ISO/TS 23810:2018 心血管インプラントと人工臓器—体外循環装置の使用に関するチェックリスト | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 2, Cardiovascular implants and extracorporeal systems.

This third edition cancels and replaces the second edition (ISO/TS 23810:2012), which has been technically revised.

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 (e.g. 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. While this checklist is intended to be comprehensive for many types of equipment used for ECC, inclusion of specific checklist items does not necessarily mandate their use.

The purpose of this document 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 checklists before, during, and after a patient is placed on ECC support and also for post-operative management is an aid to reducing errors and to ensuring proper operation. Both users and patients can benefit from the use of such checklists. The manufacturer can also receive assurance that the product and/or equipment are being used according to the purposes for which it was designed and in accordance with the instructions for use.

The development of this document 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.

Extracorporeal circulation technology has been used clinically in a variety of concepts for more than 50 years and the equipment, techniques, and applications continue to evolve. While much technological advancement 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 Scope) 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 use such guidelines 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 document 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.

1 Scope

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).

2 Normative references

There are no normative references in this document.

3 Terms and definitions

No terms and definitions are listed in this document.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography