Subsection 11: Interventional activities under medical imaging in neuroradiology.

I.- Authorisation is only granted if the holder has an inpatient unit. II.The authorisation is only granted if the holder has on-site access at all times to: 1° For Category A sites mentioned in Article R. 6123-107, a digital interventional angiography room that meets the same anaesthetic and aseptic conditions as an operating theatre and has the means to visualise the cerebral parenchyma; 2° For Category B sites mentioned in…

The authorisation holder shall ensure that equipment exposing patients to ionising radiation is equipped with tools to optimise radiation protection for patients and staff.

I.-The medical staff required for interventional neuroradiology procedures include: 1° Doctors with proven experience and training in the practice of interventional neuroradiology procedures, certified in accordance with the procedures laid down by order of the Minister for Health, the number of which must be sufficient to ensure the continuity of care mentioned in article L. 1110-1 ; 2° At least one doctor specialising in anaesthesia and intensive care, on the…

Ongoing care and continuity of care are provided by a doctor who fulfils the conditions mentioned in 1° of I of article D. 6124-149 and a doctor specialising in anaesthesia and intensive care. The doctors referred to in the previous paragraph carry out their duties on site or on call or, where applicable, by agreement with other authorisation holders. The response time must be compatible with safety requirements. A doctor…

The patient’s care pathway is organised, including reception, the performance of the procedure and management until discharge.

Patient management procedures are defined in a protocol agreed between the medical heads of interventional neuroradiology and those of the units concerned. This protocol specifies, in particular, the number and location of beds made available, admission and discharge rules, patient management procedures and staff qualifications.

Agreements organising the emergency management of patients are concluded between the holders of the authorisation performing the interventional activity and the establishments authorised to practice emergency medicine called upon, where appropriate, to participate in the emergency management of patients received in these establishments.

I.-The holder ensures that the medical and paramedical team identifies and regularly updates the recommendations for good practice to be applied, and implements an assessment of compliance with these standards. All actions taken to improve the appropriateness of care must be identified. As part of the objective of improving practices and managing risks, the holder of the authorisation ensures that data from professional practices is collected and analysed. All complex…

The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19.

Authorisation for interventional activity using medical imaging in neuroradiology is only granted if the equipment is connected to a system for archiving and sharing images to improve the quality of care and the relevance of the procedures performed. The authorisation holder must ensure that the equipment used for exposure to ionising radiation is connected to a system for the systematic collection and archiving of dosimetric data.