• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Radiation-Emitting Products

  • Print
  • Share
  • E-mail

When I perform the semiannual compression QC test, our unit’s initial power drive provides an initial compression force of 37 pounds. However, it cannot maintain that force. The force decreases to less than 25 pounds in approximately 1 second. How long does the initial power drive have to maintain a force of at least 25 pounds?

Policy Guidance Help System logo

If the initial power drive is the sole means of providing compression for this mammographic unit, the unit must maintain a compression force of at least 25 pounds for the length of time it usually takes the radiologic technologist to complete an average exposure. If, during the semiannual compression QC test, the unit cannot maintain a force of at least 25 pounds for the specified timeframe, it fails the test and must be repaired, modified or replaced. If the unit passes this test, but still loses compression force during clinical examinations (see Question 4, Application of Compression), the unit must be repaired, modified or replaced. If the unit also has fine adjustment control (required on all units as of October 28, 2002, 21 C.F.R. 900.12(b)(8)(i)(B)), the initial power drive must maintain a compression force of at least 25 pounds for the length of time it usually takes the radiologic technologist to engage the fine adjustment control. The fine adjustment control must then maintain a compression force of at least 25 pounds for the length of time it usually takes the radiologic technologist to complete an average exposure. If, during the semiannual compression QC test, the unit cannot maintain a force of at least 25 pounds for the specified timeframe, it fails the test and must be repaired, modified or replaced. If the unit passes this test, but still loses compression force during clinical examinations (see Question 4, Application of Compression), the unit must be repaired, modified or replaced.

Back Compression Device Performance- Semiannual Quality Control Tests