The ongoing COVID-19 pandemic has prompted the U.S. Food and Drug Administration (FDA) to issue new guidelines that relax some of the regulatory requirements for breast imaging facilities under the Mammography Quality Standards Act (MQSA).
In a guidance issued December 4, the FDA explained that it would not be strictly enforcing some of the facility inspection requirements of the MQSA. The guidelines are an update to an advisory issued in March on how the agency would be enforcing the MQSA in an environment in which in-person inspections are difficult to perform due to social distancing rules.
In the new document, the FDA noted that while the MQSA requires that mammography facilities undergo an annual inspection by a medical physicist, travel restrictions imposed during COVID-19 could prevent medical physicists from reaching facilities.
"The COVID-19 public health emergency has created an unavoidable scenario where some facilities may have found it difficult to undergo an annual on-site survey due to COVID-19 infection control measures, and FDA anticipates that medical physicists may have a large backlog of facility surveys to complete once these control measures are lifted," the guidance states.
The FDA said that it will not object to mammography facilities completing their annual inspection outside the annual time period specified by the MQSA. The agency asks that surveys be completed "as soon as possible," ideally within six months of the 14-month date calculated from the date of their previous survey. The agency also asks facilities to document the reason for the delay as it relates to the COVID-19 public health emergency.
The FDA further notes that facilities that temporarily stopped performing mammography due to COVID-19 but have since resumed should be aware that they are also subject to the annual inspection requirements.
The FDA stated that it was aware that some mammography facilities could go as many as 20 months without a survey by a medical physicist due to the emergency rules. These sites are asked to contact the FDA's MQSA hotline as soon as possible to discuss their plans for completing the survey.
Finally, the FDA noted that it recognized that mammography facilities might have difficulty complying with other elements of the MQSA, such as staff training and continuing education, the relocation of mammography workstations offsite, and delaying other program assessments due to COVID-19. The FDA said that as a general rule, the agency would not object to these facilities continuing to operate as long as they do not create an undue risk to patient safety or mammography quality.
Situations that the FDA believes would create a risk to patients include having personnel who do not meet MQSA requirements interpreting and performing mammography exams, using equipment not designed for mammography, and/or failing to perform a mammography equipment evaluation after installation of a new unit or image processor.
The guidance document is available on the FDA's website.
