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Training in radiological protection for interventionalists. Initial Spanish experience

¹ Radiology Department, Complutense University, 28040 Madrid, ² Medical Physics Service, San Carlos University Hospital, 28040 Madrid, ³ President of the Spanish Society of Vascular and Interventional Radiology, Reina Sofia University Hospital, Cordoba and ⁴ Past President of the Spanish Society of Vascular and Interventional Radiology, Severo Ochoa Hospital, Leganes, Madrid, Spain

Correspondence: E Vano

Interventional radiology uses fluoroscopy extensively to guide and document the procedures. This usually involves major radiological risk for professionals and patients. Radiological protection (RP) is an important issue in the design of the laboratories (X-ray rooms), the purchase of the imaging equipment, and the routine practice of the speciality.

In 1994 the Food and Drug Administration in USA [1] sent out Alert Notices regarding "serious X-ray induced skin injuries to patients during fluoroscopically guided procedures". In 1995, the British Institute of Radiology and the World Health Organization (WHO) [2, 3] promoted specific scientific meetings to address recommendations to improve safety during such procedures. The Council Directive 97/43/EURATOM on medical exposures highlighted these aspects in Europe [4] and considers interventional radiology (article 9) as a "special practice" involving high doses to the patient.

During 2000, the International Commission on Radiological Protection published its recommendations on this topic [5]. Also, the International Electrotechnical Commission (IEC) issued a Standard on particular requirements for the safety of X-ray equipment for interventional procedures [6]. Furthermore, the European Commission published a guideline on education and training in radiation protection for medical exposures [7] containing specific recommendations for interventional radiology.

In addition, the International Atomic Energy Agency in its recent International Conference on Radiological Protection of Patients in Diagnostic and Interventional Radiology, Nuclear Medicine and Radiotherapy, held in Malaga in 2001, included this topic as a part of the future action plan [8]. The European Commission has also included this topic in its Fifth Research Framework Programme, as a part of the DIMOND III project [9] (DIMOND, Digital Imaging: Measures for Optimizing Radiological Information Content and Dose). Important efforts have been made in the USA as well as Europe to produce training material [10–13].

One of the key issues is education and training in RP (both initial and on-going). The WHO and the European Directive (in its article 7) specifically recommend this training in RP over and above that which is required by general radiologists. The European Guideline [7] gives recommendations about the training time required (20–30 h) and the accreditation process. Interventional practices imply additional risks owing to more complex procedures with more operator time near the patient during fluoroscopic screening, and the issue of deterministic effects to the patient. RP training of the specialists helps to minimize these risks.

In Spain, a Royal Decree on Quality Criteria for Diagnostic Radiology was enacted in 1999 [14]. For interventional practices its requirements are:

1. Laboratories or fluoroscopic screening rooms specifically designed for these procedures.
   
2. Imaging systems specifically designed for interventional procedures (in compliance with International Electrotechnical Commission standards).
   
3. A system for measuring and registering doses received by patients.
   
4. An accreditation in RP (called "second level", to differentiate it from the first level which is mandatory for all the radiologists [15]) for the specialists conducting these procedures. This accreditation shall be supervised by the Health Authority.
   

The Spanish Society of Vascular and Interventional Radiology (SERVEI) cooperated fully with the Spanish Ministry of Health during the drafting of the Royal Decree. Later the Society was active in supporting the application of the Royal Decree in clinical practice, whilst fulfilling its role as a leading medical society in aspects of radiation safety in fluoroscopically guided procedures.

In June 2000, SERVEI proposed that Complutense University (Medical Physics Group), Madrid, design a pilot course with a large practical content, to be presented to the Health Authority, in order to obtain the legal accreditation referred to above. The intention was to offer this pilot course to the most senior Spanish interventional radiologists, then to decide if the duration and content could be appropriate for a wider audience, and further to establish the programme as part of the regular training for all specialists practising interventional procedures.

The proposal made by Complutense University and SERVEI was for a 20 h training course (over 2 and a half days). The programme (see Appendix) and specific educational objectives covered the items suggested by the European Guideline [7]. Several discussion sessions were included. These sessions were to be chaired by senior interventional radiologists. A final examination (comprising of a set of 50 multiple choice stems with 4 alternatives was also included. Achievement of a set minimum score was a condition of accreditation.

During the course preparation, several meetings between the lecturers and interventional radiologists allowed refinement of the content of the lectures and avoided excessive overlapping of subject matter. Some overlap of important topics was considered useful. In addition to the European Guideline [7], the document prepared by the DIMOND Group [16] was used to help define the content of different lectures.

The Health Authority (Spanish Ministry of Health) gave the accreditation to the course on June 2002 (2 years were needed to fulfil all the administrative and technical requirements). The Authority considered that the programme and planning as presented satisfied the legal conditions.

The course was held between the 4th and 6th of July, 2002 at the San Carlos University Hospital in Madrid. 18 senior interventional radiologists from 9 Autonomous Communities of Spain participated in the course. One of the practical sessions was given over to the use of the MARTIR CD-ROM (Multimedia and Audiovisual Radiation Protection Training in Interventional Radiology) [13].

All the delegates passed the examination and were accredited.

A survey was carried out at the end of the training in order to obtain information to improve the programme for future versions of the course. The results were the following:

• The course length (short/suitable/long) was considered suitable by 95% of delegates. Only one believed the course too short.
  
• The typical course score (maximum of 10 points) was 8.4.
  
• The typical lecturer score (maximum of 10 points) was 8.4.
  
• The global score of the course syllabus (maximum of 10 points) was 8.3.
  
• The documentation distributed to the delegates, consisted of a hard copy of the slides presented in the lectures. This was considered sufficient by 95% of delegates.
  
• The subjects related with "biological effects", "RP of the specialist" and "dosimetry" are to be given further emphasis in future versions of the course.
  
• 27% of the delegates stated the course could be complemented with some practical sessions in an interventional laboratory. The rest did not consider practical sessions necessary. The percentage is relatively low, probably because delegates were senior and experienced interventionalists.
  
• The usefulness of the MARTIR project CD-ROM was positively received by 100% of the attendants.
  

In conclusion, the group of senior members attending the course, representing SERVEI, considered the effort worthwhile and benefit was derived. They propose the organization of similar courses for the rest of the members of the Society and to promote improvements in RP by continuous training actions. They propose to include refresher courses on RP in the future national meetings. Finally, they also consider it appropriate to initiate a national survey on doses to the patients in interventional procedures with the aim of establishing dose reference levels for typical interventions. Similar training courses for interventional cardiologists and for other medical practitioners conducting interventional procedures shall be organized according with Spanish law. To this respect, RP-116 document [7] states that "A system for credentialing RP training programmes should be established at national or regional level. This process should be undertaken by the Regulatory Authority, with the help of Academic Institutions (Universities) and scientific or professional societies". It is to be hoped that other Member States have similar experiences in their attempt to implement the European guideline on education and training in radiation protection for interventionalists.

Appendix

Course syllabus
X-ray systems for interventional radiology (IR) (effect of additional filtration, operation of continuous and pulsed X-ray emission modes, road mapping, temporal integration and its benefits in terms of image quality, etc).

Dosimetric quantities specific for IR (dose-area product (DAP), entrance dose and entrance dose rate, correlation between skin dose and DAP, relationship between DAP and effective dose, etc).

Radiological risks in IR (deterministic effects which may be observed in IR, risks of deterministic effect induction as a function of the surface doses, relationship between received doses and deterministic effects in the lens of the eye, time intervals between irradiation and occurrence of the different deterministic effects, the required follow-up and control of patients, stochastic risks in interventional procedures and their age dependence, etc).

Radiological protection of the staff (factors which influence staff doses in IR laboratories, influence of the X-ray C-arm positioning on occupational doses, effects of using different fluoroscopy modes on occupational doses, effects of using personal protection, benefits and drawbacks of using articulated screens, importance of the suitable location of personal dosimeters, etc).

Radiological protection of patients (correlation between fluoroscopy time and number of images and dose received by patients, effects of the focus to skin distance and patient image intensifier input distance, dose reductions attainable by modifying the image rate in cine or in digital acquisition, typical examples of patient entrance dose value per image in different procedures, effect of using different magnifications in the patient dose, parameters which should be recorded in the patient history regarding the doses received, etc).

Quality assurance (QA) in IR (difference between parameters that usually do not downgrade with time and those which could require periodical control, importance of establishing simple criteria to compare doses at the patient in different situations, importance in QA programs of the periodical control of patient dose and its comparison with reference dose levels, etc).

Local and international rules for RP in IR (National and European regulations, recommendations of the ICRP and WHO, standardization documents, etc).

Optimization in IR (importance of optimization in IR radiation procedures, importance of periodical patient dose control and comparison with reference levels, etc).

Acknowledgments

This Spanish pilot course profited from the experience of the DIMOND European Programme. Authors want to thank Dr R H Corbett and Dr K Faulkner for their help in the revision of this commentary.

Received for publication August 20, 2002. Revision received November 11, 2002. Accepted for publication February 6, 2003.

References

1. U.S Food & Drug Administration (FDA). Avoidance of serious x-ray induced skin injuries to patients during fluoroscopically guided procedures. Med Bull 1994;24:7–17.
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