energy georgi simeonov european commission dg ener, radiation protection unit (d3) justificação e...
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EnergyEnergy
Georgi SimeonovEuropean CommissionDG ENER, Radiation Protection Unit (D3)
Justificação e Optimização das Exposições Médicas a Radiações Ionizantes 16 September 2015, Lisbon
Implementation of Euratom Basic Safety Standards into Radiological PracticeIn Focus: Justification
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European market for medical equipment … €20 billion for COCIR member companies
COCIR is the European Trade Association representing the medical imaging, health ICT and electromedical industries
The total annual frequency of x-ray procedures in the European countries is 590 million, or 1100 examinations per 1000 of population, or 1,1 examinations per European citizen
Monitored workers in Europe: ~1 million
MEDICAL RADIATION The EU Context
~700 000
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JUSTIFICATION:The EU Context
W. Leitz, A. Almén, S. Richter, A study on justification of CT examinations in SwedenContribution to medical exposure in the EU (RP 180, EC 2015)
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OPTIMISATION:The EU Context
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BenefitRisk
JUSTIFICATION: What is it?
Consider alternatives:
?
New class /type
Individual patient
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Responsibilities
Referring physician Radiological practitioner National authorities
Justification process:- Establish patient
characteristics and exam objectives
- Seek previous information
- Inform patient
Justification process:- verify patient
characteristics and exam objectives (?)
- Seek / provide previous information
- Inform patient
- Who can refer patients
- Who can take clinical responsibility
- Who should inform patients (what)?
- Specify involvement of referrer and practitioner
Clinical responsibility!
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Education and Training
Radiation protection course in basic med / dental curricula
- Procedure-specific- Radiation protection- Theoretical + practical- Initial + continuing- New techniques
Encourage - Establish / verify appropriate curricula
- Recognise diplomas / certificates / qualifications
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Referral Guidelines
Member States shall ensure that referral guidelines for medical imaging, taking into account the radiation doses, are available to the referrers
CDS systemElectronic requestingEducationReferrer involvementOther
Internal clinical auditExternal clinical auditVoluntary reportingInspection
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Clinical Audit
Member States shall ensure that clinical audits are carried out in accordance with national procedures
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Information to Patients
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Define Who
• Can refer (for what)
• Can take clinical responsibility
• Does what as part of justification process
• Will inform patients
Establish
• Clinical audit procedures
• E&T curricula and recognition
Make available
• Referral guidelines
Takes responsibility
• Individual exposures
• Obtaining information
• Providing records
• Informing patients
Takes part in
• Justification process
• Clinical audits
• RP education and training
Could take part in
• Referral guidelines development
Takes responsibility
• Seek information
Takes part in
• Justification process
Could be responsible
• Informing patients
Could take part in
• RP education and training
• Clinical audits
• Referral guidelines development
RESPONSIBILITIES:Summary
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Define Who
• Can refer (for what)
• Can take clinical responsibility
• Does what as part of justification process
• Will inform patients
Establish
• Clinical audit procedures
• E&T curricula and recognition
Make available
• Referral guidelines
The Competent Authority
Competent authority:an authority or system of authorities designated by Member States as having legal authority for the purposes of this Directive
functionally separate from … promotion or utilisation of practices
Withdraw authorisation
Inspectionestablish inspection programme
legal powers and human and financial resources necessary to fulfil its obligations
Require remedial / preventive action
Notification and authorisation of practice
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Evaluation of national plans – BSS in medicine• Survey: Jan – June 2016
• Workshop: Sep 2016
Commissionfuture activities
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http://ec.europa.eu/energy/en/topics/nuclear-energy/radiation-protection/radiation-medical-use
Thank you for your attention