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U.S. Department of Health and Human Services

Radiation-Emitting Products

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2008 Scorecard Statistics

December 2008
November 2008
October 2008
September 2008
August 2008
July 2008
June 2008
May 2008
April 2008
March 2008
February 2008
January 2008


 

 December 2008

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of December 1, 2008
 
  Total certified facilities / Total accredited units8,818 / 13,293
 Certified facilities with FFDM2 units / Accredited FFDM units
3,993 / 6,052
FY 2009 inspection statistics, as of December 1, 2008
 
 Facilities inspected

1,278

 Total units at inspected facilities

1,807
 

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.6%
 

  Level 2 violation

17.5%

  Level 3 violation
4.9%
 Percent of inspections with no violation
 

76%

Total annual mammography procedures reported, as of December 1, 20081

36,405,898

 

 November 2008

Certified facilities, as of October 1, 2008

8,814

Certification statistics, as of November 1, 2008
 
  Total certified facilities / Total accredited units8,827 / 13,360
 Certified facilities with FFDM2 units / Accredited FFDM units
3,896 / 5,913
FY 2009 inspection statistics, as of November 1, 2008
 
 Facilities inspected

599

 Total units at inspected facilities

838

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1%

  Level 2 violation

16.5%

  Level 3 violation
4.5%
 Percent of inspections with no violation
 

78%

Total annual mammography procedures reported, as of November 1, 20081

36,339,294

 

 October 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of October 1, 2008
 
  Total certified facilities / Total accredited units8,814 / 13,404
 Certified facilities with FFDM2 units / Accredited FFDM units
3,774 / 5,729
FY 2008 inspection statistics, as of October 1, 2008
 
 Facilities inspected

8,432

 Total units at inspected facilities

12,294

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.5%

  Level 2 violation

17.1%

  Level 3 violation
6%
 Percent of inspections with no violation
 

75.4%

Total annual mammography procedures reported, as of October 1, 20081

36,287,070

 September 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of September 1, 2008
 
  Total certified facilities / Total accredited units8,827 / 13,434
 Certified facilities with FFDM2 units / Accredited FFDM units
3,626 / 5,502
FY 2008 inspection statistics, as of September 1, 2008
 
 Facilities inspected

7,691

 Total units at inspected facilities

11,239

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

16.9%

  Level 3 violation
6.1%
 Percent of inspections with no violation
 

75.6%

Total annual mammography procedures reported, as of September 1, 20081

36,199,049

 August 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of August 1, 2008
 
  Total certified facilities / Total accredited units8,835 / 13,465
 Certified facilities with FFDM2 units / Accredited FFDM units
3,515 / 5,356
FY 2008 inspection statistics, as of August 1, 2008
 
 Facilities inspected

6,945

 Total units at inspected facilities

10,186

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

16.4%

  Level 3 violation
6%
 Percent of inspections with no violation
 

76.1%

Total annual mammography procedures reported, as of August 1, 20081

36,154,201

 

 July 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of July 1, 2008
 
  Total certified facilities / Total accredited units8,845 / 13,450
 Certified facilities with FFDM2 units / Accredited FFDM units
3,366 / 5,119
FY 2008 inspection statistics, as of July 1, 2008
 
 Facilities inspected

6,228

 Total units at inspected facilities

9,195

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

16.2%

  Level 3 violation
6.1%
 Percent of inspections with no violation
 

76.3%

Total annual mammography procedures reported, as of July 1, 20081

36,132,415

 June 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of June 1, 2008
 
  Total certified facilities / Total accredited units8,869 / 13,517
 Certified facilities with FFDM2 units / Accredited FFDM units
3,264 / 4,942
FY 2008 inspection statistics, as of June 1, 2008
 
 Facilities inspected

5,436

 Total units at inspected facilities

8,058

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

15.9%

  Level 3 violation
6%
 Percent of inspections with no violation
 

76.6%

Total annual mammography procedures reported, as of June 1, 20081

35,968,645

 May 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of May 1, 2008
 
  Total certified facilities / Total accredited units8,863 / 13,534
 Certified facilities with FFDM2 units / Accredited FFDM units
3,121 / 4,723
FY 2008 inspection statistics, as of May 1, 2008
 
 Facilities inspected

4,753

 Total units at inspected facilities

7,043

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.3%

  Level 2 violation

15.9%

  Level 3 violation
6.1%
 Percent of inspections with no violation
 

76.6%

Total annual mammography procedures reported, as of May 1, 20081

35,915,399

 April 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of April 1, 2008
 
  Total certified facilities / Total accredited units8,853 / 13,518
 Certified facilities with FFDM2 units / Accredited FFDM units
2,977 / 4,506
FY 2008 inspection statistics, as of April 1, 2008
 
 Facilities inspected

4,031

 Total units at inspected facilities

5,998

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.2%

  Level 2 violation

16%

  Level 3 violation
6.2%
 Percent of inspections with no violation
 

76.6%

Total annual mammography procedures reported, as of April 1, 20081

35,842,106

 March 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of March 1, 2008
 
  Total certified facilities / Total accredited units8,871 / 13,547
 Certified facilities with FFDM2 units / Accredited FFDM units
2,847 / 4,310
FY 2008 inspection statistics, as of March 1, 2008
 
 Facilities inspected

3,284

 Total units at inspected facilities

4,917

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.3%

  Level 2 violation

16.1%

  Level 3 violation
6.1%
 Percent of inspections with no violation
 

76.5%

Total annual mammography procedures reported, as of March 1, 20081

35,787,362

 February 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of February 1, 2008
 
  Total certified facilities / Total accredited units8,861 / 13,575
 Certified facilities with FFDM2 units / Accredited FFDM units
2,743 / 4,132
FY 2008 inspection statistics, as of February 1, 2008
 
 Facilities inspected

2,549

 Total units at inspected facilities

3,844

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

15.9%

  Level 3 violation
6.3%
 Percent of inspections with no violation
 

76.4%

Total annual mammography procedures reported, as of February 1, 20081

35,653,548

 January 2008

Certified facilities, as of October 1, 2007

8,837

Certification statistics, as of January 1, 2008
 
  Total certified facilities / Total accredited units8,859 / 13,610
 Certified facilities with FFDM2 units / Accredited FFDM units
2,627 / 3,945
FY 2008 inspection statistics, as of January 1, 2008
 
 Facilities inspected

1,921
 

 Total units at inspected facilities

2,892

 Percent of inspections where the highest noncompliance was a:

 

   Level 1 violation

1.4%

  Level 2 violation

15.5%

  Level 3 violation
6.1%
 Percent of inspections with no violation
 

77.0%

Total annual mammography procedures reported, as of January 1, 20081

35,577,538


 

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.