News | Mammography | March 25, 2020

MQSA Inspection Information Related to COVID-19

The FDA has received numerous inquiries about COVID-19 and its increasing impact on mammography facilities, and is providing information about common scenarios that may arise due to the evolving COVID-19 situation in the United States

#COVID19 #Coronavirus #2019nCoV #Wuhanvirus #SARScov2

March 25, 2020 — The Division of Mammography Quality Standards (DMQS) has received numerous inquiries regarding COVID-19 and its increasing impact on mammography facilities. The FDA has temporarily postponed domestic inspections including ones performed under contract with its state regulatory partners. The FDA press release can be found here. As such, DMQS is providing appropriate regulatory flexibility and posting the following information regarding common scenarios that may arise due to the evolving COVID-19 situation in the United States.

Facilities that choose to close

Facilities that choose to cease operations due to the coronavirus should document the period in which they are not performing mammography and ensure all required quality control testing is performed prior to resuming operations. This includes the annual medical physicist survey or other quality assurance duties which may have been required during the closure period.

Facilities that cannot schedule an annual medical physicist survey due to circumstances out of their control

If the medical physicist cannot travel to the facility to conduct the annual survey due to coronavirus travel restrictions or other circumstances out of their control, the facility should contact the FDA or State Certifying Agency to request an extension of the annual medical physicist survey if it will be conducted beyond 14 months. Extension requests should be submitted in writing and received prior to the date that marks the 14th month since the last annual survey. Additional instructions for the extension process can be found here.

Facilities that continue to operate and have non-compliance citations that are due to circumstances out of their control

For any circumstance due to coronavirus which the facility cannot control and that could lead to non-compliance citations, the facility should be prepared to provide detailed documentation. Examples may include (1) the failure of mammography personnel to meet the continuing education requirement due to cancellation of courses/meetings due to coronavirus; and (2) the failure to meet certain aspects of EQUIP due to staffing absences related to coronavirus.

DMQS will continue to monitor the situation and will issue other communications should the need arise. For any other inquiries, please contact the MQSA Hotline at 1-800-838-7715 or [email protected].

Related Coronavirus Content:

 CDRH Issues Letter to Industry on COVID-19

Qure.ai Launches Solutions to Help Tackle COVID19 

ASRT Deploys COVID-19 Resources for Educational Programs

Study Looks at CT Findings of COVID-19 Through Recovery

VIDEO: Imaging COVID-19 With Point-of-Care Ultrasound (POCUS)

The Cardiac Implications of Novel Coronavirus

CT Provides Best Diagnosis for Novel Coronavirus (COVID-19)

Radiology Lessons for Coronavirus From the SARS and MERS Epidemics

Deployment of Health IT in China’s Fight Against the COVID-19 Epidemic

Emerging Technologies Proving Value in Chinese Coronavirus Fight

Radiologists Describe Coronavirus CT Imaging Features

Coronavirus Update from the FDA

CT Imaging of the 2019 Novel Coronavirus (2019-nCoV) Pneumonia

CT Imaging Features of 2019 Novel Coronavirus (2019-nCoV)

Chest CT Findings of Patients Infected With Novel Coronavirus 2019-nCoV Pneumonia 

Find more related clinical content Coronavirus (COVID-19)

Related Content

Although it is likely that existing ultrasound systems will be repurposed to treat COVID-19 patients, growth is still expected as companies plan to ramp up production. The ultrasound systems market will therefore outpace other diagnostic imaging such as computed tomography (CT) and magnetic resonance imaging (MRI). Leading data and analytics company GlobalData forecasts the market will reach $6bn by 2028, but increased usage due to COVID-19 is anticipated have a tangible effect.
News | Ultrasound Imaging | June 05, 2020
June 5, 2020 — Although it is likely that existing...
Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration, discussed The COVID-19 Pandemic — Finding Solutions, Applying Lessons Learned, on June 1

Stephen M. Hahn, M.D., Commissioner of Food and Drugs - Food and Drug Administration

News | Coronavirus (COVID-19) | June 05, 2020
June 5, 2020 — The following speech was delivere
Chief among the myriad practical updates to minimize risks for patients and imaging personnel alike is a tiered approach for delaying both outpatient and inpatient cross-sectional interventional procedures

For procedural delays that will not adversely affect patient outcome, Fananapazir and colleagues proposed the following tiered approach for both outpatient and inpatient scenarios: urgent procedures, procedures that should be performed within 2 weeks, procedures that should be performed within 2 months, and procedures that can safely be delayed 2 or 6 months. Courtesy of American Journal of Roentgenology (AJR)

News | Coronavirus (COVID-19) | June 05, 2020
June 5, 2020 — An...
This is Figure 2 from the article in Radiology: Acute encephalopathy. A 60 year-old-man without history of seizures presenting with convulsion. (A-B) Multifocal areas of FLAIR hyperintensity in the right cerebellum (arrows in A), left anterior cingular cortex and superior frontal gyrus (arrows in B). (C-D) Restricted diffusion in the left anterior cingulate cortex, superior frontal and middle temporal gyrus (arrows in D) and right cerebellum (arrows in E), consistent with cerebellar diaschisis. F)  #COVID19

This is Figure 2 from the article in Radiology: Acute encephalopathy. A 60 year-old-man without history of seizures presenting with convulsion. (A-B) Multifocal areas of FLAIR hyperintensity in the right cerebellum (arrows in A), left anterior cingular cortex and superior frontal gyrus (arrows in B). (C-D) Restricted diffusion in the left anterior cingulate cortex, superior frontal and middle temporal gyrus (arrows in D) and right cerebellum (arrows in E), consistent with cerebellar diaschisis. F) No hemosiderin deposits in gradient echo sequences.

Feature | Coronavirus (COVID-19) | June 02, 2020 | Dave Fornell, Editor
Four recent radiology studies, from New York, Italy, Iran and China, show how...
Developed by medical AI company Lunit, Software detects breast cancer with 97% accuracy; Study in Lancet Digital Health shows that Lunit INSIGHT MMG-aided radiologists showed an increase in sensitivity

Lunit INSIGHT MMG

News | Artificial Intelligence | June 02, 2020
June 2, 2020 — Lunit announced that its artificia...
Nuclear Cardiology Optimistic About Return to Pre-COVID-19 Exam Levels. An American Society of Nuclear Cardiology (ASNC) member survey are confident nuclear cardiology volumes will return to pre-pandemic levels. #COVID19 #SARScov2
News | Nuclear Imaging | June 01, 2020
June 1, 2020 — While acknowledging the challenges their specialty is facing, more than two-thirds of respondents to a
Largest case series (n=30) to date yields high frequency (77%) of negative chest CT findings among pediatric patients (10 months-18 years) with COVID-19, while also suggesting common findings in subset of children with positive CT findings

A and B, Unenhanced chest CT scans show minimal GGOs (right lower and left upper lobes) (arrows) and no consolidation. Only two lobes were affected, and CT findings were assigned CT severity score of 2. Image courtesy of American Journal of Roentgenology (AJR)

News | Coronavirus (COVID-19) | May 29, 2020
May 29, 2020 — An investigation published open-access in the ...
The paradox is that COVID-19 has manifested the critical need for exactly what the rules require: advancement of interoperability and digital online access to clinical data and imaging, at scale, for care coordination and infection control.

The paradox is that COVID-19 has manifested the critical need for exactly what the rules require: advancement of interoperability and digital online access to clinical data and imaging, at scale, for care coordination and infection control. Getty Images

Feature | Coronavirus (COVID-19) | May 28, 2020 | By Matthew A. Michela
One year after being proposed, federal rules to advance interoperability in healthcare and create easier access for p
The opportunity to converge the silos of data into a cross-functional analysis can provide immense value during the COVID-19 outbreak and in the future

Getty Images

Feature | Coronavirus (COVID-19) | May 28, 2020 | By Jeff Vachon
In the midst of the coronavirus pandemic normal