International Eye Banking Perspective

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International Eye Banking Perspective

• Sandra Shaw FAMLS
• EBAA 2009 Annual Meeting
• Seattle

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Objectives

• Irish Eye Bank
• Collaboration with an US bank
• Eye Banking in Europe
• Differences between US and EU.
• Challenges

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Irish Eye Bank

• Established in September 1989 with a grant of
  75,000 from Irish Fight for Sight
  organisation.
• In 1996 approx 33 were imported from the UK.
• By 1999 approx 50 were imported from the UK.
• October 2000 moved to purpose built tissue bank.

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IBTS Headquarters
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Irish Eye Bank

• April 1 2001
• - Introduced restriction on UK donors and
• those who had resided in the UK .
• - Stopped importing tissue from the UK
• May 2001 we imported our first cornea from the
  US.
• November 2001 decision to stop issuing Irish
  sclera.
• January 2004 stopped procuring Irish corneas.
  All corneas imported from the US.

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Source of Corneas
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Indications for Corneal Grafting in Ireland 2008

• Population of 4.2 million
• 142 corneal grafts during 2008
• 29 were DSAEK
• Keratoconus
• Bullous keratopathy
• Fuchs

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Working with a US Bank

• Challenge in 2001 was finding a bank that could
  exclusively supply our needs and work with our
  criteria.
• Different selection criteria.
• Irish criteria was based on the standards of
  the
• - Irish Blood Transfusion Service
• - European Eye Bank Association (EEBA)
• Audit

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Initial differences

• Excluded donors who were 1 cumulative year
  resident in the UK.
• Permanent deferral for MSM
• Permanent deferral for drug users / prostitutes
• Organ / cornea / sclera recipients
• All encompassed in a Service level agreement
  (SLA)

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European Tissue Directive

• Directive 2004/23/EC on setting the standards of
  quality and safety for the donation, procurement,
  testing, processing, preservation, storage and
  distribution of human tissues and cells.
• Issued on 31 March 2004 and transposed into
  National Law by 07 April 2006
• 2 Commission Directives (technical annexes) 2nd
  one implemented in Sept 2007

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European Union

• In 1973 there were 9 countries in the EU
• 1995 - 15
• 2004 - 25
• 2007 - 27
• Council of Europe has 47 member states.

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European Tissue Directive

• Each country has a Competent Authority
• e.g. Ireland - Irish Medicines Board (IMB), in
  the United Kingdom - Human Tissue Authority
  (HTA)
• The competent authority shall establish and
  maintain a publicly accessible register of Tissue
  Establishments (TE) and specify the activities
  for which they have been licensed.
• Each Tissue Establishment must submit an annual
  report on their activities to the competent
  authority

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European Tissue Directive

• All serious adverse events and reactions must be
  reported to the competent authority.
• Each TE must designate a Responsible Person (RP)
  and inform the competent authority of his/her
  name.

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Article 9 of the Directive

• Import / Export of human tissues and cells.
• All imports are undertaken by licensed
  establishments, authorised by the competent
  authority.
• All imports can be traced from donor to recipient
  and vice versa.
• That imports meet the standards of quality and
  safety equivalent to the ones laid down in the
  Directive.

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Eurocet / Eustite

• Eurocet Project is a network linking the
  national tissue establishment registers.
• www.eurocet.org
• Eustite project objectives is to harmonise
  inspections and authorizations of establishments
  and to develop a common reporting system for
  adverse events and reactions.
• www.eustite.org

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GMP vs. GTP

• Air Quality
• Where Tissues and cells are exposed to the
  environment during processing without a
  subsequent microbial inactivation process an air
  quality equivalent to that of Grade A is
  required.
• A less stringent environment maybe acceptable in
  certain circumstances but it must be demonstrated
  that the chosen environment achieves the quality
  and safety required for that tissue.

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Record Retention

• Tissue Establishments shall keep the data
  necessary to ensure traceability for a minimum of
  30 years

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Virology Testing
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European Eye Bank Association

• The aim of EEBA is to develop and maintain
  standards for Eye Banking throughout Europe.
• Agreement on minimum standards
• Technical guidelines for ocular tissue.
• Annual meeting every January.
• www.europeaneyebanks.org

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EEBA Members
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Number of Corneas processed 2003-2007
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EEBA

• In 2008, 70 of eye banks in Europe used Organ
  culture, cold storage 20 and 10 of banks used
  both methods.
• In 2007 only 7.6 of all issued corneas were
  distributed out of the source country.

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Challenges

• Initially the Irish contra indications were more
  restrictive than those of the US, mainly due to
  vCJD.
• Shipping was problematic. Use of loggers in all
  shipments.
• Surgeons were not used to handling cold storage
  corneas.

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Challenges

• Most of the differences were overcome by the use
  of an SLA.
• Article 14 Data protection and confidentiality.

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