ETB-BISLIFE’s work methods comply with European directive 2004/23 and its annexes, the Dutch Body Material (Safety and Quality) Act (WVKL) and the Body Material Requirements Decree (Eisenbesluit Lichaamsmateriaal). ETB-BISLIFE is a recognised tissue institution and is regularly visited by the Health and Youth Care Inspectorate for enforcement purposes.
Continuous improvement through planned and secured implementation processes ensure that changes are embedded in the organisation and that the organisation continues to comply with laws and regulations.
We also regularly host audits by other tissue banks and an external institution accredited by the RvA (Dutch Accreditation Council) for our ISO certification.
In addition, ETB-BISLIFE holds an FDA (Food and Drug Administration) registration for post-mortem bone and tendon tissue processed in the USA, under which the FDA can conduct on-site inspections.
Concerning the tissue types corneas, skin, heart valves and blood vessels, ETB-BISLIFE fulfils the requirements of the German Medicinal Products Act (Arzneimittelgesetz) and Human Tissue Act (Gewebegesetz). The permit issued by the German authorities (i.e. the Paul Ehrlich Institute [PEI]) allows us to supply these tissues to German hospitals. For tendon tissue (calcaneal, bone-tendon-bone, tibial and semitendinosus), the assessment of our permit applications is still ongoing. A transitional arrangement is in place for the period leading up to the permit being issued, during which these tissues can be supplied as well.
In addition to internal audits within our own organisation, ETB-BISLIFE periodically conducts audits for external partners, including other tissue banks and suppliers of critical materials or services.