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[Quality plan of a bone tissue bank]
V Lemercier1, L Vastel, J P Courpied
1Banque de Tissus Osseux, Groupe Hospitalier Cochin Saint-Vincent-de-Paul - La Roche-Guyon, 27, rue du Fg Saint-Jacques, 75679 Paris Cedex 14.
Annales Pharmaceutiques Francaises
|January 10, 2001
Summary
French regulations for donated human tissues were updated in 1994 and 1998. A quality system at Cochin Hospital
Area of Science:
- Biomedical Engineering
- Tissue Banking
- Regulatory Affairs
Context:
- The French bioethics laws of 1994 and the decree of December 29, 1998, established new regulations for donated human tissues and bone tissue banks.
- Prior to these regulations, a quality system was implemented at the Cochin Hospital bone tissue bank to ensure safety and therapeutic use.
- This system integrated quality control measures throughout the entire process of bone allograft handling.
Purpose:
- To describe the quality plan implemented at the Cochin Hospital bone tissue bank.
- To demonstrate how specific quality practices, resources, and activity sequences enhance the distribution of human bone allografts.
- To ensure the maintenance of traceability for all donated bone tissues.
Summary:
- A comprehensive quality system was established at the Cochin Hospital bone tissue bank, aligning with French regulatory requirements for donated human tissues.
- The quality plan encompasses meticulous control at each stage of the bone allograft process, from donation to distribution.
- Specific quality practices and resource allocation were optimized to improve the efficiency and safety of bone allograft distribution.
Impact:
- The implemented quality plan successfully improved the distribution of human bone allografts.
- Traceability of donated bone tissues was effectively maintained throughout the process.
- This approach provides a model for other bone tissue banks seeking to comply with stringent regulations and optimize allograft distribution.