With the obvious patient safety implications firmly in the minds of meeting participants, standards for the U.S. ‘anesthesia workstation’ were the subject of a Nov. 17-18 meeting of the ASTM Committee on Anesthesia Workstations. This work closely parallels the European Community Standards discussed in the APSF Newsletter in Fall of 1992 (“International Standards’) and Summer of 1994 (Italy and Japan).
The Committee dealt with draft number 5, dated October 1994, and, also, written comments regarding the oxygen failure protection device clause and related test methods were presented. Clinicians on the committee expressed the opinion that the capability of medical air to flow should remain available on the machine when the oxygen failure protection (referred to as ‘fag safe’) device activates and cuts off gases from the machine.
In the section on pressure monitoring, requirements were added for a negative pressure alarm which will activate at -10 cm H20 within one second of the event occurring. In the section on protection against incorrect vaporizer output, lengthy discussion again ensued over the requirement for agent monitoring to be a mandatory component of the anesthesia workstation.
By majority vote, the committee left an amended requirement in the draft which will state that, “the anesthesia workstation shall have means for monitoring the vapor concentration of the agent either in the fresh gas or inspiratory gas.”
The document section on electronic interface requirements was again revisited with the introduction of reformulated guidelines from the ad hoc group leader. Proposed wording was tabled, and both users and manufacturers stated their positions on the issue. Several changes were presented, and the modified text was put to a vote. By majority vote on sections of the text, it was voted that ‘the manufacturer shall make available and offer as appropriate technical support related to the functioning of the communication protocol.’ Wording on availability and services without cost was deleted, and complete wording of the clause will appear in the next draft.
In a separate discussion, the ad hoc committee of infusion pump manufacturers had provided wording describing a protocol specifically formulated for infusion pumps as a component of the anesthesia workstation whereby control of the pump may be turned over to the central control of the anesthesia workstation.
The group of Automated Anesthesia Record Keeper (AARK) systems manufacturers met concurrently to define and formulate the section on automated anesthesia record keeping with its particular requirements. This group will present its proposal to the committee at the next meeting.
Future meetings of the ASTM Committee on Anesthesia Workstations were scheduled for February and April of 1995.