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.