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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, 20098,713
Certification statistics, as of December 1, 2009 
  Total certified facilities / Total accredited units8,687 / 12,727
 Certified facilities with FFDM2 units / Accredited FFDM units5,154 / 7,644
FY 2010 inspection statistics, as of December 1, 2009 
 Facilities inspected1,227
 Total units at inspected facilities1,707
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.3%
  Level 2 violation17.0%
  Level 3 violation3.3%
 Percent of inspections with no violation78.3%
Total annual mammography procedures reported, as of December 1, 2009137,321,810

November 2009

Certified facilities, as of October 1, 20098,713
Certification statistics, as of November 1, 2009 
  Total certified facilities / Total accredited units8,709 / 12,781
 Certified facilities with FFDM2 units / Accredited FFDM units5,069 / 7,529
FY 2010 inspection statistics, as of November 1, 2009 
 Facilities inspected574
 Total units at inspected facilities784
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation0.5%
  Level 2 violation15.9%
  Level 3 violation3.0%
 Percent of inspections with no violation80.7%
Total annual mammography procedures reported, as of November 1, 2009137,201,371

October 2009

Certified facilities, as of October 1, 20088,814
Certification statistics, as of October 1, 2009 
 Total certified facilities / Total accredited units8,713 / 12,813
 Certified facilities with FFDM2 units / Accredited FFDM units4,972 / 7,394
FY 2009 inspection statistics, as of October 1, 2009 
 Facilities inspected8,470
 Total units at inspected facilities11,969
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation17.4%
  Level 3 violation4.5%
 Percent of inspections with no violation76.9%
Total annual mammography procedures reported, as of October 1, 2009137,183,610

September 2009

Certified facilities, as of October 1, 20088,814
Certification statistics, as of September 1, 2009 
  Total certified facilities / Total accredited units8,705 / 12,806
 Certified facilities with FFDM2 units / Accredited FFDM units4,863 / 7,243
FY 2009 inspection statistics, as of September 1, 2009 
 Facilities inspected7,720
 Total units at inspected facilities10,939
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation17.3%
  Level 3 violation4.6%
 Percent of inspections with no violation76.9%
Total annual mammography procedures reported, as of September 1, 2009136,997,258

August 2009

Certified facilities, as of October 1, 20088,814
Certification statistics, as of August 1, 2009 
  Total certified facilities / Total accredited units8,711 / 12,844
 Certified facilities with FFDM2 units / Accredited FFDM units4,743 / 7,087
FY 2009 inspection statistics, as of August 1, 2009 
 Facilities inspected6,933
 Total units at inspected facilities9,891
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation17.0%
  Level 3 violation4.7%
 Percent of inspections with no violation77.1%
Total annual mammography procedures reported, as of August 1, 2009136,983,579

July 2009

Certified facilities, as of October 1, 20088,814
Certification statistics, as of July 1, 2009 
  Total certified facilities / Total accredited units8,714 / 12,875
 Certified facilities with FFDM2 units / Accredited FFDM units4,659 / 6,964
FY 2009 inspection statistics, as of July 1, 2009 
 Facilities inspected6,259
 Total units at inspected facilities8,957
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation17.0%
  Level 3 violation4.5%
 Percent of inspections with no violation77.3%
Total annual mammography procedures reported, as of July 1, 2009136,874,475

June 2009

Certified facilities, as of October 1, 20088,814
Certification statistics, as of June 1, 2009 
  Total certified facilities / Total accredited units8,743 / 12,958
 Certified facilities with FFDM2 units / Accredited FFDM units4,567 / 6,838
FY 2009 inspection statistics, as of June 1, 2009 
 Facilities inspected5,494
 Total units at inspected facilities7,863
 Percent of inspections where the highest noncompliance was a: 
   Level 1 violation1.2%
  Level 2 violation17%
  Level 3 violation4.5%
 Percent of inspections with no violation77.3%
Total annual mammography procedures reported, as of June 1, 2009136,914,920

May 2009

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of May 1, 2009
 
  Total certified facilities / Total accredited units8,758 / 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 units8,764 / 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 units8,786 / 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 units8,800 / 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 units8,817 / 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.