FDA clears the air on mammography during pandemic after ‘numerous inquiries’
The Food and Drug Administration said Thursday that it’s fielded “numerous inquiries” on breast imaging best practices during the COVID-19 outbreak and is attempting to clear the air for radiologists.
Prior to that, FDA officials had already announced that they were suspending inspections of such facilities on March 18, including any contracted at the state level. Now, the agency is outlining next steps that imaging practices need to take if they choose to shut down.
“Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration,” Commissioner Stephen Hahn MD, said in a statement. “As a nation we must do everything we can to help slow the spread of the virus and help flatten the curve of the COVID-19 pandemic.”
In its guidance issued March 19, the FDA’s Division of Mammography Quality Standards said it plans to allow “regulatory flexibility” for breast imaging providers facing varying circumstances. The agency outlined three specific scenarios, and how radiologists should respond:
1) Facilities forced to close due to COVID-19 should document the time period in which they are not performing mammography and ensure that required quality testing is performed upon reopening. That includes yearly physicist surveys, or any other quality-assurance duties needed during the closure.
2) Practices that cannot schedule an annual medical physicist survey because of travel restrictions or other circumstances beyond their control should contact the FDA or state agency for an extension. That’s only necessary, however, if the inspection will be conducted beyond 14 months. Radiology practices should submit written requests for a delay prior to hitting that anniversary.
3) Providers that stay open but have noncompliance citations because of circumstances beyond their control should keep detailed documentation. This includes imaging personnel failing to complete continuing education requirements because of travel or course cancellations, or practices falling short of EQUIP (Enhancing Quality Using the Inspection Program) requirements because of coronavirus-related staff absences.
“DMQS will continue to monitor the situation and will issue other communications should the need arise,” the FDA noted, adding that those with questions can call 800-838-7715 or email MQSAhotline@versatechinc.com.
One of the top breast cancer nonprofits in the U.S. also urged radiologists and women to delay routine imaging until later this year in response to the pandemic.
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.