A769
October 19, 2008
2:00 PM - 4:00 PM
Room Hall E2-Area N,
Development of a Global Standard for Anaesthetic Workstations
Carl Wallroth, Ph.D., Mark Graber, Alan Green, M.S., Norman Jones, Ph.D., Dwayne Westenskow, Ph.D.
Draeger Medical AG&Co.KG, Luebeck, Germany
Introduction: Advances in the use of technology in the care and treatment of patients have been key factors in the improvement in health-care in many parts of the world. A key role of standards and regulation in this area has been to ensure that the increased potential risks associated with complexity have been more than balanced by adequate monitoring and control. This intent is transposed into device requirements for risk control such as fail safe design, alarms, monitoring, or instructions for device use.

Methods: An international standard is being developed for an anesthesia workstation that is built from individual components and intended for administering inhalational anesthesia. The standard identifies requirements for each component and associated monitoring and alarm devices. This standard applies to workstations that are continuously attended by a trained professional. For example: unacceptable risks to the patient can occur when an actuator exceeds preset values. To minimize the associated risks to acceptable levels, appropriate risk control measures have been selected.

Results: Table 1 lists the risk control measures for workstation components which are protection devices, monitoring equipment and alarm systems.[figure1]Conclusions: Patient safety should improve globally during inhalational anesthesia as workstations are designed to comply with the proposed standard, which will replace three regional standards and a series of six partial international standards.

Reference: A New Work Item Proposal has been submitted: IEC ISO 8060-2-13: Particular requirements for basic safety and essential performance of an anesthetic workstation. Voting closed February 2008, the proposal was approved and work will begin in June 2008 in London.

Anesthesiology 2008; 109 A769
Figure 1

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