2002 OPEN FORUM Abstracts
THE ANATOMY OF A PRODUCT EVALUATION: NELLCOR N-595 AND MASIMO SET RADICAL PULSE OXIMETERS.
Mitchell Goldstein, MD1,2, Sharon Kemp, RNC, BSN2, Gilbert Martin, MD1,2, Bruce Sindel, MD1,2, M. Luchia Pernia, MD1,2, Clark Ochikubo, MD1,2, Linda Yang, MD1,2, Perpetua Lawas-Alejo,MD1,2, and Gilbert Furman, MD1,2, 1Pediatrix Medical Group, 2Queen of the Valley Campus, Citrus Valley Medical Center, West Covina, CA
Evaluation of equipment for the NICU environment is extremely important. Issues of motion artifact, low perfusion, high intensity light interference, and necessity of rapid response have confounded previous generations of pulse oximeters and required introduction of the newer generation pulse oximeters. Masimo SET has been shown to be superior in clinical trials describing its ability to reliably track saturation changes, bradycardia, resist motion artifact, and perform in situations with low perfusion. The new Nellcor N-595 has alarm management technologies in addition to changes to the core algorithm designed to enhance performance. Of primary importance in the use of these oximeters is the perception of how each performs relative to the clinical expectation of the nurses, respiratory therapists, and physicians using the technology. To demonstrate whether product improvements in the Nellcor N-595 would give rise to perceived clinical superiority to Masimo SET technology, both manufacturers were invited to demonstrate their product in a 40-bed level III NICU that had used Nellcor technology based oximeters for at least 15 years. Both manufacturers were then invited to submit their latest oximeters for clinical evaluation over the course of a week?s period of time, consecutively but non-concurrently. During that time, product representatives from each company were permitted to give in-services to the nursing and respiratory staff. The two physician groups were inserviced separately. During the trial of the Nellcor N-595, several staff members insisted on having the Masimo SET pulse oximeter continued on one patient who was ?extremely difficult?. At the conclusion of the product evaluation, each company gave separate evaluation forms with different inventory items to the nursing and respiratory staff. Physician response to the evaluation was elicited separately. A drawing for a prize was promised for respondents to the Nellcor survey. 26 responses were obtained for the Nellcor N-595; and 31, for the Masimo SET. In analyzing responses, both the Masimo SET and Nellcor N-595 elicited marks at the upper end of the checked inventories, although most of the inventories were dissimilar and not comparative. However, in reliability and accuracy of display or correlation of oximeter with other data, the Masimo SET was judged to be superior. (p<0.05) Although both manufacturers supplied areas for comments, only the Masimo SET was given separate unsolicited praise for its clinical feature set. Of the submitted written surveys, 75% exalted Masimo SET for its improved performance with motion, low perfusion, transport, sensor durability, or day-to-day clinical use. Only 12% of the staff indicated any separate positive comments after filling out the Nellcor survey. Although an improvement of the N-595 over Nellcor?s earlier models was noted, these staff members ultimately indicated a preference for Masimo SET. After both evaluation periods, in a separate survey, preference for final NICU purchase was elicited from NICU nurses, respiratory staff, and physicians (n=28). 93% of respondents preferred the Masimo SET technology. Despite improvement in monitoring promised by the Nellcor N-595, the Masimo SET Radical was selected on the strength of its clinical performance.