Using a Phantom while Sensitometer is being serviced
While a sensitometer is being serviced can a Phantom be used instead?Conducting the daily processor QC tests when the sensitometer is not available.
MQSA and the FDA have approved the use of a mammographic phantom for daily processor QC in the absence of a sensitometer for a maximum period of two weeks. This is acceptable for daily processor QC while the sensitometer is in for service.
This alternative standard was approved on October 18, 1999 and was made retroactive to April 28, 1999. The alternative to sensitometric-densitometric testing of processor performance can be used for a period of two weeks when the facility's sensitometer is unavailable. This alternative is based on evaluating a phantom image through measurements described in 21 CFR 900.12(e)(1) and (2).