1. IAEA Senior Regulators’ Meeting 21 September 2017, Vienna
Session II: Regulating New and Complex Medical Applications
Steps in the introduction of new medical applications
and related equipment
Steve Ebdon-Jackson (UK)
Chair, HERCA WGMA
Heads of the European Radiological protection Competent Authorities - HERCA

2. HERCA is a voluntary association
HERCA, the Heads of European Radiological protection Competent Authorities, was founded in 2007.
It is a voluntary association in which the heads of the Radiation Pro­tec­tion Authorities work together in order to identify and discuss common interests in sig­ni­fi­cant regulatory issues.
32 countries (EU MS + IS, NO, CH, RS)
56 organisations (RPA + TSO),
310 nominations
Observers
EC, IAEA, OECD/NEA, WHO, US FDA

3. HERCA is a voluntary association
Working Groups (WG)
Emergencies
Medical Applications
Veterinary Applications
Non-medical sources & practices
Education & Training
Board
Technical
Secretariat
Networks (NT)
Dose Passbook/Outside workers
Collective medical doses
Transposition Euratom BSS
Chairmanship
Mr MAGNUSSON, IRSA, IS,
Mr HARBITZ, NRPA, NO, 2008 – 2011
Mr LACOSTE, ASN, FR,
Vice-Chairmanship
Mr CHEVET, ASN, FR,
Ms PETROVA, SUJB, CZ,
Workshops (WS)
Emergencies, Medical applications, Radon, NORM & Building materials

4. Medical exposures are beneficial
Rapid development of new technologies
for diagnosis
for treatment
Unrelenting development of new applications
commercially driven
professionally driven
BUT the adoption of new technologies and applications
needs to be justified

5. Pet CT

6. Pet MR

8. High resolution, high speed, low dose cardiac image
Also CT is a non-invasive procedure, it’s quicker and cheap and outpatient proceudure. Cardiac CT performed with optimisation- less dose than diagnostic cardiac angiogram
Image capture in less than a heartbeat
<1mSv cardiac scanning

9. Linear accelerator
Truebeam – varian

10. MRI linac
The viewray MRIdian system at the university of california

11. Proton therapy

12. Are all medical exposures beneficial?
Other considerations
Rapid development of new technologies not involving
ionising radiation
Coronary artery restenosis
irradiation
drug eluting stents
Over-diagnosis, over-use, over-treatment
CT for Gout …or
clinical observation
blood tests – uric acid
FNA

13. Application of system of justification in radiation protection
ICRP LEVEL I
ICRP LEVEL II – type of practice
ICRP LEVEL III – individual exposures

14. System of justification in radiation protection
ICRP LEVEL I
accepted
ICRP LEVEL II – type of practice
ICRP LEVEL III – individual exposures

15. System of justification in radiation protection
ICRP LEVEL I
accepted
ICRP LEVEL II – type of practice
role of the regulator
ICRP LEVEL III – individual exposures

16. System of justification in radiation protection
ICRP LEVEL I
accepted
ICRP LEVEL II – type of practice
role of the regulator
ICRP LEVEL III
role of the professional

17. Regulatory approaches to new technologies and applications using ionising radiation
Safety in principle
Medical Devices Regulations
Safety in practice
- Basic Safety Standards No. GSR Part 3
- Basic Safety Standards Directive 2013/59/Euratom
- Radiation Protection Regulations

18. HERCA approach to generic justification – MSW October 2016, France

19. Role of the radiation protection regulator – ICRP Level II
Types of practice need to be justified before being generally adopted
new types of practice should be justified
existing types of practice should be reviewed
Components for assessment
safety
research
Health Technology Assessment processes
expert panels

20. Processes required for justification for the general introduction of new types of practice
Notes of caution
no one component is sufficient
HTA may not prioritize technology over pharmaceuticals
evidence base expectations will be different

21. Processes required for justification for the general introduction of new types of practice
Processes should be specified in legislation
application processes should be clear
assessment process should be comprehensive and transparent
assessment should involve radiation protection bodies, Health Ministries etc. - but beware conflicts of interest
Processes should be responsive and timely
undue haste may impede appropriate control
undue delay may impede improvements in healthcare
decisions should not be by bodies with a role to promote technology

22. Case study: Individual Health Assessment – a new type of practice?
assessment of asymptomatic individuals outside screening programmes
i.e. no symptoms, only probability or individual’s wishes within the context of self-help or culture
Fast and high resolution CT
- ideal for imaging
- commercially viable

24. Case study: Individual Health Assessment – a new type of practice?
- assessment of asymptomatic individuals outside screening programmes
Issues relating to detection of pathology using CT
- patient autonomy v patient safety
- exquisite image quality – but what does it mean?
- consequent over-diagnosis and over-treatment
- impact on resources – equity and ethical issues
- impact on individual – morbidity and mortality
There is a clear role for the regulator

25. Acknowledgements Dr Juergen Griebel (BfS)
Members of HERCA Working Group on Medical Applications

26. Thank you for your attention
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