FDA eases inspection, quality regulations for mammography facilities struggling during COVID crisis
The U.S. Food and Drug Administration on Friday issued new recommendations to ease quality regulations for mammography facilities struggling to keep up during the ongoing pandemic.
Under the Dec. 4 policy, the FDA said it will grant some leeway to mammography centers that can’t meet requirements normally mandated under the Mammography Quality Standards Act. A chief goal of this new guidance, it noted, is to increase exam availability during the ongoing crisis.
“This guidance provides FDA’s current thinking in response to questions received from mammography facilities about compliance with the MQSA quality standards during the COVID-19 public health emergency to help facilitate the availability of mammography services in light of operational challenges during the public health emergency,” the administration said on Friday.
This new document is an update to its March guidance, which suspended in-person inspections and allowed regulatory flexibility for providers facing varying circumstances. The FDA, in May, said it was devising a “phased approach” to resuming in-person inspections.
In its update, the administration acknowledged that travel restrictions, quarantine and facility closures may have prevented providers from scheduling their annual on-site medical physicist surveys required under the MQSA.
As a result of these “unavoidable” scenarios, the FDA said it anticipates a large backlog once COVID-19 measures are lifted. With this in mind, the administration said it “generally” won’t object to facilities completing the survey beyond MQSA timelines. It does, however, encourage facilities to do so “as soon as possible,” specifically within six months of the 14-month date of their original survey and with documented information about the delay.
Groups that have not had an annual survey over the past 20 months should call the MQSA hotline as soon as possible to determine their plan. Such instances will be reviewed on a case-by-case basis, the FDA said.
Additionally, the FDA offered guidance on facilities struggling to meet additional MQSA requirements, including planned training, moving workstations off-site and medical physicist equipment evaluations.
“In light of these unavoidable challenges … FDA generally does not intend to object to the continued operation of facilities that have faced difficulty in complying with certain aspects of the quality standards when these facilities do not create an undue risk to patient safety or mammography quality and where the facility had no control over the events and actions that led to the noncompliance,” the administration said on Friday.
Read the entire document from the FDA here.
Matt joined Chicago’s TriMed team in 2018 covering all areas of health imaging after two years reporting on the hospital field. He holds a bachelor’s in English from UIC, and enjoys a good cup of coffee and an interesting documentary.