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The FDA under MQSA, Mammography Quality
Standards Act, regulates the storage requirements of breast
images. MQSA requires a facility to maintain mammography images in a
permanent medical record of the patient for a period of not less than
5 years, or not less that 10 years if no additional mammograms of the
patient are performed at the facility, or longer if mandated by State
or local law. More information about recordkeeping can be found on line
at : http://www.fda.gov/cdrh/mammography/.
All facilities must put into place an archiving infrastructure that
will support this requirement. Image storage is not new to radiology
and digital storage avoids many of the pitfalls of analog. Images will
no longer be misfiled, lost or deteriorate due to light, heat, and humidity.
Nor will there be only one original set.
The digital image will never degrade but the storage mechanism
must meet FDA standards for storage of digital images and be kept current
as technology continues to improve. Computer failure is inevitable and
is not a question of if, but more of when. Therefore, most facilities have
primary and secondary storage of digital images that are usually kept at
different locations and go as far as creating a third digital copy to ensure
that in the event of a crash all digital data can be rebuilt. |
