Controlling Risks of Human Allografts in Tissue Banking Peter De Corte Quality & Compliance Officer LabMCT HCB QA

Controlling Risks of Human Allografts in Tissue Banking Military Hospital – HCB QA Burns Center Lab Molecular & Cellular Technology 2 Tissue Banks

Controlling Risks of Human Allografts in Tissue Banking • Tissue Banks (Tissues & Cells Banks)  Human Skin Allografts  Human Keratinocyte Allografts

• Accredited by FAGG • Certified ISO 9001:2000 by AIB Vincotte

Controlling Risks of Human Allografts in Tissue Banking

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – Characteristics:  Special type of ‘product’  Not pharmaceutical  No medical device

 Small scale  Small batches  Limited quantities involved

 Non profit environment  Tissue banks need to be attached to a hospital  Investments not commercially driven

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – Requirements: Quality  GMP-’like’  Controlled environment  Screening of source (donor) material  Control of end product

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – Contrary to organs • 1 donation (1 ‘piece’) = 1 acceptor

– 1 Donation can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors (= patients) Multiple preparations (= processing) Multiple users (= doctors) Multiple potential ‘reactions’ (=‘complications’)

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – Multiple donations (N ‘collections’) can generate multiple transplants, dependent on type of tissue: • Multiple acceptors: x N • Multiple preparations: x N • Multiple users: x N • Multiple potential ‘reactions’:x N

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – Multiple donations (N) can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors: x N Multiple preparations: x N Multiple users: x N Multiple potential ‘reactions’:x

Responsibility of each Tissue Bank (specific banks for specific tissues)

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – 1 Donation can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors Multiple preparations Multiple users Multiple potential ‘reactions’

Controlling Risks of Human Allografts in Tissue Banking • Cells and Tissues – 1 Donation can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors Multiple preparations Multiple users Multiple potential ‘reactions’

MULTIPLE RISKS TO CONTROL

Controlling Risks of Human Allografts in Tissue Banking • Multiple Risks to control  need for a structured system • What & How to set up? – Not an isolated system, but integrated – Multi level controls

• Set up a Quality Management System • Which one? – Scope? – Full QMS – ISO 9001 and ISO 13485

Controlling Risks of Human Allografts in Tissue Banking • ISO 9001 and ISO 13485 – ISO 13485:2003? • Specific for medical devices • ‘Static’ QMS (maintain effectiveness) • Also used in some foreign tissue establishments

– ISO 9001:2000 • • • •

Applicable to all types of products Process model Continuous improvement Also used in some foreign tissue establishments

Controlling Risks of Human Allografts in Tissue Banking • ISO 9001 vs ISO 13485 –Both are ‘full QMS’ ‘It should be noted that EN ISO 13485:2003 is a Quality Management System for medical devices specifically for regulatory purposes. lt is based on EN ISO 9001:2000 but in particular the requirements for "customer satisfaction" and "continual improvement' have been modified. Therefore, while EN ISO 13485:2003 has the same format as EN ISO 9001:2000 and most of the same requirements, compliance with EN ISO 13485:2003 does not provide conformity with EN ISO 9001:2000.’

Controlling Risks of Human Allografts in Tissue Banking

Conclusion: ISO 9001:2000

Controlling Risks of Human Allografts in Tissue Banking • Filling in the norm: 8 Chapters 1 Scope 2 Normative References 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realisation 8 Measurement, Analysis and Improvement

Controlling Risks of Human Allografts in Tissue Banking • Filling in the norm: 8 Chapters 1 Scope 2 Normative References 3 Terms and Definitions 4 Quality Management System 5 Management Responsibility 6 Resource Management 7 Product Realisation 8 Measurement, Analysis and Improvement

Controlling Risks of Human Allografts in Tissue Banking • 1 Donation can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors Multiple preparations Multiple users Multiple potential ‘reactions’

Controlling Risks of Human Allografts in Tissue Banking • 1 Donation can generate multiple transplants, dependent on type of tissue: • • • •

Multiple acceptors Multiple preparations Multiple users Multiple potential ‘reactions’

TRACEABILITY! TRACEABILITY

Controlling Risks of Human Allografts in Tissue Banking

TRACEABILITY! TRACEABILITY

Controlling Risks of Human Allografts in Tissue Banking • Traceability needs Product Identification – No ID = No existence !

• To set up an ID or coding system – We make use of 3 Tools: Donor codification Product codes Lot numbering

Controlling Risks of Human Allografts in Tissue Banking • Donor codification –Donor name is coded at start of procurement: BSB YY-xxx –This string is always used for all analysis on donor material and results – This code is also the string for filing of the donor ‘dossier’.

Controlling Risks of Human Allografts in Tissue Banking • Product code= Article Code –All products used in the processing of tissues and cells are identified with an internal product (article) code: • Product specs sheets are created for each product used • Allows clear instructions and consistency in processing documents

Controlling Risks of Human Allografts in Tissue Banking • Lot numbering – All actions in our tissue bank are given an internal lot number, which is then specific to that manipulation. • Allows discrimination between similar actions on different times • Creates an extra level of control • Allows tracing: – per operator, – per day, – per manipulation

Controlling Risks of Human Allografts in Tissue Banking • In practice (1) – Donor BSB 08-020: 020 skin prelevation • Anamnesis – exclusion criteria • Testing serology • Identification of equipment (SN - dermatome) and materials (Lot numbers) used in the prelevation • Identification of operators

– Processing of the skin • Assign Lot 08L105 on a specific BRF linking BSB 08-020 to that processing manipulation • Linking of Lot 08L105 to all materials used (having also an own lot number) is also done on the Form • This own lot number  Product Conformity guarantee!

Controlling Risks of Human Allografts in Tissue Banking • In practice (2) – Measuring and packaging the allografts: • Each package contains the surface and an extra Serial Number in the Lot Number

– Final packaged allografts receive also a specific Article Code linked to a specific processing history: • • • •

Cryopreserved Keratinocyte Sheets 150cm²: Art. 50/001 Cryopreserved Skin: Art. 50/002 Cryopreserved Keratinocyte Sheets 50cm²: Art. 50/003 Glycerolised Skin: Art 50/004

Controlling Risks of Human Allografts in Tissue Banking • In practice (3) – Final packaged allograft label contains: • • • • •

Donor Code: BSB 08-020 Lot Number: 08L105 Art. Code: Art. 50/004 Serial Number (SN): SN 1 Surface of the allograft: xxx cm²

 With this info on the final packaging we can guarantee the reconstruction of the complete history of this single unit!

Controlling Risks of Human Allografts in Tissue Banking Cryogepreserveerde huidallogreffen (Art n° 50/002) (Levend Humaan Weefsel - Living Human Tissue - Tissu Humain Vivant)

Brussels Skin Bank Hospitaal Centrum van de Basis Koningin Astrid Bruynstraat 1 1120 Brussel Tel.: +32 (0)2 264 48 54 Fax: +32 (0)2 264 48 33

Lot n°: 08L108

SN° : 1

BSB n°: BSB-08 020 Size: 430 cm² Expiry date: 18/12/2010 Store below -135°C DOC 7.5.303.9 - versie 2

Controlling Risks of Human Allografts in Tissue Banking • How are we able to reconstruct the complete processing history of this single unit ?

Controlling Risks of Human Allografts in Tissue Banking

Controlling Risks of Human Allografts in Tissue Banking Lot nummer 08L001 08L002 08L003 08L004 08L005 08L006 08L007 08L008 08L009 08L010 08L011 08L012 08L013 08L014 08L015 08L016 08L017 08L018 08L019 08L020 08L021 08L022 08L023 08L024 08L025 08L026 08L027 08L028 08L029 08L030 08L031 08L032 08L033 08L034

Document WI 7.5.106 WI 7.5.102 BF 7.5.102.6 WI 7.5.102 BF 7.5.102.6 WI 7.5.102 RF 7.4.301.17 BF 7.5.103.2 RF 7.4.301.1 RF 7.4.301.15 RF 7.4.301.14 RF 7.4.301.75 BF 7.5.103.2 BF 7.5.102.6 BF7.5.102.4 WI 7.5.102 WI 7.5.102 BF 7.5.103.6 BF 7.5.102.6 WI 7.5.102 BF 7.5.102.6 RF 7.4.301.53 RF 7.4.301.84 BF7.5.102.4 BF 7.5.102.5 WI 7.5.102 WI 7.5.106 BF 7.5.102.6 RF 7.4.301.80 WI 7.5.102 BF 7.5.102.6 WI 7.5.106 WI 7.5.106 BF 7.5.103.2

Titel Produktie van neonatale keratinocyten culturen in 115 cm² kweekflessen (art.30/043) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Inkoopverificatie: aluminium zakjes (Art 60/011) Bereiden van N x 500 m l Compleet EpiLife medium Inkoopverificatie: EpiLife medium (Art 20/005) Inkoopverificatie: Fles, steriel, PETG, 1000 ml (Art 20/079) Inkoopverificatie: Fles, steriel, PETG, 125 ml (Art 20/093) Inkoopverificatie: Peel-off kweekflessen 115 cm² (Art 20/101) Bereiden van N x 500 m l Compleet EpiLife medium Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Bereiden en sterilisatie van inpakkit voor allogreffen (Art 30/033) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Bereiden van N x 1000 m l MCECtot medium (Art 30/012) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Inkoopverificatie: Steriele schorten, XL (Art 20/046) Inkoopverificatie: Cryotube 1,8ml (Art 20/030) Bereiden en sterilisatie van inpakkit voor allogreffen (Art 30/033) Recipienten voor microbiologische testen huidallogreffen Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Produktie van neonatale keratinocyten culturen in 115 cm² kweekflessen (art.30/043) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Inkoopverificatie: Klercide 70/30 steriele IPA spray (Art 20/103) Inpakken en cryopreserveren van huidallogreffen (Art 50/002) Bereiden en sterilisatie van instrumentkit voor inpakken van huidallogreffen (Art.30/047) Produktie van neonatale keratinocyten culturen in 115 cm² kweekflessen (art.30/043) Produktie van neonatale keratinocyten culturen in 115 cm² kweekflessen (art.30/043) Bereiden van N x 500 m l Compleet EpiLife medium

Aantal nvt 2156 cm² 3 kits 1568 cm² 1 kit 2753 cm² 4 dozen 8x 500ml 15x 500ml 4 dozen 2 dozen 1 doos 5x 500ml 1 kit 4 kits 2180 cm² 2020 cm² 3x 1000ml 2 kits 1785 cm² 1 kit 1 doos 2 dozen 6 kits 13 zakken 2731 cm² nvt 1 kit 4x 5000ml 1317 cm² 1 kit nvt nvt 10x 500ml

BSB n° nvt BSB-08 001 nvt BSB-08 002 nvt BSB-08 003 nvt nvt nvt nvt nvt nvt nvt nvt nvt BSB-08 004 BSB-08 005 nvt nvt BSB-08 006 nvt nvt nvt nvt nvt BSB-08 007 nvt nvt nvt BSB-08 008 nvt nvt nvt nvt

Datum 3-1-2008 3-1-2008 3-1-2008 4-1-2008 4-1-2008 7-1-2008 7-1-2008 7-1-2008 10-1-2008 10-1-2008 10-1-2008 10-1-2008 10-1-2008 10-1-2008 11-1-2008 14-1-2008 15-1-2008 15-1-2008 15-1-2008 16-1-2008 16-1-2008 17-1-2008 17-1-2008 17-1-2008 17-1-2008 21-1-2008 21-1-2008 22-1-2008 22-1-2008 23-1-2008 23-1-2008 24-1-2008 24-1-2008 24-1-2008

Operator Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Dirck Schoeters Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Dirck Schoeters Dirck Schoeters Dirck Schoeters Dirck Schoeters Gunther Verween Dirck Schoeters Gunther Verween Dirck Schoeters Dirck Schoeters Gunther Verween Gunther Verween Dirck Schoeters Dirck Schoeters Dirck Schoeters Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween Gunther Verween

Record lokatie Vernietigde keratinocyten allogreffen Gesloten klasseerkast bij MD Records bereidingen BSB 2007/2008 Gesloten klasseerkast bij MD Records bereidingen BSB 2007/2008 Gesloten klasseerkast bij MD Klasseerkast QMS systeem Records bereidingen BKB 2008 Klasseerkast QMS systeem Klasseerkast QMS systeem Klasseerkast QMS systeem Klasseerkast QMS systeem Records bereidingen BKB 2008 Records bereidingen BSB 2007/2008 Records bereidingen BSB 2007/2008 Gesloten klasseerkast bij MD Gesloten klasseerkast bij MD Records bereidingen BKB 2008 Records bereidingen BSB 2007/2008 Gesloten klasseerkast bij MD Records bereidingen BSB 2007/2008 Klasseerkast QMS systeem Klasseerkast QMS systeem Records bereidingen BSB 2007/2008 Records bereidingen BSB 2007/2008 Gesloten klasseerkast bij MD nvt Records bereidingen BSB 2007/2008 Klasseerkast QMS systeem Gesloten klasseerkast bij MD Records bereidingen BSB 2007/2008 nvt Vrijgegeven keratinocyten allogreffen 2008 Records bereidingen BKB 2008

Controlling Risks of Human Allografts in Tissue Banking

Controlling Risks of Human Allografts in Tissue Banking Artikel n° 20/001 20/002 20/003 20/004 20/005 20/006 20/007 20/008 20/009 20/010 20/011 20/012 20/013 20/014 20/015 20/016 20/017 20/018 20/018

Artikel Klercide CR steriele Biocide B IPA-Wipe Synth-A-Freeze (SAF) MCEC medium EpiLife (500 ml) EDGS (5 ml) Water gezuiverd, EP DPBS Trypsin-Versene/EDTA (0,05% / 0,02%) Aquasan Handborstel Foetal Bovine Serum Norvanol D Trypaanblauw Rea Stabil Aquanet Handschoenen L, niet steriel, nitrile Kweekfles 175 cm² (vented cap) Kweekfles 175 cm² (vented cap)

Info leverancier Leverancier Cat. n° leverancier ccsbe ccsbe Cascade Invitrogen Invitrogen Invitrogen VWR Lonza Lonza VWR Sterap Perbio Science VWR VWR VWR VWR ccsbe VWR VWR

DES10 GPX670.001.0909.12 UR-005-50 041-95816RU UM-EPI-500 S-012-5 PROL90200.9010 BE17-512F BE17-161 E GUESH8500 nvt SH30084.03 PROL90308.9010 BCHRL6323 POLB84102 B508 BDAA353112 BDAA353112

Producent

Info producent Cat. n° producent Lot n° producent Vervaldatum Verpakking

Shield Medicare KCR4242 Berkshire GPX670.001.0909.12 0107/3612/27085 Cascade UR-005-50 427736 Invitrogen 041-95816RU 458465 Cascade UM-EPI-500 200709-619 Cascade S-012-5 VWR Prolabo 90200.9010 07L100043 Lonza BE17-512F 7MB0092 Lonza BE17-161 E 7MB0104 Guest Medical H8500 9678 Medica Europe 255A480 20748324 HyClone SH30084.03 GQC0040 VWR Prolabo 90308.9010 06C020035 Biochrom AG L6323 0398S Hirschmann Laborgeräte 9780100 nvt 84102 Kimberly-Clark 62993 880660/SM630703X Becton Dickinson 353112 7229875 Becton Dickinson 353112 7229873

1 liter 28-3-2009 12 pakken / doos 30-9-2009 50 ml 31-7-2009 900 ml 31-10-2008 500 ml 5 ml 31-12-2010 10 liter 22-5-2009 500 ml 5-6-2009 100 ml 01/04/2009 100 stuks / doos 30-10-2012 25 stuks / doos 31-3-2010 500 ml 31/03/2009 10 liter 31-3-2010 100 ml nvt 200ml 1l nvt 1000 stuks / doos nvt 40 stuks / doos nvt 40 stuks / doos

Lot n° LabMCT

07L203 08L136 08L179 08L009 08L053 07L196 07L237 08L049 nvt 08L163 06L051 08L190 nvt nvt 07L270 07L268

Controlling Risks of Human Allografts in Tissue Banking • What risks have we controlled so far? – loss of donor information  unique coding – unwanted product alterations  strict instructions – untrained operators  operators identified – non compliant raw materials  product specs – unsafe animal components  suitability certificates – avoid bad quality of end product  release only after batch review – reduced lag time for tracing materials to the supplier if needed  linking in incoming inspection

Controlling Risks of Human Allografts in Tissue Banking • What do we need to control from now? – Unauthorised use of the allografts on patients

• Controlled storage – Separation: Quarantine – Released Stock – Locked storage vessels

• Detailed Inventory Management – Unit level

• Form for requesting allografts – Patient name based

Controlling Risks of Human Allografts in Tissue Banking • Complete request form (in detail)

• Return to LabMCT

Only on prescription ! • Type of allograft needed • Surfaces needed • Patient details • User details (Med.Doctor) • Indication for use • Date and hour needed

Controlling Risks of Human Allografts in Tissue Banking A Traceability Form leaves together with the allograft ! • Complete traceability form (in detail) • Return to LabMCT LEGAL REQUIREMENTS: REQUIREMENTS: • Allograft details • Identification labels • Used surfaces • Patient details (complete) • User details (Med. Doctor) • Indication for use • Details of use • Unique graft reference numbers • Results on FollowFollow-up needed

Controlling Risks of Human Allografts in Tissue Banking

When the FORM returnes, all data are registered in our Traceability Database (part of the QMS)

Controlling Risks of Human Allografts in Tissue Banking BSB donor nr

Lot nr verpakking

SN

BSB-08 023 BSB-08 023 BSB-08 026 BSB-08 026 BSB-08 026 BSB-08 026 BSB-08 025 BSB-08 025 BSB-08 023 BSB-08 023 BSB-08 023 BSB-08 023 BSB-08 026 BSB-08 026 BSB-08 023 BSB-08 025 BSB-08 025 BSB-08 026 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 021 BSB-08 024 BSB-08 026 BSB-08 018 BSB-08 026 BSB-08 024 BSB-08 023 BSB-08 025

08L089 08L089 08L101 08L101 08L101 08L101 08L099 08L099 08L089 08L089 08L089 08L089 08L101 08L101 08L089 08L099 08L099 08L101 08L081 08L081 08L081 08L081 08L081 08L081 08L081 08L081 08L097 08L101 08L073 08L101 08L097 08L089 08L099

3 4 1 2 3 4 3 4 5 6 7 8 5 6 10 6 7 7 1 2 3 4 5 6 7 8 1 8 7 10 5 9 8

Oppervlakte (cm²) Datum 424 9-4-2008 396 9-4-2008 332 10-4-2008 396 10-4-2008 438 10-4-2008 414 10-4-2008 386 11-4-2008 340 11-4-2008 410 15-4-2008 372 15-4-2008 285 15-4-2008 202 15-4-2008 408 15-4-2008 387 15-4-2008 137 16-4-2008 335 16-4-2008 297 16-4-2008 318 16-4-2008 351 16-4-2008 369 16-4-2008 411 16-4-2008 425 16-4-2008 470 16-4-2008 340 16-4-2008 427 16-4-2008 286 16-4-2008 329 16-4-2008 231 17-4-2008 172 17-4-2008 110 17-4-2008 400 17-4-2008 248 18-4-2008 293 21-4-2008

Gebruiker Instelling Behandelende Arts BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ORTIZ Socorro BWC - HCBKA ORTIZ Socorro BWC - HCBKA ORTIZ Socorro BWC - HCBKA ORTIZ Socorro BWC - HCBKA ORTIZ Socorro BWC - HCBKA ORTIZ Socorro BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ROSE Thomas BWC - HCBKA ORTIZ Socorro BWC - HCBKA LAGEY Katrien BWC - HCBKA LAGEY Katrien CHU Brugmann BOECKX Willy BWC - HCBKA LAGEY Katrien BWC - HCBKA NEUPREZ Arielle

NAAM en Voornaam RJOLLI Pjeter RJOLLI Pjeter LAIXHAY Marie LAIXHAY Marie LAIXHAY Marie LAIXHAY Marie DESROUSSEAUX Jacques DESROUSSEAUX Jacques MARESCHAL Yseult MARESCHAL Yseult MARESCHAL Yseult MARESCHAL Yseult MARESCHAL Yseult MARESCHAL Yseult RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter RJOLLI Pjeter SCIOT Geoffrey BECKER Christian BECKER Christian KOHNE Monique ROBBEN Georges DESROUSSEAUX Jacques

Geboortedatum 1-4-1959 1-4-1959 20-6-1994 20-6-1994 20-6-1994 20-6-1994 11-4-1945 11-4-1945 15-1-2002 15-1-2002 15-1-2002 15-1-2002 15-1-2002 15-1-2002 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 1-4-1959 20-8-1973 25-10-1957 25-10-1957 4-7-1950 18-12-1931 11-4-1945

Sex M M V V V V M M V V V V V V M M M M M M M M M M M M M M M M V M M

Ontvanger Plaats van applicatie Benen Benen Thorax Thorax Linkerarm Rechterarm Abdomen Abdomen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Benen Linkerhand Linkerbeen Linkerbeen Billen Thorax

Indicatie 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde 3de graad brandwonde Brandwonde 3de graad brandwonde 3de graad brandwonde

Follow-up Bedekking 3de graad brandwonde benen + thorax Bedekking 3de graad brandwonde benen + thorax Bedekking 3de graad brandwonde beide armen Bedekking 3de graad brandwonde beide armen Bedekking 3de graad brandwonde beide armen Bedekking 3de graad brandwonde beide armen Biologisch verband thorax bij 3de graad brandwonde Biologisch verband thorax bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Biologisch verband bij 3de graad brandwonde Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Huid infectievrij in situ Voorbereiding brandwonde linkerhand met vermindering infectie Infectievrije brandwonde linkerbeen Infectievrije brandwonde linkerbeen Originele fiche niet ontvangen na verschillende pogingen! Genezing brandwonde van infectie Vermindering infectie thv brandwonde thorax

Controlling Risks of Human Allografts in Tissue Banking IN CONLUSION • With our Traceability System as part of a controlled Quality Management System, we are able to trace back all necessary information to the level of a single packaged unit of allograft! • This system has been challenged during inspections with good results and feedback of the inpectors

Controlling Risks of Human Allografts in Tissue Banking IN CONLUSION • This system was set up by ourselves by lack on a commercial universal system for this kind of ‘products’ • In the near future a universal system will become available for coding human donor tissues:  ISBT 128

Controlling Risks of Human Allografts in Tissue Banking ISBT 128 ISBT 128 provides such an international standard. • It specifies: – a donation numbering system that ensures globally unique identification; – the information to be transferred, using internationally agreed reference tables; – an international product reference database; – the data structures in which this information is placed; – a bar coding system for the electronic transfer of the information from the product label to a computer system without the risk of transcription errors; – a standard layout for the product label; – a standard reference for use in electronic messaging.

Controlling Risks of Human Allografts in Tissue Banking ISBT 128 Looking forward to it, but in mean time we have to rely on our system.

Thank You !