Cardiovascular implants and artificial organs — Checklist for preoperative extracorporeal circulation equipment setup

ISO/TS 23810:2012 covers the activities performed by perfusionists 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.

Implants cardiovasculaires et organes artificiels — Liste de contrôle pour l'installation d'équipement de circulation extracorporelle préopératoire

General Information

Status
Withdrawn
Publication Date
03-Apr-2012
Withdrawal Date
03-Apr-2012
Current Stage
9599 - Withdrawal of International Standard
Start Date
20-Jul-2018
Completion Date
20-Jul-2018
Ref Project

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TECHNICAL ISO/TS
SPECIFICATION 23810
Second edition
2012-04-15
Cardiovascular implants and artificial
organs — Checklist for preoperative
extracorporeal circulation equipment setup
Implants cardiovasculaires et organes artificiels — Liste de contrôle
pour l’installation d’équipement de circulation extracorporelle
préopératoire
Reference number
ISO/TS 23810:2012(E)
ISO 2012
---------------------- Page: 1 ----------------------
ISO/TS 23810:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012

All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,

electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO’s

member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2012 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23810:2012(E)
Contents Page

Foreword ............................................................................................................................................................................iv

Introduction ........................................................................................................................................................................ v

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

2 Requirements ....................................................................................................................................................... 1

2.1 Patient information ............................................................................................................................................. 1

2.2 Sterility/cleanliness ............................................................................................................................................. 2

2.3 Pumps ..................................................................................................................................................................... 2

2.4 Cardioplegia .......................................................................................................................................................... 4

2.5 Gas supply ............................................................................................................................................................ 4

2.6 Vacuum supply ..................................................................................................................................................... 5

2.7 Components ......................................................................................................................................................... 5

2.8 Safety mechanisms ............................................................................................................................................. 6

2.9 Assisted venous return ..................................................................................................................................... 6

2.10 Monitoring ............................................................................................................................................................. 7

2.11 Anticoagulation .................................................................................................................................................... 7

2.12 Temperature control ........................................................................................................................................... 7

2.13 Supplies ................................................................................................................................................................. 7

2.14 Backup ................................................................................................................................................................... 8

2.15 Emergency reinitiation of bypass ................................................................................................................... 9

3 Documentation ..................................................................................................................................................... 9

3.1 Completion of the checklist .............................................................................................................................. 9

3.2 Retention of the checklist ................................................................................................................................. 9

3.3 Expiration date ..................................................................................................................................................... 9

3.4 Operator’s manuals ............................................................................................................................................ 9

4 Devices or equipment not part of the extracorporeal circuit .................................................................. 9

Bibliography .....................................................................................................................................................................10

© ISO 2012 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO/TS 23810:2012(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

(ISO member bodies). The work of preparing International Standards is normally carried out through ISO

technical committees. Each member body interested in a subject for which a technical committee has been

established has the right to be represented on that committee. International organizations, governmental and

non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International

Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.

The main task of technical committees is to prepare International Standards. Draft International Standards

adopted by the technical committees are circulated to the member bodies for voting. Publication as an

International Standard requires approval by at least 75 % of the member bodies casting a vote.

In other circumstances, particularly when there is an urgent market requirement for such documents, a technical

committee may decide to publish other types of document:

— an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in

an ISO working group and is accepted for publication if it is approved by more than 50 % of the members

of the parent committee casting a vote;

— an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical

committee and is accepted for publication if it is approved by 2/3 of the members of the committee

casting a vote.

An ISO/PAS or ISO/TS is reviewed after three years in order to decide whether it will be confirmed for a further

three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed,

it is reviewed again after a further three years, at which time it must either be transformed into an International

Standard or be withdrawn.

This document is being issued in the Technical Specification series of publications (according to the

ISO/IEC Directives, Part 1, 3.1.1.1) as a “prospective standard for provisional application” in the field of surgical

implants because there is an urgent need for guidance on how standards in this field should be used to meet

an identified need.

This document is not to be regarded as an “International Standard”. It is proposed for provisional application

so that information and experience of its use in practice may be gathered. Comments on the content of this

document should be sent to the ISO Central Secretariat.

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

rights. ISO shall not be held responsible for identifying any or all such patent rights.

ISO/TS 23810 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2,

Cardiovascular implants and extracorporeal systems.

This second edition cancels and replaces the first edition (ISO/TS 23810:2006), which has been technically revised.

iv © ISO 2012 – All rights reserved
---------------------- Page: 4 ----------------------
ISO/TS 23810:2012(E)
Introduction

This document has been published as a Technical Specification instead of an International Standard for provisional

application, so that individuals and/or professional groups who operate extracorporeal circulation (ECC) equipment

(i.e. perfusionists) may gather information and experience of its use in practice. It can be used as a checklist,

or a reasonable equivalent, before initiating extracorporeal circulation, which users are encouraged to adapt to

accommodate differences in circuit design or variations in institutional clinical practice. It is intended to be used

by healthcare facilities to create a checklist appropriate to the particular needs of their institution.

The purpose of this Technical Specification is to provide generic guidelines for the safe use of ECC equipment.

Errors and omissions in the setup of ECC equipment have the potential to compromise the equipment’s

intended functionality. In some cases, compromised functionality may result in severe injury to, or the death of,

the patient supported by ECC. Completing a checklist before a patient is placed on ECC support is an aid to

reducing errors and to ensuring proper pre-use setup. Both users and patients can benefit from the use of such

a checklist. The manufacturer can also receive assurance that the product and/or equipment is being used

according to the purposes for which it was designed and in accordance with the instructions for use.

The development of this Technical Specification has been made possible thanks to the efforts of professional

groups (see the Bibliography) in developing similar checklists, and provides for their wider dissemination and

recognition.

ECC technology has been used clinically in a variety of concepts in the past 50 years and the equipment,

techniques, and applications continue to evolve. While many technological advancements in devices and

techniques have occurred during this time, the fundamental purpose of ECC remains unchanged. Thus, generic

checklists are applicable to several modalities of ECC (see Clause 1) and may be customized by clinicians

for specific use depending on institutional or physician-mandated applications. The acceptance into general

practice of any guideline is most reasonably ensured if those who must put such guidelines into use can reach

consensus agreement on the key issues to be covered in a checklist. The benefits to be gained assume a

reduction in errors when a variety of ECC equipment is used clinically.

Finally, this Technical Specification fills an important niche in the improvement of patient safety, since no

regulation or standard exists in the area of preoperative checklists for ECC equipment.

© ISO 2012 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 23810:2012(E)
Cardiovascular implants and artificial organs — Checklist for
preoperative extracorporeal circulation equipment setup
1 Scope

This Technical Specification covers the activities performed by perfusionists 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.
2 Requirements
2.1 Patient information
2.1.1 Patient interviewed

Interview the patient and/or review the patient’s records, as per hospital protocol.

2.1.2 Patient identity confirmed

2.1.2.1 Confirm the patient’s identity from the patient’s chart and with the circulator nurse and verify.

2.1.2.2 Other methods for patient identification may be used per institutional protocol.

2.1.3 Medical record number transcribed and verified

Crosscheck the hospital identity number for the patient with the patient’s medical record and record it on any

chart-work associated with the procedure.
2.1.4 Allergies verified

Review the patient’s medical record to determine whether the patient has any known or reported allergies and

record such information on any chart-work associated with the procedure.
2.1.5 Blood bank number verified

2.1.5.1 Match the identity of all designated blood bank products to the patient and double-check before

administrating to the patient or into the extracorporeal circuit.
2.1.5.2 Confirm the number of units of blood available.
2.1.6 Blood type, antibodies verified

Review the patient’s blood type and possible antibody status by reading laboratory reports in the patient’s chart

before the procedure.
2.1.7 Chart reviewed

Review the patient’s medical chart before the procedure to determine vital statistics (e.g. height, weight) or any

other relevant information that could affect the performance of extracorporeal circulation.

© ISO 2012 – All rights reserved 1
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ISO/TS 23810:2012(E)
2.1.8 Procedure verified

2.1.8.1 Review the patient’s medical chart before the procedure to determine the intended medical indication

or surgical procedure.
2.1.8.2 Confirm the procedure with the surgeon.
2.1.9 Instructions for use read

2.1.9.1 Confirm that the user has read and understood the manufacturer’s instructions for use and is aware of

any current modifications/changes in order for the products to be operated and used safely.

2.1.9.2 Ensure this before the products are used, including before the preparation period.

2.2 Sterility/cleanliness
2.2.1 Components checked for package integrity/expiration dates

Visually inspect all component packaging and labelling prior to assembly to verify sterility.

2.2.2 Lot numbers

Record the lot numbers of components (oxygenator, reservoir, circuit), as well as the identification of the

pump consoles.
2.2.3 Equipment clean
Verify that reusable equipment is blood-free and clean prior to assembly.
2.2.4 Heat exchanger(s) leak-tested

2.2.4.1 For the water phases of all heat exchanger components, connect water source(s) with circulating

water and visually verify that they are free from water leakage into the blood pathway(s) prior to adding fluid

priming volume.

2.2.4.2 Pressurized air without decay may be used as a method to verify heat exchanger water phase integrity.

2.2.5 Maintenance

Verify that all equipment has been maintained according to manufacturers’ recommendations.

2.3 Pumps
2.3.1 Electrical
2.3.1.1 Power cord connection secured

2.3.1.1.1 Verify that all electrical power cords are securely connected to the appropriate power source(s).

2.3.1.1.2 Route all electrical power cor
...

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