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U.S. Department of Health and Human Services

Radiation-Emitting Products

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2009 Scorecard Statistics

December 2009

Certified facilities, as of October 1, 2009 8,713
Certification statistics, as of December 1, 2009  
   Total certified facilities / Total accredited units 8,687 / 12,727
  Certified facilities with FFDM2 units / Accredited FFDM units 5,154 / 7,644
FY 2010 inspection statistics, as of December 1, 2009  
  Facilities inspected 1,227
  Total units at inspected facilities 1,707
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.3%
    Level 2 violation 17.0%
    Level 3 violation 3.3%
  Percent of inspections with no violation 78.3%
Total annual mammography procedures reported, as of December 1, 20091 37,321,810

November 2009

Certified facilities, as of October 1, 2009 8,713
Certification statistics, as of November 1, 2009  
   Total certified facilities / Total accredited units 8,709 / 12,781
  Certified facilities with FFDM2 units / Accredited FFDM units 5,069 / 7,529
FY 2010 inspection statistics, as of November 1, 2009  
  Facilities inspected 574
  Total units at inspected facilities 784
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 0.5%
    Level 2 violation 15.9%
    Level 3 violation 3.0%
  Percent of inspections with no violation 80.7%
Total annual mammography procedures reported, as of November 1, 20091 37,201,371

October 2009

Certified facilities, as of October 1, 2008 8,814
Certification statistics, as of October 1, 2009  
  Total certified facilities / Total accredited units 8,713 / 12,813
  Certified facilities with FFDM2 units / Accredited FFDM units 4,972 / 7,394
FY 2009 inspection statistics, as of October 1, 2009  
  Facilities inspected 8,470
  Total units at inspected facilities 11,969
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.2%
    Level 2 violation 17.4%
    Level 3 violation 4.5%
  Percent of inspections with no violation 76.9%
Total annual mammography procedures reported, as of October 1, 20091 37,183,610

September 2009

Certified facilities, as of October 1, 2008 8,814
Certification statistics, as of September 1, 2009  
   Total certified facilities / Total accredited units 8,705 / 12,806
  Certified facilities with FFDM2 units / Accredited FFDM units 4,863 / 7,243
FY 2009 inspection statistics, as of September 1, 2009  
  Facilities inspected 7,720
  Total units at inspected facilities 10,939
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.2%
    Level 2 violation 17.3%
    Level 3 violation 4.6%
  Percent of inspections with no violation 76.9%
Total annual mammography procedures reported, as of September 1, 20091 36,997,258

August 2009

Certified facilities, as of October 1, 2008 8,814
Certification statistics, as of August 1, 2009  
   Total certified facilities / Total accredited units 8,711 / 12,844
  Certified facilities with FFDM2 units / Accredited FFDM units 4,743 / 7,087
FY 2009 inspection statistics, as of August 1, 2009  
  Facilities inspected 6,933
  Total units at inspected facilities 9,891
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.2%
    Level 2 violation 17.0%
    Level 3 violation 4.7%
  Percent of inspections with no violation 77.1%
Total annual mammography procedures reported, as of August 1, 20091 36,983,579

July 2009

Certified facilities, as of October 1, 2008 8,814
Certification statistics, as of July 1, 2009  
   Total certified facilities / Total accredited units 8,714 / 12,875
  Certified facilities with FFDM2 units / Accredited FFDM units 4,659 / 6,964
FY 2009 inspection statistics, as of July 1, 2009  
  Facilities inspected 6,259
  Total units at inspected facilities 8,957
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.2%
    Level 2 violation 17.0%
    Level 3 violation 4.5%
  Percent of inspections with no violation 77.3%
Total annual mammography procedures reported, as of July 1, 20091 36,874,475

June 2009

Certified facilities, as of October 1, 2008 8,814
Certification statistics, as of June 1, 2009  
   Total certified facilities / Total accredited units 8,743 / 12,958
  Certified facilities with FFDM2 units / Accredited FFDM units 4,567 / 6,838
FY 2009 inspection statistics, as of June 1, 2009  
  Facilities inspected 5,494
  Total units at inspected facilities 7,863
  Percent of inspections where the highest noncompliance was a:  
     Level 1 violation 1.2%
    Level 2 violation 17%
    Level 3 violation 4.5%
  Percent of inspections with no violation 77.3%
Total annual mammography procedures reported, as of June 1, 20091 36,914,920

May 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of May 1, 2009
 
   Total certified facilities / Total accredited units 8,758 / 12,999
  Certified facilities with FFDM2 units / Accredited FFDM units
4,478 / 6,719
FY 2009 inspection statistics, as of May 1, 2009
 
  Facilities inspected

4,780

  Total units at inspected facilities

6,843

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.5%

    Level 2 violation

17.5%

    Level 3 violation
4.5%
  Percent of inspections with no violation

76.9%

Total annual mammography procedures reported, as of May 1, 20091

36,879,731

April 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of April 1, 2009
 
   Total certified facilities / Total accredited units 8,764 / 13,052
  Certified facilities with FFDM2 units / Accredited FFDM units
4,371 / 6,577
FY 2009 inspection statistics, as of April 1, 2009
 
  Facilities inspected

4,042

  Total units at inspected facilities

5,841

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.2%

    Level 2 violation

17.2%

    Level 3 violation
4.6%
  Percent of inspections with no violation

77%

Total annual mammography procedures reported, as of April 1, 20091

36,830,812

 March 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of March 1, 2009
 
   Total certified facilities / Total accredited units 8,786 / 13,081
  Certified facilities with FFDM2 units / Accredited FFDM units
4,274 / 6,441
FY 2009 inspection statistics, as of March 1, 2009
 
  Facilities inspected

3,243

  Total units at inspected facilities

4,720

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.3%

    Level 2 violation

17.1%

    Level 3 violation
4.8%
  Percent of inspections with no violation

76.9%

Total annual mammography procedures reported, as of March 1, 20091

36,730,142

 February 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of February 1, 2009
 
   Total certified facilities / Total accredited units 8,800 / 13,151
  Certified facilities with FFDM2 units / Accredited FFDM units
4,192 / 6,325
FY 2009 inspection statistics, as of February 1, 2009
 
  Facilities inspected

2,507

  Total units at inspected facilities

3,657

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.3%

    Level 2 violation

17.3%

    Level 3 violation
5.2%
  Percent of inspections with no violation

76.3%

Total annual mammography procedures reported, as of February 1, 20091

36,603,161

 

 January 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of January 1, 2009
 
   Total certified facilities / Total accredited units 8,817 / 13,241
  Certified facilities with FFDM2 units / Accredited FFDM units
4,086 / 6,181
FY 2009 inspection statistics, as of January 1, 2009
 
  Facilities inspected

1,924

  Total units at inspected facilities

2,769

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.2%

    Level 2 violation

17.6%

    Level 3 violation
5%
  Percent of inspections with no violation

76.1%

Total annual mammography procedures reported, as of January 1, 20091

36,495,211


1 This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation body. Facilities are asked to disclose this information at their initial accreditation, and then at the time of their re-accreditation, which takes place once every three years. FDA began collecting these data in 1998. The aggregate does not reflect the current number of procedures performed at these facilities, but only the numbers reported by them during the three-year period prior to the current date. We have aggregated only the numbers reported by certified, non-Veterans Administration facilities.

2 FFDM - Full Field Digital Mammography unit.

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