In the wake of Hurricane Sandy, the U.S. Food and Drug Administration (FDA) has issued a guidance document for mammography facilities affected by natural disasters.
"In the event of a natural disaster, there are certain actions mammography facilities can take to help ensure that they continue to provide high-quality mammography services," the agency said. "Depending on the amount of damage sustained by a facility, its equipment, critical records, and even patient records and/or mammogram films may have been damaged or destroyed. In the aftermath of these events, your mammography facility may find it a challenge to comply with [Mammography Quality Standards Act] MQSA regulations."
The FDA advised mammography facilities damaged by natural disaster to take the following steps:
- Inform its accreditation body and state radiological health department of the situation
- Inform the MQSA Facility Hotline
- Request instructions from the accreditation body if, due to the disaster, scheduled reaccreditation can't be completed before current accreditation expires
- Record the date range for which facility records and patient records and/or mammogram films have been lost or damaged
- Inform patients if records and/or mammograms were damaged or lost
- Have a medical physicist conduct an equipment evaluation of any devices that undergo major repair, are disassembled and reassembled, or are replaced
Facilities may contact the FDA, state radiological health departments, state certifying agencies, or its accreditation body for further information if a natural disaster has affected its operations, FDA said.
