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

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

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, 2012 - 2017 Mr HARBITZ, NRPA, NO, 2008 – 2011 Mr LACOSTE, ASN, FR, 2007-2008 Vice-Chairmanship Mr CHEVET, ASN, FR, 2015-2017 Ms PETROVA, SUJB, CZ, 2015-2017 Workshops (WS) Emergencies, Medical applications, Radon, NORM & Building materials

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

Pet CT

Pet MR

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

Linear accelerator Truebeam – varian

MRI linac The viewray MRIdian system at the university of california

Proton therapy

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

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

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

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

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

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

HERCA approach to generic justification – MSW October 2016, France

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

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

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

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

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

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

Thank you for your attention For further information see www.herca.org