Section 3: Sterilisation of medical devices.

The provisions of this section apply to health care organisations with an in-house pharmacy and to health cooperation groups managing an in-house pharmacy which provide their own sterilisation of medical devices, whether they subcontract it to another health care organisation with an in-house pharmacy or another health cooperation group managing an in-house pharmacy, or entrust it to a third party.

Sterilisation is the set of operations used to obtain the sterile state of a medical device and to maintain this state. The activity of sterilising medical devices is subject to the granting of an authorisation mentioned in 10° of article R. 5126-9.

On the basis of a contract that complies with good hospital pharmacy practice, the principles of which are laid down by order of the Minister for Health, and after obtaining the opinion of the regional health agency, a health care establishment or a healthcare cooperation group may entrust one or more sterilisation operations to a third party. The draft contract is sent by registered letter with acknowledgement of receipt to…

Exceptionally, if it is temporarily no longer able to carry out one or more of the sterilisation operations, an internal-use pharmacy may entrust the performance of these operations to other internal-use pharmacies authorised to carry out such operations by the regional health agency. The Director General of this agency is immediately informed of any such organisation and of the expected duration of its implementation.

The director, the administrator of the health cooperation group or the legal representative of the establishment defines, on a proposal from the chairman of the establishment’s medical commission or the chairman of the establishment’s medical conference, a system to ensure the quality of sterilisation of medical devices in compliance with good hospital pharmacy practice and the technical standards laid down by the Minister for Health. This system : 1° Describes…

In consultation with the chair of the hospital medical committee or the chair of the hospital medical conference, the director, the administrator of the health cooperation group or the legal representative of the hospital appoints a person to be responsible for the system used to ensure the quality of sterilisation, including when all or part of the sterilisation is subcontracted. This person is responsible for the following tasks 1° Proposing,…