The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) presented two exhibits at the recent American Society of Anesthesiologists’ annual meeting as part of a continuing effort to support the goal of greater safety in anesthesia.
One of the exhibits was a component part of the cooperative study of pre-operative anesthesia equipment checkout procedures currently being conducted by the George Washington University Department of Anesthesiology and the FDA. This project, discussed in previous Newsletter articles, has been designed to measure the effectiveness of anesthesiologists’ equipment checkout and to assess their understanding of anesthesia equipment as well as to determine to what extent the FDA pre-use checklist, published in 1986, is a useful tool in the detection of machine faults.
Considerable thanks are due to the 130 anesthesiologists who contributed to the study by participating in the exercises conducted at the checklist exhibit. These participants will receive their individual results and the overall results win be presented in a journal article that will be submitted for publication.
FDA also cosponsored another scientific exhibit, entitled “Central Venous and Pulmonary Artery Catheters Complications and Avoiding Them.” This exhibit was authored by Drs. D. Paulus, R. Virmani, E. Pierce, N. Gravenstein and W. Scott (FDA/CDRH). The exhibit consisted of. (1) presentation of anatomy relative to the placement of CVCs and PA Catheters with a number of anatomic illustrations specifically developed for this purpose; (2) radiographs depicting various catheter-related complications; (3) photographs of the gross pathology of catheter related mishaps; (4) two handouts of published information on catheter complications: “Complications Associated with Central Venous Catheters: a Survey” by Dr. Scott and a generic newsletter article on CVC Complications developed by the CVC-working Group; and (5) actual operating room cases on videotape showing surgical technique-related complications. The exhibit was well received and attended by approximately 500-600 anesthesiologists.
As a follow-up to the cooperative successes at the ASA annual meeting, FDA will investigate several possible educational projects, including the journal article on validation of the checkout procedures and an exhibit highlighting the benefits of improved patient safety. In the CVC area, a videotape on possible complications of their use is being developed. FDA will keep the readers of the Anesthesia Patient Safety Foundation Newsletter informed about progress on these and related activities.