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U.S. Department of Health and Human Services

Radiation-Emitting Products

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2004 Scorecard Statistics

December 2004
November 2004
October 2004
September 2004
August 2004
July 2004
June 2004
May 2004
April 2004
March 2004
February 2004
January 2004

 December 2004

Certified facilities, as of October 1, 2004

9,011

Certified statistics as of December 1, 2004
 
   Total certified facilities / Total accredited units 8,999 / 13,659
  Certified facilities with FFDM2 units / Accredited FFDM units
553 / 756
FY 2005 Inspection Statistics, as of December 1, 2004
 
  Facilities inspected

1,356

  Total units at inspected facilities

2,078

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

1.8%

    Level 2 violation

21.9%

    Level 3 violation
9.7%
  Percent of inspections with no violation

66.6%

Total annual mammography procedures reported, as of December 1, 20041

32,886,194

 

 November 2004

Certified facilities, as of October 1, 2004

9,011

Certified statistics as of November 1, 2004
 
   Total certified facilities / Total accredited units 9,020 / 13,670
  Certified facilities with FFDM2 units / Accredited FFDM units
530 / 722
FY 2005 Inspection Statistics, as of November 1, 2004
 
  Facilities inspected

625

  Total units at inspected facilities

957

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.0%

    Level 3 violation
9.9%
  Percent of inspections with no violation

68.0%

Total annual mammography procedures reported, as of November 1, 20041

32,678,309

 October 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of October 1, 2004
 
   Total certified facilities / Total accredited units 9,011 / 13,652
  Certified facilities with FFDM2 units / Accredited FFDM units
508 / 686
FY 2004 Inspection Statistics, as of October 1, 2004
 
  Facilities inspected

8,623

  Total units at inspected facilities

13,019

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.3%

    Level 3 violation
8.6%
  Percent of inspections with no violation

69.0%

Total annual mammography procedures reported, as of October 1, 20041

32,398,101

 September 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of September 1, 2004
 
   Total certified facilities / Total accredited units
9,001/ 13,625
  Certified facilities with FFDM2 units / Accredited FFDM units
483 / 647
FY 2004 Inspection Statistics, as of September 1, 2004
 
  Facilities inspected

7,817

  Total units at inspected facilities

11,797

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.6%

    Level 3 violation
8.8%
  Percent of inspections with no violation

68.5%

Total annual mammography procedures reported, as of September 1, 20041

32,207,807

 

 August 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of August 1, 2004
 
   Total certified facilities / Total accredited units
9061 / 13,635
  Certified facilities with FFDM2 units / Accredited FFDM units
467 / 623
FY 2004 Inspection Statistics, as of August 1, 2004
 
  Facilities inspected

7,085

  Total units at inspected facilities

10,754

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.4%

    Level 3 violation
8.9%
  Percent of inspections with no violation

68.6%

Total annual mammography procedures reported, as of August 1, 20041

31,995,298

 

 July 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of July 1, 2004
 
   Total certified facilities / Total accredited units
9,041 / 13,662
  Certified facilities with FFDM2 units / Accredited FFDM units
448 / 595
FY 2004 Inspection Statistics, as of July 1, 2004
 
  Facilities inspected

6,543

  Total units at inspected facilities

9,936

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.4%

    Level 3 violation
9%
  Percent of inspections with no violation

68.5%

Total annual mammography procedures reported, as of July 1, 20041

31,789,173

 

 June 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of June 1, 2004
 
   Total certified facilities / Total accredited units
9,047 / 13,639
  Certified facilities with FFDM2 units / Accredited FFDM units
427 / 565
FY 2004 Inspection Statistics, as of June 1, 2004
 
  Facilities inspected

5,882

  Total units at inspected facilities

8,941

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2%

    Level 2 violation

20.5%

    Level 3 violation
9.1%
  Percent of inspections with no violation

68.4%

Total annual mammography procedures reported, as of June 1, 20041

31,752,978

 

 May 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of May 1, 2004
 
   Total certified facilities / Total accredited units
9,062 / 13,645
  Certified facilities with FFDM2 units / Accredited FFDM units
414 / 541
FY 2004 Inspection Statistics, as of May 1, 2004
 
  Facilities inspected

5,212

  Total units at inspected facilities

7,976

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2%

    Level 2 violation

20.6%

    Level 3 violation
9.1%
  Percent of inspections with no violation

68.3%

Total annual mammography procedures reported, as of May 1, 20041

31,540,553

 April 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of April 1, 2004
 
   Total certified facilities / Total accredited units
9,079 / 13,643
  Certified facilities with FFDM2 units / Accredited FFDM units
400 / 520
FY 2004 Inspection Statistics, as of April 1, 2004
 
  Facilities inspected

4,491

  Total units at inspected facilities

6,883

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.6%

    Level 3 violation
9.0%
  Percent of inspections with no violation

68.3%

Total annual mammography procedures reported, as of April 1, 20041

31,601,572

 March 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of March 1, 2004
 
   Total certified facilities / Total accredited units
9,099 / 13,654
  Certified facilities with FFDM2 units / Accredited FFDM units
379 / 497
FY 2004 Inspection Statistics, as of March 1, 2004
 
  Facilities inspected

3,689

  Total units at inspected facilities

5,621

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.1%

    Level 2 violation

20.4%

    Level 3 violation
9.2%
  Percent of inspections with no violation

68.3%

Total annual mammography procedures reported, as of March 1, 20041

31,520,148

 February 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of February 1, 2004
 
   Total certified facilities / Total accredited units
9,107 / 13,656
  Certified facilities with FFDM2 units / Accredited FFDM units
365 / 475
FY 2004 Inspection Statistics, as of February 1, 2004
 
  Facilities inspected

3,021

  Total units at inspected facilities

4,600

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.2%

    Level 2 violation

20.7%

    Level 3 violation
9.2%
  Percent of inspections with no violation

67.9%

Total annual mammography procedures reported, as of February 1, 20041

31,230,581

 

 January 2004

Certified facilities, as of October 1, 2003

9,114

Certified statistics as of January 1, 2004
 
   Total certified facilities / Total accredited units
9,117 / 13,652
  Certified facilities with FFDM2 units / Accredited FFDM units
345 / 451
FY 2004 Inspection Statistics, as of January 1, 2004
 
  Facilities inspected

2,268

  Total units at inspected facilities

3,477

  Percent of inspections where the highest noncompliance was a:

 

     Level 1 violation

2.3%

    Level 2 violation

21.2%

    Level 3 violation
9.2%
  Percent of inspections with no violation

67.3%

Total annual mammography procedures reported, as of January 1, 20041

31,045,362


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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