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

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.

Managed by © In-Touch Survey Systems, Inc.

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.

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

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

Inspected by “Others”

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

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

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%

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

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

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

# of Donor Recoveries by Type

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

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

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

Multiple Tissues Recovered/Tissue Bank

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.

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

“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.

“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.

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

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

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.

Processing

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

Tissue Banks - Specialization of Processing Services

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

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

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

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

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 1.5-2.5 Mrads 8 tissue banks use radiation to treat allografts 6 of 24 process Musculoskeletal tissue 8 of 20 process Soft Tissue

“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 ******************

Treatment Methods

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

Processors Reporting Recovery

Infectious Disease Testing

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.

Distribution

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.

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.

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.

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

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

© 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

Implant Card Return Experience % Returned % of Tissue Banks 0 - 25% 6% 26 - 50% 21% 51 - 75% 43% 76 - 100% 30% 47 Tissue Banks reporting, of which 18 report actual, tracked information.

Send inquiries to brubakers@aatb.org