Essentials of Tissue Banking

Aparadigmshiftistakinginraisingstandardsonallaspectsoftissuebankingfrom procurementtoprocessing,fromstoragetoclinicalusage. Anumberofmonographs haveappearedgivingguidanceonGMPandqualitysystemsthatshouldbeadhered to. Therearealsogoodguidelinesonthesigni?canceofthenewregulationsthat havebeenenacted. However there is a signi?cant lack of information on the scienti?c basis and rationaleonwhytissuebankingpracticeshavedevelopedthewaytheyhave. Many ofthemhavedevelopedwithoutmuchvalidationandhavebeeninuseformany years, copied from one tissue bank to another. There are some good articles on somescienti?caspectsoftissuebankingpractices,buttheyareinrelativelyoldand insomewhatobscurejournals. Thisbookisintendedto?llthisgapbygettinga seriesofeminentexpertstoeachwriteachapterortwoonuptodatetissuebanking practices. Moreoverinthemodernworldoftissuebanking,safetyandqualityoftissues havetakenanincreasinglyimportantrole. Infacttheseactivitiesformthebasisof manylicensureactivitiesthatrelatetotissueestablishments. Anattempthasbeen madetocovertheseaspectsaswell. Althoughthelegislationcoversalltypesofcells,includingstemcells,theyhave beendeliberatelyomitted. Thetargetaudiencesforstemcellsaredifferentandthe setupisalsogenerallyquitedifferentunlikecordblood,whichisverysimilarto tissuesandthereforeincluded. Inordertolimitthesizeofthebooktoamanageableleveltheauthorshavebeen onlyaskedtocoverthebasisofcurrentpractices,ratherthanfuturedevelopments, suchasembryoniccelldevelopments,tissueengineeringandgenetherapy,which aremorecellulartherapiesthantissuebanking,perse. Coursesconferringcert- catesanddiplomashavejuststartedtobeprovidedbyvariousprofessionalbodies. Thisisimportantbecausetissuebankingisbecomingadistinctmodalityforsci- tistswhowanttoworkinthe?eld. Ibelievesuchanaudiencewouldbeverykeen tousethisbook. Alsoanyscientistandmedicalpersonworkinginthe?eldshould beinterestedinit. Itwillalsobeusefulformanysurgeonswhousetissuesintheir dailyclinicalpractice. Iamverygratefultoalltheauthors,whowithoutexceptionwillinglygaveso muchtime,effortandenergyinwritingtheirchapters. Theyarewithoutexception, v vi Preface leadersintheir?eld. Theyhaveallproduceduptodateandstateoftheartchapters. Theyhavedoneitinthestyletheyfeltwasappropriateandnoattemptwasmadeto modifythis. Thekeyobjectivewastocollateallthisinformationinoneplace. Ihave learntalotwhilsteditingthisworkandIhopethatthereaderswillbeengrossedin readingthisbookasmuchasIhave. Edinburgh,Scotland GeorgeGalea Contents Part I Management of 1 Live Donors of Tissue . . . . . . . . . . . . . . . . . . . . . . . . . 3 RuthWarwick 2 Deceased Donors of Tissue. . . . . . . . . . . . . . . . . . . . . . . 23 AuroraNavarro 3 Banking of Cord Blood. . . . . . . . . . . . . . . . . . . . . . . . . 41 ElianeGluckman 4 Banking of Corneas. . . . . . . . . . . . . . . . . . . . . . . . . . . 59 W. JohnArmitage 5 Banking of Heart Valves. . . . . . . . . . . . . . . . . . . . . . . . 69 RobertParker 6 Banking of Skin. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 EllenHeck Part II Principles of 7 Storage, Processing and Preservation. . . . . . . . . . . . . . . . . 95 JohnN. Kearney 8 Cryopreservation. . . . . . . . . . . . . . . . . . . . . . . . . . . . 109 DavidPegg 9 Sterilisation by Irradiation . . . . . . . . . . . . . . . . . . . . . . 123 ArturKaminski,IzabelaUhrynowska-Tyszkiewicz, andWaclawStachowicz Part III Ensuring Safety by 10 Testing the Donor. . . . . . . . . . . . . . . . . . . . . . . . . . . . 141 AlanKitchenandJohnBarbara 11 Testing the Tissue and the Environment . . . . . . . . . . . . . . . 167 TedEastlundandMartellK. Winters vii viii Contents Part IV Ensuring Quality by 12 Establishing a Quality System. . . . . . . . . . . . . . . . . . . . . 191 ScottA. Brubaker 13 IT System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217 LindaLodge Part V Legal and Ethical Environment 14 Regulatory and Ethical Issues. . . . . . . . . . . . . . . . . . . . . 231 DavidPegg Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 243 Contributors W. John Armitage CTSBristolEyeBank,UniversityofBristol,BristolEye Hospital,BristolBS12LX,UK,w. j. armitage@bristol. ac. uk John Barbara NHSBloodandTransplant,ColindaleAvenue,London NW95BG,UK,Marina. mobed@nhsbt. nhs. uk Scott A. Brubaker AmericanAssociationofTissueBanks,McLean,VA22101, USA,brubakers@aatb. org Ted Eastlund DepartmentofPathology,UniversityofNewMexicoSchool ofMedicine,Albuquerque,NM87131,USA,deastlund@salud. unm. edu Eliane Gluckman Eurocord,HematologyDepartment,APHPUniversityParis VII,Paris,France,eliane. gluckman@sls. aphp.