Radiation-Emitting Products

2011 Scorecard Statistics

December 2011

Certified facilities, as of October 1, 2011			8,620
Certification statistics, as of December 1, 2011
	Total certified facilities / Total accredited units		8,617 / 12,287
	Certified facilities with FFDM² units / Accredited FFDM units		6,988 / 10,117
FY 2012 inspection statistics, as of December 1, 2011
	Facilities inspected		1,181
	Total units at inspected facilities		1,654
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	1.1%
		Level 2 violation	14.9%
		Level 3 violation	2.5%
	Percent of inspections with no violation		81.5%
Total annual mammography procedures reported, as of December 1, 2011¹			39,245,668

November 2011

Certified facilities, as of October 1, 2011			8,620
Certification statistics, as of November 1, 2011
	Total certified facilities / Total accredited units		8,624 / 12,301
	Certified facilities with FFDM² units / Accredited FFDM units		6,942 / 10,050
FY 2012 inspection statistics, as of November 1, 2011
	Facilities inspected		499
	Total units at inspected facilities		681
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	1.2%
		Level 2 violation	13.4%
		Level 3 violation	2.2%
	Percent of inspections with no violation		83.2%
Total annual mammography procedures reported, as of November 1, 2011¹			39,203,398

October 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of October 1, 2011
	Total certified facilities / Total accredited units		8,620 / 12,299
	Certified facilities with FFDM² units / Accredited FFDM units		6,895 / 9,976
FY 2011 inspection statistics, as of October 1, 2011
	Facilities inspected		8,328
	Total units at inspected facilities		11,481
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.5%
		Level 2 violation	13.8%
		Level 3 violation	2.6%
	Percent of inspections with no violation		83.0%
Total annual mammography procedures reported, as of October 1, 2011¹			39,098,089

September 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of September 1, 2011
	Total certified facilities / Total accredited units		8,614 / 12,277
	Certified facilities with FFDM² units / Accredited FFDM units		6,837 / 9,875
FY 2011 inspection statistics, as of September 1, 2011
	Facilities inspected		7,618
	Total units at inspected facilities		10,505
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.6%
		Level 2 violation	13.7%
		Level 3 violation	2.7%
	Percent of inspections with no violation		83.0%
Total annual mammography procedures reported, as of September 1, 2011¹			39,271,233

August 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of August 1, 2011
	Total certified facilities / Total accredited units		8,620 / 12,270
	Certified facilities with FFDM² units / Accredited FFDM units		6,766 / 9,760
FY 2011 inspection statistics, as of August 1, 2011
	Facilities inspected		6,813
	Total units at inspected facilities		9,433
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.5%
		Level 2 violation	13.6%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.4%
Total annual mammography procedures reported, as of August 1, 2011¹			38,844,222

July 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of July 1, 2011
	Total certified facilities / Total accredited units		8,624 / 12,274
	Certified facilities with FFDM² units / Accredited FFDM units		6,714 / 9,674
FY 2011 inspection statistics, as of July 1, 2011
	Facilities inspected		6,151
	Total units at inspected facilities		8,540
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.5%
		Level 2 violation	13.6%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.5%
Total annual mammography procedures reported, as of July 1, 2011¹			38,849,021

June 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of June 1, 2011
	Total certified facilities / Total accredited units		8,627 / 12,288
	Certified facilities with FFDM² units / Accredited FFDM units		6,654 / 9,571
FY 2011 inspection statistics, as of June 1, 2011
	Facilities inspected		5,365
	Total units at inspected facilities		7,440
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.5%
		Level 2 violation	13.3%
		Level 3 violation	2.4%
	Percent of inspections with no violation		83.8%
Total annual mammography procedures reported, as of June 1, 2011¹			38,882,880

May 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of May 1, 2011
	Total certified facilities / Total accredited units		8,636 / 12,305
	Certified facilities with FFDM² units / Accredited FFDM units		6,586 / 9,477
FY 2011 inspection statistics, as of May 1, 2011
	Facilities inspected		4,639
	Total units at inspected facilities		6,457
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.4%
		Level 2 violation	13.3%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.8%
Total annual mammography procedures reported, as of May 1, 2011¹			38,803,773

April 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of April 1, 2011
	Total certified facilities / Total accredited units		8,641 / 12,313
	Certified facilities with FFDM² units / Accredited FFDM units		6,523 / 9,387
FY 2011 inspection statistics, as of April 1, 2011
	Facilities inspected		3,931
	Total units at inspected facilities		5,484
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.4%
		Level 2 violation	13.4%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.7%
Total annual mammography procedures reported, as of April 1, 2011¹			39,211,644

March 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of March 1, 2011
	Total certified facilities / Total accredited units		8,636 / 12,338
	Certified facilities with FFDM² units / Accredited FFDM units		6,421 / 9,269
FY 2011 inspection statistics, as of March 1, 2011
	Facilities inspected		3,082
	Total units at inspected facilities		4,318
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.4%
		Level 2 violation	13.7%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.4%
Total annual mammography procedures reported, as of March 1, 2011¹			39,132,016

February 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of February 1, 2011
	Total certified facilities / Total accredited units		8,636 / 12,344
	Certified facilities with FFDM² units / Accredited FFDM units		6,349 / 9,163
FY 2011 inspection statistics, as of February 1, 2011
	Facilities inspected		2,447
	Total units at inspected facilities		3,427
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.4%
		Level 2 violation	13.6%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.4%
Total annual mammography procedures reported, as of February 1, 2011¹			39,090,923

January 2011

Certified facilities, as of October 1, 2010			8,652
Certification statistics, as of January 1, 2011
	Total certified facilities / Total accredited units		8,639 / 12,394
	Certified facilities with FFDM² units / Accredited FFDM units		6,275 / 9,074
FY 2011 inspection statistics, as of January 1, 2011
	Facilities inspected		1,900
	Total units at inspected facilities		2,635
	Percent of inspections where the highest noncompliance was a:
		Level 1 violation	0.5%
		Level 2 violation	13.5%
		Level 3 violation	2.5%
	Percent of inspections with no violation		83.5%
Total annual mammography procedures reported, as of January 1, 2011¹			39,028,464

¹ This number is an aggregate of the total number of procedures performed annually as reported by facilities to their accreditation bodies. 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.