Annex A > Chapter 14 - Care in the Operating Theatre and the `Learning Curve' > The `learning curve' > The approach to a new procedure
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The approach to a new procedure
63 In the course of his evidence, Dr Howard Swanton, President of the British Cardiac Society, was asked:
`Q. There is obviously a difference between the development of a new technique where previously there was no technique at all, where the surgeon or the cardiologist would say, "Until the development of this technique, there was nothing we could do, but now we can try this", on the one hand, and on the other hand, the development of a new technique where there is an existing technique, where it is thought that the new technique might provide better and longer life, but at least initially with a higher mortality.
`At the moment, as I understand it, there is no formal structure in which debate would take place as to when and in what respects the new technique would be developed in that second example; is that right?
`A. Well, not quite right. Every hospital has its ethical committee with lay members on the Board, certainly, if you were planning, for instance, to try a new drug or a new drug trial on the medical side, you would submit the protocol to the ethical committee.
`Q. So the surgeon who wanted to do a new operation would submit the proposal to the committee?
`A. That would be appropriate, yes.' [78]
64 It was put to Dr Michael Godman, President of the British Paediatric Cardiac Association (BPCA), that often a new procedure `may burst onto the world' and that following publication there was `perhaps naturally a temptation, in the rest of the world, to wish to follow suit?' [79]
65 Dr Godman agreed that there was, and added:
`I listened earlier this morning to some of the evidence that was produced on the ethics of the Arterial Switch procedure in the early 1980s and late 1970s, and I think many of the arguments and points raised in that ethical debate obviously hold true for any new technique that is introduced.' [80]
66 Dr Godman was questioned about the approach urged by the BPCA:
`Q. When you are talking about the learning curve here, you are talking about somebody visiting from one centre to another centre?
`Q. That has funding implications?
`Q. So the position of the BPCA would be that this is necessary in the protection of the patient, and necessary to divert a surgeon from his operating list in Birmingham so that he can go to - again, purely hypothetical - Newcastle? ...
`Q. And work there for a week, two weeks, hands-on, before he comes back to Birmingham?
`A. No, in practice it would not be a week or two weeks. We are talking about individual procedures. We are talking about small numbers in congenital heart surgery, so if we are talking about a particularly complex lesion a visiting surgeon was asked to come to help with or introduce, that might be a series of visits, four, five or six in the course of a year, rather than coming and spending a week or two weeks. It is more probable it would be a visit for a day.
`Q. If it is to be a learning curve, that has to be done before the surgeon actually operates himself for the first time?
`Q. That would mean your four or five visits would have to be sufficiently narrowly spaced so that -
`A. Ideally yes.' [81]
`I know a number of centres where increasingly, for example, there are two paediatric cardiac surgeons in the centre, they are working together, particularly on more complicated cases, so they are not working in isolation, you have two assisting each other with the procedure. If one is a relatively new appointment, his senior colleague may at least help him in a significant number of cases, for example, in his first six or nine months in a post.' [82]
68 He also illustrated his views by describing the steps that had been taken in respect of the `progressive' introduction in the last two and a half/three years in the UK of:
`... a new device, an occlusion device to close a hole in the partition between the two upper chambers of the heart, the Atrial Septal Defect. The practice there has been that a centre has to do a minimum of six procedures with an experienced investigator or clinician who has done the procedure in a substantial number of cases. He needs to be present for 6 procedures.' [83]
`In terms of what was written in contracts or professional guidance no appraisal or training was required by a paediatric cardiac surgeon before embarking on a new operative procedure. I believe that most surgeons would acquaint themselves fully with the requirements, and details of any new procedure and be in a position to perform it competently.' [84]
`There was no professional guidance or contractual obligations at that time available for clinicians to follow any particular regimen or protocol when embarking on a new procedure. Decisions were made in regard to a clinicians training, confidence and skill. The support and advice of fellow clinicians was very important in deciding to do so, and in achieving a team spirit, essential for the success of any programme.' [85]
`The practice has become widespread of inviting experts to visit one's own centre in connection with starting a new and complex operation. At the beginning of this period [the period of the Inquiry's Terms of Reference], however, it was not at all common, but it probably grew slowly during the period up to 1995.' [86]
72 Mr Wisheart explained the effects of introducing a new procedure:
`If any member of the Team introduces a new procedure or technique, that may alter what is expected from other members of the Team. For example, if the surgeon is doing something different, then he may expect the nurse to supply him with different instrumentation or equipment. Similarly, if the anaesthetists change their management of anaesthesia, it may well interact with what the perfusionist is doing in his management of the circulation on bypass.' [87]
`If the surgeon is going to undertake a radically new procedure in paediatric cardiac surgery, he would need to explain it to the nurse, the anaesthetist, and the perfusionist. To the nurse he would want to explain what will be done, and in what order, so that the nurse can have the appropriate instruments and equipment available. To the anaesthetists he will wish to explain the plan of the operation so that they can place the patient in the appropriate position, can provide for all appropriate monitoring needs and can tailor what they do to the plan and needs of the operation. Similarly the perfusionist will want to know how the operation is likely to proceed, what temperature the patient will need to be at, whether there will be periods of low flow or circulatory arrest and so forth.' [88]
74 Professor Angelini, Professor of Cardiac Surgery, University of Bristol, stated:
`Every time a new procedure has been introduced I have been in lengthy discussions with the medical as well as the nursing and perfusion personnel, with a specific purpose to try to plan ahead what we wanted to do.' [89]
`For a brand new procedure the members of the cardiac surgery team would need to be trained. However, variations on operations already performed or operations performed on patients at a different age or size may not seem to be sufficiently new to warrant further training.' [90]
76 Dr Williams referred to the anaesthetists':
`... responsibility for ensuring that those who assist them, that is, operating department assistants, nurses and trainee anaesthetists were appropriately trained for the task delegated to them.' [91]
77 Ms Barbara Sherriff, Assistant General Manager at the BRHSC since 1992, stated:
`If a surgeon introduced new surgical procedures and other members of staff needed to be aware of any implications, then the medical staff trained those who needed to know ... For a procedure with clinical implications which was not purely a nursing matter ... then liaison took place between medical staff and ward staff.' [92]
78 The way in which managers were involved was addressed by Kathleen Orchard, General Manager of the Directorate of Surgery from 1991 to 1993, now a Senior Manager, Avon Health Authority, in her witness statement:
`Clinicians would ask their theatre managers for any new equipment and the first I would hear of it was when managers were concerned about costs or staff. This was something I would have to address, as it would affect the budget ... Sometimes the ward manager or the theatre sister would come to me and say that Dr X wanted a new procedure, particularly if it would require extra resources. If this was the case, the Clinical Director and I would meet with the clinician and find out what the implications of this new procedure were.' [93]
79 Kathryn Hale, a senior nurse at the BRHSC from 1983 to 1989, stated:
`... the paediatric cardiologists (and indeed the paediatric cardiac surgeons) were excellent at appraising staff of the need to introduce new clinical procedures. They, along with the clinical manager, developed the written procedures. Unit meetings, open to all grades of staff, were fora at which staff would have the opportunity to discuss new procedures and their possible implications on practice. Nursing staff were involved in preparing documentation to support new care interventions.' [94]
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Footnotes
[84] WIT 0120 0313 Mr Wisheart
[85] WIT 0084 0111 Mr Dhasmana
[86] WIT 0120 0316 Mr Wisheart
[87] WIT 0120 0321 Mr Wisheart
[88] WIT 0120 0322 Mr Wisheart
[89] WIT 0073 0008 Professor Angelini
[90] WIT 0318 0008 Dr Underwood
[91] WIT 0352 0021 Dr Williams
[92] WIT 0234 0034 - 0035 Ms Sherriff
[93] WIT 0170 0032 - 0033 Mrs Orchard
[94] WIT 0180 0042 - 0043 Ms Hale