66.8% of women above 40 have had a mammogram within the past two years in the U. S. It is said that 1 in 9 women will acquire breast cancer at some point with 1 in 30 dying as a result. According to Atlantis Worldwide, “50% of MRI machines being installed today will have to be replaced within 11 years. In today’s market place, it is estimated that 1 out of 5 MRI systems is older than 10 years.” Because the medical imaging field is always changing such statistics beg the question, is it time to evaluate your mammography equipment?
Read on for answers to this question based on the Mammography Quality Standards Act (MQSA) by the U.S. Food and Drug Administration Agency (FDA).
Under what circumstances mammography equipment should be evaluated?
Equipment should be checked under two circumstances: annual survey and mammography equipment evaluation as a result of various circumstances. As to whether a physicist should be on-site during adjustment, changes, or repair of equipment is a matter that needs to be looked at further. MSQA requires that mammography equipment evaluation “must be conducted whenever a new unit or processor is installed, a unit or processor is disassembled and reassembled at the same or a new location, or major components of a mammography unit or processor are changed or repaired.”
Examples of major changes/ repair:
- Replacement of an X-ray tube/ filter, collimator, AEC unit/ sensor
- Total processor overhaul
This evaluation is needed to verify that all affected functions to the mammography unit have been restored regardless of whether a full survey had been done not long ago. There is also an MQSA Alternative Standard #6 that provides for equipment evaluation after a software upgrade. The FDA considers software changes/ upgrades major repairs hence the need for evaluation. Conditions for its use can be found here. Also read Medical physicists’ involvement in equipment adjustments, changes, or repairs
Mammography tests that must be performed
The following tests must be done whether it is a replaced, repaired, or completely new processor as captured in FDAs Quality Standard Regulations 900. 12(e):
- Phantom testing
- System artifact evaluation to applicable portions-900. 12(e)(5)(ix)
- Use of appropriate chemical solutions-900. 12(b)(13)
- Dose determination as a result of change in clinical technique factors-900. 12(e)(5)(vi)
- Retention test in case darkroom integrity is compromised (recommended)-900. 12(e)(3)(i) and darkroom fog test-900. 12(e)(4)(i)
Various Equipment tests and checks you can look at.
Who must conduct mammography equipment evaluations?
Equipment evaluation must be performed by a qualified medical physicist or by another individual under direct instruction and supervision of the physicist. A physicist or their representative must fill a report on the evaluation and subsequent attestation form on the information contained in the report. Find out more on validity of kVp(s) used in the evaluation here.
The physicist must be present during evaluation whether he does it himself or through a surrogate that he must supervise. Read more on medical physicist qualification requirements as well as those for the equipment and facilities.
In the event of equipment evaluation test failure
While conducting his evaluation, a physicist may determine that a mammography unit has failed certain tests. After the necessary adjustments, changes, or repairs, the particular tests will have to be redone to confirm conformity.
Under regulation 900. 12(e)(8)(ii)(A), failure of a test means that the equipment cannot be used until re-approved again. For those under 900.12(e)(8)(ii)(B), the facility is given 30 days maximum to correct. This link explains further the timing and extent of both physicist and facility involvement in case of a failed test.
Need a refurbished Mammography System?
Choosing the right digital mammography system can be complicated. The experts at Atlantis Worldwide can help you weigh your options and choose a solution that fits your needs and your budget. We can help you understand the options available from the top brands (Hologic, General Electric and Seimens), as well as whether you should purchase a brand new system, or a refurbished one. To find out more, Contact Us Today!
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- Mammography or Breast MRI? Which is More Effective?
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- The Difference Between Digital Mammography and Tomosynthesis
- 3 Considerations When Choosing a Digital Mammo System
- Choosing A Digital Mammography System: GE vs. Hologic
Meet the author: Vikki Harmonay