Changes in European Eye Banking over the past 15 years The authors have no financial interest in the subject matter of this poster Ilse Claerhout 1, Hanneke.

Changes in European Eye Banking over the past 15 years

The authors have no financial interest in the subject matter of this poster

Ilse Claerhout1, Hanneke Maas2 and Liesbeth Pels2

1. Department of Ophthalmology, Ghent University Hospital, Belgium2. Cornea Bank Amsterdam, division Euro Tissue Bank Beverwijk, The Netherlands

• The European Eye Bank Association (EEBA) is a technical-scientific organization for eye banks throughout Europe, and beyond.

• Founded in 1989 with the simple objective of sharing information on eye banking, the Association is today the leading pan-national association in Europe dedicated to the advancement of eye banking and an authoritative reference point for eye banks which work according to quality standards.

• Details concerning technical aspects of European eye banks, along with a yearly overview of the activities of those banks, have been collected and presented since 1991 in the form of an annual Directory, published in time for the Annual Meeting.

• Unfortunately, not all banks submit annual data and therefore some analyses do not include all the statistics from the total number of banks present in Europe

Common standards for tissue banking

• The European Union:– The EU Directive, mother part (2004/23/EC) became mandatory in April

2004.– The first Annex concerning the Technical Requirements for donation,

procurement and testing of human tissues and cells (2006/17/EC) has been approved in February 2006.

– The second Annex, concerning the Technical Requirements for the coding, processing, preservation, storage and distribution of human tissues and cells (2006/86/EC) has been approved in October 2006.

• The EEBA Medical Special Interest Group: Agreements on Minimum Standards, Donor Medical Assessment

• EEBA Technical Special Interest Group: EEBA Technical Guidelines, presented annually at the business meeting in January and accepted during the year

Number of responding banks

Number of differently sized banks

Size of EEBA

0

20

40

60

80

100

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

num

bers

countries responding banks corneas processed (x 500)

The observed trend in former years of a steady increase in total number processed and stored corneas was disturbed due to the fact that a significant number of banks in 2005

stopped their activities or had changed into collection centers. This might have been due to the future EU regulations

Storage methods

0

5000

10000

15000

20000

25000

30000

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

num

ber

of c

orne

as

4° C storage moist chamber not defined organ culture

Organ-culture remained the preferred storage method in EEBA, bothin number of corneas and in number of banks applying this method.

Growing popularity of organ culture

present

Growing popularity of organ culture

Percentage of corneas discarded for transplantation

The increase in the percentage of corneas discarded for transplantation over the period 1991-2007

can be attributed to the more stringent quality and safety standards and regulations with regards to donor screening, serologic and microbiological testing and corneal evaluation criteria

(e.g. minimal endothelial cell density accepted).

Corneas issued for transplantation

0

20

40

60

80

100

1991

1992

1993

1994

1995

1996

1997

1998

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

% o

f rec

eive

d co

rnea

s

organ culture 4° C storage

As expected, because organ culture is considered a stress test, the total percentage of corneas judged unsuitable for transplantation always was a little

higher in organ culture banks than in hypothermic storage banks. This was observed until 2006. Since 2007 this difference seems to disappear.

Serology: % of corneas tested

0

10

20

30

40

50

60

70

80

90

100

toxo

EBV

CMV

HTLV

syph

All banks test all donors for HIV Abs, Hepatitis B and Hepatitis C, either antigen, antibodies or both. Most banks (58) test additionally for syphilis. A validated testing algorithm to exclude the presence

of Treponema pallidum is prescribed by the EU Commission Directive 2006/19/EC of 8 February 2006. Testing for HTLV is performed by 17 banks. It is prescribed for specific donors coming from certain regions

as a minimum requirement according to the European Directive.

Conclusions

• The Association’s annual meetings over 20 years, and the collection and exchange of detailed information from member eye banks, amount to a significant track record such that EEBA can rightly claim to speak with a confident voice on eye banking in Europe.

• As a scientific group the EEBA remains committed to defining and upholding minimum standards and to encouraging banks to produce Standard Operating Procedures as required by the relevant authorities in each country.

• The continued support of its membership is essential in maintaining and enhancing the Association’s strong reputation and all medical, scientific and technical colleagues working in the field of eye banking (tissues and cells for treatment of eye diseases) are invited to join the Association www.europeaneyebanks.org

• Those interested can also listen to the talk of Prof John Armitage on Friday morning 8.30 am on corneal transplant registries.