Interpreting Physician New Mammographic Modality Training
Citation:
900.12(a)(1)(ii)(C): Before an interpreting physician
may begin independently interpreting mammograms produced by a new mammographic
modality, that is, a mammographic modality in which the physician has
not previously been trained, the interpreting physician shall have at
least 8 hours of training in the new mammographic modality.
Discussion:
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 received
after October 1, 1994, in certain cases.
Questions:
-
There
is a requirement for 8 hours of training for any new mammographic
modality before an interpreting physician may begin independently
interpreting mammograms produced by this new mammographic modality.
If the physician did not have this training during residency, would
it have to be category I continuing education? What about applications
training from the manufacturer of the new mammographic modality?
-
What
are examples of 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
8-hour mammographic modality training requirement?
-
Some
personnel may receive continuing medical education (CME/CEU) in full-field
digital mammography as part of the CME/CEU requirement. Can they also
use this toward meeting the initial 8-hour mammographic modality training
requirement?
-
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 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 model of FFDM by a manufacturer?
-
What
qualifications have to be met by the individual providing the training?
-
I'm
an interpreting physician 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
an interpreting physician and received training in digital image receptors
used for stereotactic biopsy. Can that training count toward the 8
hours of training specific to FFDM?
-
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 physician who wishes to become intially qualified as an interpreting
physician. I have completed my three months of intial mammography
training in screen-film mammography and read 240 mammograms during
the last six months of the residency program under direct supervision
but all of the examinations were performed on a FFDM unit. Does this
satisfy the regulatory requirement?
- I
am the physician in question 11. Once I have completed my initial
requirements, can I independently read both screen-film and FFDM examinations?