Scott Brubaker - American Association of Tissue Banks

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Reporting Requirements • State (continued) ❖ ๏ Florida (AHCA) Requires tissue bank to report ALL potential adverse reactions using Part 1 <strong>of</strong> Adverse Reaction Report ✴ ✴ Only required when the report is made to the tissue bank by the transplanting physician or hospital Required within one working day ๏ After investigation by tissue bank, then requires reporting using Part 1I <strong>of</strong> Adverse Reaction Report ✴ Required when investigation concluded ๏ AHCA not involved in investigations
Reporting Requirements • International ❖ ๏ Canada Proposed CTO Regulations ❖ ๏ ๏ ๏ ✴ Report all adverse reactions within 24 hrs to Health Canada and provide updates ever 30 days Medical Device Reporting Schemes EU Authorities - Medical Device Vigilance Canada - Therapeutic Products Program Australia - Therapeutic Goods Act ๏ Japan - Adverse Reaction Reporting
Page 1 and 2: AATB’s Report: Adverse Reporting
Page 3: Reporting Requirements • Federal
Page 7 and 8: AATB Standards • 1996 (7th editio
Page 9 and 10: AATB Standards In A2.000 Definition
Page 11 and 12: AATB Standards G3.000 Labeling Info
Page 13 and 14: AATB Standards K1.000 QUALITY ASSUR
Page 15 and 16: AATB Standards K1.000 QUALITY ASSUR
Page 17 and 18: AATB Standards Section L - Tissue D
Page 20 and 21: “Possible/Suspected” definition
Page 22 and 23: Medical Director Pathway
Page 24 and 25: CAPA; Publications; Meeting Present
Page 26 and 27: “Possible” Definition
Page 28 and 29: Rationale for “Possible” • Po
Page 30 and 31: Probable & Proven
Page 32 and 33: Implant Card Compliance 2006 AATB S
Page 34 and 35: Comments from Tissue Banks • Diff
Page 36: Thank you! (questions will be enter

Scott Brubaker - American Association of Tissue Banks

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