Importing/Exporting Conventional HCT/Ps

Transcription

1 Importing/Exporting Conventional HCT/Ps ISCT/FDA Liaison Meeting January 4, 2007 Scott A. Brubaker, CTBS American Association of Tissue Banks

2 Conventional Tissue Banks! FDA term from the preamble to the CGTP Final Rule that was used to describe the type of tissue bank that follows the AATB s Standards for Tissue Banking

3 Conventional HCT/Ps Bone Cartilage Dura mater Fascia Heart valve Ligament Pericardium Skin Tendon Vascular graft Amniotic membrane AATB designations: (MS) musculoskeletal - includes soft tissue grafts (OA) osteoarticular (DM) dura mater (SB) living donor surgical bone (C) cardiac (V) vascular (S) skin But realize we also cover: (R) reproductive semen, oocyte, embryo (A) autologous (LD) living donors

4 Related AATB Standards Section B - GENERAL ORGANIZATIONAL REQUIREMENTS OF A TISSUE BANK B1.000 GENERAL INSTITUTIONAL REQUIREMENTS B1.500 Multi-Facility Tissue Banking B1.510 Written Agreements/Contracts B1.521 Inspections/Audits of Other Facilities Section D - ACQUISITION OF TISSUE: CONSENT, DONOR SCREENING, AND TISSUE RETRIEVAL D4.000 DONOR SUITABILITY D4.300 DISEASE SCREENING D4.353 Infectious Disease Testing D4.355 Interpretation of Infectious Disease Testing Section G - LABELING G3.000 LABELING INFORMATION G3.300 Transport Package Labeling - G3.320 International Shipments Section H - DISTRIBUTION AND DISPENSING H1.000 General H1.100 Tissue Distribution and Dispensing Restrictions

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11 Import of Conventional HCT/Ps Imported for contract processing only (unprocessed tissue received, processed, and returned to country of origin for distribution) Tissue originates from Canada, Spain, Bulgaria Imported for processing & distribution (unprocessed tissue received, processed, and distributed within the US or exported) Tissue originates from Ukraine

12 Import of Conventional HCT/Ps Problems experienced at port of entry Shipment delays of frozen tissue & tissue loss Requests for info already provided by overnight courier w/signature, date/time of authority who was in receipt Notices of adulteration of package even though package passed examination by Customs Border Protection and carton was delivered to bank intact, sealed, clean, and properly labeled Delays experienced when specific border personnel are absent or on vacation Issuance of Notice of Action when only donor blood is sent for testing - blood seized/detained without apparent federal jurisdiction Formal Notice of Release delayed due to unannounced change to submission of information (paper copies vs electronic) Contacts can be unresponsive to calls and s Verbal release of tissue occurs without written Notice of Release

13 Import of Conventional HCT/Ps Problems experienced at port of entry Delays affect wet ice shipments of recovered tissues that require immediate processing Heart for valve donations and vessel donations Delays in issuance of Notice of Release affects time-sensitive processing parameters for this tissue type. See Standard E1.036 Time Limit for Dissection (C,V) = 48 hr limit from time of asystole to time of subjecting tissue to disinfection solution at processing. Tissue release from quarantine (so tissue can be processed) is dependant on issuance of the Notice of Release. These tissues are sent at wet ice temperatures (1-10 C). Delays in release from quarantine (so processing can begin) does not allow tissue banks in the US to process HVs or vessels recovered by programs in Canada. Delays can affect the return of previously shipped, processed tissues that are frozen - these have arrived at tissue bank thawed

14 Import of Conventional HCT/Ps General frustration occurs every few months no problems after tissue bank responds but there often was no apparent need for original delay since all was in order (notice of pending shipment was made, labeling, description, product code, tariff #, packaging, submission of required documents, etc.)

15 Export of Processed, Conventional HCT/Ps Tissue types exported ligaments, tendons, amniotic membrane, bone (cancellous, cortical, corticocancellous, shafts, segments, strips, tricortical, demineralized, Cloward dowels), costal cartilage, meniscus, bone+cartilage (condyles, humeri, fibulae, pelvis), proprietary tissue forms for spinal surgery, medical devices Tissue types in short supply (pediatric heart valves, skin for burns) are not exported unless supplied for processing by that country (Canada) Export occurs to approximately 40 countries

16 Export of Processed HCT/Ps Problems experienced at port of export Certificates of Foreign Government for tissue devices Few reports of delays, but these can be caused by the tissue bank Certificates of Exportability Reports of delays Website applications completed and submitted as instructed, then were returned via mail w/cover letter stating info was incomplete (but needed info was not identified); further review of initial submission shows info is complete

17 International Regulations in Development re: Importation European Union Commission Directive Specific Commission Directive will address import/export of cells & tissues (in support of original Directive 2004/23/EC) Health Canada CTO Regulations near finalization AATB provided comments on proposed regs and current standards to both CSA & HC; some donor screening, processing and labeling issues appear to be resolved United Kingdom (Human Tissue Authority) Specific Code of Practice in development - comments due by January 12th; restrictions are proposed regarding consent practices of country of origin

18 Importation of Reproductive HCT/Ps Issue presented at most recent TSEAC meeting Expect Final DE Guidance s vcjd screening restrictions to be burdensome Semen, oocytes, embryos have not been implicated as cells/tissues at risk Semen: prion disease has not been identified as a Sexually Transmitted Disease Importation of embryos by individuals for personal use has been difficult More permissive regulations could be developed

19 Thank you! dziękuję bardzo!

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