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Question: Must the training be provided by the manufacturer? Under mqsa, the new modality training, including the training on the unique features (the technological differences and the ifu) of a particular dbt system, does not need to be provided by the manufacturer.(1). Manufacturer Specific and General dbt initial Training Programs for mqsa *Interpreting song Physician New Mammographic Modality Training 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. In addition to digital Breast Tomosynthesis (DBT) cme and dbt technology specific modality training, it is recommended that every physician new to dbt participate in hands on training prior to independent clinical interpretation. For further information, check: (1) may 22, 2015 update facility certification and Inspection (mqsa) Frequently Asked questions about dbt and mqsa training Requirements.
using any of these dbt units are subject to mqsa requirements. Fda/mqsa update may 22, 2015, question: Is digital breast tomosynthesis (DBT) a mammographic modality under mqsa? Answer: Under mqsa, there are currently not one, but three different dbt modalities. Mqsa defines a mammographic modality as a technology for radiography of the breast. As of April 2015, three dbt systems have been approved for marketing in the United States: Hologic Selenia dimensions, ge senoClaire, and. Due to the technological differences between these dbt systems, and differences in their fda-approved Indications for Use (ifu each manufacturers dbt system is currently treated as a separate mammographic modality under the mqsa definition. Facilities that perform mammography using any of these dbt modalities are subject to mqsa requirements.(1). Question: What documentation should mqsa inspectors look for in order to determine that a facility is in compliance with new mammographic modality training? (1) 8 hours of training in general dbt topics, plus training in the unique features of the specific dbt system they will use; or 8 hours of training in one specific dbt system they will use; or 8 hours of training in one dbt system.
Hologic continues to expand our family of gyn surgical products, offering a wide range of customized, minimally invasive solutions that can help you dramatically improve the lives of your patients. Contact us for additional information. The ge breast Tomosynthesis Training is an online service training course summary designed for participants who are senographe Essential trained. This course will provide information on installing and servicing the ge breast tomosynthesis option. Note: An end of course exam should be taken after completing the material and a score of 80 or greater is required to receive credit for this training. Large multicenter studies demonstrate that Digital Breast Tomosynthesis reduces call back and increases breast cancer detection. The mqsa and fda require documented training in Digital Breast Tomosynthesis prior to independent use in clinical practice. Fda/mqsa update january 1, 2017, question: Is digital breast tomosynthesis (DBT) a mammographic modality under mqsa?
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