Questions Key Words/Related Topics
Citation:
900.12(a)(3)(iii)(C): Before a medical physicist may begin independently performing mammographic surveys of a new mammographic modality, that is, a mammographic modality other than one for which the physicist received training to qualify under paragraph (a)(3)(i) or (a)(3)(ii) of this section, the physicist must receive at least 8 hours of training in surveying units of 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. (see Attestation - Acceptable Uses for Personnel Requirements)
The term mammographic modality refers to a technology for radiography of the breast. 21 C.F.R. 900.2(z). Examples of long available mammographic modalities are screen-film mammography and xeromammography. An example of a relatively new mammographic modality is full field digital mammography (FFDM). Personnel whose training pertained solely to screen-film mammography would be required to obtain 8 hours of training in FFDM, if they are to begin providing services or interpretations using this mammographic modality after April 28, 1999. However, if those personnel gained their experience using investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), they are considered to have met the 8 hour requirement.
New mammographic modality training can be in many forms, including, but not limited to, graduate training, special training courses, continuing medical education, and training provided by the manufacturer.
Yes. They may use this training in digital mammography to count toward the 8-hour new mammographic modality training.
Yes. They may use this CME in full-field digital mammography to count toward the 8-hour mammographic modality training.
Yes. Medical physicists who began testing and performance evaluations of investigational FFDM units (units that were used for research purposes before being approved by FDA for commercial distribution), are considered to have met the requirement for 8 hours of training with that mammographic modality. However, these medical physicists must either attest to or document that they were providing such services. Attestation should be done using an FDA attestation form (or equivalent) indicating where and when the FFDM testing and performance evaluations were performed. An example of acceptable documentation would be a letter from an appropriate official at the facility where the work was done. For more information, see acceptable documents for medical physicists in the PGHS.
Medical physicists who begin working with non-investigational FFDM units after April 28, 1999 must document that they had 8 hours of training in that mammographic modality before independently surveying FFDM units. Medical physicists must document this training using the same methods as those used to document other training (certificates, letters from the training provider, etc.). For more information, see acceptable documents for medical physicists in the PGHS.
The 8 hours of initial training related to FFDM should include practical (hands-on) training in any aspects of the use of such systems in the medical physicist’s area of responsibility that are unique to the FFDM system (such as FFDM QC testing to be performed by the medical physicist). The remainder of the 8 hours, if any, can be didactic or practical training related to any aspect of FFDM. The instruction must be provided by a qualified instructor. Such training can also be counted towards the medical physicist’s continuing education requirement.
FDA strongly recommends that medical physicists whose 8 hours of FFDM training did not include any training in QC tests related to soft copy interpretation, obtain such practical training under a qualified instructor before beginning to independently perform such tests.
For other changes that can occur in the field, such as introduction of a new quality control manual by the manufacturer or the introduction of a new model of a FFDM unit, the same general principle as described above should be followed. If the new manual or model introduces new unique features to an FFDM system that fall into the medical physicist’s area of responsibility, practical training under a qualified instructor on those features should be included in the training of any medical physicist who has not already met the 8 hour requirement. Medical physicists who have previously met this requirement should also receive training in the new unique features under a qualified instructor before beginning to evaluate them independently. Such training can also be counted towards the medical physicist’s continuing education requirement.
The individual providing the training must be a qualified instructor. A qualified instructor is defined in 21 CFR 900.2(oo) as an individual whose training and experience adequately prepares him or her to carry out specified training assignments. FDA recognizes medical physicists who have previously met the 8 hour requirement for FFDM training as qualified to instruct other medical physicists in this area.
No. Because these stereotactic biopsy systems are currently excluded from MQSA regulation, experience with these systems cannot be used to exempt someone from the 8 hours of training specific to FFDM.
Training received in digital image receptors used for stereotactic biopsy can count toward the 8 hours of training specific to FFDM if the training is essentially the same as that being given for FFDM. For example, if the medical physicist received training in the performance of a QC test for stereotactic digital image receptors, and the FFDM QC test is essentially the same as the stereotactic QC test, that training could count toward the 8 hours of training specific to FFDM.
No. Only the facility at which these personnel are actually using the FFDM unit is responsible for maintaining the documentation.
New Mammographic Modality Training
Related Topics:
Medical Physicist's Initial Training
Medical Physicist's Continuing Education