Eye Bank (EB)
- Is an institution that should provide a round-the-clock public response system over the telephone and conduct public awareness programmes on eye donation.
- Co-ordinate with donor families and hospitals to motivate eye donation Hospital
- Cornea Retrieval Programme - (HCRP)
- To harvest corneal tissue
- To process, preserve and evaluate the collected tissue
- To distribute tissue in an equitable manner for Keratoplasty
- To ensure safe transportation of tissue.
Donor Cornea / Eye Retrieval Related Standards
Donor eye / cornea retrieval
Care must be taken that EB resources are utilized optimally and eye bank personnel are not exposed to any health hazards.
- Personnel authorized to retrieve eyes / corneas
- A registered medical practitioner trained in enucleation / excision from an EB Training Centre is only allowed to retrieve eyes / corneas from the donor after satisfying self that life is extinct, in the absence of a death certificate.
Pre Recovery Procedure
Before proceeding for recovery, EB personnel should ascertain the following details:
- Age of the donor
- Cause of death
- Time of death
- Retrieval procedure could be either Enucleation or Corneal scleral rim excision.
- Carry only validated sterile instruments for retrieval.
- On arrival at the location should locate the next of kin and convey condolence and obtain death certificate.
- In the absence of a death certificate the registered medical practitioner should satisfy self that life is extinct as per procedures laid down
- Obtain consent on a consent form from the legal custodian of the donor.
- After obtaining consent the donor should be identified either through a tag or through the next of kin
- Then proceed to prepare the site as per guidelines
- Conduct Gross physical examination with utmost respect for observations regarding build: average / healthy / emaciated
- Look out for needle marks on the arm, skin lesions etc., Ulcers / gangene in exposed areas, Ocular examination.
- Medical records / Medical information should be obtained as per guidelines Information for hemodilution should be obtained
- Social history of the donor obtained wherever possible from the next of kin Once all the above are completed the retrieval can be started
- Screening of donors
Contraindications for Retrieval:
Conditions with potential risk of transmission of local or systemic communicable from donor to recipient
- Death of unknown cause
- Death with neurologic disease of unestablished diagnosis
- Subacute sclerosing panencephalitis
- Progressive multifocal leukoencephalopathy
- Active meningitis or encephalitis
- Encephalopathy of unknown origin or progressive encephalopathy
- Active septicemia (bacteremia, fungemia, viremia, parasitemia)
- Active viral hepatitis
- Creutzfeldt-Jakob disease
- Congenital rubella
- Reye's Syndrome
- Active miliary tuberculosis or tubercular meningitis
- Patients on ventilator for > 72 hrs
- Hepatitis B surface antigen positive donors
- HTLV-I or HTLV-II infection
- Hepatitis C Seropositive donors
- HIV seropositive donors
- HIV or high risk for HIV corneas from: persons meeting any of the following criteria should not be offered for transplantation.
- Active ocular or intraocular inflammation conjunctivitis, sclerits, iritis, uveitis, vitreitis choroiditis and retinitis (at the time of death
Conditions with potential risk of transmission of non-communicable disease from donor to recipient.
- Death due to cyanide poisoning
- Intrinsic eye disease
- Malignant tumours of the anterior ocular segment or known adenocarcinoma in the eye of primary or metastatic origin
- Active disseminated lymphomas
Conditions that will affect graft outcome.
- Congenital or acquired disorders of the eye that would preclude a successful outcome for the intended use e.g., a central donor corneal scar for an intended penetrating keratoplasty preserve of keratoconous and keratoglobus. Corneas which have undergone refractive surgical procedures etc.
- Patients on ventilator for >72 hrs
Interval-between death, enucleation, excision and preservation
- Acceptable time intervals from death, enucleation or excision to preservation may vary according to the circumstances of death and interim means of storage of the body.
- It is generally recommended that corneal preservation should occur as soon as possible after death.
- All time intervals for each donor, e.g., the time of death to the time of enucleation and preservation and/or the time to corneal excision, shall be recorded.
- If the donor has been refrigerated prior to enucleation or in situ corneal excision, this information shall be noted.
Donor Tissue Preservation Standards
- In situ and laboratory removal of the corneoscleral rim
- Individuals specifically trained for in situ retrieval and/or laboratory removal of the corneal scleral segment shall perform removal of the corneal scleral rim using sterile technique.
- If the procedur.e is done in a laboratory the removal must be Ferfòmed in a laminar flow hoöd, cabinet or-in an operation room.
- For cornel scleral removal, the eye shall be examined with the use of a penlight preferably and a slit lamp prior to excision.
Use of short or intermediate term preservation medium
EB shall use approved corneal storage medium (such as MK, Optisol GS, EUSOL, etc) from a reliable source.
The medium shall.be used and •stored according to the manufacturer's recommendations for temperature, date and 'other factors.
• Long term preservation
•Some EBs employ long-term preservation of corneal tissue, such as glycerine preservation or organ culturing.
•EB that store whole eye shall employ aseptic practice.
•EB shall preserve scleral tissue aseptically.
•A preservation date for sclera) tissue shall be indicated.
- All surgical tissue shall be stored in quarantine until results of HIV, HbsAg, HCV and any other relevant donor screening tests have been recorded as non-reactive.
- All tissue shall be stored aseptically at a temperature appropriate to the method preservation used.
- EB must precisely document their procedures for storage of corneal tissue, whether is in the form of the whole eye or the cornea only in an appropriate medium.
Each corneal or scleral tissue container shall be clearly and indelibly labelled to include at least the information below:
- Name of source EB
- Tissue identification number. There must be unique identification number for each ocular tissue or fraction there of that is distributed for surgical use.
- Type of tissue
- Date and time of donor's death
- Date and time of Cornea/scleral preservation
- Preservation date for scleral tissue and long-term preserved tissue
- A statement that the tissue is intended for single patient application only and that it is not to be considered sterile and culturing or re-culturing is recommended.
- Type of preservation medium
Distribution of Tissue
Review of donor medical history
- Prior to distribution of tissue for transplantation, the MD or his/her designee shall review and document the medical and laboratory information in accordance with medical standards.
Receivers of tissue
- Tissue shall be distributed only to ophthalmologists, institutions and other eye banks who are registered under applicable laws like Transplantation of Human Organs Act.
- All tissues sent from an accredited EB must comply with the recommended medical standards.
Fair and equitable system
- EBs shall establish and document a system of distribution that is just, equitable and fair to all patients served by the eye bank. Documentation of distribution time and date of requests and delivery of eye tissue to be maintained. Access to tissue shall be provided without regard to recipient sex, religion, race, creed, colour or caste.
- For corneas returned and redistributed, tissue transportation and storage information must be documented and made available to the transplanting surgeon.
- EBs must have a policy and procedure for potential recall of tissue
Equipment maintenance and cleaning
- Each EB laboratory shall have a refrigerator with a device, internal or external for recording temperature variations.
- Temperature variations must be recorded twice daily and should remain within the range of 20 -60 C.
- The refrigerator should be maintained exclusively for use by the 13B. It must contain clearly defined and labelled areas for all tissues stored e.g. surgical tissue, awaiting distribution, quarantined tissue, tissue for research etc. The refrigerator should be calibrated once a year.