Cardiovascular implants and artificial organs — Checklists for use of extracorporeal circulation equipment

This document covers the activities performed by perfusionists before, during, and after extracorporeal circulation. Clause 4 covers the perfusionists' actions during preoperative extracorporeal circulation (ECC) equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB/RHB) or venovenous (VV) extracorporeal support for liver transplantation. Its requirements can serve as a checklist for verifying that the equipment, devices or systems have been set up correctly. The sequence of use of checklist items listed below can vary depending on customary institutional use or individual user preference. There are also four additional checklists for different phases of ECC (see Clause 5, Termination; Clause 6, Post-extracorporeal circulation; Clause 7, Emergent reinstitution of extracorporeal circulation; and Clause 8, Peri-procedural).

Implants cardiovasculaires et organes artificiels — Listes de contrôle pour l'équipement de circulation extracorporelle

General Information

Status
Published
Publication Date
19-Jul-2018
Current Stage
9060 - Close of review
Start Date
03-Dec-2021
Ref Project

RELATIONS

Buy Standard

Technical specification
ISO/TS 23810:2018 - Cardiovascular implants and artificial organs -- Checklists for use of extracorporeal circulation equipment
English language
17 pages
sale 15% off
Preview
sale 15% off
Preview

Standards Content (sample)

TECHNICAL ISO/TS
SPECIFICATION 23810
Third edition
2018-07
Cardiovascular implants and artificial
organs — Checklists for use of
extracorporeal circulation equipment
Implants cardiovasculaires et organes artificiels — Listes de contrôle
pour l'équipement de circulation extracorporelle
Reference number
ISO/TS 23810:2018(E)
ISO 2018
---------------------- Page: 1 ----------------------
ISO/TS 23810:2018(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2018

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting

on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address

below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2018 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23810:2018(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................vi

Introduction ..............................................................................................................................................................................................................................vii

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Preoperative requirements ....................................................................................................................................................................... 1

4.1 Patient information ............................................................................................................................................................................. 1

4.1.1 Rationale ................................................................................................................................................................................. 1

4.1.2 Patient interview ............................................................................................................................................................. 2

4.1.3 Patient identity .................................................................................................................................................................. 2

4.1.4 Medical record number .............................................................................................................................................. 2

4.1.5 Allergies ................................................................................................................................................................................... 2

4.1.6 Blood bank numbers .................................................................................................................................................... 2

4.1.7 Blood type and antibodies ....................................................................................................................................... 2

4.1.8 Chart ........................................................................................................................................................................................... 2

4.1.9 Procedure ............................................................................................................................................................................... 2

4.2 Equipment and Instructions for Use .................................................................................................................................... 3

4.2.1 Rationale ................................................................................................................................................................................. 3

4.2.2 Equipment ............................................................................................................................................................................. 3

4.2.3 Instructions for Use ....................................................................................................................................................... 3

4.3 Sterility/cleanliness............................................................................................................................................................................ 3

4.3.1 Rationale ................................................................................................................................................................................. 3

4.3.2 Component package integrity/expiration dates .................................................................................. 3

4.3.3 Serial/lot numbers ......................................................................................................................................................... 3

4.3.4 Equipment ............................................................................................................................................................................. 3

4.3.5 Heat exchanger(s) ........................................................................................................................................................... 3

4.3.6 Maintenance ........................................................................................................................................................................ 4

4.4 Pumps ............................................................................................................................................................................................................. 4

4.4.1 Rationale ................................................................................................................................................................................. 4

4.4.2 Electrical ................................................................................................................................................................................. 4

4.4.3 Batteries .................................................................................................................................................................................. 4

4.4.4 Roller pumps ....................................................................................................................................................................... 4

4.4.5 Centrifugal pumps .......................................................................................................................................................... 5

4.5 Cardioplegia ............................................................................................................................................................................................... 5

4.5.1 Rationale ................................................................................................................................................................................. 5

4.5.2 Solutions ................................................................................................................................................................................. 5

4.5.3 Method of delivery ......................................................................................................................................................... 6

4.5.4 Heat exchanger leaks.................................................................................................................................................... 6

4.5.5 Temperature control ........................................................................................................................................... .......... 6

4.5.6 Bubble removal ................................................................................................................................................................. 6

4.5.7 Leak-free ................................................................................................................................................................................. 6

4.6 Medical gas supply ............................................................................................................................................................................... 6

4.6.1 Rationale ................................................................................................................................................................................. 6

4.6.2 Circuit gas line(s) connection(s) ........................................................................................................................ 6

4.6.3 Source(s) and connections of gas(es) ............................................................................................................ 6

4.6.4 Flow meter/gas blender ............................................................................................................................................ 6

4.6.5 Hoses .......................................................................................................................................................................................... 6

4.6.6 Gas exhaust ........................................................................................................................................................................... 7

4.6.7 Inhalational gas scavenge line .............................................................................................................................. 7

4.6.8 Oxygen sensor .................................................................................................................................................................... 7

4.6.9 Operating pressures for gas sources............................................................................................................... 7

4.6.10 Gas filter .................................................................................................................................................................................. 7

4.7 Vacuum supply ........................................................................................................................................................................................ 7

© ISO 2018 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TS 23810:2018(E)

4.7.1 Rationale ................................................................................................................................................................................. 7

4.7.2 Vacuum line connections .......................................................................................................................................... 7

4.7.3 Vacuum source connections ................................................................................................................................... 7

4.7.4 Vacuum source pressures ........................................................................................................................................ 7

4.8 Components ............................................................................................................................................................................................... 7

4.8.1 Rationale ................................................................................................................................................................................. 7

4.8.2 Connections/stopcocks/caps ............................................................................................................................... 8

4.8.3 Tubing and shunts .......................................................................................................................................................... 8

4.8.4 Tubing direction ............................................................................................................................................................... 8

4.8.5 Tubing lengths and kinks ......................................................................................................................................... 8

4.8.6 One-way valve(s) ............................................................................................................................................................. 8

4.8.7 Bubble removal ................................................................................................................................................................. 8

4.8.8 Leaks........................................................................................................................................................................................... 8

4.8.9 Patency of arterial line/cannula ......................................................................................................................... 8

4.9 Safety mechanisms .............................................................................................................................................................................. 8

4.9.1 Rationale ................................................................................................................................................................................. 8

4.9.2 Alarms ....................................................................................................................................................................................... 8

4.9.3 Arterial filter/bubble trap ....................................................................................................................................... 9

4.9.4 Cardiotomy/hard-shell venous reservoir(s) ........................................................................................... 9

4.9.5 Venous line occluder ........................................................................................................................................... .......... 9

4.9.6 Devices attached to console ................................................................................................................................... 9

4.9.7 Arterial line occluder ................................................................................................................................................... 9

4.9.8 Vent(s) and suctions ..................................................................................................................................................... 9

4.9.9 Level sensor for dynamic priming .................................................................................................................... 9

4.10 Assisted venous return .................................................................................................................................................................... 9

4.10.1 Rationale ................................................................................................................................................................................. 9

4.10.2 Positive pressure-relief valve ................................................................................................................................ 9

4.10.3 Negative pressure-relief valve .............................................................................................................................. 9

4.10.4 Vacuum regulator ............................................................................................................................................................ 9

4.10.5 Kinetic-assisted venous drainage ...................................................................................................................10

4.11 Monitoring ...............................................................................................................................................................................................10

4.11.1 Rationale ..............................................................................................................................................................................10

4.11.2 Temperature probes ..................................................................................................................................................10

4.11.3 Pressure transducers/monitors ......................................................................................................................10

4.11.4 Flow probe(s) ..................................................................................................................................................................10

4.11.5 In-line sensor(s) ............................................................................................................................................................10

4.12 Anticoagulation ...................................................................................................................................................................................10

4.12.1 Rationale ..............................................................................................................................................................................10

4.12.2 Monitoring devices .....................................................................................................................................................10

4.12.3 Time and dose .................................................................................................................................................................10

4.12.4 Anticoagulation tested and reported ..........................................................................................................10

4.13 Temperature control .......................................................................................................................................................................11

4.13.1 Rationale ..............................................................................................................................................................................11

4.13.2 Water source(s) .............................................................................................................................................................11

4.13.3 Temperature range(s) ..............................................................................................................................................11

4.13.4 Water lines .........................................................................................................................................................................11

4.14 Supplies ......................................................................................................................................................................................................11

4.14.1 Rationale ..............................................................................................................................................................................11

4.14.2 Tubing clamps .................................................................................................................................................................11

4.14.3 Drugs .......................................................................................................................................................................................11

4.14.4 Solutions ..............................................................................................................................................................................11

4.14.5 Blood products ...............................................................................................................................................................11

4.14.6 Sampling syringes/laboratory tubes and supplies .........................................................................12

4.14.7 Inhalational anaesthetic .........................................................................................................................................12

4.15 Backup .........................................................................................................................................................................................................12

4.15.1 Rationale ..............................................................................................................................................................................12

4.15.2 Hand cranks or uninterruptible power supply ...................................................................................12

4.15.3 Emergency lighting .....................................................................................................................................................12

iv © ISO 2018 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23810:2018(E)

4.15.4 Backup oxygen tank with flow meter .........................................................................................................12

4.15.5 Duplicate circuit components and hardware .......................................................................................12

4.15.6 Ice ...............................................................................................................................................................................................12

5 Weaning and termination ........................................................................................................................................................................12

5.1 Rationale....................................................................................................................................................................................................12

5.2 Inhalational anaesthetic ...............................................................................................................................................................12

5.3 Assisted venous return .................................................................................................................................................................13

5.4 Cardiotomy/venous reservoirs ..............................................................................................................................................13

5.5 Shunt(s) ......................................................................................................................................................................................................13

5.6 Vent(s) .........................................................................................................................................................................................................13

5.7 Gas flow ......................................................................................................................................................................................................13

5.8 Extracorporeal flow with centrifugal pump ...............................................................................................................13

6 Post-extracorporeal circulation ........................................................................................................................................................13

6.1 Rationale....................................................................................................................................................................................................13

6.2 Termination ............................................................................................................................................................................................13

6.3 Clamping ....................................................................................................................................................................................................13

6.4 Bubble removal ....................................................................................................................................................................................13

6.5 Suction .........................................................................................................................................................................................................13

6.6 Patient haemodynamics ...............................................................................................................................................................13

7 Emergent re-initiation of extracorporeal circulation .................................................................................................14

7.1 Rationale....................................................................................................................................................................................................14

7.2 Anticoagulation ...................................................................................................................................................................................14

7.3 Circuit volume .......................................................................................................................................................................................14

7.4 Bubble removal ....................................................................................................................................................................................14

7.5 Medical gas supply ............................................................................................................................................................................14

7.6 Alarms and alerts ...............................................................................................................................................................................14

7.7 Water supply ..........................................................................................................................................................................................14

7.8 Tubing ..........................................................................................................................................................................................................14

8 Peri-procedural ..................................................................................................................................................................................................14

8.1 Entrainment of air into the ECC ............................................................................................................................................14

8.2 Reservoir level ......................................................................................................................................................................................14

8.3 ECC parameters ...................................................................................................................................................................................14

8.4 Water supply ..........................................................................................................................................................................................15

8.5 Fluid balance ..........................................................................................................................................................................................15

8.6 Personnel ..................................................................................................................................................................................................15

9 Documentation ....................................................................................................................................................................................................15

9.1 Rationale....................................................................................................................................................................................................15

9.2 Completion of the checklist and procedure record ..............................................................................................15

9.3 Retention of the checklist ...........................................................................................................................................................15

9.4 Expiration date .................................................................................................................................................................................

...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.