Quality Control

Regulatory Aspects & Certification

Amnitrans EyeBank Rotterdam is ISO 9001 certified and a member of the European Eye Bank Association. Amnitrans EyeBank International (AEI), the internationally oriented sister-eye bank, founded in 2015 to supply the still growing international demand for ready-to-use pre-dissected corneal tissue, is a member of the Eye Bank Association of America. AER and AEI share staff, techniques and quality system.

Both eye banks have been granted accreditation by the Dutch Ministry of Health, Welfare and Sports as an organ bank on the ground of the Body Material (Safety and Quality) Act. Both eye banks have the license to export amniotic membrane and corneal tissue outside the European Union. The import of corneal tissue is also allowed. The Health and Youth Care Inspectorate (IGJ) regularly inspects whether both eye banks work according to the current laws. Furthermore, AER has a permit from the German authorities to supply corneal tissue to German clinics (PEI G.11919.01.1) (“Humane Augenhornhaut, organkultiviert, Amnitrans EyeBank Rotterdam)”.

Quality criteria

To assess whether a donor cornea is suitable for keratoplasty, Amnitrans EyeBank Rotterdam uses the general Dutch eye bank exclusion criteria which can be summarized as follows:

I. Slit lamp evaluation and cell density exclusion criteria:

X: exclusion criterion, not acceptable for this type of surgery / pre-dissection
?: depends on location/depth
n.a.: not applicable; not important for this type of surgery /pre-dissection

Notification of Adverse Events and Side Effects

Adverse events and side effects occurring after use of tissue of AER and AEI are reported by the banks to the National Office for Hemovigilance and Biovigilance. All severe adverse events and side effects are also reported to the Health and Youth Care Inspectorate (IGJ).