Volume 6, No. 3 • Fall 1991

FDA Preanesthesia Checklist Being Evaluated, Revised

David E. Lees, M.D.

How many anesthesiologists can face themselves in the mirror and honestly claim each morning to perform the infamous step 16 in the FDA Pre Anesthetic Checklist? Not many, the FDA believes, and most anesthesiologist would probably agree. The original checklist was not intended to supplant the manufacturer’s specific checklist, but rather offers clinicians a system to checkout any machine they might encounter. At the time the checklist project was begun in 1985, there were a large number of older machines in use which predated the original ANSI Z-79 1979 standard for anesthesia gas machines.

New Developments

Many things have happened since the FDA Checklist was first issued in 1986 with the aid of the ASA, AANA and other interested parties. A large number of these older machines have been retired as a result of withdrawn manufacturer support, state regulations, or aggressive risk management policies. Additionally, the major organizations representing clinical practitioners have promulgated similar monitoring standards and a new generation of anesthesia machines has followed with the Issuance of ASTM F1161-88 standard for anesthesia gas machines.

Presently, the FDA is revisiting the Preoperative Checklist issue in association with the AANA and ASA with an eye towards several goals:

1. A modified checklist must be easily understood by all practitioners.

2. The checklist should contain only those items critically necessary.

3. Certain steps should be modified to ensure complete and thorough performance of the checklist.

4 .An accompanying training guide must be developed that both teaches the correct test methods and also explains the importance and clinical relevance of each step.

The original checklist had 24 steps, with many having four or more sub-steps. It represented an engineering approach to the problem; present thinking sides more with a consumer (clinician) approach to the problem. A draft of a new checklist of 16 steps has been proposed which is now divided into systems that can be readily visualized and understood by the practitioner. New steps have been added and many deleted or combined with others to make a simpler document. A user approach to a checklist might contain the following sections:

  • Backup Ventilatory Equipment
  • High Pressure System
  • Low Pressure System
  • Breathing System
  • Scavenger System
  • Ventilator Monitors

New would be an initial first step that backup ventilation equipment be available; a resuscitator bag should be available if all else fails! This would replace the gratuitous inspection language contained in Step 1 of the extant checklist (ID number, hoses, cylinders, etc.). Additionally Step 19 regarding suction in the old document might be dropped; while checking to ensure adequate suction is a good work habit, it is not integral to the proper functioning of an anesthesia delivery system.

In the old checklist, nitrous oxide and gas cylinders other than oxygen had to be checked in the same manner as oxygen (old Step 5). The new checklist might concentrate only on the oxygen delivery system, as this is the critical component. Old Step II requiring the testing of central pipeline gas supplies might also be substantially reduced; one need only know the pipeline pressure

The new draft is predicated on the use of ascending bellows ventilators, which are far more popular now than models with descending bellows. It is interesting to note, however, that the ASTM F1161-88 standard did not specify the type of ventilator bellows on anesthesia gas machines.

The new checklist could eliminate old step 14, the Sniff Test. Experience has shown the test to be useless and the fear of being mistaken for a substance abuser makes most clinicians reticent to be seen breathing through their own anesthesia machines.

Old Step 16 concerning gas leaks was at worst abstruse; when understood it still remained a cumbersome exercise. An improved low pressure leak check will use a simple suction bulb that will work whether or not the machine incorporates a back check valve in the low pressure circuit.

In homage to the patient monitoring standards, the new checklist would require calibration and establishment of alarm limits for inspired oxygen monitors, oximeters, capnograph, spirometers and airway pressure alarms.

Preliminary tests of modified checklist drafts indicate users find the revised checklists to be straightforward, logical, and easily performed. Assuming that evaluation moves along in a timely manner, a new FDA-endorsed checklist can be expected in early 1992.

Those interested in contributing to the revision efforts for the FDA Checklist should contact either their ASA or AANA representatives. Alternatively, the FDA may be contacted directly by writing or calling:

Mr. Jay Crowley

Center for Devices and Radiological Health


Food and Drug Administration

1901 Chapman Drive

Rockville, Maryland 20857

(303) 443-2436

Dr. Lees, Georgetown University, Washington, D.C., is Chairman of the ASA Committee on Equipment and Facilities as well as an Associate Editor of the APSF Newsletter.