Section 1
Introduction
Operator’s
Responsibility for
Patient Safety
North American Dräger anesthesia products are designed to provide the
greatest degree of patient safety that is practically and technologically
feasible. The design of the equipment, the accompanying literature, and
the labeling on the equipment take into consideration that the purchase
and use of the equipment are restricted to trained professionals, and
that certain inherent characteristics of the equipment are known to the
trained operator. Instructions, warnings, and caution statements are
limited, therefore, to the specifics of the North American Dräger design.
This publication excludes references to hazards which are obvious to a
medical professional, to the consequences of product misuse, and to
potentially adverse effects in patients with abnormal conditions. Product
modification or misuse can be dangerous. North American Dräger
disclaims all liability for the consequences of product alterations or
modifications, as well as for the consequences which might result from
the combination of North American Dräger products with products
supplied by other manufacturers if such a combination is not endorsed
by North American Dräger.
The operator of the anesthesia system must recognize that the means of
monitoring and discovering hazardous conditions are specific to the
composition of the system and the various components of the system. It
is the operator, and not the various manufacturers or suppliers of
components, who has control over the final composition and
arrangement of the anesthesia system used in the operating room.
Therefore, the responsibility for choosing the appropriate safety
monitoring devices rests with the operator and user of the equipment.
Patient safety may be achieved through a variety of different means
depending on the institutional procedures, the preference of the
operator, and the application of the system. These means range from
electronic surveillance of equipment performance and patient condition
to simple, direct contact between operator and patient (direct
observation of clinical signs). The responsibility for the selection of the
best level of patient monitoring belongs solely to the equipment operator.
To this extent, the manufacturer, North American Dräger, disclaims
responsibility for the adequacy of the monitoring package selected for
use with the anesthesia system. However, North American Dräger is
available for consultation to discuss monitoring options for different
applications.
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