PS27

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1.   INTRODUCTION

Major extracorporeal perfusion (ECP) involves the diversion of patient blood through an artificial circuit incorporating a pumping device for the purpose of assisting the circulation, and usually achieving gas exchange for oxygen and carbon dioxide. The circuit will usually include an oxygenator and a heat exchanger and various pressure and flow monitoring devices for major cardiopulmonary bypass. This process is used for partial or total body perfusion as a life support system during cardiac and major vascular surgery and in profound heart or lung failure. The practice includes management and monitoring of procedures such as whole body perfusion, isolated limb perfusion, temperature control, specific organ protection or perfusion, blood coagulation control and blood conservation.

These guidelines are the recommended requirements for appropriate patient care.

2.   TRAINING AND MAINTENANCE OF STANDARDS

2.1   Specific Perfusion Training for Specialist Anaesthetists (or Fellows of ANZCA)

2.1.1   This training should include at least 12 months of regularly supervised experience in the practice of perfusion, covering all practical aspects of perfusion, including circuit set-up, priming and direct management of perfusion.

2.1.2   Training should result in a detailed knowledge of all medical aspects of management of patients undergoing major ECP. This includes managing the anaesthetised patient with cardiopulmonary bypass and drug and medication requirements. Management and knowledge of cardiovascular variables, gas exchange, acid base homeostasis, glucose and electrolyte homeostasis, coagulation and transfusion of blood and blood products, are essential components of perfusion management.

2.2   Education and Quality Assurance

All Fellows who practise major ECP should participate in:

2.2.1   A Continuing Education and Quality Assurance Program,

2.2.2   Auditing and data collection on all patients, with periodic review of data and all incidents occurring during or associated with major ECP.

3.   PRE-OPERATIVE PATIENT ASSESSMENT

3.1   The Fellow who practises major ECP must assess the patient preoperatively, as advised in the College Professional Document PS7 Recommendations on the Pre-Anaesthesia Consultation.

3.2   The Fellow who practises major ECP must inform the patient of the planned procedure and the anaesthesia, as outlined in the College Professional Document PS26 Guidelines on Providing Information about the Services of an Anaesthetist.

4.   CLINICAL MANAGEMENT OF MAJOR ECP

4.1   Major ECP Circuit Assembly and Priming.

4.1.1   Prior to application, the major ECP circuit must be assembled, checked and primed according to written protocols developed by each institution. These protocols must encompass standards for handling of sterile equipment, consistence with manufacturers’ recommendations, appropriate selection of priming solutions and a procedure for checking the circuit.

4.1.2   A written pre-bypass checklist for the assembled and primed circuit and all components of the major ECP machine must be completed and signed and kept on record.

4.1.3   Drugs added to the major ECP circuit must be checked and signed for according to protocols.

4.2   Initiation of Extracorporeal Perfusion

4.2.1   Prior to the initiation of extracorporeal perfusion, the Fellow who is conducting the perfusion must relieve himself/herself of any conflicting responsibility.

4.2.2   The anticoagulation status of the patient must be confirmed as appropriate for the procedure, and noted on the perfusion record.

4.3   Maintenance of Extracorporeal Perfusion

4.3.1   During maintenance of major ECP, continuous and vigilant assessment and management is required of all patient monitored physiological parameters and monitored machine parameters and anticoagulation. A clear display of monitored parameters is essential.

4.3.2   Medical management includes responsibility for all drugs administered and the maintenance of cardiovascular flows and perfusion pressures and of acid base homeostasis and gas exchange. Consideration of co-morbid medical conditions such as diabetes and renal failure is essential at this time.

4.3.3 Continuous communication with the surgeon, anaesthetist, and technical assistants is essential during perfusion.

4.4   Cessation of Major ECP

4.4.1   Weaning from major ECP and resumption of adequate cardiac and pulmonary function requires particular care and skill as difficulties may occur at this time. As in all stages of major ECP, close cooperation and communication between the perfusionist, anaesthetist and surgeon is essential.

4.4.2   The major ECP circuit must be kept in a functional state until it is agreed by all medical carers that it is no longer required.

4.5   Protocols for Management of Major ECP

Basic clinical management protocols for extracorporeal perfusion and anticoagulation should be established in consultation with perfusion, anaesthesia, and surgical staff and be regularly reviewed.

Protocols for management of critical events should be distributed and regularly practised by all perfusion staff.

Such protocols must cover gas leaks or failure, blood circuit leaks or rupture, pump failure, oxygenator, filter or heat exchanger malfunction and the detection of clots in the circuit.

5.   PATIENT RECORDS OF MAJOR ECP

A contemporaneous record of the conduct of extracorporeal perfusion must be made on a form appropriate for retention in the medical records of the patient. The record should include:

5.1   Patient details, operative procedure and relevant pre-operative clinical information.

5.2   Names of medical and technical perfusion staff.

5.3   Equipment and circuit details, including prime constituents, administered drugs and fluids.

5.4   Monitored physiological parameters.

5.5   Monitored machine parameters.

5.6   Notations of relevant events during extracorporeal perfusion

5.7   Notation of administration of cardioplegia.

5.8   A completed and signed pre-bypass check list.

6.   ORGANISATION OF THE MAJOR ECP SERVICE

Fellows who practise major extracorporeal perfusion should be part of an organized hospital based service that is staffed with an appropriate number of trained and qualified personnel.

6.1   Staffing

6.1.1   The Head of the major ECP Service is responsible for all aspects of the administration and quality in delivery of the service as detailed in this document. He/she will be responsible for decisions relating to equipment selection and ordering.

6.1.2   The Head of the Service should ensure that the extracorporeal perfusion service is staffed at all times with appropriately trained staff to cover in hours and out-of-hours requirements, including emergencies.

6.1.3   Other staff will include appropriately trained personnel to support the service.

6.2   Facilities and Equipment

The Head of the Service should ensure that the extracorporeal perfusion service has appropriate staffing, facilities and equipment, and that members of the service are designated to:

6.2.1   Maintain and regularly review an inventory of all hardware equipment, including records of maintenance and repairs and preventative maintenance. All equipment must meet current standards in electrical safety for cardiac protection.

6.2.2   Maintain an inventory of orders, receipts and supplies of all disposable equipment.

6.2.3   Provide on-going assessment of the efficacy and cost-benefit of currently used and potentially available equipment.

6.3   Physical Facilities

The Major ECP Service requires adequate dedicated space in close proximity and with easy access to the operating theatre and postoperative recovery/intensive care unit for:

6.3.1   Storage of hardware items

6.3.2   Storage of adequate supplies of disposable equipment in appropriate areas, with respect to lighting and protection from humidity, moisture and temperature extremes.

6.3.3   A clean area, in accordance with standards applicable and relevant to assembly of circuits, for use during extracorporeal perfusion.

6.3.4   Storage of patient perfusion records and other data used for quality assurance, research and other activities, including the performance of all devices used during the conduct of extracorporeal perfusion.

6.3.5   Offices and secretarial assistance for the Head of the Service and other members of the Service.

COLLEGE PROFESSIONAL DOCUMENTS

College Professional Documents are progressively being coded as follows:

TE Training and Educational

EX Examinations

PS Professional Standards

T Technical

POLICY – defined as ‘a course of action adopted and pursued by the College’. These are matters coming within the authority and control of the College.

RECOMMENDATIONS – defined as ‘advisable courses of action’.

GUIDELINES – defined as ‘a document offering advice’. These may be clinical (in which case they will eventually be evidence-based), or non-clinical.

STATEMENTS – defined as ‘a communication setting out information’.

This document has been prepared having regard to general circumstances, and it is the responsibility of the practitioner to have express regard to the particular circumstances of each case, and the application of this document in each case.

Professional documents are reviewed from time to time, and it is the responsibility of the practitioner to ensure that the practitioner has obtained the current version. Professional documents have been prepared having regard to the information available at the time of their preparation, and the practitioner should therefore have regard to any information, research or material which may have been published or become available subsequently.

Whilst the College endeavours to ensure that professional documents are as current as possible at the time of their preparation, it takes no responsibility for matters arising from changed circumstances or information or material which may have become available subsequently.

Promulgated: 1994

Reviewed: 2001

Date of current document: Feb 2004

© This document is copyright and cannot be reproduced in whole or in part without prior permission.

College Website: http://www.anzca.edu.au/