Volume 7, Issue 1
Winter 2000
In This Issue...
Mammography Matters Goes Digital!
From the Director
MQSA Information Available on Website
Feature on Interpreting Physicians
Mammography Today
Inspection Results under the Final Regulations: The First Six Months
FDA Publishes Draft Guidance Document #3
Q&A
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Q&A
The following questions and answers come from FDA's Policy Guidance Help System, part of the Mammography Program website (www.fda. gov/cdrh/mammography) to help facilities comply with MQSA regulations. People with questions about MQSA guidance should refer to the Help System for approved FDA answers. FDA welcomes any questions about MQSA or its Mammography Program.
Q. Can experience obtained in a Veterans Administration (VA) facility count towards meeting the continuing experience requirement?
A. Yes. Experience obtained in VA facilities can be used to meet the continuing experience requirement. VA facilities are recognized by MQSA in that they operate under rules that are substantially equivalent to MQSA, are accredited by FDA approved accreditation bodies, and undergo annual inspections performed by MQSA inspectors.
Q. Concerning motion of tube-image receptor assembly, could you clarify what is meant by the statement that the mechanism "shall not fail in the event of power interruption"?
A. This means that if the power to the x-ray system is unexpectedly terminated during an examination, the tube-image receptor assembly will not move without operator intervention. This requirement is intended to provide additional safety for the patient in the event of power interruption during an examination and to prevent patient injury that might occur if the assembly moves.
The system must prevent motion until the operator determines that such motion is acceptable. Depending on the circumstances in each facility, the time required for the operator to safely remove the patient from the unit may vary. Therefore, the length of time required for the system to remain locked in place will also vary. However, removing the patient from the unit can usually be accomplished in a minute or less. Note: systems that lack built-in mechanisms to prevent unintended gantry motion may meet the requirement using external battery backup or mechanical mechanisms that prevent unintended motion for the amount of time it takes to remove the patient from the machine.
Q. Our mammography exams are interpreted off-site. Do we need to have a viewbox, hot light, and masking materials on-site?
A. No. Facilities are required to have these items where the exams are interpreted, but are not specifically required to have them where the exams are produced. However, FDA recommends that the above items be provided to the technologists as an aid in performing their duties.
Q. What documentation should I get when a patient, or an individual acting on the behalf of the patient, or the patient's physician requests the release of the patient's records? How long should I keep this documentation?
A. Facilities should request that the patients, physicians, or individuals acting on behalf of patients sign a release form, or submit a written release request; however, if the facility chooses to accept oral transfer requests, a notation should be made in a log. Other documentation may also be possible. Facilities should check to see if State or local laws related to release of records require additional documentation.
The documentation should be retained for at least as long as the facility would have had to keep the patient's mammograms.
