NOTIFY - E xploring V igilanc E n otification for o rgans , t issu E s and c E lls NOTIFY Exploring VigilancE notification for organs, tissuEs and cElls A Global Consultation e 10,00 Organised by CNT with the co-sponsorship of WHO and the participation of the EU-funded SOHO V&S Project February 7-9, 2011 NOTIFY Exploring VigilancE notification for organs, tissuEs and cElls A Global Consultation Organised by CNT with the co-sponsorship of WHO and the participation of the EU-funded SOHO V&S Project February 7-9, 2011 Cover Bologna, piazza del Nettuno (photo © giulianax – Fotolia.com) © Testi Centro Nazionale Trapianti © 2011 EDITRICE COMPOSITORI Via Stalingrado 97/2 - 40128 Bologna Tel. 051/3540111 - Fax 051/327877 [email protected] www.editricecompositori.it ISBN 978-88-7794-758-1 Index Part A Bologna Consultation Report ............................................................................................................................................7 Part B Working Group Didactic Papers ......................................................................................................................................57 (i) The Transmission of Infections ..........................................................................................................................59 (ii) The Transmission of Malignancies ....................................................................................................................79 (iii) Adverse Outcomes Associated with Characteristics, Handling and Clinical Errors ..............................................99 (iv) Adverse Reactions in Donors ..........................................................................................................................119 (v) The Transmission of Genetic Diseases .............................................................................................................131 Part A Bologna Consultation Report 7 NOTIFY Exploring Vigilance Notification for Organs, Tissues and Cells Bologna, February 7-9, 2011 PARTICIPANTS Scientific Committee Chairmen Alessandro NANNI COSTA, Italian National Transplant Centre (Italy) Luc NOEL, World Health Organization (Switzerland) Mike STRONG, Notify Working Group Coordinator (USA) Deirdre FEHILY, Italian National Transplant Centre (Italy) Scientific Committee Scott A. BRUBAKER (USA) Matthew J. KUEHNERT (USA) Emanuele COZZI (Italy) Sophie LUCAS-SAMUEL (France) Carlo DE CILLIA (Italy) Rafael MATESANZ (Spain) Francis DELMONICO (USA) Dietger NIEDERWIESER (Germany) Antonia DERRICO (Italy) Francesco PROCACCIO (Italy) Beatriz DOMINGUEZ-GIL (Spain) Axel RAHMEL (The Netherlands) Luca GIANAROLI (Italy) Lorenza RIDOLFI (Italy) Walter Francesco GRIGIONI (Italy) Lucia RIZZATO (Italy) Paolo GROSSI (Italy) Naoshi SHINOZAKI (Japan) Organizing Committee Paola DI CIACCIO (Italy) Claudia CARELLA (Italy) Deirdre FEHILY (Italy) Conference Agency Donatella PARIALI (Italy) Working Group Leaders Group 1: Organs Paolo Grossi, Frank Delmonico, Matthew Kuehnert Group 2: Tissues (other than ocular) Ted Eastlund, Johann Kurz, Maurice Hinsenkamp Group 3: Haematopoietic Stem Cells (HPC) Dietger Niederwieser, Laura St Martin, Kathy Loper Group 4: Ocular Tissues Naoshi Shinosaki, Marian Macsai, Paul Dubord Group 5: Gametes and Embryos Luca Gianaroli, Mauro Costa, Anne Cathrine Bollerup Group 6: Infection Jay A. Fishman, Michael G. Ison, Richard Tedder Group 7: Malignancy Jeremy Chapman, Rafael Matesanz, Antonietta Derrico Grigioni Group 8: Product Properties Diego Ponzin, Scott Brubaker, Axel Rahmel 9 Group 9: Clinical Practice. Lorenza Ridolfi, Rene de Vries, Paula Nolan Group 10: Genetic and Donor Emanuele Cozzi, Carolina Stylianou, Dennis Confer Rapporteurs Frances DELANEY (Luxembourg) Lead Rapporteur Michael G. ISON (USA) (Organs) Mauro COSTA (Italy) (Gametes and Embryos) Mike STRONG (USA) (HPC) Deirdre FEHILY (Italy) (Tissues) Other participants: Anil AGARWAL (India), Ines ALVAREZ SALDIAS (Uruguay), Margarida AMIL (Portugal), Fiorenza BARIANI (Italy), Tommaso BELLANDI (Italy), Anne-Cathrine BOLLERUP (Denmark), Pavel BREZOVSKY (Czech Republic), Audrone BÜZIUVIENE (Lithu- ania), Marina BUZZI (Italy), Gorazd C ˇ EBULC (Slovenia), Jeremy R. CHAPMAN (Australia), Bernard COHEN (Belgium), Dennis L. Confer (USA), Jane COOK (Australia), Daniel R. CORADI FREITAS (Brazil), Michael COX (Denmark), Hervé CREUSVAUX (France), Vibeke DALEN (Norway), Filip DANNINGER (Slovak Republic), Jennifer DE MATTEO (USA), Renè DE VRIES (The Netherlands), Visist DHITAVAT (Thailand), Paul DUBORD (Canada), Małgorzata DUDKIEWICZ (Poland), David EASTLUND (USA), Susie ELSAADANY (Canada), Jay A. FISHMAN (USA), Presmyl FRYDA (Czech Republic), Jacques Olivier GALBART (France), Christian GARZONI (Switzerland), Maria GICHEVA (Bulgaria), Angelo GHIRARDINI (Italy), Marjan HAPPEL (The Netherlands), Donna HARKIN (Ireland), Tomonori HASEGAWA (Japan), Charlotte HENRIKSEN (Denmark), Maurice HY- SENKAMP (Belgium), Stefano INGLESE (Italy), Hilga KATERBERG (The Netherlands), Hauwa J. KERI (Nigeria), Guenter KIRSTE (Germany), Yvonne KOH (Singapore), Jan KOLLER (Slovakia), Johann KURZ (Austria), Letizia LOMBARDINI (Italy), Kathy LOPER (USA), Marian MACSAI (USA), Mitra MAHDAVI-MAZDEH (Iran), Diane MALONEY (USA), Martí MANYALICH (Spain), Rosario MARAZUELA (Spain), Elmi MULLER (South Africa), Vanja NIKOLAC (Croatia), Christiane NIEDERLAENDER (UK), Paula NOLAN (UK), Olga ORLOVA (Russia), Marie-Odile OTT (Council of Europe), Alessandro PACINI (Italy), Annarita PANEBIANCO (Italy), Jordan PEEV (Bulgaria), Giuseppe PICCOLO (Italy), Roberto PERESSUTTI (Italy), Diego PONZIN (Italy), Eliana PORTA (Italy), Tim PRUETT (USA), Leo ROELS (Belgium), Giuseppe RUOCCO (Italy), Giulia SCARAVELLI (Italy), Bron- wen SHAW (UK), Mike SMITH (Belgium), Olga SOLOMON (European Commission), Laura ST. MARTIN (USA), Kellathur N SRINIVASAN (Singapore), Kristina STANKOVIC ´ (Croatia), Daniela STORANI (Italy), Carolina Stylianou (Cyprus), Richard Tedder (UK), Fewzi TESKRAT (France), Esteve TRIAS (Spain), Izabela UHRYNOWSKA-TYSZKIEWICZ (Poland), Assen VELKOV (Bulgaria), Ruth WARWICK (UK), Jan WONDERGEM (Austria), Jun WU (Canada), Richard ZAMMIT (Malta), Victor-Gheorhe ZOTA (Romania) 10 Table of Contents Preamble .......................................................................................................................................................................13 1. Opening session and background .............................................................................................................................15 1.1. Introduction .....................................................................................................................................................15 1.2. CTO Vigilance at CNT .......................................................................................................................................15 1.3. CTO Vigilance and Surveillance in WHO ...........................................................................................................16 1.4. SOHO Vigilance in the EU .................................................................................................................................17 1.5. Lessons learned from 7 years of experience: Biovigilance as part of SOHO vigilance ..........................................18 1.6. From EUSTITE to SOHO V&S with WHO ............................................................................................................18 1.7. Traceability and Biovigilance in the USA ............................................................................................................19 2. V&S: Communication for Action. An exploration of vigilance developments around the globe. ................................21 2.1. ART vigilance in France: overview of a new vigilance system .............................................................................21 2.2. V&S in Brazil: link with clinicians and achievements ..........................................................................................21 2.3. Haematopoietic stem cell donor reactions and events .......................................................................................22 2.4. 50 years of cornea vigilance by the Eye Banking Association of America ...........................................................22 2.5. EFRETOS: EU organ project with V&S as part of recipient follow-up ..................................................................24 2.6. V&S for SOHO in Singapore ..............................................................................................................................25 2.7. Croatia, the challenge of establishing a SOHO V&S system ...............................................................................26 2.8. AATB guidance on ‘Identifying, reporting, and investigating tissue recipient adverse reactions’ .........................27 3. Engaging all relevant stakeholders in V&S. ................................................................................................................28 3.1. FDA and Biovigilance ........................................................................................................................................28 3.2. Italy’s outreach to transplant clinicians, recipients, donors and the public ..........................................................28 3.3. The significance of serious adverse events in tissue and cell vigilance ................................................................29 3.4. Vigilance notification