Following the incident on 24th April, the remaining bottles of the affected batch were withdrawn. Two bottles out of 48 sent to the Public Health Laboratory Service were found to contain some organisms. The manufacturer has tested over 500 bottles but has found nothing wrong.
Meanwhile, my inspectors have conducted a thorough investigation at the premises of Travenol Laboratories. They have examined in detail the production processes, the records of quality control and the testing procedures and results. They have made various tests themselves and have also had the assistance of the Public Health Laboratory Service. They have found the manufacturing processes to be generally in accordance with current industrial practice, and the testing procedures are the same as those which have been published in the European Pharmacopoeia.
I have therefore had no reason to suspend the use of all fluids manufactured by Travenol Laboratories, nor has any fault been found in the procedures governing the use of intravenous fluids at the Kettering and District General Hospital. There is no scientific evidence to establish beyond doubt the source of the contamination found in the dextrose solution used at that hospital. A number of theories have been developed and tested. Most have been discarded detailed investigation, which may he prolonged. is continuing.
I have also, as I previously reported to the House, passed to the Medicines Commission panel the facts about this incident at the Kettering and District General Hospital and the subsequent inquiries so that it may take account of them in its general review of safety measures. I have asked it, too, to look particularly at the British Pharmacopoeia requirement for intravenous fluids to see whether, in the light of knowledge gained since those requirements were formulated, they are now capable of being improved.
There has always been a very small degree of risk associated with the use of intravenous fluids. Defects in sterilising practice which could lead to large-scale contamination can be detected through the medium of the recordings and quality tests made by the manufacturers. There remains a risk, however, that some imperfection will result from, for example, a minute flaw in a bottle or some tiny temporary defect in a manufacturing process. A number of isolated examples, involving single bottles, occur from time to time, including some in the last month, but the routine hospital procedures ensured that these bottles were withdrawn from use.
These procedures constitute the last check. The main safeguards remain the strict adherence to a satisfactory manufacturing and sterilising procedure, the keeping of good records, the identification and tracing of any contaminants found during the testing procedures, and a programme of frequent examination of all the processes involved by the manufacturer, together with a continuing effort on the part of my Department and the manufacturers to introduce improvements as technological progress permits.
I thank the right hon. Gentleman for having made this statement to the House. I am sure that we are all relieved that the extent of the contamination seems to have been so limited. I particularly welcome the fact that the right hon. Gentleman has asked the Medicines Commission to look at the adequacy of the British Pharmacopoeia requirement for the tests of contaminated fluids. No doubt the right hon. Gentleman will have seen the important article by Dr. Max Sterne in the New Scientist of 7th May. Will he, therefore, ask the Commission to look at the points raised by Dr. Sterne? Finally, can the right hon. Gentleman state whether. following the talks he said he would have with Mr. Clothier, we can expect some interim report at any rate very soon arising from the inquiry into Evans Limited?
The answer to the right hon. Lady's first question is "Yes". I fear that the answer to the second question is "No". Mr. Clothier and his distinguished colleagues are aware of the urgency we attach to their report, but it is extremely unlikely, in view of the complexity of the subject—they have had a mass of highly technical evidence—that they will be able to complete their task before the early days of July.
I thank my right hon. Friend for confirming that the procedures of Travenol Laboratories are fully satisfactory according to the standards of his own Department and of the British Pharmacopoeia. Is he aware that the firm and its overseas associates manufacture 100 million bottles a year of this fluid and have never yet had a batch returned on grounds of any sterility problem? They are naturally keen to retain that unblemished record and not to have it spoiled through any misunderstanding of what may happen to a sterile package after it has left the manufacturer's care and after the seals have been broken.
I was very glad to say what I did about the firm's processes in my statement. But we are puzzled by the possibility of some minute flaw in a single bottle or in a single cap or in some other part connected with the bottle—I am talking of a single bottle and not a batch—whether it be in the firm's hands or after it has left its hands. The pursuit of the various possibilities may take some time to produce results.
I, too, thank my right hon. Friend for that statement. Can he reassure us that he will pursue further the matter of the mixture of various substances that are put on the ends of these infusion tubes and passed into the patient, as there are a large number of them and some hospitals have received circulars on certain substances which are incompatible? Will he draw the attention of all hospitals to this matter?
I am uncertain about entering into something which is clinical practice. If my hon. Friend will send me details of cases he has in mind which should worry me, I will gladly consult the medical profession about what steps may need to be taken.
How many other firms manufacture this fluid? Have they also been inspected? Is my right hon. Friend satisfied that the hospitals to which these bottles are sent have adequate accommodation for giving them the utmost care?
There are three firms—Travenol Laboratories, Allen and Hanbury's, and Boots. Evans Medical was producing this material but at the moment is not doing so for sale. There may be a few smaller firms involved but those I have listed are the main ones. I do not think the problem is one of accommodation. There are procedures in hospitals for applying tests of their own to bottles before use.
Would my right hon. Friend agree that the possibility of contamination can occur in the hospital ward, particularly now that drips are used so much more often? Very often, the actual infusion set itself is left in place for a long while, the bottle being merely changed and contamination can occur in the tubing. Is my right hon. Friend aware that this is causing some anxiety to the medical profession?