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Eye Banking : biovigilance

Eye Banking : biovigilance. diego.ponzin@fbov.it The Veneto Eye Bank Foundation, Venice. Workshop on Quality Systems in Ocular Tissue Banking , TAIEX 50564 . Zagreb , Croatia, 30-31 January 2013. Biovigilance.

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Eye Banking : biovigilance

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  1. Eye Banking: biovigilance diego.ponzin@fbov.itThe Veneto Eye Bank Foundation, Venice • Workshop on Quality Systems in Ocular Tissue Banking, TAIEX 50564. • Zagreb, Croatia, 30-31 January 2013

  2. Biovigilance • A set of surveillance procedures covering the entire transplantation chain (from the donation to the follow-up of recipients), intended to: • collect and assess information on unexpected or undesirable effects, and errors, resulting from the therapeutic use of blood products, organs, tissues, and cellular therapies; • prevent the occurrence or recurrence of such incidents; • improve clinical outcomes. • A permanent assessment of the risk / benefit ratio

  3. Biovigilance • The best opportunity to learn!

  4. The best opportunity to listen! • We have one mouth and two ears: in our dealing with others is enough to respect the ratio (…listentwiceasmuchasyouspeak)Epictetusquotes (Greek, Stoicphilosopher, born AD 55 The perfect murder is one that isn’t actually discovered Rabl Walter. European Hospital 2013;21(6)12:1-2

  5. The best opportunity to investigate The perfect murder is one that isn’t actually discovered Rabl Walter. European Hospital 2013;21(6)12:1-2

  6. Transparency Curvature

  7. LK: replacing only the diseased layers of the cornea • Safer surgery, faster visual recovery, better and more predictable visual outcome • DSAEK: refractive-neutral procedure, most common EK Tan DTH, Dart JKG, Holland EJ, Kinoshita S. Cornealtransplantation. Lancet 2012;379:1749-61

  8. EK: the eye bank work station Microkeratome Artificial anterior chamber

  9. Indicators (structure, process, outcome, efficiency, efficacy) • Positive: outcomes expected and pursued benefit • Negative: outcomes unexpected and unwanted risk • Tissue-related(adverse event, reaction) • SeriousAdverseEvent: somethingwrongduring the processcould cause harm to a patient • SeriousAdverseReaction: somethingwrong in a donor or in a patientcouldhavebeencaused by the tissues/cells • Non-tissue related(complication, failure) Directive 2004/23/EC: standards of quality and safety… Directive 2006/17/EC: technical requirements… Directive 2006/86/EC: traceability requirements, notification of serious adverse reactions and events…

  10. Tissue-related, negative indicators in corneal transplantation Any communicable or other disease transmissible by, and attributable to, transplantation of donor eye tissue, including: • Infections: systemic diseases, endophthalmitis (six months) keratitis (six weeks) • Biologic dysfunctions: immediate donor endothelial failure, donor corneal dystrophy, donor refractive surgery Eye Bank Association of America, Medical Standards, 2012

  11. Immediate donor endothelialfailure • Presence of a diffusely edematous penetrating corneal graft on the first postoperative day • Failure of the cloudy graft to clear at any time postoperatively • Lack of an identifiable cause of corneal graft failure • FBOV risk: 0.2% PK: biologic dysfunctions Wilhelmus KR. ArchOphtalmol1995;113:1497-502 • Donor corneal dystrophy • FBOV risk: <0.1%

  12. Endothelial rejection Cystoid macular edema LK: biologic dysfunctions, complications Graft dislocation Graft failure

  13. Risk of local transmission of bacteria, fungi, viruses • Pathology: keratitis, endophthalmitis, uveitis • Risk: <0.1% (bacteria, fungi), occasional (virus) • Prevention: donor screening, asepsis conditions, microbiological screening of tissues Herpetic keratouveitis after PK FBOV risk: • 0.05% (bacteria, fungi) • 0.005% (virus)

  14. Positive indicators for the evaluation ofclinical outcomes of corneal transplantation • Graft survival • Visual acuity (BCVA) • Anthalgiceffect • Reconstruction • Health related quality of life (SF-36, SF-12) • Visual function (VF14) • Surgeon’s satisfaction • Patient’s expectation and satisfaction • Delbosc et al, J FrOphthalmol, 2003. Fasolo A et al. Cornea 2006. Williams KA et al Eye, 1995. Vail A et al Ophthalmol, 1996. Bourne WM Ophthalmol, 1998. ClaessonM et al BJO, 2002. KA Williams et al Ophthalmol 1991. Uiters E et al Cornea2001; Fasolo A et al. J Ophthalmol2012.

  15. Biovigilance • The Agreement • The Procedures • The Reasons • Triennial agreement for the provision of services and tissues for ocular surgery

  16. The procedures • SOP - Standard Operating Procedures • Forms

  17. Cornea/Lenticule Request Form

  18. Non-SurgicalTissuesRequest/ UtilizationForms

  19. Cornea/Lenticule Evaluation Form

  20. Cornea/Lenticule Utilization Form

  21. Monitoring of adverse events / reactions

  22. Questionnaire of satisfaction

  23. The statistical report

  24. Reporting: the reasons • 200 surgeons involved

  25. Reporting: the reasons

  26. Donor-to-host transmission of Acanthamoeba from an asymptomatic cornea donor • Active monitoring • Cooperation with surgeons • Transparency • Rare events more likely to occur in high-volumes TE • Multidisciplinary approach • Dec 2009: thanksgiving letter sent to the eye bank by patient A (!)

  27. Results (2012) • Rate of reporting by FBOV cooperating surgeons: • Short term: 98% (within three months post op) • Long term: 44% (SAE /SAR monitoring), 37% (satisfaction) • Current risk: • Systemic diseases: theoretical • Endophthalmitis, keratitis: <0.1% (bacteria, fungi), <0.005% (virus) • Biologic dysfunctions: <0.2% • Current benefit: • Fasolo A et al. The CORTES study: corneal transplant indications and graft survival in an Italian cohort of patients. Cornea 2006; 25:507-15. • Fasolo A et al. Risk factors for graft failure after penetrating keratoplasty: 5 year follow-up from the Corneal Transplant Epidemiological Study. Cornea2011,30:1328–35. • FasoloA et al. Health status and patient satisfaction after corneal graft: results from the Corneal Transplant Epidemiological Study. J Ophthalmol2012; Vol2012, Art. ID 230641.

  28. Results Overall Kaplan–Meier probability of 5-year survival: 83.0% • Fasolo A et al. The CORTES study: corneal transplant indications and graft survival in an Italian cohort of patients. Cornea 2006; 25:507-15. • Fasolo A et al. Risk factors for graft failure after penetrating keratoplasty: 5 year follow-up from the Corneal Transplant Epidemiological Study. Cornea 2011,30:1328–35.

  29. Results • FasoloA et al. Health status and patient satisfaction after corneal graft: results from the Corneal Transplant Epidemiological Study. J Ophthalmol 2012; Vol 2012, Article ID 230641.

  30. A take-home message Leape LL. Reporting of adverseevents. NEJM 2002;347(20):1633-8

  31. Conclusions • Tissue Establishment, Surgeon, Competent Authority, Transplant Coordinators: an alliance to realize and improvement of patient’s care • Fundamental role of reporting is to enhance patient safety by learning from failures of the healthcare system • Individuals who report incidents must not be punished or suffer other ill-effects from reporting • Reporting: • reliable if based on positive arguments (clinicians involved) • only of value if it leads to a constructive response • must be personally, professionally, institutionally rewarding • Ponzin D et al. Eye banking at the Fondazione Banca degli Occhi del Veneto: present and perspectives. Organs and Tissues 2003; (2)111-9 • Ferrari S et al. Advances in corneal surgery and cell therapy: challenges and perspectives for the eye banks. Expert Review of Ophthalmology 2009; 4(3):317-29

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