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U.S. Department of Health and Human Services

Radiation-Emitting Products

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October 28, 2002 is Fast Approaching... Are you ready?

This is an Archived Document - Not for Official Use

We are less than a year away from the end of the five-year equipment phase-in period. 

The final Mammography Quality Standards Act (MQSA) regulations were published on October 28, 1997. Most of the new requirements in those regulations went into effect on April 28, 1999. However, the effective date of several equipment-related standards was delayed until October 28, 2002. It was believed that these standards, while important, should be phased in over a longer period in order to minimize the cost to facilities for equipment improvements. This phase-in permitted many facilities to implement the improvements as they followed their normal equipment replacement schedule. This avoided the need to make immediate purchases of new equipment or equipment upgrades.

Facilities that have not already done so should take steps to make sure that they are in compliance with the standards listed below by October 28, 2002.

  • The unit must provide a hands-free controlled power-driven initial compression that can be activated from both sides of the patient. It must also provide a fine adjustment of the compression, operable from both sides of the patient [900.12(b)(8)(i)]. The maximum compression force for the initial power drive must be between 25 and 45 pounds [900.12(e)(4)(iii)(B)].
  • In AEC mode, the unit must maintain the optical density of the film within plus or minus 0.15 of the average optical density, as tested by a medical physicist. [900.12(e)(5)(i)(B)].
  • The unit (and entire imaging system) must resolve 11 line pair/mm (bars perpendicular to the anode-cathode axis) and 13 line pair/mm (bars parallel to the anode-cathode axis). This requirement must be met regardless of the measured focal-spot size. [900.12(e)(5)(iii)].
  • The unit must produce a radiation output rate of 800 mR/second, measured at 28kV averaged over 3 seconds, at 4.5 cm above the breast support.[900.12(e)(5)(x)].

If you have any questions about whether your equipment meets these requirements, your medical physicist is your best resource for getting those questions answered.