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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 units8,999 / 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 units9,020 / 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 units9,011 / 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.