Report of the 2007 Annual Survey AATB-accredited Tissue Banks in Canada

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 Canada. McLean, VA: AATB, 2010.

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7 Survey Participants All are Tissue Banks in Canada accredited by AATB o All of them recover, process, store and distribute tissue o 5 Tissue Banks were inspected by agencies in 2007  3 AATB  4 ISO  1 CAP  1 Other (identity not specified)

Was your tissue bank inspected in 2007? Yes = 5 (71.4%)

Inspected by Whom

Recovery (includes referral, screening, consent, &/or recovery)

Recovery How many tissue donors did your Tissue Bank recover for transplantation? Total = 795 o Deceased = 50.3%  How many had an autopsy performed? 35% o Living = 49.7% How many tissue donors were also organ donors? 28.8% How many tissue donors were also ocular donors? 33.8%

Tissue Type*# of Donors # of Tissue Banks % of Tissue Banks that Recover That Tissue Type Musculoskeletal (bone, cartilage, OA) Soft Tissue (fascia, ligaments, tendons, pericardium, dura, nerves) Skin (thin, thick, full thickness) Cardiac (heart for valves, thoracic aorta) Vascular (veins, arteries) 000 * These definitions are used throughout the Survey Recovery - Deceased Donors

Site% Heath Care Facility Operating Room75 Dedicated Tissue Recovery Suite (own facility) 25 Hospital Morgue; Funeral Home; Other; or, Medical Examiner Office (Dedicated Room, or Open Autopsy Room) 0 Sites of Recovery - Deceased Donors

“Consent” - All Donation Associated ActivityTotal # of Tissue Banks Responding Approaches1,0263 Obtained1,0184 1st P/Donor Designation/Registry 2431 NOK or Other Consenting Person 4643 Denied2394 Unsuccessful - NOK Unavailable 63 Consent Obtained, No Recovery 2914 Only a subset of the 7 Tissue Banks answered these questions.

“Consent” - All Donation Successful Consents Obtained by:% Tissue Bank Personnel56 Hospital Personnel27 OPO Personnel16 Other1

Ineligible During Screening PrevalenceReason% 1Medical Hx Other (no COD, coroner refusal, consent, pathologist refusal, no referral) Time Restrictions Age8.1 5Behavioral Risk Hx7.3 6Infectious Disease Testing6.3 7Plasma Dilution3.4 8Trauma1.5 (Prior to going on site for recovery)

Determined Ineligible at Site of Recovery PrevalenceReason% 1Chart findings38 2Physical findings28 3 Logistics (e.g., insufficient body cooling, time expired, body no longer available, etc.) 25

Determined Ineligible After Recovery PrevalenceReason% 1Medical Hx47 2Pre-processing cultures21 3Infectious disease testing21

Processing

# of Tissue Banks = 7 o Process bone = 6 o Process soft tissue = 6 o Process skin = 4 o Process cardiac and/or vascular = 4 o Process tissue from Living Donors = 4 ? Total donors processed = 665 Average graft yield per donor = 21 Processing

# of Musculoskeletal Donors = 233 o Bone = 295 o Cartilage = 1 o Osteoarticular (fresh) = 5

# of Soft Tissue Donors = 174 o Tendons = 138 o Ligaments = 24 o Fascia = 129 o Pericardium = 5 Processing

# of Cardiac and/or Vascular Donors = 170 o Heart Valves = 146 o Non-valved conduits = 44 o Artery = 1 Processing

# of Skin Donors = 146 o Thin = 144 o Thick = 2 Processing

Use of Radiation No Tissue Banks treated tissues with radiation prior to processing (non-terminal irradiation). 1 Tissue Bank treated tissues with Gamma radiation (above 2.5 Mrads) as a final treatment. Musculoskeletal and soft tissue grafts were primarily treated with antibiotics during processing.

Infectious Disease Testing

Test# tested% RR % Confirmed Positive* HBsAg HBcAb (total) HBV NAT HCV Ab HCV NAT HIV 1/2 Ab HIV-1 NAT HIV-1/HCV NAT HTLV I/II Ab Syphilis WNV NAT CMV Ab The most frequently relied upon test to confirm a repeat-reactive syphilis screening test was FTA- ABS, which was used by 4 Tissue Banks. * Not all tissue banks perform confirmatory testing. Of those who did, these %s are from their experience.

Distribution

All 7 Tissue Banks distributed tissue from deceased donors: Soft tissue = 7 MS = 6 Cardiac = 4 Skin = 4 5 Tissue Banks distributed tissue from living donors. 99% of tissues were distributed directly to Hospitals/Medical Facilities.

Distribution (tissue from deceased donations) Graft type# of grafts reported Musculoskeletal3,051 Skin1,141 (pkgs) Soft Tissue940 Cardiac187 Vascular0

Distribution (tissue from living donors) Total grafts distributed = 270 o Surgical/Allogeneic Bone = 176 o Amniotic Membrane = 58 o Other Tissues = 28 o Autologous bone = 8

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