900.12(a)(2)(iii)(E): Before a radiologic technologist may begin independently performing mammographic examinations using a mammographic modality other than one of those for which the technologist received training under paragraph (a)(2)(ii)(C) of this section, the technologist shall have at least 8 hours of continuing education units in the new modality.
Copies of certificates earned or other documentation from the training provider will suffice for the new mammographic modality training. FDA will continue to accept a limited form of attestation for CME/CEU received after October 1, 1994, in certain cases.
- What are examples of new mammographic modalities? What types of training would be acceptable as training in new mammographic modalities?
- Some personnel may receive some training in full-field digital mammography as part of their initial qualifications. In addition to counting toward their initial requirements, can this training also be applied to the eight hour new modality training requirement?
- Some personnel may receive continuing medical education in full-field digital mammography as part of the CME/CEU requirement. Can they also use this toward meeting the initial eight hour new modality training requirement?
- I met all the radiologic technologist initial requirements prior to April 28, 1999, exempting me from the increased initial requirements found in 900.12(a)(2)(ii) of the final regulations including the 8 hours of training in each mammographic modality used. Does that mean that I am also exempt from the similar requirement found in 900.12.(a)(2)(iii)(E)?
- Can experience obtained using investigational Full Field Digital Mammography (FFDM) units count toward the 8 hour mammographic modality training requirement?
- Are there any requirements for the content of the FFDM training and are they affected in any way by the changes in the field such as the publication of a new QA manual, FDA approval of soft copy interpretation, or the introduction of a new FFDM model by a manufacturer?
- What qualifications have to be met by the individual providing the training?
- I'm a radiologic technologist and worked with stereotactic biopsy systems with digital image receptors prior to 4/28/99. Am I considered to have met the 8 hours of training specific to FFDM?
- I'm a radiologic technologist and received training in digital image receptors used for stereotactic biopsy. Can that training count toward the 8 hours of training specific to FFDM?
- What is the training requirement for a QC technologist working with digital units?
- We do not have an FFDM unit at our facility, however, some of our personnel use an FFDM unit at another facility. Are we responsible for maintaining documentation showing that these people have received their initial training in the new mammographic modality?
- I am a technologist who wishes to become initially qualified as a radiologic technologist. I completed my 40 hours of initial mammography training in screen-film mammography and performed 25 mammograms under direct supervision but all the examinations were performed on a full field digital mammographic unit. Does this satisfy the regulatory requirement?
- I am a technologist who wishes to become initially qualified as a radiologic technologist. I completed 27.5 hours of initial mammography training in screen-film mammography and performed 25 mammograms under direct supervision. I wish to count the time spent performing these mammograms toward the 40 hour requirement. All of the examinations were performed on a full field digital mammographic unit. Is this acceptable and am I qualified to independently perform both screen-film and FFDM examinations?