Medical exposures directive: implications for interventional radiology.

The new European Directive on Medical Exposures (97/43/EURATOM) specifically mentions 'high dose procedures' among the areas requiring special attention. This is universally interpreted as including the interventional procedures in radiology, cardiology and many of the special procedures involving fluoroscopy in these and related areas. This communication will focus on a definition of interventional procedures. It will examine the equipment, processes and patient and staff risks involved. From this examination it will be evident that new development is rapid in these areas and proceeding at a rate that is well ahead of both supporting research and regulatory framework. It will further note that the level of patient risk which is acceptable may be higher than in many other procedures. Finally it will note where the general provisions of the new Directive must be brought to bear on this new and developing field.