HERCA activities on Medical Applications covers radiation protection issues concerning medical applications of ionizing radiation for diagnosis and therapy and in particular, aiming at improving the safety of all individuals involved in medical exposures, taking into consideration the rapid changes in equipment capability and healthcare delivery. One focus is to contribute to harmonizing the implementation of the radiation protection regulation in Europe, especially concerning new medical applications. These activities are carried out by the Working Group on Medical Applications (WG MA).

Justification in medical imaging  

HERCA position papers on justification in medical imaging

The HERCA position paper “Justification of Individual Medical Exposures for Diagnosis” and its addendum have been released in 2014. These papers provide the regulator’s view on the roles and responsibilities in the justification process of medical exposure and concludes that appropriate justification processes offer the most effective method to achieve a reduction in medical exposures, for the individual and for the exposed population.

For more information:

Stakeholder involvement

On 26 September 2014, HERCA organised a multi stakeholder meeting in Brussels. The objective of the meeting was to exchange views with a variety of key stakeholders on issues with regard to the application of the principle of justification in medical imaging procedures and the justification process. All organisations present welcomed HERCA’s initiative, recognising the importance of the principle of justification of exposures in particular in the medical field. They welcomed the proposal to commit to measures to improve the justification process. Each of them committed to contribute to improving justification in medical imaging, according to an agreed identification of their specific contributions to the justification process. Further concrete steps were agreed upon and will be followed up. The ultimate goal of these efforts is to avoid unnecessary imaging procedures, whereby patients would be submitted to unjustified radiation exposure. It has been decided to establish a range of multi-stakeholder meetings where collaborative efforts can be discussed by all concerned stakeholders.

For more information:

Meeting between European radiation protection authorities and major stakeholders on justification of medical imaging procedures leading to commitments to contribute to improving justification in medical imaging   http://www.herca.org/herca_news.asp?newsID=38

HERCA activities with regard to Individual Health Assessment (IHA)

The working group has produced a position paper on IHA in spring 2012. This document offers a very clear distinction between IHA and regular health screening programs. These efforts have certainly contributed to the explicit addressing of IHA in the EU BSS as well as in the Bonn “Call for Actions”.

For more information:

HERCA “Position Paper on Screening” in the framework of the exposure of asymptomatic individuals in healthcare

In June 2013, HERCA has released a survey about the situation in Europe regarding the use of CT on asymptomatic individuals outside screening programs. This report presents an overview of the use of CT on asymptomatic individuals in Europe for individuals undergoing “on request” exams with no clinical indication (no symptoms/clinical signs) and thus often occurring as a result of an individual request. This report confirms that there is reason for concern, even in countries where this practice is forbidden.

For more information:

Survey about the situation in Europe regarding the use of CT on asymptomatic individuals outside screening programs

“Inspection Competence of Authorities” 

Action Plan

The HERCA Board considered three recommendations regarding this activity. These were:

  1. staff undertaking either inspection or audit functions should be able to demonstrate adequate clinical training and up-to-date knowledge to be able to advise and influence the optimisation of medical exposures. They should be trained including clinical knowledge.
  2. further information is required regarding the clinical competence of staff of Regulatory Authorities and Audit Bodies. A further survey should be conducted to provide this information.
  3. formal pan-European training programmes for regulatory and audit staff with regard to optimisation of practical aspects of medical exposures should be considered and assistance provided for development and coordination.

The Board agreed that further work should be undertaken to clarify the level of clinical knowledge, training, competence and skill of inspectors relating to optimisation of medical exposures and to identify and make available information on training packages and programmes that might be considered as models of best practice. These should reflect and be relevant to different types of inspection and audit processes throughout Europe.

HERCA''s Medical Applications Working Group agreed to provide this and presented its findings at the meeting of Heads in June 2012. The report included plans to hold a pilot training course in January 2013.

This course, which lasted three days, was held in the UK and provided by staff from Public Health England. It covered practical aspects of optimization in diagnostic radiology and would include classroom teaching and hospital visits. The course was run for two inspectors from Slovenia, with an observer from Denmark.

Feedback, from the organisers, the participants and the observer for the course was presented at the HERCA Medical Applications Working Group meeting held on April 2013 in Den Haag. Feedback was largely positive, although it was recognized that the full value of the course would require careful targeting.

A summary was then presented at the Board of Heads meeting in Reykjavik, held on June 2013. The Board of Heads acknowledged the work undertaken and recognized the value of extending this to include optimization in nuclear medicine and radiotherapy and the justification process. The UK has indicated it has developed training of a similar nature in nuclear medicine and radiotherapy and would be willing to offer this on a pilot basis.

The Board of Heads also requested that an Inspector Workshop be considered, focusing on radiology.

HERCA WG MA members agreed to plan for an Inspector Workshop, focusing on how to inspect justification and optimization in radiology at the September meeting in Copenhagen 2014.

The workshop will take place in Brussels on 6-8 October 2015. The core-group is represented by members from Norway (chair), Sweden, Greece, Hungary and UK, and will draw heavily on the experience from previous Nordic Inspection Workshops.

Cooperation with the CT manufacturers 

Action Plan

The cooperation with the CT manufacturers was initiated by a kick-off meeting organized in Bonn in February 2010, when a dialogue started with the four main CT manufacturers (GE, Philips, Siemens and Toshiba) and COCIR, which represents the radiological, electromedical and healthcare IT industry in Europe. As an important result of this process, COCIR and the CT manufacturers were willing to underline their responsibility on patient dose reduction and provided a voluntary self-commitment by May, 13th 2011. Hereby, they committed themselves to actions which offer the potential to achieve this goal. The actions include:

  1. the development and implementation of a standardized benchmarking of CT systems by characterizing the dose efficiency related to image quality,
  2. the implementation of dose reduction measures in CT,
  3. the implementation of dose management and reporting tools, and
  4. the provision of specific training curricula.

A further important result of this process was the insight that international cooperation is increasingly important for success, and that this cannot be limited to a European level. To address this issue, HERCA initiated a process to intensify its cooperation with other international regulatory and scientific bodies such as FDA and NCRP.

Since 2010, HERCA has been working together with the CT manufacturers and COCIR following the voluntary self-commitment provided by COCIR in 2011. A number of dose optimisation and management tools have been developed by the CT manufacturers and are now available on modern CT scanners. A large amount of work has been accomplished by the CT manufacturers for commitments 2, 3 and 4. These commitments are in part completed, partially completed and on going which means that a long term partnership with the CT manufacturers is the most interesting approach for HERCA. For commitment 1, the CT industry has designed and developed reference phantoms for assessing Low Contrast Detectability and the associated dose level. The methodology for the use of these phantoms is in the process of being elaborated.

With these considerations in mind, the action plan 2014-15 of the work package includes the following steps:

  1. To continue the collaboration with COCIR and the CT manufacturers in order
    • to closely assist and support the implementation of the voluntary self-commitment of COCIR and the CT-manufacturers and
    • to foster a joint approach to inform both the public and relevant scientific bodies about the nature and scope of the voluntary self-commitment, including common press releases and, when appropriate, a common press conference.
  2. To establish a platform of communication between HERCA and COCIR which will allow a Panel of Advisers, design to assist HERCA members, to actively participate in and be informed of the work carried out by MITA, FDA and the IEC.
  3. To continue the work that is being carried out for commitments 1, 2, 3 and 4.
  4. To expand the number of stakeholders involved in the work package to include Radiologists, Radiographers and Medical Physicists.

In 2014:

Activities relating to the implementation of the European Basic Safety Standards (BSS) Directive 

For the radiological community, the publication on 17 January 2014 of the latest European Basic Safety Standards Directive (2013/59/Euratom) will have impact as it will require changes of national legislation and regulation across Europe. HERCA as an organisation had no role in negotiation of the Directive, or its transposition into national legislation. These are matters for individual Member States. In most cases however members of HERCA will be responsible for producing new legislation and regulations and in all cases will be responsible for its enforcement. It is clear therefore that HERCA as a whole can be a positive influence on transposition and implementation by:

  • acting as a platform to identify and discuss practical and technical regulatory problems
  • exploring a common understanding of new requirements and common approaches including providing guidance where appropriate and feasible
  • informing the transposition process by being a resource for Competent Authorities
  • acting as an interested stakeholder with the European Commission
  • adding value on areas involving trans-boundary processes

Within this context, HERCA WG MA has identified five thematic areas, which include additional or new requirements. Two of these – the process of justification and the notification of significant events to Competent Authorities following accidental and unintended exposures – have already been addressed by HERCA WG MA in the last few years.

Thus, HERCA WG MA has published on justification, including a position paper and addendum on individual justification (at ICRP level III), addressing conceptual and practical matters and a separate paper addressing issues relating to individual health assessment of asymptomatic health assessment. Both papers address concepts and frameworks, which are pivotal in the latest European Basic Safety Standards Directive. It continues to work in this area with key stakeholders, under a formally constituted work package, to develop an approach centred on voluntary self-commitments. This is intended to improve justification processes for diagnostic medical exposures through collaborative and coordinated initiatives, with appropriate engagement of referring clinicians and specialist practitioners. The goal is that patients will receive the most appropriate examination and that the justification processes will stand-up to scrutiny.

In 2014, the HERCA Board of Heads agreed a second work package on the notification of significant events to Competent Authorities following accidental and unintended exposures. The Directive identifies that different requirements exist for those events which might be considered as clinically significant and those which are considered as significant by the Competent Authority and therefore reportable. This is an area where stakeholder engagement is essential if common understanding is to be achieved by professionals and regulators alike. To aid this process, HERCA WG MA is considering holding a workshop in 2016, involving a range of medical, clinical and scientific societies, where different views can be debated.

The other areas relevant to the Directive address medical equipment (Article 60), procedures relating to incorporation of information relating to patient exposure in the report of the medical radiological procedure (Article 58b) and education and training relating to continuing education on radiological practice as well as radiation protection (Article 18) and will be considered in 2015 and beyond.

Other Medical Activities

Handled portable dental X-Ray equipment

In 2014, a position paper on justification of the use of Handled portable dental X-Ray equipment was approved by HERCA.

For more information:

HERCA proposal of harmonization of Dose area product (DAP) display on X-ray equipment

In the framework of HERCA WG MA missions to enhance the implementation of the radiation protection regulation on medical applications, focusing on justification and optimization, the issue of the need for harmonisation of units for Dose Area Product (DAP) has been raised by HERCA. Indeed, to avoid misinterpretation of the DAP information displayed on different X-ray equipments and hence, to avoid the risk of error in the transmission of information, it is essential that the value displayed and the associated unit are readily understood by the user who may be working with many other X-ray equipments from various manufacturers in different places.

In 2012, HERCA approved a proposal for harmonization of DAP units in general and in interventional radiology .For ease of interpretation of dosimetric data, HERCA proposes that that the DAP unit is:

  • the same for the same domain of use, i.e. general radiography and interventional radiology;
  • suited to the range of doses delivered depending on domain, including paediatrics procedures.

The HERCA WG MA proposes to use as DAP unit:

  • Gy×cm² for interventional radiology and mGy×cm² for general radiography.

HERCA believes that the use of harmonized DAP units can highly contribute to the objective of reducing patient dose. Consequently, two respective letters have been sent to COCIR and IEC inviting them to take this proposal into account in its future works.

For more information:

HERCA Proposal on Harmonization of DAP Units (http://www.herca.org/herca_news.asp?newsID=23)

Release of Patients after metabolic radiotherapy

Throughout Europe, tens of thousands of patients benefit from treatments by radiopharmaceuticals containing iodine-131 every year. Their numbers continue to rise.

Iodine -131, used as iodide, serves as a highly selective and very efficient treatment for patients who suffer from either benign functional thyroid disorders or from thyroid cancer. In addition, 131I in alternative chemical forms is used for the treatment of other malignant diseases such as neuro-endocrine tumors (I-131-MIBG) and primary liver cancer. (I-131-lipiodol).

Indications for these treatments are supported by an extensive evidence base so that their justification from a radiological protection point of view is well founded. Clinical practice and administration protocols however, differ from one country to another as does the practical application of the optimisation principle. This holds especially true for decisions regarding the period after which the patient can be allowed to leave hospital following treatment. A patient treated for an over active thyroid condition will be treated as an outpatient in one country, whereas an equivalent treatment in a neighbouring country may necessitate up to a week hospitalisation time. The public are aware of these differences and this has given rise to a practice known as “medical tourism”, whereby patients travel to a different country to obtain treatment which better suits their economic or social circumstances.

In this context, several international bodies have made recommendations on the maximum (residual) activity in patients going home after treatment with I-131: IAEA, EC, ICRP, …

When HERCA was created, a Working Group was set up and tasked with investigating the reasons behind the important cross border differences. In doing so, it soon became clear that they relate to differences in societal sensitivity, appraisal and values. Although the working group was unable to achieve full consensus on criteria that determine hospitalisation duration, some agreement was reached regarding general principles and approach. The results of this consensus are presented in an HERCA document entitled: “131I therapy: patient release criteria” been approved by HERCA.

According to that statement, when a patient is released from a nuclear medicine ward, a “card” or a “paper” should be given to him. This information sheet will be referred to as a “card” further on, whatever the actual form might be used. The aim of the information, given in this “card” is to contribute in assuring a better radiation protection after the release of patients treated with 131I. It can help avoiding unnecessary exposure of health professionals, undertakers and members of the public.

HERCA has agreed on a model for such a card drawn up in English. A template of such a card is available on the HERCA protected website and should be available from the National Authorities participating in HERCA (http://www.herca.org/participating_auth.asp).

For more information:

Related documents:

 

Surveillance of collective doses from medical exposures- Network on Dose Reference Levels

The activities of the WG MA include the update and maintenance of a network of expert organizations involved in population dose estimations with the purpose of encouraging national population dose estimates consistent with European guidance given in the report Radiation Protection No. 154 [1], and updating and sharing information about national initiatives and experiences on nationwide surveys of x-ray examination frequencies and patient doses in Europe.

These activities are related to the Dose Datamed 2 project (DDM2). The objectives of the Dose Datamed 2 project (DDM2) were to collect available data on the patient doses from the radiodiagnostic procedures (X-ray and nuclear medicine) in the European Union and to facilitate the further implementation of Radiation Protection 154. Visit the homepage of the Dose Data Med II project for further information: http://www.ddmed.eu

[1] European guidance on estimating population doses from medical x-ray procedures and annexes. Radiation protection no. 154. Brussels: European Commission, Directorate General for Energy and Transport, 2008. http://ec.europa.eu/energy/nuclear/radioprotection/publication/doc/154_en.zip (06.10.2008)

Cooperation with other organisations and stakeholders

HERCA collaborates with relevant international organisations stakeholders and approaches stakeholder involvement with a view on maximizing the efficiency and efficacy of its efforts.

The EC, IAEA and WHO are invited on regular basis to the meetings of the WG MA as an observer, in order to keep both parties informed on their respective activities in issues of common interest and jointly discuss and express views on the practical implementation of activities of each party, such as guidelines or legislative texts. This contributes to optimize the coordination of efforts by all parties on issues of common interest.

Additionally, HERCA and the FDA (Food and Drug Administration) of the United States of America have signed on 1 February 2012 a Memorandum of Understanding which formalizes HERCA’s and FDA’s intention to collaborate in areas of mutual interest, providing a framework for coordination and collaborative efforts between the Parties.

For more information:

http://www.herca.org/herca_news.asp?newsID=14