Pulse Echo Ultrasound Imaging Systems: Performance Tests and Criteria-0655AC54

1.1 Several acceptable documents on quality control of pulseecho diagnostic ultrasound systems exist, and improvements in these techniques are being made rapidly. However, these quality control procedures are of value primarily in following the performance of a given system as a function of time to detect, document, and in some cases quantify system malfunctions. With these tests many of the most critical aspects of system performance are not determined with enough general validity to indicate whether the system is performing adequately in absolute terms or even to allow meaningful comparison of two different models of ultrasound systems. Quality control tests of many performance features also are not sensitive enough to differentiate between mediocre and very good, state of the art systems; they are consistently of value on those performance features only in identifying systems which obviously are very bad. Although many narrower or less detailed standards exist or are becoming available, 1-8 what has not been available is a set of higher level performance tests with the following characteristics: testing of a sufficiently wide range of features; general enough validity for comparison of different models of units; provision of quantitative results; and availability of expected values for interpretation of results. Such a set or sets of tests would be useful in evaluation of new systems to add an objective measure of performance for decisions involving cost, safety and performance trade-offs. They should be most useful in specification and acceptance testing of new equipment as well as in determining when system performance has degraded or become outdated enough to necessitate replacement of major system components or the entire system.