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

ISO/TS 23810:2006 covers activities performed by perfusionists during equipment setup prior to cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support (CPS), left or right heart bypass (LHB, RHB) and venovenous (VV) extracorporeal support for liver transplantation.

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

General Information

Status
Withdrawn
Publication Date
06-Jul-2006
Withdrawal Date
06-Jul-2006
Current Stage
9599 - Withdrawal of International Standard
Start Date
04-Apr-2012
Completion Date
04-Apr-2012
Ref Project

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ISO/TS 23810:2006 - Cardiovascular implants and artificial organs -- Checklist for preoperative extracorporeal circulation equipment setup
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TECHNICAL ISO/TS
SPECIFICATION 23810
First edition
2006-07-15
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 23810:2006(E)
ISO 2006
---------------------- Page: 1 ----------------------
ISO/TS 23810:2006(E)
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ii © ISO 2006 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 23810:2006(E)
Contents Page

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

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

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

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

3 Requirements ........................................................................................................................................ 1

3.1 Patient information ............................................................................................................................... 1

3.2 Sterility/cleanliness .............................................................................................................................. 2

3.3 Pumps [all pumps used with subsystems including vent(s), cardioplegia, and sucker(s)] ......... 3

3.4 Cardioplegia .......................................................................................................................................... 4

3.5 Gas supply............................................................................................................................................. 5

3.6 Components .......................................................................................................................................... 5

3.7 Safety mechanisms .............................................................................................................................. 6

3.8 Assisted venous return........................................................................................................................ 6

3.9 Monitoring ............................................................................................................................................. 7

3.10 Anticoagulation..................................................................................................................................... 7

3.11 Temperature control............................................................................................................................. 7

3.12 Supplies ................................................................................................................................................. 8

3.13 Backup ................................................................................................................................................... 8

3.14 Emergency re-initiation of bypass ...................................................................................................... 9

4 Documentation...................................................................................................................................... 9

4.1 Completion of the checklist................................................................................................................. 9

4.2 Retention of the checklist .................................................................................................................... 9

4.3 Expiration date .................................................................................................................................... 10

4.4 Operator's manuals ............................................................................................................................ 10

5 Devices or equipment not part of the extracorporeal circuit ......................................................... 10

© ISO 2006 – All rights reserved iii
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ISO/TS 23810:2006(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 normative 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.

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.
iv © ISO 2006 – All rights reserved
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ISO/TS 23810:2006(E)
Introduction

This Technical Specification is proposed for provisional application so that individuals and/or professional

groups who operate extracorporeal circulation equipment (i.e., perfusionists) may gather information and

experience of its use in practice. This checklist, or a reasonable equivalent, should be used before initiating

extracorporeal circulation. This checklist is a guideline that users are encouraged to modify to accommodate

differences in circuit design or variations in institutional clinical practice. This document 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 a generic guideline for safe use of extracorporeal

circulation (ECC) equipment. Errors and omissions in the setup of ECC equipment have the potential to

compromise the intended functionality of ECC equipment. In some cases, compromised functionality may

result in severe injury or death of the patient supported by ECC. Completing a checklist before a patient is

placed on ECC support is an aid intended to reduce errors and ensure proper pre-use setup of ECC. Both

users and patients will be beneficiaries of ECC preoperative checklists. Manufacturers also receive assurance

that their products and/or equipment are/is being used according to the purposes for which they are designed

and in accordance with the Instructions for Use. This Technical Specification is feasible because of efforts to

develop checklists by professional groups (see Clause 2). The evolution of these checklists into a Technical

Specification by the International Organization for Standardization (ISO) provides wider dissemination and

greater recognition of these recommendations. To assure optimal execution of this Technical Specification,

input from perfusionist professional organizations play a key role. Extracorporeal circulation technology has

been used clinically in a variety of concepts in the last 50 years and the equipment, techniques, and

applications continue to evolve. While much technological advancement in devices and techniques has

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

recommended guideline is most reasonably assured if those who must put such guidelines into use can reach

consensus agreement on 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 improving patient safety since no regulation or standard exists in the area of

preoperative checklists for ECC equipment.
© ISO 2006 – All rights reserved v
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TECHNICAL SPECIFICATION ISO/TS 23810:2006(E)
Cardiovascular implants and artificial organs — Checklist for
preoperative extracorporeal circulation equipment setup
1 Scope

This Technical Specification covers activities performed by perfusionists during equipment setup prior to

cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), cardiopulmonary support

(CPS), left or right heart bypass (LHB, RHB) and venovenous (VV) extracorporeal support for liver

transplantation. These checklist items should be considered for assuring verification that the equipment,

devices or systems have been set up correctly. This checklist is comprehensive by design and may be

modified by each institution in order to conform to specific procedures or institutional practice.

2 Normative references

The following referenced documents are indispensable for the application of this document. For dated

references, only the edition cited applies. For undated references, the latest edition of the referenced

document (including any amendments) applies.

American Academy of Cardiovascular Perfusion (Allentown, PA): Standards of practice. Proc. Am. Acad.

Cardiovasc. Perfusion 1987, 8, pp 272-274

American Society of Extra-Corporeal Technology (Reston, VA): Pre-bypass perfusion safety checklist.

Perfusion Life 1990, 7, pp 76-77

American Society of Extra-Corporeal Technology (Reston, VA): AmSECT Perfusion Checklist, updated by

AmSECT Quality Committee, 2004

Anonymous: Anesthesia apparatus checkout recommendations, 1993, [Source unknown, but endorsed by

American Society of Anesthesiology and U.S. Food and Drug Administration]
3 Requirements
3.1 Patient information
3.1.1 Patient interviewed

The patient shall be interviewed and/or the patient’s records shall be reviewed, as per hospital protocol.

3.1.2 Patient identity confirmed

3.1.2.1 The patient identity shall be confirmed from the patient’s chart and with the circulator nurse then

verified.

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

© ISO 2006 – All rights reserved 1
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ISO/TS 23810:2006(E)
3.1.3 Medical record number transcribed and verified

The hospital identity number for the patient shall be crosschecked with the patient’s medical record and shall

be recorded on any chart work associated with the procedure.
3.1.4 Allergies verified

The patient’s medical record shall be reviewed to determine whether the patient has any known or reported

allergies and such information shall be recorded on any chart work associated with the procedure.

3.1.5 Blood bank number verified

3.1.5.1 The identity of all designated blood bank products shall be matched to the patient and double-

checked before administration to the patient or into the extracorporeal circuit.
3.1.5.2 The number of units of blood available shall be confirmed.
3.1.6 Blood type, antibodies verified

The patient’s blood type and possible antibody status shall be reviewed by reading laboratory reports in the

patient’s chart before the procedure.
3.1.7 Chart reviewed

The patient’s medical chart shall be reviewed before the procedure to determine vital statistics (e.g., height,

weight) or any other relevant information that could affect performance of extracorporeal circulation.

3.1.8 Procedure verified

3.1.8.1 The patient’s medical chart shall be reviewed before the procedure to determine the intended

medical indication or surgical procedure.
3.1.8.2 The procedure shall be confirmed with the surgeon.
3.1.9 Instructions for Use read

3.1.9.1 The user shall understand the manufacturer’s Instructions for Use and be aware of any current

modifications/changes in order to operate and use the products safely.

3.1.9.2 This shall be done before the products are used, including the preparation period.

3.2 Sterility/cleanliness
3.2.1 Components checked for package integrity/expiration dates
...

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