Volume 4, No. 2 • Summer 1989

FDA Study Organized to Validate Pre-Operative Checkout Recommendations

Mollyann G. March, M.D.; Jay Crowley

The failure to perform a thorough pre-use check of the anesthesia equipment has been cited as the most frequently noted single factor associated with intra-operative anesthesia critical incidents(1,2). The consistent, careful use of an anesthesia preuse checklist will greatly reduce the risk of a broad variety of anesthesia related incidents(3). However, some practitioners may have difficulty finding errors and faults in anesthesia equipment, especially faults that do not render the equipment inoperable(4).

In March, 1986, the FDA issued a pre-use checkout recommendations list to aid the clinician in the checkout of anesthesia equipment. A study is being undertaken to assess anesthesiologists’ machine checkout routines and to determine to what extent the FDA checkout recommendations assist clinicians in detecting faults in the anesthesia equipment. Utilizing the study results, the investigators will (1) measure the effectiveness of anesthesiologists’ checkout methods, (2) assess anesthesiologists’ understanding of anesthesia equipment, and (3) determine to what extent the FDA checklist is a useful tool in the detection of machine faults.

The study should be completed by the end of 1989. The investigators plan to submit the analysis of the results of the study for publication, and present them at the 1990 ASA annual meeting. For more information, please contact Mollyann G. March, M.D.; Assistant Professor; Department of Anesthesiology; George Washington University Medical Center; 901 23rd Street, Northwest; Washington, D.C. 20037.

As noted, Dr. March is from George Washington University. Mr. Crowley is a staff member of the Food and Drug Administration.

References

1. Cooper JO: Toward prevention of anesthetic mishaps. International Anesthesiology Clinics, Analysis of Anesthetic Mishaps, Pierce and Cooper (eds), Little, Brown and Company, Vol 22, No 2, 1984.

2. Cooper JB Newbower RS, Kitz RJ: An analysis of major errors and equipment failures in anesthetic management: considerations for prevention and detection. Anesthesiology, 60.34-42, 1984.

3. Spooner PA ” RR: Experiment related incidents. International Anesthesiology Clinics, Analysis of Anesthetic Mishaps, Pierce and Cooper (eds), Little, Brown and Company, Vol 22, No 2, 1984.

4. Buffington CW, Ramanathan S, Tumdorf H: Detection of anesthesia machine faults, Anesthesia and Analgesia, 63:79-82,1984.