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Applicable Statutes and Regulations |
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Over recent years, numerous official decisions
(laws, decrees and circulars) have reinforced regulations in order
to better ensure the safety of patients in operating theatres.
Laws, decrees and orders are imposed on public and private hospitals,
and other medical institutions. The circulars are to specify the interpretation
of the laws and decrees but do not have any legal value as such. The
recommendations and good practices appended to the circulars are not
enforceable but bind the public servants responsible for verification
and inspection who must refer to these..
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| Recall of the main official
decisions concerning the safety of patients in operating theatres |
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It lists the precautions to be taken in respect
to woven fabrics when washing and sterilising to reduce the risk of
the transmission of the Creutzfedt-Jacob disease.
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concerning the implementation of a quality system
and the management of the procedure relating to the sterilisation of
medical devices in hospitals and other medical institutions. The requirements
of traceability, quality and result announced by this circular are
exacting since they place the sterilisation department of a hospital
or other medical institution at the same level as a certification establishment.
Consequently, the premises, staff and equipment must meet very exacting
quality criteria where no half measures will be acceptable.
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provides for the creation in France of an accreditation
system for hospitals or other medical institutions
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concerns the non re-use of single-use sterile medical
devices (DM) in private or public hospitals or other medical institutions.
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relating to the technical conditions of the functioning of
hospitals and other medical institutions in respect to the practice
of anaesthesia and modifying the code of public health: "the table
fixing the planning of operations shall be drawn up… taking into
account, in particular, requirements regarding hygiene, safety and
organisation of the functioning of the operating sector.
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Over and above these official decisions concerning
organisation in the operating theatres, the different regulations concerning
medical devices have underlined the importance of garments and drapings
both for the users and the operated patients.
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