Sri Lanka International Eye Bank is in a unique position of having supplied 70307
donor corneas to 114 cities in 57 countries by the 24 th August 2015. The eye bank's
experiences span a period of 52 years as an international donor. This is because we
were not content merely to supply our own requirement. When we knew that there
was a world-wide shortage of donor eyes and Sri Lanka had the potential to help
so many countries, we did not relax. Even when we were receiving hundred
percent extra eyes than needed in Sri Lanka way back ii 1966, we kept on trying to
get more and more eyes until today the supply is ten times the need of the country
Today we have a dedicated staff of 47 consisting of highly competent Medical
Director, managers, technologist and others. We have decentralized our operations
with the establishment of 06 centers in the outstation with a technician for each
center. In addition we have 450 branches spread throughout this country.
1,120,600 persons all over the country have officially consented to donate their
eyes after death by singing consent forms. These facts by itself speak for the
enormous charitable service rendered by this eye bank not only in Sri Lanka but
also internationally.
PROCUREMENT
For the requirements in a small hospital, equipment and man power needed are minimal. The aim of these causes is to provide sterile and excellent quality eyes. Eyes are retrieved from the donor within 4 hours of death. A refrigerator, enucleating instruments, a telephone, transport, and access to laboratory for some tests are the basic requirements; the most important factor needed is a highly
motivated doctor or/and technician who are prepared to work long and irregular hours
PRESERVATION OF CORNEAS (at 4 degrees 0C)
Storage in a refrigerator at this temperature may be the only method of preservation needed in a small hospital where the keratoplasty operation is likely to be done on the same day or the next. Moist Chamber method of preservation of the complete globe after antibiotic treatment seems adequate.
Over 45 years ago fresh globes were kept immersed in liquid paraffin until used. Washing off liquid paraffin was a real hazard taking much of a surgeon's time and the uncertainty at the end whether all the oliy substance has been removed. Moist Chamber method gets rid of this very real problem.
If the cornea have to be kept for more than a day or two, either because patients are not immediately available or the cornea have to be transported to another part of the country, one of the preservative fluids has to be used
McCAREY – KAUFMAN (MK)
This fluid is ideally suited to preserve a corneal button up to 3 or 4 day. This fluid is prepared at the Eye Bank.
OPTISOL
Fluid gives a longer life span (up to 14 days) and is a commercial product costing US $ 100 - 150 for single vial.
MINIMUM ESSENTIAL MEDIUM
Which is a culture medium is ideally suited for long term (up to 3 weeks) preservation. Another advantage is that THERE IS NO REFREGIRATION NEEDED once the cornea has been immersed in this fluid. Cornea may be transported very long distance over a number of days because refrigeration on the way is not needed.
All corneas are examined by slit lamp Bio-microscopy. Endothelial counts and Pachymetry are done using the endothelial microscope.
The longest time interval we have experienced between the death of donor in Sri Lanka, and the utilization of the cornea in Kitwe (Zambia) has been 11 days. The result was good.
QUALITY POLICY
The Quality policy of the Sri Lanka International Eye Bank, is to guarantee ethical, Legal, safe and efficient supply of sterile and viable corneas by using modern techniques.
The Quality policy of the Sri Lanka International Eye Bank, is to guarantee ethical, Legal, safe and efficient supply of sterile and viable corneas by using modern techniques.
PURCHASING
General
SLIEB ensure that purchasing materials meet specified requirement by use of reliable suppliers and inspection techniques according to documented procedure. (W.H.O.)
Donated corneas are procured under strictly controlled procedure to ensure Health and safety of personal and the recipient of the donated eyes.
Assessment of supplier
Supplier of purchased materials is selected from approved sources. All chemicals used are in analytical grade quality.
Purchasing data
Purchasing documents specify the identification, grade, relevant specification, Quantity and packing arrangements of all products or services.
Verification of Purchased Products
The lab manager (LM) is responsible for ensuring that system exists for product identification and traceability.
Positive material identification is practiced at all stages from donor sources to recipients of sterile tissue materials.
Management and staff are responsible for initiating and for maintaining such identification and traceability of the activities under their control.
Identification and traceability is applied to non-sterile tissue, part-processed Materials and finished products and the staff is responsible for product manufacture and inspection.
Inspection and process records bear the specific identification of batches to which they relate. They are done according to W.H.O. requirements.
Inspection and Testing
LM is responsible for establishing and maintenance of testing equipment.
Obsolete and unsuitable equipment is removed from services and are either Disposed off or identified to prevent inadvertent use.
Inspection and Test Status
Responsibility for identifying the inspection and test status of material intermediates and finished product lies with LM.
Procured tissue awaiting result of blood tests is identified during refrigerated storage to prevent inadvertent commencement of processing
HANDLING, STORAGE, PACKING AND DELIVERY
Handling
Safe handling methods are maintained and employed during all activities to prevent damage and deterioration of materials and finished products and to maintain health and safety requirement.
Sealed containers are used at all times for the handling of materials and finished products.
Processed tissues are stored in conditions according to the type of preservation Media.
MK - +4oC
Optisol - +4oC
MEM - Room Temperature
Packaging
Procured and processed tissues are contained in glass containers with media. These are sealed to prevent contamination of contents. Sterile tissue package are labeled with Graf /batch numbers description of content and information necessary to trace source of tissue.
Sterile tissues are accompanied by users’ forms to enable tractability to recipients and review of post-operative performance. Samples of media and tissues are checked for evidence of infection.
Delivery
Is done by the SLIEB or the relevant Hospital/Doctor which the operation is to carried out.
Delivery box can maintain the cornea +40C upto 2-3 days.
Each delivery is accompanied by identifiable and traceable documentation.
Quality Record. (Maintained by the LM)
LM is responsible for identification of quality record requirements and assessing the contribution of the quality records to the overall effectiveness.
In addition he is responsible for ensuring the collection and filling of quality records.
Quality records are reviewed on a regular basis by the LM and trends are investigated prior to presentation for review.
Training
Medical Director (MD) is respo4sible for identification of training and for ensuring that the staff is trained according to such needs.
Training records and training needs are maintained for all personnel on-an individual basis according to approved procedures and relevance to their Job activity
LM monitors and ensures that documented procedures are followed and all the necessary process and inspection records are prepared.
CRITERIA FOR ISSUING OF CORNEAS
- Tissue grafts are limited to use by physician only
- This tissue is intend for use in one patient, on a single occasion only
- No known possible significant adverse reaction
- Tissue was prepared from a donor who was negative when tested of HIV 1/2, Hepatitis B, Hepatitis c, VDRL
- Tissue is sterile under recommended procedures
- Once opened cannot be sterilize or re-sterilize
- It is the sole responsibility of the clinician to store and transplant the tissue under the guidelines and maintain records to trace them post-transplant.,
- No known Sensitizing agents.
- Recommended Storage conditions: +40C or room temperature.
- Exp Time: MK (5days) Optisol (14days) MEM (2ldays)
