HC Deb 04 May 1972 vol 836 cc593-6

Mrs. Castle (by Private Notice) asked the Secretary of State for the Social Services if he will make a statement about the latest discovery of supplies of contaminated dextrose infusion fluids following the administration of a drip feed to a patient in Kettering General Hospital.

The Secretary of State for Social Services (Sir Keith Joseph)

On 24th April a patient in the Kettering and District General Hospital suffered a reaction during the administration of 5 per cent. dextrose solution manufactured by Travenol Laboratories at Thetford, Norfolk. Fortunately, this was not fatal. The hospital arranged for the solution to be examined by the Public Health Laboratory Service and it was found to be contaminated. The results of the examination were reported to my Department on 1st May and inspectors were sent the following day to the manufacturer's factory. They examined all the production and quality control procedures and the records of the particular batch of 7,000 bottles which was manufactured at the beginning of last month and which included the one that was contaminated.

The preliminary report showed that the routine tests which had been made by the manufacturer on samples from the batch had revealed the presence of bacteria. Following the firm's normal procedure, the tests were repeated on other samples after an interval and gave no evidence of contamination. The batch was then released for issue and was distributed mainly to hospitals in the South-East and to two wholesalers.

There was and still is no conclusive evidence that the contamination found at Kettering is the fault of the manufac- turer but as a precautionary measure the 25 hospitals and the two wholesalers who had received bottles from the batch were advised by telephone to withdraw them from use.

The inspectors are now making thorough tests of the manufacturer's autoclaves and are examining in detail the production and quality control procedures.

Mrs. Castle

Is not this third incident in a short period of the presence, and in two cases the use, of contaminated fluid in hospital extremely disturbing? Whatever the cause of the contamination, or wherever it may have taken place, is not the risk to the patient the same? There is, therefore, grave anxiety whether the public are being adequately protected against this serious danger.

Will the Secretary of State tell us when we can expect the report on the inquiry which he set up seven weeks ago into the case of contamination concerning Evans Medical Ltd.? In this alarming situation is it not essential that we should have that report without further delay?

Will the Secretary of State ask the Medicines Commission to expedite its fuller and wider inquiry with a great sense of urgency bearing in mind the circumstances of this latest case?

Sir K. Joseph

Mr. Clothier, who has chaired the inquiry that I set up into the Devonport episode, tells me that he hopes to have the report in my hands by the end of June or early in July. There is a lot of evidence to be considered. The Medicines Commission is studying this whole problem. I am arranging for the details that I have given the House to be sent to the Commission, under a panel of which Lord Rosenheim himself is chairman. I doubt whether it will be able to finish its work quickly. It will want to do it thoroughly. But I shall keep the House informed.

Mr. John E. B. Hill

While welcoming the fullest inquiries into the procedures of this firm, which is in my constituency, and into the processes of checking contamination generally, may I ask my right hon. Friend whether he agrees that in fact this batch passed the requirements of the Britist Pharmacopoeia before being released and that subsequently there was no difficulty in identifying the hospitals and wholesalers holding all the 7,000 bottles? Provided that there is some control just before the point of use, the patient should be satisfactorily safeguarded. But from the manufacturer's point of view there is no certainty that a product leaving his factory sterile will not become contaminated before being used by the patient.

Sir K. Joseph

As I said, there is no evidence at the moment to show that any fault lay with the manufacturer. But I am disconcerted to find as a result of this episode that there may be different interpretations of what is good practice in testing. I am now put on inquiry as regards that, and my inspectors will be satisfying themselves as to what is good practice and discussing it urgently with the Medicines Commission and the pharmaceutical industry.

Mr. Pavitt

In view of the fact that only three large manufacturers make this fluid, producing only 45 per cent. of the total used, and that the remaining 55 per cent. comes from regional hospital boards and a multiplicity of small manufacturers, will the right hon. Gentleman ensure that the present inquiry looks not just at the three large manufacturers but at the multiplicity? Secondly, will he issue immediate instructions to hospitals to discontinue the practice of using the same set for different fluids over a lengthy period and to ensure that immediately one intravenous drip is finished fresh bottles are put into operation? Will he see to it that the practice of continuing not only with the same fluid but with different fluids in the same set ceases?

Sir K. Joseph

The answer to the first part of the hon. Gentleman's question is" Yes ". As to the second part, fresh instructions to hospitals making the fluid are going out this week. I will ensure that they take into account the hon. Gentleman's final point, which is too technical for me to deal with in an off-the-cuff reply.

Mr. Geoffrey Finsberg

While I do not wish to minimise anything in this series of three incidents, is it possible for us, now or later, to be given an idea of the total number of bottles in use, which, therefore, are not contaminated? In that way, we might be able to see the proportion about which we are talking in the three incidents.

Sir K. Joseph

The proportion is absolutely infinitesimal. What is at issue is the procedure to ensure that any contamination is identified in time.

Dr. Miller

Will the right hon. Gentleman say which bacteria were the ones contaminating the bottles, since that could give an indication of the sources of the contamination? Secondly, notwithstanding the difficulty in perfecting an immediate test for contamination, will the right hon. Gentleman turn the attention of his experts to the possibility of an instant test which can be done just before bottles are used? Even in the interim period it is possible to have some kind of test which may take a day or two. But there is no reason why every day in the week a batch of bottles in every hospital should not be tested for use two days in advance, as an interim measure.

Sir K. Joseph

I do not know the names of the bacteria. As for an instant test, certainly samples of a batch could be tested if the Medicines Commission recommended such a practice. But any bottle tested will have been opened and cannot be used.

Mrs. Castle

Is it not very unsatisfactory that we should have to wait another seven weeks or more for the report on the Evans Medical Limited disaster—it can only be called that? Cannot the right hon. Gentleman use his influence to get the report hurried up? Surely it is not beyond the wit of those concerned to let us have it within three weeks or so. Finally, will the right hon. Gentleman please make another statement when he has concluded his inquiry into this recent case?

Sir K. Joseph

I shall ask Mr. Clothier, who has two extremely distinguished colleagues on the inquiry, to see whether he can give me any results, even if they are only a first instalment. There is a lot of evidence for them to master. Through the usual channels, I shall discuss a suitable time for keeping the House informed.