High-flow laparoscopic insufflators.
In this Update of our July 1995 Evaluation (Health Devices 24[7]), we tested three high-flow laparoscopic insufflators not covered in the original study. In this issue, we are again using the Product Profile Evaluation format that we introduced in our August 1996 (25[8]) Update Evaluation of automated external defibrillators; see the inset on page 14 for a detailed explanation of this new format. In brief, we evaluated the three new units using the same criteria and test methods as in the July 1995 study and rated and ranked the units according to the same overall scheme. Because our criteria and test methods have not changed since the original study, we have not repeated them in this issue; readers should refer to the July 1995 issue for that information. Instead, in a series of Product Profiles, we present the characteristics, test results, and ratings for each newly evaluated unit individually. Following the profiles, a comprehensive Conclusions section details how the newly evaluated units compare with those evaluated in our original study. One of the units evaluated in this issue is rated Acceptable. The other two are rated Conditionally Acceptable because of their inability to provide adequate pressure relief; a secondary gas source should not be applied in the pneumoperitoneum while these units are in use. Of the 16 units we have evaluated to date, nine are rated Acceptable and seven are rated Conditionally Acceptable.
D004867:Equipment Design; D004868:Equipment Failure; D006801:Humans; D007327:Insufflation / Q000295:instrumentation*; D020706:Laparoscopes; D011027:Pneumoperitoneum / Q000517:prevention & control; D013673:Technology Assessment, Biomedical