1. TISSUE DONATION
EXPERIENCE IN THE USA
AND CANADA
11 th Congress
of ISODP
2 nd Congress of
ISTC
Buenos
Aires, Argentina
28 Nov 2011
Scott A. Brubaker, CTBS
Chief Policy Officer

2. OVERVIEW
 2007 Survey Data
 Focus on donation & recovery in the USA
 2007 vs 2010 Survey Data - CV Tissue
 Includes donation, processing & distribution in Canada &
the USA
 An Important Project & Data
 Canadian Blood Services
2

3. SURVEY
RESULTS
ARE
AVAILABLE
ON THE
AATB
WEBSITE
3

4. RECOVERY DATA – USA 2007
 Landmark survey: participation by both AATB -accredited
tissue banks and those not accredited by AATB
 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
4

5. RECOVERY DATA – USA 2007
# of tissue donors recovered for transplantation
= 30,380
 Deceased = 29,799 (98%)
 How many had an autopsy performed? 27%
 Living = 581 (2%)
# of tissue donors that were also organ donors
= 9%
# of tissue donors that were also ocular donors
= 39%
5

6. Male Female
10000
3,223
7500
5000 2,056 2,053
1,194 6,805
2500
4,176 4,026
399
348 2,583
489 946
0
Newborn 13 - 20 21 - 40 41 - 60 61 - 70 >70
- 12
AGE RANGES - ALL TISSUE DONORS – USA 2007
( # S R E P O R T E D A R E F O R O N LY 2 9 , 3 5 8 O F 3 0 , 3 8 0 D O N O R S ) 6

7. Average 395 Donors/Tissue Bank; 7 Tissue Banks exceeded 1,000 Donor recoveries;
Most recovered by one Tissue Bank= 1,438 Donors
RECOVERY DATA – USA 2007
7

8. DECEASED DONORS – USA 2007
% of Tissue Banks
# of Tissue
Tissue Type # of Donors that Recover
Banks
Tissue
Musculoskeletal 25,157 72 94
(bone, cartilage , OA)
Soft Tissue
(fascia, ligaments, tendons, 21,157 69 90
pericardium, dura, nerves)
Skin 19,854 71 92
(thin, thick, full thickness)
Cardiac 7,216 74 96
(heart for valves, thoracic aorta)
Vascular 5,153 62 81
(veins, arteries)
Vertebral Bodies 75 2 3
8

9. “CONSENT” - ALL DONATION – USA 2007
Successful Consents Obtained by: %
Tissue Bank Personnel 45
〉
Combine for 78%
of all successful
consents
OPO Personnel 33.4
Designated Screening/Consent Service 11.2
Hospital Personnel 9.1
Other 1.3
Information was not available for 12 Tissue Banks, 8 of which are accredited by AATB. 9

10. 2007 - USA
ORIGIN OF DEATH NOTIFICATION (REFERRAL)
10

11. SITES OF RECOVERY - DECEASED DONORS - USA
2003 VS 2007
Site % in 2003 % in 2007 Change
Heath Care Facility Operating Room 46.1 51.3 Up
Dedicated Tissue Recovery Suite 19.4 22.7 Up
Medical Examiner Office
9.6 9.4 Same
(Dedicated Room)
Hospital Morgue 15.6 9 Down
Funeral Home 6.2 5.4 Down
Medical Examiner Office
2.1 2.1 Same
(Open Autopsy Room)
Other 0.9 0.1 Down
11

12. 2007 - USA
INELIGIBLE DETERMINATION AT RECOVERY
Prevalence Reason %
1 Physical findings 36.6
2 Chart findings 25.4
Logistics
3 (e.g., insufficient body cooling, time 19.8
expired, body no longer available, etc.)
Related to blood sample
4 (e.g., plasma dilution, no sample 9.5
available)
5 Other 8.8
12

13. 2007 - USA
INELIGIBLE DETERMINATION AFTER RECOVERY
Prevalence Reason %
1 Infectious Disease Testing 39.1
2 Pre-processing Cultures 23.8
3 Medical History 18.7
4 Other 7.5
5 Autopsy Results 7.1
6 Behavioral Risk History 3.7
7 Tissue Quality 1.7
A few donors may have more than one reason for an ineligible determination. 13

14. AATB- ACCREDITED “CV” TISSUE BANKS
2007 VS 2010 ACTIVIT Y
 Canada
 Comprehensive Tissue Centre – Edmonton, Alberta (C)
 Héma-Québec – St. Laurent, Québec (C)
 Hospital for Sick Children – Toronto, Ontario (C)
 Regional Tissue Bank – Halifax, Nova Scotia (C)
 United States
 CryoLife – Kennesaw, Georgia (C,V)
 LifeNet Health – Virginia Beach, Virginia (C,V)
 Musculoskeletal Transplant Foundation – Costa Mesa,
California (C,V) - 2007 data only
 Northwest Tissue Services – Renton, Washington (C,V)
14

15. CANADA (C)
2007 2010 *
Recovered
Cardiac 146 148
Processed
Heart Valves 146 144
Non-valved conduits 45 31
Distributed 187 129
Aortic Valves 52 32
Aortic Segments/Conduits (non-valved) 22 6
Pulmonary Valves 89 63
Pulmonary Segments/Conduits (non-valved) 24 28
* 3 of 4 reporting
15

16. USA (C)
2007 2010
Recovered
Cardiac 7273 5470
Processed
Heart Valves 7026 4250
Non-valved conduits 4492 3419
Distributed 5472 6136
Aortic Valves 1637 1345
Aortic Segments/Conduits (non-valved) 83 64
Pulmonary Valves 1721 1547
Pulmonary Segments/Conduits (non-valved) 2031 2080
Decellularized valves 0** 651
Decellularized conduits 0* 449
* distribution began for one in 2009 and was restarted** for another in 2008 16

17. USA (V)
2007 2010
Recovered
Vascular 5953 4708
Processed
Arteries 1705 550
Veins 4312 7570
Distributed 3819 4743
Arteries 405 628
Veins (saphenous, iliac) 3414 4104
Other vascular 0 11*
* femoral veins 17

18. Details regarding the following information will
be presented tomorrow morning (0800 to
0900) during the plenary titled:
WHO’s Guiding Principles on HCTO
Transplantation and the Quest for Self-
Sufficiency
Kimberly Young – Canada
Executive Director, Organs & Tissues
Canadian Blood Services
18

19. CURRENT STATE - TISSUE DONORS
Canada - Donors per USA - Donors per
Tissue Type Million Population Million Population
Musculoskeletal 11 83
Skin 6 65
Cardiovascular 5 24
Ocular 105 135
19

20. TISSUE IN CANADA - AT A GLANCE
2008 Statistics
• Approximately 40,000
tissue allografts
transplanted annually
(surgical and dental)
• More than 20 tissue and
eye banks in Canada
(outside Quebec) - Most
attached to a hospital
• Approximately 80% of
allografts transplanted in
Canada are imported
(largely driven by dental
work and “advanced”
tissue product)
20

21. STAKEHOLDER INVOLVEMENT
Public Engagement
Expert Engagement
Expert Committees
Steering Committee
Patient Groups Strategic Plan
Government Engagement
International Consultation
Ethics Review
R&D Roundtable
21

22. PROPOSED TISSUE SYSTEM STRATEGY
A responsive and efficient Canadian system that assures
a secure supply of quality tissue by 2017
S2 - Ensure timely and
System S1 - Ensure safety and
equitable access to tissue
S3 - Be an efficient part of
Outcomes quality the health care system
products
to drive Quality and Safety Efficient and Secure Supply A Responsive, Forward -
P3 - Ensure safe tissue
Looking System
product consistent with P6 - Manage imports P9 - Ensure clear, inclusive,
specifications effectively and efficiently and timely decision making
System P8 - Partner with
P2 - Enhance surveillance P5 - Optimize recovery,
Processes and assure 100% processing, and inventory to physicians to understand
align supply with demand demand
traceability
P7 - Partner with research
P1 - Operate an P4 - Optimize donation in and industry to leverage
that enables effective quality acute care and non-acute innovations in product and
management system care settings practice
Infrastructure C1 - Ensure the
C2 - Enable effective
workforce is sustainable C3 - Optimize the
and Capability and aligned to the
data and information
infrastructure
management
strategy
22

23. brubakers@aatb.org