Section 23.7, Section 23.8
23.7 Tracking of tissues
Each Tissue establishment shall ensure that it has the ability to locate and identify all tissues/cells during any step from procurement through to distribution to recipient or disposal and vice versa. This traceability shall also apply to all relevant data relating to products and materials coming into contact with these tissues and cells.
Tissue establishments shall have effective and accurate systems to uniquely identify and label tissues/cells received and distributed.
Tissue establishments shall keep the data necessary to ensure traceability at all stages. Data required for full traceability shall be kept for a minimum of 30 years after clinical use. Data storage may also be in electronic form. Data that must be kept are shown in Table 23.6 (Annex VI, Directive 2006/86/EC of 24 October 2006).
Table 23.6 Minimum donor/recipient data set to be kept
A. BY TISSUE ESTABLISHMENTS
Donation identification that will include at least:
- Identification of the procurement organisation or tissue establishment
- Unique Donation ID number
- Date of procurement
- Place of procurement
- Type of donation (e.g. single v multi-tissue; autologous v allogenic; living v deceased)
Product identification that will include at least:
- Identification of the tissue establishment
- Type of tissue and cell/product (basic nomenclature)
- Pool number (if applicable)
- Split number (if applicable)
- Expiry date
- Tissue/cell status (i.e. quarantined, suitable for use etc.)
- Description and origin of the products, processing steps applied, materials and additives coming into contact with tissues and cells and having an effect on their quality and/or safety
- Identification of the facility issuing the final label
Human application identification that will include at least:
- Date of distribution/disposal
- Identification of the clinician or end user/facility.
B. BY ORGANISATIONS RESPONSIBLE FOR HUMAN APPLICATION
(a) Identification of the supplier tissue establishment
(b) Identification of the clinician or end user/facility
(c) Type of tissues and cells
(d) Product identification
(e) Identification of the recipient
(f) Date of application
23.8 Notification of serious adverse events and reactions
Tissue establishments shall ensure that there is a system in place to report, investigate, register and transmit information about serious adverse events and reactions which may influence the quality and safety of tissues and cells, which may be attributable to the procurement, testing, processing, storage and distribution of tissues and cells as well as any serious adverse reactions observed during or after clinical applications which may be linked to the quality and safety of tissues and cells.
All persons and tissue establishments using human tissues and cells regulated by this Directive shall report any relevant information to tissue establishments to facilitate traceability and assure quality and safety control.
The tissue establishment shall ensure that the HTA is notified of any serious adverse events and reactions according to procedures laid down by the authority. A root cause analysis should be performed. Moreover each tissue establishment shall ensure that an accurate, rapid and verifiable procedure is in place which will enable it to recall from distribution any product which may be related to an adverse event or reaction.