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Regulations & Quality

Introduction/overview

Eye Banks are responsible for the safe retrieval, storage, preparation and distribution of medical devices from human origin and have a duty of care to both donor and recipient to ensure best evidence-based practice is implemented within this process.

Around the world, eye bank and corneal groups are calling on the industry to implement standardised levels of service and quality to ensure that staff involved in the process are professionally trained and supported.

WHO and Ethical Frameworks

The WHO, in conjunction with industry specialists, have developed several materials to support regional groups and eye banks, such as:

For regional specific regulations, please visit the partner association website or the WHO Transplantation page

Coding Systems, Traceability and Donor Registry

The global standard for vigilance and surveillance of allogeneic material, recommends that eye banks submit donor and recipient data through a collective national registry, usually developed in conjunction with in-country Ministries/Departments of Health.

Through this registry eye banks agree to provide traceable data to assist in the identification of donor and recipient numbers and types of donors. Standardized coding systems are also recommended to ensure consistency in definition and reporting. The WHO advocate for a global coding system for traceability in order to ensure safety and ethics.

Examples: Corneal Graft Registry ACGR (Australia) and Surveillance Systems Notify Library (WHO and Italy)

Data Collection

Through a globally recognised coding system, eye banks are able to submit their data to local, national or international bodies. Such collections are advocated to support the long term safe and ethical tracking for the safety of the recipient and to provide the eye banking community with a collective picture of the current and potential future trends in eye banking.

Quality Systems, Audits and Accreditation

By implementing a standards based system, which advocates quality improvement practices, an eye bank has the potential to ensure that their practices are standardised. Through a quality system, an eye bank may benefit from implementing practical and usable tools to support practice, including evidence-based; policies and procedures, standard operating processes (work instructions), non-conformance reporting, maintenance, and service logs and contracts and staff competency.

Eye Banks are also encouraged to implement an auditing process, either locally through peer, government or health care bodies or via a formal accreditation process. In these instances, peer professionals are invited, confidentially, to examine the services provided by the eye bank and provide constructive and positive feedback to assist the eye bank to improve its practice.

There are several accreditation agencies available. Please contact your local regional association to ascertain accreditation options in your region. Alternatively, please contact the Global Alliance via: info@gaeba.org for assistance in locating a locally accredited group.

Standards

Standards are the foundation to developing evidence-based peer best-practices within eye banks. The Global Alliance partners have developed their own regionally appropriate standards in line with the international best practice, the WHO and regional policy.

For an example of a Global Alliance partner standard please visit:

EBAI – Standards and other resources

EEBA – EEBA Minimum Medical Standards Rev02-2016

EBAANZ – EBAANZ Medical and Quality Standards for Eye Donation and Tissue Banking