The Dental Practice Radiation File - Health Service Executive

National arrangements for patient radiation protectionSI 478 (2002) allows for the Director General of the HSE to introduce additionalguidelines with respect to radiation protection of patients, as appropriate.In this regard, the NRSC was established in 2007 to advise the HSE on issues pertainingto 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 necessaryto protect patients in both public and private facilities from the unnecessary harmfuleffects of ionising radiation. Producing an annual report which includes a report on population dose frommedical exposure to ionising radiation. Receiving reports of audits, incidents and inspections. Gathering lifetime data on equipment and an assurance that each piece of equipmentis recorded as being maintained. Monitoring diagnostic reference levels. Advising on guidance and direction to Holders, practitioners, other staff andstatutory bodies on relevant matters.MERU is the executive, administrative and advisory unit for the NRSC and regulatespatient 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 medicalionising radiation. Managing the mandatory incident reporting system. Developing and providing guidance and direction to Holders, practitioners, otherstaff and statutory bodies on relevant matters as guided by the NRSC. Ensuring quality assurance programmes are in place in radiological facilities whichadminister medical ionising radiation to patients. Maintaining a register of installations.Page 12Dental Practice Radiation File

Publications Relating to Patient Radiation ProtectionSee Appendix B for a list of pertinent radiation protection legislation.In addition, a number of key documents and reports have been published to assistwith the interpretation and implementation of legislative requirements. Some of thesedocuments are listed in Appendix C. It must be noted, however, that this list is notexhaustive.Protection of workers and the publicThe BSS 96/26/EURATOM lays down the requirements for protection of workersand the public against the dangers of exposure to ionising radiation. It encapsulatesthe principles of justification, optimisation and dose limitation, articulated by theICRP, and gives legal authority to the regulatory framework for monitoring thosepractices 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, aswell as the environment, are adequately protected from the harmful effects of ionisingradiation.The ORPEM fulfils this statutory responsibility through a system of regulatory controland 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 radiationexposure incidents Co-operating with similar regulatory bodies, both within Ireland and internationally.SI 125 (2000) requires all locations which use radioactive sources and/or irradiatingapparatus (such as an X-ray unit) to hold a valid licence from the ORPEM, unlessthey have been exempted. Licensees must also adhere to the conditions the ORPEMattaches to each licence.Inspections undertaken by the ORPEM are designed to assess compliance with thelegislative requirements of SI 125 (2000) and the individual conditions set out in eachlicense. Inspectors also assess the level of radiation protection in place at each licensed facilityto ensure licensees are striving to attain best practice in relation to radiation protection.Page 13Dental Practice Radiation File

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 renewalThe ORPEM licenceAll users of ionising radiation are required to hold a valid license, issued by theORPEM. The licensee is responsible for ensuring that high standards of radiationprotection are maintained in order to promote a robust safety culture, and that alllicense requirements are met.This chapter outlines the obligations of licensees. It is a condition of each licence thata copy of the licence front cover must be displayed in a prominent public location, oneach 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 forRadiological Protection in Dentistry (RPII, 1996).Where work practices involve local arrangements that are not covered in the Code ofPractice, these should be documented in the Dental Radiation Safety File, prepared inconsultation with the Radiation Protection Advisor (RPA).See Appendix D for ORPEM guidance notes for compiling a radiation safetyprocedures / local rules file.Radiation Safety CommitteeAs mentioned previously, it would be impractical for an individual dentist to establisha radiation safety committee. However, dental licensees holding large numbers of x-rayunits, or based across several locations, such as the HSE or teaching hospitals, are requiredto establish a radiation safety committee which must meet twice a year. This committeeis responsible for overseeing radiation safety throughout the practice. Appendix F isa sample set of “Terms of Reference” for a Dental Radiation Safety Committee. Insituations where a number of dentists work in the same premises, a Radiation SafetyPage 14Dental Practice Radiation File

Committee can still be set up to review incidents, equipment issues and audit results asa peer review environment is often beneficial in quality improvement initiatives.Dosimetry in Dental RadiologyPrior to 2011, it was mandatory that all users of dental x-ray equipment wear personaldosimeters which were to be replaced every eight weeks. In 2011, the ORPEM, thenentitled the Radiation Protection Institute of Ireland, reviewed the available evidenceregarding the use of personal dosimeters in dentistry, in order to determine whetherthis 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 requirementwas introduced. Since 2008, all licence holders are required to appoint and consult with an approvedRPA to ensure best practice in regards radiation safety. European and international guidelines do not support a requirement for personaldosimetry. A review of available dose records for Irish licensees demonstrated that, over a tenyear period, there was only one reportable dose recorded.The review concluded that the mandatory wearing of personal dosimeters in dentistryis not warranted where a risk assessment, carried out by the RPA, indicates thatoperators of dental x-ray equipment are not expected to receive doses in excess of1millisievert (mSv) per year.This risk assessment should take into consideration the annual workloads and the typeof equipment being used, with special attention being given to panoramic equipmentand cone beam computed tomography (CBCT) equipment. Whilst it is unlikely thata dentist or a member of staff could expect to be exposed to a dose exceeding 1mSvper year, if the risk assessment indicates otherwise, then continuous personal dosemonitoring should be used, in accordance with the requirements of SI 125 (2000).Licensing RequirementsA licence is required for the custody, use or distribution of dental x-ray equipment inIreland.All undertakings (sole traders, partnerships, limited companies, government agenciesetc) must apply to the ORPEM for a licence. The ORPEM has classified dental licencesinto three separate categories which reflect the sector in which they apply:Page 15Dental Practice Radiation File

Figure 1: Dental x-ray licence categoriesCATEGORYDESCRIPTIONDental Level 1Dentists in private practice(no limit on number of x-ray units)Dental Level 2Government departments (Defence and Justice)Academic teaching hospitalsDental Level 3HSE Dental clinicsThe possession of an ORPEM licence is a legal requirement under SI 125 (2000).New InstallationsWhen 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 theappointed RPA to ascertain if any additional shielding is required. The RPA mayalso advise on the location of the x-ray equipment within the room so as to preventthe 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 issueda licence by the ORPEM. The licence will initially restrict the use of the x-rayunit “for commissioning purposes only”. This will allow the RPA to carry out thenecessary tests to ensure that it can be used safely on patients. At this stage, thex-ray unit may not be used on patients.3. Following installation by a qualified engineer, the equipment must be tested to seeif it meets requirements under the terms of a dental x-ray licence. This test mustbe carried out by the RPA and their report submitted to the ORPEM. Once theORPEM is satisfied with the RPAs commissioning report, the licence restrictionwill 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, servicingor any other relevant information relating to the items on the inventory.- Ensure that any changes or proposed changes to the licensed facilities (e.g. newequipment, relocation of equipment) are approved by the RPA.- Develop and maintain a radiation safety manual or radiation safety proceduresPage 16Dental Practice Radiation File

(Local Rules) where routine activities are not covered by the Dental Code ofPractice, 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 licensedequipment and ensure such equipment is put out of commission.- Ensure the x-ray equipment on the licence is tested at least every two years bythe RPA.Licence RenewalA valid x-ray licence for dental surgeries normally covers a four year period. Licencesshould 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 theirlicence as needed. Documents such as RPA reports can also be uploaded to the accountand reviewed by the ORP/EPA.Page 17Dental Practice Radiation File

4. Radiation Safety Incidents Recording of incidents in a Dental Practice Radiation File Equipment related safety incidents Content of the incident reportEnhancing patient safety and reducing risks to employees are the aims of all riskmanagement frameworks. In this regard, promoting an open, transparent culturewhere incidents are reported and managed in a well structured, timely fashion isessential. Learning from incidents and near miss events should be shared to preventrecurrence.The MERU Patient Radiation Protection Manual (HSE, 2017) highlights the need torecord and report incidents that involve the exposure of the patient to radiation, andthe importance of identifying trends in near miss events. A radiation safety incidentoccurs when medical ionising radiation is administered to the wrong patient or whenthe delivery of radiation during a therapeutic or diagnostic procedure is different tothat intended. Near miss events are potential errors identified outside the routinechecking 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 butnevertheless, any exposure carries with it a potential risk.All incidents should be reported, reviewed and where necessary, investigated, throughthe local risk management framework within the dental practice. It is good practiceto use the HSE Safety Incident Management Policy (HSE, 2014a) and the HSEGuidelines for System Analysis Investigation of Incidents and Complaints (HSE,2012) when investigating and reporting on radiation safety incidents. Also, the HSEOpen Disclosure Policy (HSE, 2013b) should be activated, where indicated.Recording of Incidents in the Dental Practice Radiation FileDetails of all incidents, investigations, outcomes and quality improvement plansshould be documented in the Dental Practice Radiation File.Incidents that exceed the parameters below should be notified to MERU usingthe reporting template in Appendix E. However, this list is not exhaustive and anyradiation incident considered to have serious patient safety implications should bereported to MERU.If in doubt, the incident can be reported verbally or by email to MERU and advicewill be given as to the requirement for a formal report.Page 18Dental Practice Radiation File

Figure 1: Notifiable incidents in dentistryExposure muchgreater thanintendedDiagnostic overexposure of adult as a result of more thantwice the exposure intended that leads to an overexposureof 10mSv or 20 times the dose intended, regardless ofthe dose level.As dental exposures are in the range of μSv up to 1mSv,unless there is equipment failure, this dose level is unlikelyto be reached. For example, 10 CBCT procedures couldresult in 10mSv.Diagnostic overexposure of a child as a result of more thantwice the exposure intended that leads to an overexposureof 3mSv or 15 times the dose intended, regardless of thedose level.Dose given to carers without consent that is greater thanMedical Council guidelines of 3 mSv for adults under 60years of age, and 15mSv for adults 60 years or over. Such adose is unlikely to be delivered in dental practice.Exposure wherenone intendedInadvertent Dose to foetus over 1 mSvIncorrect patient exposed to over 1mSv.For example, a CBCT or more than one OPG2 could resultin delivery of a dose 1mSv.Any other relevantradiation incidentconsidered tohave seriouspatient safetyimplications.Any other relevant radiation incident involving the safetyof a patient, or a patient incident that has been reported tothe RPA and the ORP/EPA, should be notified to MERU.A near miss under any of the above headingsOPG – Orthopanthomogram, a panoramic or wide view x-ray of the lower face, which displays allthe teeth of the upper and lower jaw on a single film.2Page 19Dental Practice Radiation File

A radiation incident that did not reach a level where notification to MERU wasrequired, 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 ProcedureDose Multiples Greater Than IntendedPeri-apical, Bitewing, OPG5Dental CBCT3Exposure where none intended, for example: Incorrect Patient Incorrect Procedure Incorrect Anatomy Equipment failure, accident, error or mishap causing patient exposure.Equipment Related Safety IncidentsAll equipment related safety incidents should be notified to the Health ProductsRegulatory Authority (HPRA). The HPRA works to drive quality improvement inmedical device safety by focusing on three inter-related areas - the disseminationof safety information, the development of the role of ‘designated person / vigilanceofficer’ and the encouragement of user reporting. As the national competent authorityfor medical devices, the HPRA publishes notices relating to the safety and/or qualityof medical devices on its website www.hpra.ie.Content of the incident reportAll 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 reportbeing requested.Page 20Dental Practice Radiation File

5. Protocols for Promoting Radiation Safety Radiation safety protocols Personal protective equipment Referral criteria Justification Optimisation Dose limitation/constraint Consent Biomedical and medical research Health screeningRadiation safety protocolsDelivering care that is appropriate, evidence based and standardised is in the bestinterest of the patient and staff. Developing and implementing patient care protocolsfor common dental radiology procedures will help to reduce errors and promote aculture of safety.The purposes of dental protocols are to: Provide instructions and guidance on the most appropriate actions to be undertakenin specific circumstances Promote best evidence based practice Standardise practice and service d

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.