1. Report of the 2007 Annual Survey
AATB-accredited Tissue Banks in the United States

2. When referencing information or data from this presentation, use the following citation: 2007 American Association of Tissue Banks (AATB) Annual Survey of Accredited Tissue Banks in the United States.  McLean, VA: AATB, 2010.

3. Managed by © In-Touch Survey Systems, Inc.

4. 116 Survey Participants 7 AATB-accredited tissue banks in Canada
All data is maintained in a separate report
109 tissue banks in the United States
82 are AATB-accredited (75%)
27 are not accredited by AATB (25%; all “recover”)
77 “recover” (71%)
5 completed the Recovery Section of the survey but functions may only include receiving referrals and performing some screening, and possibly obtaining consent (does not include recovery of tissue)
63 store (58%)
32 process (29%)
52 distribute (48%)
This survey did not solicit participation from the AATB-accredited Reproductive Tissue Banks or Non-Transplant Anatomical Donation Organizations.

5. Was your tissue bank inspected in 2007? Yes = 88 (81%)

6. 29 (27%) were inspected by a State agency
Inspected by whom?
59 of 109 (54%)
36 of 82 (44%)
29 (27%) were inspected by a State agency

7. Inspected by “Others”

8. “Recovery” (includes referral, screening, consent, &/or recovery)

9. Recovery Section Data
Landmark survey: participation by both AATB-accredited tissue banks and those not AATB-accredited
55 are accredited by AATB
27 are not accredited by AATB
5 perform functions leading up to, but not including, tissue recovery
77 tissue banks recovered tissue

10. Recovery
How many tissue donors did your Tissue Bank recover for transplantation? = 30,380
Deceased = 29,799 (98%)
How many had an autopsy performed? 27%
Living = 581 (2%)
How many tissue donors were also organ donors? 9%
How many tissue donors were also ocular donors? 27%

11. Average 395 Donors/Tissue Bank; 7 Tissue Banks exceeded 1,000 Donor recoveries; Most recovered by one Tissue Bank= 1,438 Donors

12. Deceased Donors Tissue Type # of Donors # of Tissue Banks
% of Tissue Banks that Recover Tissue
Musculoskeletal
(bone, cartilage , OA)
25,157 72 94
Soft Tissue
(fascia, ligaments, tendons, pericardium, dura, nerves)
21,157 69 90
Skin
(thin, thick, full thickness)
19,854 71 92
Cardiac
(heart for valves, thoracic aorta)
7,216 74 96
Vascular
(veins, arteries)
5,153 62 81
Vertebral Bodies 75 2 3

13. Deceased Donors Tissue Type*
# of Donors Recovered by AATB -accredited TBs
# of Donors Recovered by TBs not accredited by AATB
Musculoskeletal
(bone, cartilage , OA)
19,761
8,012
Soft Tissue
(fascia, ligaments, tendons, pericardium, dura, nerves)
14,341
4,848
Skin
(thin, thick, full thickness)
13,240
4,691
Cardiac
(heart for valves, thoracic aorta)
4,999
2,274
Vascular
(veins, arteries)
4,263
1,690
* these definitions are used throughout the survey

14. # of Donor Recoveries by Type

15. Sites of Recovery - Deceased Donors%
Heath Care Facility Operating Room
51.3
Dedicated Tissue Recovery Suite
22.7
Medical Examiner Office
(Dedicated Room)
9.4
Hospital Morgue 9
Funeral Home
5.4
(Open Autopsy Room)
2.1
Other
0.1

16. Sites of Recovery - Deceased Donors
% in 2003
survey
% in 2007
Change
Heath Care Facility Operating Room
46.1
51.3 Up
Dedicated Tissue Recovery Suite
19.4
22.7
Medical Examiner Office
(Dedicated Room)
9.6
9.4
Same
Hospital Morgue
15.6 9
Down
Funeral Home
6.2
5.4
(Open Autopsy Room)
2.1
Other
0.9
0.1

17. # of all Tissue Donors (#s reported are for only 29,358 of 30,380 donors)

18. Multiple Tissues Recovered/Tissue Bank

19. Recovery - Skin Skin Donors
Full-Thickness = 8,616 (from 31 Tissue Banks)
Thin = 8,223 (from 39 Tissue Banks)
Thick = 1,092 (from 12 Tissue Banks)
More than one skin type can be recovered from a donor but double-reporting expected to be low.

20. Referral - All Donation
Source
# of Referrals %
Hospital
744,212
96.32
ME/Coroner
15,110
1.96
ECF/NH/Hospice
4,080
0.53
An OPO
3,029
0.39
Funeral Home
2,286
0.30
An Eye Bank
1,684
0.22
Other
1,300
0.17
First Responders
541
0.07
Law Enforcement
213
0.03
Another Tissue Bank 93
0.01
Home 84

21. “Consent” - All Donation
Approaches
114,173
Obtained
33,604
1st P/Donor Designation/Registry
6,411
NOK or Other Consenting Person
24,418
Denied
73,484
Unsuccessful - NOK Unavailable
11,974
Consent Obtained, No Recovery
13,595
The “average Tissue Bank” makes 1,784 approaches for consent and 64% of those are denied. It obtains 601 consents and two thirds of those result in recovery.

22. “Consent” - All Donation
Successful Consents Obtained by: %
Tissue Bank Personnel 45
OPO Personnel
33.4
Designated Screening/Consent Service
11.2
Hospital Personnel
9.1
Other
1.3 〉
Combine for 78% of all successful consents
Information was not available for 12 Tissue Banks, 8 of which are accredited by AATB.

23. Ineligible During Screening
(Prior to going on site for recovery)
Prevalence
Reason % 1
Age
43.3 2
Medical Hx
41.4 3
“Other”
(many list Medical Examiner restrictions here)
8.7 4
Behavioral Risk Hx
2.5 5
Time Restrictions
1.8 6
Infectious Disease Testing
1.3 7
Plasma Dilution
0.6 8
Trauma
0.5

24. Determined Ineligible at Site of Recovery
Prevalence
Reason % 1
Physical findings
36.6 2
Chart findings
25.4 3
Logistics
(e.g., insufficient body cooling, time expired, body no longer available, etc.)
19.8 4
Related to blood sample
(e.g., plasma dilution, no sample available)
9.5 5
Other
8.8

25. Determined Ineligible After Recovery
Prevalence
Reason % 1
Infectious Disease Testing
39.1 2
Pre-processing Cultures
23.8 3
Medical Hx
18.7 4
Other
7.5 5
Autopsy Results
7.1 6
Behavioral Risk Hx
3.7 7
Tissue Quality
1.7
A few donors may have more than one reason for an ineligible determination.

26. Processing

27. Processing # of Tissue Banks = 32 Total donors processed = 49,207
Process bone (MS) = 24
Process soft tissue (ST) = 20
Process skin = 14
Process cardiac/vascular (C & V)= 4
Process tissue devices = 8
Process tissue from Living Donors = 7
Total donors processed = 49,207
4 Tissue Banks each processed >4,000 donors
Average graft yield per donor = 49

28. Tissue Banks - Specialization of Processing Services

29. Processing # of Musculoskeletal Donors = 23,466 Bone = 19,370
Cartilage = 267
Osteoarticular (fresh) = 594
Osteoarticular (frozen) = 1,271

30. Processing # of Soft Tissue Donors = 20,578 Tendons = 12,120
Ligaments = 8,635
Fascia = 7,580
Pericardium = 5,090
Nerves = 49
Dura = 12

31. Processing Cardiac + Vascular Donors = 8,826 Heart Valves = 7,026
Non-valved conduits = 4,492
Veins = 4,312
Arteries = 1,705

32. Processing # of Skin Donors = 17,120 # of Tissue Banks Thin = 8,335
Full-Thickness = 4,767
Thick = 3,392
# of Tissue Banks
Processing skin = 14
Provide fresh skin = 5

33. Use of Radiation
≈ 10% treat tissues with radiation prior to processing and treatment is usually Gamma radiation below 1.5 Mrads (or 15 kGy)
≈ 53% treat tissues with radiation as a final treatment. Gamma radiation is type most commonly used and target dose is Mrads
8 tissue banks use radiation to treat allografts
6 of 24 process Musculoskeletal tissue
8 of 20 process Soft Tissue

34. “E-beam only” also reported by 2 tissue banks:
Treatment Methods
Antibiotics only
MS - 5 tissue banks processed ≈ 118,000 grafts
ST - 3 tissue banks processed ≈ 3,600 grafts
Antibiotics + Gamma radiation
MS - 4 tissue banks processed >158,000 grafts
ST - 3 tissue banks processed ≈ 16,000 grafts
Proprietary method only
MS - 10 tissue banks processed ≈ 760,000 grafts
ST - 9 tissue banks processed ≈ 38,000 grafts
Proprietary method + Gamma radiation
MS - 6 tissue banks processed >588,000 grafts
ST - 8 tissue banks processed ≈ 58,000 grafts
“E-beam only” also reported by 2 tissue banks:
MS ≈ 86,000
ST ≈ 950
******************

35. Treatment Methods

36. Demineralized Bone Matrix (DBM)
15 Tissue Banks process DBM
Reported applications:
43.8% dental/periodontal
43.8% orthopaedics
25% neurosurgery
3.1% “other”

37. Processors Reporting Recovery

38. Infectious Disease Testing

39. Infectious Disease Testing
% RR
% Confirmed Positive*
HBsAg
0.59
4.69
HBcAb (total)
2.54
HBV NAT
0.47
HCV Ab
1.01
13.86
HCV NAT
0.69
HIV 1/2 Ab
0.18
1.72
HIV-1 NAT
0.23
HIV-1/HCV NAT
0.42
HTLV I/II Ab
0.31
3.09
Syphilis
0.34
7.31
WNV NAT
0.27
CMV Ab
47.1 † †
Total number of “donors tested” varies from test to test but was generally ≈ 49,000 per required test. Duplicate reporting is expected since total donors recovered = 30,380 (living + deceased)
* Not all tissue banks perform confirmatory testing. Of those who did, these %s are from their experience.

40. Distribution

41. 2,110,200 tissue grafts reported as distributed by these Tissue Banks; some duplicate reporting occurs with redistributed grafts by intermediaries accredited by AATB. 4 more TBs distribute but failed to report #s. These #s are not large but will be rectified in future reports.

42. Distribution (tissue from deceased donations)
Grafts sent to:
# *
Hospital/Medical Facilities
933,200
Tissue Distribution Intermediaries
514,900
Doctors/Dentists
446,594
Another Tissue Bank
33,851
Other
(mostly to a contract manufacturing establishment)
32,298
1,960,843
*all #s adjusted for grafts reported to be (re) distributed by an intermediary (not a processor). It is not known if ALL grafts distributed by intermediaries originate from AATB-accredited processing tissue banks.

43. Distribution (tissue from deceased donations)
Graft type
# of grafts reported*
Musculoskeletal
1,166,968
Tissue Devices
501,449
Skin
312,189
(>28,958 sq ft)
Soft Tissue
152,082
Cardiac
5,349
Vascular
3,592
Dura
331
2,141,960
*all #s adjusted for grafts reported to be (re) distributed by an intermediary (not a processor). It is not known if ALL grafts distributed by intermediaries originate from AATB-accredited processing tissue banks.

44. Musculoskeletal Distribution (From Deceased Donations - #s not adjusted)
“Other” reported erroneously by 15 Tissue Banks & contained mostly cortical, demin cortical, FH/HH, and traditional spine

45. Soft Tissue Distribution (From Deceased Donations - #s not adjusted)
“Other” reported as ‘devices,’ sclera, or (erroneously) patellar tendons

46. © Matthiashaas | Dreamstime.com
International
Tissue grafts/devices are distributed to 45 countries outside the US
29 (56%) of 52 US Tissue Banks distribute to other countries
© Matthiashaas | Dreamstime.com

47. Implant Card Return Experience
% Returned
% of Tissue Banks
0 - 25% 6% %
21% %
43% %
30%
47 Tissue Banks reporting, of which 18 report actual, tracked information.

48. Send inquiries to brubakers@aatb.org