Title II: Sanitary equipment

The authorisation holder must ensure, in the context of exposure to ionising radiation, that staff and patients have access to the tools needed to optimise radiation protection. A dedicated echocardiograph must be immediately accessible from the interventional cardiology room.

The authorisation holder organises the patient’s care pathway, which in particular includes the patient’s reception, the performance of the interventional procedure and care up to and after discharge. When treating a child, the authorisation holder facilitates the presence of the parents in the hospital sector.

Protocols organising the management of patients are drawn up between the doctors performing interventional activities and, where applicable, the other doctors involved in this management, without prejudice to the provisions of articles D. 6124-91 to D. 6124-102. These protocols ensure the continuity of care provided for in article L. 1110-1.

Agreements organising the emergency management of patients are concluded between the authorisation holders performing interventional activities and the establishments authorised to practice emergency medicine called upon, where applicable, to participate in the emergency management of patients received in these establishments. These agreements specify in particular the procedures for first aid during the emergency management of patients with a suspected acute coronary syndrome. The “adult ischaemic and structural heart disease” activity…

I.-The registration holder must ensure that the medical and paramedical team identifies and regularly updates the recommendations for good practice to be applied, and sets up a system for assessing compliance with these standards. The registration holder must identify all the actions to be taken to improve the appropriateness of care. The registration holder must ensure that data from professional practice is collected and analysed with a view to improving…

The authorisation holder is subject to the obligation of quality assurance defined in I of Article L. 1333-19 and in Article R. 1333-70.

Authorisation for interventional activity using medical imaging in cardiology may only be granted if the equipment is connected to a system for archiving and sharing images in order to improve the quality of care and the relevance of the procedures performed. The holder of the authorisation, with the exception of holders of the authorisation for rhythmology mention A mentioned in article R. 6123-130, ensures that the equipment used for exposure…

I.-An interventional procedure under medical imaging in cardiology may only be performed, including in an emergency, with the participation of at least: 1° One doctor with proven training in the practice of interventional procedures under medical imaging in cardiology of the type concerned; a second doctor will intervene without delay, if necessary; 2° One medical auxiliary for rhythmology mention A mentioned in article R. 6123-130 and, for other activities, two…

I.-Without prejudice to the provisions of articles D. 6124-91 to D. 6124-102, the holder of the authorisation for interventional cardiology imaging activities shall put in place a formalised organisation describing, depending on the situation, the indications and procedures for intervention by one or more doctors specialising in anaesthesia-intensive care in conjunction with the doctors on the interventional medical team, in order to ensure the safety of the treatment. II.-When the…

The holder of the authorisation guarantees, 24 hours a day, every day of the year: 1° For Rhythmology modality A, the presence on site or on call of a doctor specialising in cardiovascular medicine; 2° For Rhythmology modality B, C or D mentioned in Article R. 6123-130, the presence on site or on call of a doctor specialising in cardiovascular medicine with proven training in interventional rhythmology; 3° For the…