireland attach to its licences.


Dental Radiation Safety Committees

Where these exist, it is recommended that their terms of reference are similarly extended. Their membership will differ to the above but should be reviewed and modified, where appropriate.

There may be some cases where the National Radiation Safety Committee will advise a Holder to establish a Radiation Safety Committee and the National Radiation Safety Committee will make contact directly with that Holder.

(b) Radiation Protection File

It is recommended that all Holders keep a Radiation Protection File on site. The Medical Exposure Radiation Unit will distribute guidelines on the contents and upkeep of this file to all Holders in 2010. This file will be expected to be made available, if requested, to the Medical Exposure Radiation Unit, HSE which has a responsibility to audit clinical practice.

2. Personnel

Engagement and training of persons involved in the use of ionising radiation.

It is recommended that the Holder ensures that all persons involved in the use of ionising radiation have the appropriate qualifications, authorisation, registration and training required to carry out their functions in compliance with the regulations and are aware of their responsibilities.

It is recommended that the holder ensures that appropriate ongoing induction and training is provided, particularly when new or updated practices are introduced and when there is a change of personnel.

The Holder is required to:

• Designate one individual as Practitioner in Charge (a Practitioner has a specific definition in SI 478(2002)) who will recommend referral criteria for use of the facility.

• Designate a named Medical Physics Expert for the facility.

3. Equipment

Equipment Suitability

In addition to the requirements placed on the Holder by the Radiological Protection Institute of Ireland, SI 478 (2002) requires that the Holder has and maintains a written inventory of all radiological equipment and the National Radiation Safety Committee recommends that it is available if requested.


The Holder must ensure that their equipment complies with criteria of acceptability and take appropriate action if it fails to meet the criteria, based on the advice or action of the Medical Physics Expert.

National Radiation Safety Committee Recommendation

The National Radiation Safety Committee is considering the use of the draft version of the European Commission Radiation Criteria for Acceptability of Radiological, Nuclear Medicine and Radiotherapy Installations (RP91). This is available to download at http://ec.europa.eu/energy. The recommendation of the National Radiation Safety Committee will be notified to Holders in a separate guidance document.

The regulations currently require that the National Radiation Safety Committee authorises the extended use of all equipment beyond its anticipated lifetime. The National Radiation Safety Committee will issue guidance to Holders on how to inform the committee on the extended use of equipment.

4. Systems

Adverse Incident Reporting

It is recommended that Holders ensure they have systems in place to prevent and report adverse incidents. Notwithstanding the incident reporting requirements of the Radiological Protection Institute of Ireland, the National Radiation Safety Committee will issue recommendations and guidance to all Holders in 2010 on an external reporting mechanism for the reporting of adverse incidents.

Clinical audit

The Holder should ensure that the clinical practice is externally audited in accordance with the criteria adopted by the Irish Medical / Dental Councils at least once every five years.

The National Radiation Safety Committee plans to issue guidance on external and internal clinical audit in agreement with the Irish Medical / Dental Councils. All guidance will be developed within the context of national developments resulting from the Report of the Commission on Patient Safety and Quality Assurance, 2008 and the Adverse Event, Clinical Audit and Patient Safety Protocols being developed.

Quality Assurance

Quality Assurance means “all those planned and systematic actions necessary to provide adequate confidence that a structure, system, component or procedure will perform satisfactorily and comply with agreed standards.” Holders must ensure that appropriate quality assurance programmes are implemented.

http://ec.europa.eu/energy


5. Protocols and Standards

Referral criteria

The Holder must ensure that referral criteria are advised to prescribers, based on the recommendation of the Practitioner in Charge.

Diagnostic Reference Levels

Diagnostic Reference Levels means “dose levels in medical radio diagnostic practices or, in the case of radio-pharmaceuticals, levels of activity for typical examinations for groups of standard-sized patients or standard phantoms for broadly defined types of equipment. These levels are expected not to be exceeded for standard procedures when good and normal practice regarding diagnostic and technical performance is applied.”Those that have been established nationally are available at http://www.hse.ie/eng/about/Who/Publications_and_Annual_Report.html

Other Responsibilities

In addition to Holders’ responsibilities, personnel involved in the use of medical and dental ionising radiation have been assigned particular responsibilities in SI 478/303. The following is a summary and must be read in conjunction with the regulations and other laws, regulations or other responsibilities attaching to these roles.

Responsibility of the Practitioner in Charge (in addition to responsibilities of the Practitioner)

• Recommend referral criteria. It is expected that most departments already have criteria in place for many procedures. For example, the Faculty of Radiologists has recommended the use of the RCR (UK) referral criteria recommendations for diagnostic practice and these would be an acceptable foundation on which to base local criteria.

• Approve adjustments to be made to the equipment that are considered necessary by the Medical Physics Expert.

Responsibility of the Practitioner

• Clinically responsible (along with his/her colleagues) for all ionising radiation exposures performed in their institution. “Clinical responsibility” means responsibility regarding individual medical exposures attributed to a Practitioner, notably: justification; optimisation; clinical evaluation of the outcome; co-operation with other specialists and the staff, as appropriate, regarding practical aspects; obtaining information, if appropriate, of previous examinations; providing existing radiological information and/or records to other Practitioners and/or prescribers, as required; giving information on the risk of ionising radiation to patients and other individuals involved, as appropriate.

• Authorise radiological procedures subject to the conditions in the regulations.


• May not authorise the use of a practice which has been considered by the Medical and Dental Councils and which has not been approved by them.

• Make arrangements to satisfy himself / herself that the procedure prescribed is justified.

• Consult with the Medical Physics Expert assigned to the installation on optimisation, including the consistent production of adequate diagnostic information or therapeutic outcome, patient dosimetry, and quality assurance, including quality control and the assessment and evaluation of patient doses or administered activities, and on matters relating to radiation protection concerning medical exposures.

Responsibility of the Prescriber

• Shall state in writing reason for requesting the particular procedure.

• Shall enquire as to and provide the Practitioner with the pregnancy status of relevant females for all ionising radiation exposures.

• With the Practitioner, shall seek, where practicable, to obtain previous diagnostic information or medical records relevant to the planned exposure and consider these data to avoid unnecessary exposure.

Responsibility of the Medical Physics Expert

Medical Physics Expert conducts the following activities or gives advice on the following:

• Patient dosimetry.

• The development and use of complex techniques and equipment.

• Optimisation, particularly in therapeutic and high dose procedures, paediatric, pregnancy and breast feeding.

• Quality assurance, including quality control.

• Periodic examinations of equipment and records, agree such adjustments to be made to the equipment subject to the approval of the Practitioner in charge, maintain a record of each examination and adjustment of equipment.

• Acceptance testing of new equipment and checking of equipment after major maintenance.

• The Medical Physics Expert must express their views on continued suitability of use of equipment beyond its anticipated lifetime, based on equipment criteria.

• Other matters relating to radiation protection.

Responsibility of the Radiographer

• Ensure adherence to justification procedures.

• Advise on dose optimisation.


• A Radiographer appointed as Radiation Safety Officer in designated locations records and maintains records of regular Quality Control tests.

• The Radiation Safety Officer, records and audits patient dose information for compliance with DRLs.

• In Clinical Audit, the Radiographic Services Manager ensures that agreed standards and protocols are in place and adhered to.

• In Adverse Incident reporting relating to medical ionising radiation, the Radiographic Services Manager ensures incidents are recorded and managed according to agreed protocols.

Radiation Protection in Dental Practices

Dental radiography differs from medical radiography in that, in the majority of cases, the dentist acting in a single handed capacity is defacto the prescriber, the radiographer and the radiologist when a radiographic examination is required.

The dentist may also, by way of being a single handed practitioner, automatically become the “Practitioner in Charge” for the purposes of the legislation.

Outside of large organisations such as the HSE dental and orthodontic services and the Dental Schools, the majority of dental practitioners operate in a general dental practice setting with some practitioners in specialist / limited practice.

As private dental practices will often be staffed by the dental practitioner, occasionally an associate and his / her support staff, it would be impractical to have a Radiation Safety Committee. Instead, dentists who are RPII x-ray licence holders are required to hold a file of compliance on site.

The practice Dental Radiation or “Compliance File” should contain the following:

• A copy of the current x-ray licence including schedules 1, 2 and 3

• Personnel Dosimetry reports to be held for 7 years

• Commissioning reports - to be held for the life time of the equipment

• Annual service reports – to be held for the life time of the machine

• Maintenance reports – to be held for the life time of the machine

• Reports from the Radiation Protection Advisor

• Reports from the Medical Physics Expert, including a record of the annual number of exposure per machine type, where possible

• Copy of the safety operating procedures (local rules)

• Clinical Audit reports and associated data

• Details of radiation Incidents and reports, guidelines to follow


• Quality assurance program data to be held for the lifetime of the machine and a record of the replacement review date for each machine

• Staff training and induction reports

• Evidence of safe disposal of developer chemistry and lead foil

• Any correspondence relating to the radiographic practice at that location

Note: this is not an exhaustive list and additional documents may be considered necessary for inclusion.

February 2010

National Radiation Safety Committee


Appendix B: Radiation Protection Legislation

Basic Safety Standard 2013/59/EURATOM (to be transposed into Irish law in 2018)

https://ec.europa.eu/energy/sites/ener/files/documents/CELEX-32013L0059-EN-TXT.pdf

SI 459 (2010) European Communities (Medical Ionising Radiation Protection) (Amendment)

http://www.irishstatutebook.ie/eli/2010/si/459/made/en/print

SI 303 (2007) European Communities (Medical Ionising Radiation Protection) (Amendment) Regulations


Safety, Health and Welfare at Work Act (2005)

http://www.hsa.ie/eng/Legislation/Acts/Safety_Health_and_Welfare_at_Work/

SI 478 (2002) European Communities (Medical Ionising Radiation Protection) Regulations


Radiological Protection (Amendment) Act, (No. 3 of 2002)

http://www.irishstatutebook.ie/eli/2002/act/3/enacted/en/print

SI 125 (2000) Radiological Protection Act (Ionising Radiation)


SI 218 (2000) Pregnant Employees Regulations


Radiological Protection Act (1991)

http://www.irishstatutebook.ie/eli/1991/act/9/enacted/en/html

https://ec.europa.eu/energy/sites/ener/files/documents/CELEX-32013L0059-EN-TXT.pdf



http://www.hsa.ie/eng/Legislation/Acts/Safety_Health_and_Welfare_at_Work/


http://www.irishstatutebook.ie/eli/2002/act/3/enacted/en/print



http://www.irishstatutebook.ie/eli/1991/act/9/enacted/en/html


Appendix C: Publications related to Radiation Protection

HSE (2010) ‘Population dose from general x-ray and nuclear medicine: 2010’

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/General%20X%20Ray%20and%20NM%20Dose%20Survey.pdf

HSE (2011) ‘Population dose from CT scanning: 2009’

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/CT_dose_Survey_2009.pdf

HSE / RCSI (2011) Requirements for Clinical Audit in Medical Radiological Practices (Diagnostic Radiology, Radiotherapy and Nuclear Medicine). Joint publication between the Health Service Executive and Royal College of Surgeons Ireland.

http://www.radiology.ie/wp-content/uploads/2012/01/Requirements-for-Clinical-Audit-in-Radiology-Jan-2011.pdf

HSE (2012) ‘Population dose from dental radiology 2010’

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/HSE%20Dental%20Radiation%20Dose%20Survey%202010.pdf

RPII (2009) ‘Guidelines for reporting incidents to the Radiological Protection Institute of Ireland’

http://www.epa.ie/pubs/advice/radiation/RPII_Guide_Report_Incidents_03.pdf

RPII (2010) ‘Guidelines on the protection of the unborn child during diagnostic medical exposures’ Radiological Protection Institute of Ireland

http://www.epa.ie/pubs/advice/radiation/RPII_Guide_Patients_Reproductive_10.pdf

RPII (2014) ‘Radiation Doses Received by the Irish Population’ Radiological Protection Institute of Ireland.

http://www.epa.ie/pubs/reports/radiation/RPII_Radiation_Doses_Irish_Population_2014.pdf

RCR (2012) ‘iRefer Guidelines’ Royal College of Radiologists, United Kingdom

Http://irefer.org.uk

2009 Code of Practice on the Design of Diagnostic Medical Facilities where Ionising Radiation is used (RPII)

http://www.epa.ie/pubs/advice/radiation/RPII_Code_Design_Medical_Facilities_09.pdf

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/General%20X%20Ray%20and%20NM%20Dose%20Survey.pdf

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/CT_dose_Survey_2009.pdf

http://www.radiology.ie/wp-content/uploads/2012/01/Requirements-for-Clinical-Audit-in-Radiology-Jan-2011.pdf

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/HSE%20Dental%20Radiation%20Dose%20Survey%202010.pdf

http://www.epa.ie/pubs/advice/radiation/RPII_Guide_Report_Incidents_03.pdf


http://www.epa.ie/pubs/reports/radiation/RPII_Radiation_Doses_Irish_Population_2014.pdf

Http://irefer.org.uk

http://www.epa.ie/pubs/advice/radiation/RPII_Code_Design_Medical_Facilities_09.pdf


Appendix D: Guidance Notes for the Compilation of Radiation Safety Procedures/Local Rules

http://www.epa.ie/pubs/advice/radiation/Guidance_complilation_Radiation_Safet y_Manual_2016.pdf (accessed 8/9/2016).

Introduction

The conditions attached to licenses issued by the ORPEM, in respect of any activity involving ionising radiation, require the licensee to draft, approve and maintain a Radiation Safety Manual. In those cases where only small sources of radiation are involved, the manual is more often referred to as `Radiation Safety Procedures’ since the content can be contained in a few pages only.

A typical layout and content of the Manual is given below.

Section Content

1 Technical description of licensed items covering particulars, as appropriate, such as x-ray machine/isotope type; half life; radiation source holder type; serial number; activity; makers name; ISO 2919 classification.

2 Normal Operating Procedures.

3 Emergency Operating Procedures (Contingency Plans) such as in case of fire, explosion, spill or loss; (including methods of contacting responsible personnel outside working hours)

4 Details of planned maintenance such as routine radiation surveys; performance testing; routine surveillance when equipment is not in use.

5 Radiological safety procedure such as dosimetry; designation of controlled and supervised areas; radiation labels and notices; testing and calibration of monitoring equipment.

6 Administration, such as name of Radiological Protection Officer and Deputy; terms of reference; reporting lines and working relations with other members of staff and management; list of qualified operators; list of Category A and B workers.

7 Records. Description of method keeping records which are required by licence or Radiation Safety Manual.

8 Transport. How to package and transport the licensed items in order to comply with condition of licence.

http://www.epa.ie/pubs/advice/radiation/Guidance_complilation_Radiation_Safet y_Manual_2016.pdf�

http://www.epa.ie/pubs/advice/radiation/Guidance_complilation_Radiation_Safet y_Manual_2016.pdf�


Appendix E: MERU Incident Reporting Template for Dental Practice

Appendix E: MERU Incident Reporting Template for Dental Practice

PATIENT SAFETY RADIATION INCIDENT: DENTAL PRACTICE

Dental Practice Location: Date of Birth: Near Miss Event:

Yes No

Referring Clinician:

Treating Clinician:

INCIDENT DETAILS Date and Time of Incident: Discovered by (name & title): Estimated Effective Dose in mSv: Details of Incident:

Immediate Actions taken to Manage Situation and Prevent Recurrence: INVESTIGATION Investigation policy / methodology used HSE Safety Incident Management Policy 2014

Yes No If no, please specify policy followed:

Causal Factors: Contributory Factors: Recommendations:


Reviewed by Local Radiation Safety Committee or equivalent Yes No Date: Was the HSE Open Disclosure Policy (2012) activated? Yes No If yes, please outline details of communication with patient / carer: INCIDENT TYPE: NOTIFICATION TO MERU REQUIRED Incorrect patient >1mSv

Incorrect anatomy

Inadvertent foetal dose >1mSv Dose given to carers without consent > medical council guidelines

Child: Diagnostic overexposure (> twice) of 3mSv or 15 times dose intended

Any other incident that poses a risk to patient safety

Adult: Diagnostic overexposure (> twice) of 10mSv or 20 times dose intended

NOTIFICATION OF STAKEHOLDERS Patient / Carer

Yes No Date:

Local Radiation Safety Committee or equivalent

Yes No Date:

MERU

Yes No Date:

Other regulatory agencies, where necessary Yes No Details of agency and date notified:

SIGNATURES

Dentist:

Date:

Practitioner in Charge (if different person from Dentist):

Date:

Radiation Protection Adviser / Medical Physics Expert:

Date:


Appendix F: Sample Terms of Reference for a Dental Radiation Safety Committee

DRAFT Terms of Reference 2015

Dental Radiation Safety Committee

Health Service Executive, CHO Areas 1 and 2

Authority:

The Dental Radiation Safety Committee (DRSC) is an advisory committee to HSE West dental and orthodontic services established by the Radiation Protection Officers (RPOs) following a recommendation by the National Radiation Safety Committee (NRSC).

Mandate:

The committee assists the RPOs, to assess and advise clinical practices and radation protection procedures and processes to ensure that the exposure and outcome for the patient is in line with international best practice.

The committee provides advice and guidance on issues arising from the legislative obligations placed on it in SIs 125 (2000), 478 (2002), 303 (2007) and 459 (2010).

Membership

RPAs

RPOs (usually PDSs)

PDS + 1

Orthodontic practitioner in charge

with Radiographer working with Orthodontics (observer).

Dental Radiology Advisor.

The role of the Dental Radiation Safety Committee will also include:

• RPAs to advise on radiation dose reference levels as may be established by the Dental Council from time to time.

• Investigate incidents as reported by RPOs.

• Liaise with other HSE departments / sections including other regional DRSCs, Hospital Radiation Safety Committees and outside bodies as required to advise on issues relevant to dental radiology.

• Assist and advise RPOs on dental radiology staff training programmes.

• Assist and advise RPOs on matters of Dental radiology equipment, maintenance and radiological services.


• Oversee issuing of Guidance Notes, Standard Operating Procedures, Local Rules, Policies and Protocols where applicable.

• Production of an annual work plan and annual report.

• Assist and advise the RPOs on clinical audit.

• Any other relevant matters that may arise.

• Work with National Dental Office.

Meetings

Meetings are held with sufficient frequency to enable the committee to carry out its functions. If appropriate, the Chairperson will consult with RPOs in determining the frequency of meetings. (min 2 per year)

Members may participate in meetings after their meeting by telephone, teleconference. Key meetings require attendance in person.

Substitution of an RPO member must be made by arrangement with the chair of the committee.

Meetings are chaired by the Chairperson. In his/her absence, an acting Chairperson is appointed.

The quorum for meetings is one half of the appointed committee membership plus one.

The agenda is established by the Chairperson in consultation with RPOs. It is circulated with related papers in advance of the meeting.

The chair may convene emergency meetings should urgent matters arise.

Decisions are made by consensus or by a majority of the votes of the members present. Each member of the committee present has one vote. If there is an equal division of votes, the Chairperson has a casting vote.

Minutes of Meetings

Minutes of each meeting are prepared by the secretary to the committee.

The minutes indicate the names of the attendees, and in respect of each item on the agenda:

• the documents submitted to the committee,

• a summary record of the proceedings,

• the decisions made or the conclusions reached by the committee.

Draft minutes are sent to members before the next meeting. They are adopted at the following meeting and signed by the Chairperson.

Review date 1 year, Q2 2015.


8. References

Dental Council of Ireland (2008) ‘Criteria for Clinical Audit in Dental Practice’ Dental Council of Ireland.

http://www.dentalcouncil.ie/files/ionisingradiation/Clinical%20Audit%20-%20SI%20478%20of%202002.pdf

HSE (2008) ‘Final Report of the HSE Task Force on Implementation of Statutory Instrument 478 (2002) and Statutory Instrument 303 (2007)’ Health Service Executive.


HSE (2010) Dental review of compliance

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/Dental%20Review%20of%20Compliance%202010.pdf

HSE (2012) ‘Guidelines for Systems Analysis Investigations of Incidents and Complaints’ Health Service Executive

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/resourcesintelligence/Quality_and_Patient_Safety_Documents/QPSDGL5211.pdf

HSE (2013a) ‘A Practical Guide to Clinical Audit’ Health Service Executive

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/Clinical_Audit/clauditfilespdfs/practicalguideclaudit2013.pdf

HSE (2013b) ‘National Open Disclosure Policy’ Health Service Executive.

https://hse.ie/eng/about/Who/QID/Other-Quality-Improvement-Programmes/opendisclosure/opendiscFiles/opendiscpolicyoct13.pdf

HSE (2014a) ‘Safety Incident Management Policy 2014’ Health Service Executive

https://www.hse.ie/eng/about/Who/qualityandpatientsafety/MeasuringandLearning/SCDQIDQIProgramme/Safety_Incident_Management_Policy.pdf

HSE (2014b) ‘National Consent Policy 2014’ Health Service Executive

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/National_Consent_Policy/consenttrainerresource/trainerfiles/NationalConsentPolicyM2014.pdf

http://www.dentalcouncil.ie/files/ionisingradiation/Clinical%20Audit%20-%20SI%20478%20of%202002.pdf


http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/Dental%20Review%20of%20Compliance%202010.pdf

http://www.hse.ie/eng/about/Who/QID


https://hse.ie/eng/about/Who/QID/Other-Quality-Improvement-Programmes/opendisclosure/opendiscFiles/opendiscpolicyoct13.pdf

https://www.hse.ie/eng/about/Who/qualityandpatientsafety/MeasuringandLearning/SCDQIDQIProgramme/Safety_Incident_Management_Policy.pdf



HSE (2017) ‘Patient Radiation Protection Manual’ Health Service Executive

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/RP%20Manual%202013.pdf

RPII (1996) ‘Code of Practice for Radiological Protection in Dentistry’ Radiological Protection Institute of Ireland.

https://www.epa.ie/pubs/advice/radiation/RPII_Code_Practice_Radiation_Protection_Dentistry_1996.pdf

RPII (2011) ‘Personal Dosimetry in Dental Radiology’ Radiological Protection Institute of Ireland.

http://www.epa.ie/pubs/advice/radiation/RPII_Personal_Dosimetry_Dental_11.pdf

http://www.hse.ie/eng/about/Who/qualityandpatientsafety/safepatientcare/medexpradiatonunit/RP%20Manual%202013.pdf

https://www.epa.ie/pubs/advice/radiation/RPII_Code_Practice_Radiation_Protection_Dentistry_1996.pdf

http://www.epa.ie/pubs/advice/radiation/RPII_Personal_Dosimetry_Dental_11.pdf