KEY POINTS:
The purpose of this conference is to inform our community and the public of a rare and unusual event that occurred in our hospital concerning a patient who recently developed symptoms consistent with the diagnosis of Creutzfeldt-Jakob Disease (CJD).
First and foremost, I would like to extend our deepest sympathy to this patient, family and whanau who are understandably very distressed by the situation.
I have talked these matters over with the family and they have specifically asked me to request that they not be approached by the media.
Linked to our patient with suspected CJD, are 43 patients and their families.
These 43 patients - adults and children - are linked by the surgery they received recently, because the surgical instruments used, were used in common with the suspected case, a link that remains, despite faultless sterilisation for all instruments in all cases.
To these 43 patients, on behalf of the staff in this hospital I give our sincere apologies for the unnecessary anxiety, fear and distress inevitable with this announcement, distress which will diminish only when we can explain how small, how tiny, how remote the risk of developing CJD from this cause actually is, anxiety that will diminish only when we can explain that transmission of CJD in this way has not been reported since 1970, when we can explain to them that confidence in our sterilising methods now compared to pre 1970 makes transmission highly, highly unlikely.
This has been a difficult decision for us because we didn't want to alarm patients or the public, but we feel the better approach is be open and honest.
Inevitably this has upset those affected, and we apologise for the distress we are causing by being unable to say there is zero risk for this group of patients.
However I cannot emphasise too much how close to zero we believe their risk to be.
Over the past week we have studied this case in some detail with international experts, we have compared notes with other Australasian hospitals in which this same event has occurred, and we are confident that the risk of patients acquiring CJD from neurosurgery here in future is miniscule.
QUESTION AND ANSWER SESSION
How sure are you the patient had CJD?
Barry Snow, neurologist: "It's likely but not certain. We have taken certain test samples and those have been analysed both here and in Australia. We don't know when we'll be able to confirm the diagnosis and sometimes you cannot absolutely confirm the diagnosis, but it's sufficiently likely for us to take these extra measures."
Can you tell us what symptoms they had that alerted you to the disease?
Snow: "After her operation she didn't recover in the way we would have expected and that lead us to perform more investigations including brain scans which raised the possibility of CJD.
"She has had some seizures and hasn't regained awareness in the same way that we expect people to do."
Did the 43 patients have brain surgery?
David Sage, chief medical officer: "No, the 43 patients, the patients who may have come into contact with the instruments, most of them had brain surgery, some had head and neck operations similar to brain surgery."
Is there any risk that someone else could contract that disease here in New Zealand?
Sage: "The concern we have is that this patient received back in 1984 a graft of dura and perhaps I could ask Dr Mee to comment about the use of dura in the 70s and the consequences for this case."
Edward Mee, neurosurgery: "Any operation on the brain or spinal column usually involves opening the dural coverings to operate within and neurosurgeons have looked at various techniques over the last 50 or 60 years to close those coverings when we operate.
"In the 1970s it was considered that cadaver dura would be an ideal substitute and companies produced this substitute and there was a product developed in Germany that was known as Lyodura. That product was used widely throughout the world including in the United Kingdom, Europe, America, France, Australia and New Zealand.
"The number of surgeons who have used it, the number of cases it was put it in is indeterminate and the first case of CJD that was related back to a live dural graft was identified in 1987. The product had been available since 1972 and many thousands of people had Lyodura made by the German company inserted and it was realised that this was a potential health risk for those patients.
"The second case in fact was in 1987 when a New Zealand patient was reported in the literature as having had a dural graft previously and spontaneously developed CJD symptoms.
"So there has been a concern that neurosurgeons and their patients could contract CJD from tissue including tissue that's come from other patients that may have developed the disease spontaneously and then been part of a donor.
"And in this patients case we believe that Lyodura was used [unclear] of her [unclear] operation in 1984 which raises our concern or indeed our suspicion that her current could be CJD. So for that reason we have considered what to do about all the patients that have had Lyodura done in the past. Australia has considered this, United Kingdom has considered, there are working parties and those parties have considered whether all those patients should be identified and told.
"The actual risk that patients could develop CJD is very, very low, even if a dural graft has been put in and it's considered to be somewhere around about a 0.4 to 2.0 per cent risk. Well under a 1 per cent risk if you've had neurosurgery in the 1980s and a graft had been put in that you could develop this illness many years later."
Does the Lyodura come in batches and are you able to trace a particular batch?
Edward Mee: "It does come in batches and the original case was identified from a particular batch. The case that turned up in '87 was looked at and the company could not identify the batch.
"We believe there have been five cases in Australia related back to Lyodura, two cases already identified in New Zealand and this case would potentially be the third case in New Zealand."
Barry Snow: "And it's worth saying the processing of Lyodura subsequently changed and people who had Lyodura inserted since the early 90s are likely not to be at significant risk of developing this today."
Can you estimate how many could have had Lyodura inserted?
Edward Mee: "It's very difficult because we don't know whether surgeons use it regularly, routinely or occasionally.
"Some surgeons use it as a preferred substitute, others don't. So based on the Australian figures my estimate would be there would be a maximum of 500 cases that could have had Lyodura inserted but that really is a guess based on the estimate that they came up with in Australia where they thought 2,500 people had had Lyodura inserted in Australia."
And that's right up to the change?
Mee: "It's in that period. The change occurred in 1987 where the company changed its processing.
"In 1987 when the literature in neurosurgery alerted surgeons to the facts there was a dramatic drop-off in use of the product and so again we would have to identify for particular patients at what date the Lyodura used if they wished us to do that.
"It's important to know that the United Kingdom has decided, having reviewed the situation, that it would be unreasonable to alert those patients for fear of the emotional stress that would create for something that has less than a one per cent risk.
"When they look at their general health issues this is a very, very low risk to them and the panels there that have reviewed what should be done decided that the patient would not be contacted.
"If though any patient wishes to be contacted and discussed we would make efforts to obtain previous operation records and review it and give them the information [muffled]."
What is actually happening with the 43 other patients? Are there any tests that can show if they have been infected?
David Sage: "We have made contact with most of them yesterday and today and the facts have been explained to them.
"There's no test that can predict whether they will ever develop this."
"We have had a team working on this yesterday and this morning, phoning the patients, talking with them, asking them if they'd like to come in and talk to clinicians and so on.
"We have also set up an 0800 number for patients who are concerned."
Will there be any monitoring programme?
David Sage: "We need to have a national approach to this. We've just come upon it ourselves and so we haven't developed what we're going to do in future.
"It needs to have a New Zealand-wide approach - we'll need assistance from the Ministry of Health to decide where to go to from here."
Are you able to do something like an MRI scan on these 43 people?
Barry Snow: "If the event were to occur, and it's important to stress that it is extremely unlikely to - it hasn't following surgery since the 1970s, but the event wouldn't be likely to occur for months or more likely many years and sometimes decades after the exposure to the surgery."
What is the prognosis for the patient?
Barry Snow: "It is a fatal condition and there is no cure for it."
If the patient does have the disease, how long is she likely to have had it?
Barry Snow: "Well obviously if it came from the dura then perhaps the seed of it has been there, but the actual disorder has probably only developed over the last couple of months."
What sort of reaction have you had from the 43 people you have had to contact?
Edward Mee: "Well I've been involved in a large proportion of those contacts and the patients have been very concerned initially and we've discussed it in the same way we have here and that concern has led to an understanding and I think that they've gone away with a recognition that the chance of them contracting this disease is remote. It's not zero, but it is extremely unlikely and there's been no recorded case in the last 30 years where instrument to instrument transfer has occurred. So it's easy in a sense to say to patients that this is a very, very unlikely event to occur.
Is there anything you can do for these 43 people to reassure them?
Mee: "There are no tests and we have offered further discussion, further information involving several practitioners looking at further information regarding the disorder.
"We've put it up in outpatient clinics and we will continue providing the information we as neurosurgeons have had since the 1980s about this.
"We work with brains every day, we are reassured ourselves by the processes that are in place, that we are not putting ourselves or our nurses or our patients at risk."
Mark Thomas, infectious disease specialist: "The message...that as a result of contamination of surgical instruments, that there were four cases in the UK in the 1950s, there was one in France in the 1960s and two in Switzerland in the 1970s and that's the total body of recognised complication from the sort of event we're that talking about.
"It's very reassuring for people. We're talking about something that has happened in the past in a total of about eight people in total and it hasn't happened since the 1970s.
"Presumably it hasn't happened since the 1970s because the cleaning and sterilisation procedures that are used for surgical instruments have advanced greatly since then.
"It's not something that people aren't looking for. It's been looked for on many occasions - it just doesn't seem to happen any more."
- NZHERALD STAFF
