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EC Directive2004/23/ECSolid TissueBone- Corneas-Heart Valves

Definition of a TissueEstablishment• Tissue Establishment: a tissue bank ora unit of a hospital or another bodywhere activities of processing, storageor distribution of human tissues andcells are undertaken. It may also beresponsible for procurement or testingof tissues and cells.Directive2004/23/EC.

USA:Americal Association of Tissue Banks• Large active membership throughout theUSA.Provide standards and work with Governmentagencies for the advancement of safety andquality issues in Banking.Validation and Accreditation programme forBanks.• Standards for Tissue Banking 2003.

UK: British Association forTissue Banking.• Active in the development of standardsfor tissue banking with EC workingparties and nationally working the DoHtowards an initial peer review system ofauditing and accrediting affiliated banks.• The Code of Practice 2001 Standardsfor Tissue Banking 2002 & 2003

Europe: European Associationof Tissue Banks:• Developed European standards for TissueBanking.These are not legislative or recommendationsbut guidelines for minimum standards.Large variation over the countries.Input into EC Tissue directive.• EATB/EAMST Common Standards 2003

Sources of Tissue• Cadaveric Donors.• Living Donors

Cadaveric Banking…• Cadaveric retrieval: None in Ireland.Bone: long bones, iliac crest, ribs, pelvis,mandible, spinal bodies.Soft Tissue:Tendons, ligaments, FasciaLata.Heart Valves. VeinsEyesSkin

Surgical Bone Banking• Living donors undergoing surgicalprocedure that involves the amputationof bone.

Surgical Bone Bank….• Removal of the femoral head duringTotal Hip Arthroplasty,Femoral condyles and tibial plateau inTotal Knee Arthroplasty, , andSections of rib or vertebral body duringspinal surgery.Most common: femoral head banking.

Cappagh Bone Bank

Donor selection• The selection of the donor is pivotal in theinitial prevention of infection transmission.• International guidelines and standards.• Exclusion criteria:EC, BATB, AATB, EATB, EAMST, IBTS.Existing EC and Proposed Irish legislation.

Donor Selection andScreening• History review• Face to face interview for History takingand Informed Consent to donation.• Pre-operative infection screening• Screening for Viral markers• X-ray review• Intra-operative opinion on bone aspotential graft

Serology screening Tests• HBsAganti-HBcHCVanti HIV 1&HIV 2anti-HTLV 1 & HTLV2 andSyphilisAll tests repeated at 180 days follow-up screen.

Exclusion Criteria• Evidence of significantactive infection• History of malignancy• Evidence of clinical viralhepatitis, syphilis, HIVinfection or high riskcategory• vCJD risk orneurological disorders• Autoimmune diseases.• Tuberculosis• Brucellosis• Human derivedHormone treatment/transplant• Travel/ residencerelated infection risk• Other… Bone/ GraftQuality issues- e.g.AVN, Pagets

Initial Exclusions: pre-operative• Any infection 56• T. B. 134• Brucellosis 9• Malaria 19• UK residence 53• Transfused 56• Cognitiveimpairment 46• Rheumatoid 210• Malignancy 252• Poor bone quality415• Femoral headresurfacing269• Refused/ reluctant19

Retrieval Rate 1996-2003• Total Hip Arthroplasty 6300• Femoral heads Harvested 2450• Harvest rate (average) 35.5%

Procurement Protocol• Femoral head removed as part of thePrimary Total Hip Arthroplasty• The Head/ bone is prepared• Microbiological specimens taken• Bone Packed and sealed• All within the laminar air flow

Microbiological Assay:Specimens• 6 bone chips- cancellous and cortical boneand two culture swabs.• The head and two chips into smaller bonecontainer• This is double packed in larger container• The remaining bone chips are divided into 2specimen jars.• The 2 swabs and one set of chips are sent forculture.• The head and chip set plus spare one set ofchips are placed in the quarantine storage.

Microbiological Assay:Specimens• No further testing of the bone is carried out ifinitial assay report shows no growth at 14days.• The stored (archived) bone chips are sent forfurther evaluation and repeat culturing whenthe report indicates a growth in eithermedium of any specimen.

Microbiological Assay:Evaluation• Consultant Microbiologist evaluate allpositive reports, including subsequentresults of the stored bone chips• Acceptance or rejection of the donation.• This is only one aspect of the continuingdonor/ donation suitability evaluation.

Results of MicrobiologicalAssay• Total assayed: 1992• Report of no growth 1798• Positive/ inconclusive culture report: 159Comment: initial method of culturing lead toequivocal results on 65 donations. Thesewere irradiated at 25 kGy.

Results of SubsequentCultures• 2 nd set of chips negative 72Results acceptable.• 2 nd set of chips positive 22 (0.01%)Results unacceptable.DONATION DISCARDED

Irradiated Bone Graft• 65 irradiated and issued for implant• 61 implanted (4 discarded – not clinicallyindicated or required- unsuitable for return toBone Bank storage)• Culture swabs taken at implantation 55• Results: 54 negative, 1x reported as laboratorycontaminant (no clinical significance)• No swabs taken or reports available on 6implanted grafts.

Quarantine• Standard living donor protocol on repeatserology re-screening of donors after180 days.• Reports of new illnesses or recentdiagnosis from GP/ OPD follow-up• Deferral of donors on repeat serologytest positive 2• New illness or Diagnosis 14.

Post-retrieval Screening• 263 donations deferred.• 55 donors lost to follow-upup- donationsdiscarded due to incomplete serology.• 23 Deceased• 20 (0.01%) had evidence ofundiagnosed or recent infection on post-retrieval review.

Issued Bone 1997-2005• Total Completed donations authorisedfor implant - 1963• Total implanted 1717• Total Discard 198

Graft Use• Revision Hip Arthroplasty - 1433grafts• Revision Knee Arthroplasty -109• Spinal Surgery -146• Tumours -68• Miscellaneous -134

Graft Use• Cappagh Implant 930• Non-Cappagh Implant 940

Microbiological Assay atImplantation• Routine Quality Assurance swabs x2taken at time of implantation from theissued graft• 6 grafts had positive culture forStaphylococcus Epidermidis but noevidence of clinical infection in therecipient.

Recipient Follow-up• Questionnaire to all Implanting surgeons• Requesting data on any graft relatedunwarranted outcomes and requesting ifthere was previous evidence of infection inthe patient• 75% Response rate. (1089 grafts)• 2 cases of suspected graft related infectionwere reported

Discussion• The exclusion of donors at any pointfrom initial review to final issue of thedonation should be rigorously appliedfor non- conformity to Standards

ConclusionQuality performance of a Bone Bank depends- full time bone bank co-ordinatorordinator,- identification of donors,- retrieval & harvesting of grafts- haematological & microbiologicalassessment,- medical supervision for decisions aboutcontaminated grafts,- a strict follow up protocol and a regularaudit of bone bank(I P Ivory, I H Thomas;JBJS 75-B; May

Conclusion• Quality Management System