Terms and conditions of use
Article 1 : PURPOSE
The purpose of this cooperation agreement is to define the commitments of the parties named on the reverse of page involved in activities of distribution and use of grafts of human origin, according to the relevant regulations.
Article 2 : DEFINITIONS
OST-Developpement is a Bank of Tissue authorised by the ANSM (authorisation No FR06301T-20-01) and which developed the “Osteopure process” for tissue preparation.
OST's mission is to organise harvest, collection, securing, processing, storage, distribution and traceability of bone tissues of human origin for their transplantation to humans or for scientific research on allografts.
Article 3 : TISSUE BANK COMMITTMENTS
• To supply the surgeon with allografts as long as its stocks last and subject to the surgeon's compliance with his/her own commitments.
• To provide medical and technical support to the surgeon, in particular with regards to the use of traceability documents.
• To provide secure grafts in compliance with the serological analyses laid down by French regulations (French Public Health Code, Decrees of 23/12/10 and 14/05/10 and decision of 27/10/10).
• To conduct all the operations of collection, securing and processing of grafts in line with the laws specific to tissue banks and in particular the decision of 27/10/10.
• To comply with the bioethics law on the respect of the human body.
Article 4 : COMMITTMENTS OF THE DENTAL IMPLANT SURGEON
• be authorised to implant bone grafts as part of its activity, and to comply with the decree of 1 February 2018 relating to the rules of Good Tissue Practice by doctors and dental surgeons outside healthcare institutions, and in particular:
• check the product upon receipt: integrity of the packaging and the product, presence of the delivery document, matching report information regarding identifications and expiry date
• comply with the product storage instructions listed on the label
• review all documentation attached to any graft of human origin distributed by OST and ensure its suitability for the intended use
• inform the recipient patient, in according to law, of the human origin of the graft, and obtain his/her free and informed consent
• fill in the Medical Prescription for his/her patient and use the products ordered for that patient only.
• forward the duly completed and signed traceability documents for each implanted or destroyed graft to OST.
• add the traceability document and the validation certificate of the transplanted tissue to the patient's medical record and archive this information for 30 years.
• agree on any audit commissioned by OST regarding activities related to the use and traceability of grafts.
• report any vigilance-related event (email@example.com) or any other anomaly detected without delay to OST
Article 5: GRAFT RETURN
If the surgeon wants to return a graft, he/she must first contact the customer service of the Tissue Bank.
In any event, the graft must be returned to OST in its original packaging and in the condition in which it was sent