Collection & Selection

Collection:

BIOBank grafts derives from femoral heads which are exclusively harvested from living donors during hip arthroplasties. As such, the tissue is removed during a surgery in an operating room, guaranteeing optimal quality and asepsis. All samples are obtained in France by orthopaedic surgeons within approved health care establishments.

Collection Traceability:

Tissue traceability is an essential part of a tissue bank’s management. It is managed by a specially designed information system with locks and access rights compulsory for the activity of a tissue bank.

The traceability of the tissues is based on a unique, anonymous ID number, assigned during harvesting, in addition to a product code related to the operation.

The information necessary for the traceability is transcribed on labels and documents that accompany the tissues throughout their life cycle, preserving the anonymity of both donor and receiver.

Documents exchanged between the harvesting establishments and BIOBank for the femoral heads and blood samples traceability:

• Removal form signed by the orthopaedic surgeon
• Traceability labels affixed to the collection kit

Information to the donor:

In accordance with the French bioethics law, the femoral head harvested from a living donor during hip arthroplasty performed for his interest is considered as an operating residue.

As such:

1. This tissue can be used for therapeutic or scientific purposes, except if the patient expresses his opposition after being informed of such purposes (Article L. 1245-2 of the CSP, French “Public Health Code”);
2. The orthopaedic surgeon, or the anaesthetist, must obtain the donor’s agreement to the execution of the serological screening of contagious diseases caused by the following viruses or bacteria: HIV, HCV, HBV, HTLV and Treponema pallidum (syphilis). The analysis laboratory (independent and approved by the ANSM) in charge of the screening will send the results directly to the orthopaedic surgeon who will inform the patient;
3. The donor must be informed and give his agreement for a computer registration of his name by BIOBank, which will be the guarantor of the data’s confidentiality and the preservation of the donor anonymity with grafted patients (French Data Protection Act).

The donor’s consent is obtained by the orthopaedic surgeon, or the anaesthetist, through the “tissue donor’s information letter” (REME-ENR-03-5) provided by BIOBank in each sampling kit.

By signing the removal form, the orthopaedic surgeon, or the anaesthetist, certifies that the donor has been informed and gave his consent on the three points listed above.

The information letter provided by BIOBank is signed by the donor and kept in his medical file, or attached to the harvested tissue sent to BIOBank.

Clinical Selection:

Clinical selection is an essential step which contributes to the safety of grafted patients, removal surgical teams and tissue banks. These terms and conditions are defined in the good practice rules for tissue removal and collection of operating residue used for therapeutic purposes.

Thus, each donor is taken charge of by the surgical team under the responsibility of the orthopaedic surgeon, who must:

• Check the donor’s medical file,
• Make sure that there are no regulatory contraindications for the tissue’s collection,
• Inform the patient that his femoral head is being harvested for therapeutic use,
• Complete and sign the removal form that will be attached to the operating residue.

The clinical selection of the donors adheres to the exclusion criteria drawn up by the Biomedicine Agency (ABM) and fixed by the French ministerial order of 4 November 2014 concerning tissue removals. The conformity of these criteria and the search for signs of a pathology that could contraindicate the removal aim to avoid the spread of diseases. The spread of diseases is avoid by the compliance with these criteria and the search for signs of a pathology that could contraindicate the bone harvesting.

Biological Selection:

The legal framework is ruled by health safety rules fixed by the French Public Health Code and the order of 23 December 2010 regarding the infectious diseases screening.

The examination report is approved by a certified analysis laboratory. It mentions the techniques and reagents used and is signed by the person responsible for biomarkers searching. It is communicated to the orthopaedic surgeon who can inform the donor of the results during a medical consultation.

A serum bank is created for each serum which is analysed and identified. Serums are stored at -20°C for 5 years. The serum bank enables confirmations or additional biological examinations using other screening techniques.

The results of the clinical selection and serological screening are transcribed on the “Graft identity form”, the traceability document that accompanies each graft delivered. This form is filed by the grafting surgeon in the receiver’s medical file.