§ The Secretary of State for Social Services (Sir Keith Joseph)
With permission, Mr. Speaker, I should like to make a statement on the report of the Committee which, the House will recall, I appointed under the chairmanship of Mr. C. M. Clothier, QC, to inquire into the circumstances which led to the use of contaminated dextrose infusion fluids at Devonport Hospital and which involved the death of five patients. The report has been published today and copies are available in the Vote Office.
The Committee concludes—in its own words in paragraph 79—that the fundamental cause of this disaster is to be found in human failings at Evans 1577 Medical, ranging from simple carelessness to poor management of men and plant. The Committee heard of no imminent technological advance in the field of production of intravenous fluids which will eliminate the need for skilful men devoted to their work. The Committee considers that too many people believe that sterilization of fluids is easily achieved with simple plant operated by men of little skill under a minimum of supervision, a view of the task which is wrong in every respect".The Government accept the report, and I have referred to the Medicines Commission a number of technical recommendations. These include consideration of the use of plastic containers, methods of identifying individual batches of dextrose, sterility testing methods, the possibility of incorporating bacterial filters and technical advice on the maintenance of autoclaves. There are also recommendations on prevention of contamination during cooling and after distribution.
Steps have been taken in my Department to improve its methods for dealing with reports of defective supplies. I have had extracts from the report which illustrate good practice in the production of infusion fluids circulated to manufacturers of sterile products. A meeting with nurses, doctors and pharmacists to discuss a number of points on hospital procedure has taken place and recommendations will be circulated as soon as they are finally agreed.
Officers of my Department have visited a sample of hospitals and identified in some of them necessary improvements in the organisation of sterilising facilities. Some can be made at once and others only after suspension of operations for a period. These hospitals have been advised accordingly. All hospitals within the National Health Service which produce their own sterile infusion fluids have been asked to examine their production methods in the light of the "Guide to Good Pharmaceutical Manufacturing Practice". Where the organisation requires improvements which cannot quickly be secured, hospitals have been asked to seek other sources of supply until the necessary improvements have been made.
I should like to thank Mr. Clothier and his colleagues for their urgent and penetrating review of the causes of this tragedy, and for their technical and other recommendations. Some have already 1578 been acted upon: all will have urgent attention.
§ Dr. Summerskill
We welcome the fact that this inquiry has now been concluded, and also welcome the Secretary of State's statement. It is to be deplored that human failings were the main cause of the tragedy, but it is hoped that all who are concerned with the preparation of infusion fluids will take a lesson from this case. I include in that remark the management and the laboratory staff.
When will the second and wider inquiry by the Medicines Commission make its report since that inquiry covers major issues which were not covered by the Clothier inquiry, including methods of production, distribution, storage and use of infusion fluids? When will the Secretary of State report on the Kettering general hospital incident, which has taken place since the Devonport incident? Although there were no deaths at Kettering, similar issues were involved there.
The right hon. Gentleman in his statement said that only a sample of hospitals had been visited by officers of his Department. Could he say what sample this was? Are we to conclude that other hospitals will not be visited? Will he consider some inspection of every hospital in the long term? Indeed, will he consider setting up an inspectorate on the lines of the Medicines Commission Inspectorate, which concerns itself with quality control? Clearly, it is insufficient to have inspection of only a sample of hospitals.
Finally, would the right hon. Gentleman bear in mind that we welcome the fact that the review by his own Department on emergency procedures covering incidents such as the one at Devonport is taking place?
§ Sir K. Joseph
I agree that there are lessons for all to be learned from this report.
In answer to the hon. Lady's first question, I should like to point out that the Medicines Commission is proposing to make an interim report on a number of issues. When I have had its judgment, I intend to report to the House, by an answer in Hansard, the date when it expects to complete its task.
1579 In regard to the incident at Kettering, my Department is discussing with the manufacturers a number of modifications in their procedures, but none of this should in any way be interpreted as casting doubt on the quality of the firm's products.
In reply to the third question, I should point out that the hospitals visited were a random sample. I intend to set up a continuing system of inspection of infusion fluid products.
§ Mr. Pardoe
Is the right hon. Gentleman aware that it is not only those of us who have lost constituents in this tragedy who feel that the report is a deeply worrying document, since it reveals alarming inadequacies in one of the best known medical firms in the country? Will he clear up one point on paragraph 79 of the report, which says that…too may people believe that sterilisation of fluids is easily achieved…"?It is not immediately obvious just who these people are. Is he satisfied that they existed only in Evans Medical—or in other firms, in hospitals, or even in his Department?
§ Sir K. Joseph
I think that if all of us were put under test we would have said—and I confess that I am one who would have said it—that in a world with infinitely sophisticated medical techniques the production of infusion liquids was not one of the more sophisticated ingredients. To that extent this shock may, at desperate human cost, have done great good to the whole community. Out of the alarm of this report, to which the hon. Member for Cornwall, North (Mr. Pardoe) referred, much good may legitimately emerge for the future.
§ Dame Joan Vickers
I thank my right hon. Friend for the manner in which he has had this inquiry conducted, and I congratulate Mr. Clothier and his colleagues on doing such excellent and detailed work in such a short time. I am also grateful to Dr. Meers for his report on page 30. In this connection, the junior staff are to be praised because it is they who were the first to have suspicions that all was not well.
I hope that my right hon. Friend will take very seriously the recommendations 1580 on page 23 of the report, especially Nos. 7, 8 and 9. These seem to be the crux of the matter. If we can get this recommended quickly and efficiently, it should help.
Finally, as one who lost several constituents in this tragic affair, may I ask my right hon. Friend what compensation will be given to the relatives of the victims?
§ Sir K. Joseph
I cannot enter into the last point, which is for the individuals concerned. But on my hon. Friend's previous point, the Medicines Commission is studying the recommendations in chapter 6 to which my hon. Friend referred and will be making a later report on them. I am sure that all the individuals concerned with production will be studying this report deeply, as will my Department.
§ Mr. Heffer
In the interests of Evans Medical and of people all over the country who use the firm's products, can the right hon. Gentleman indicate the present position at Evans Medical? What has the firm done to ensure that this will not happen again? Is the right hon. Gentleman in a position to tell the world that the company has made efforts to clear up this situation? Secondly, can the right hon. Gentleman say in much more detail than he has given us today what future plans there are for inspection both at production and at use level so that there is inspection of these products at both points of importance? Thirdly, is it not regrettable that it appears that middle management was primarily responsible for this situation? Again, can the right hon. Gentleman indicate whether the firm has dealt with that problem?
§ Sir K. Joseph
As for Evans Medical, this report reflects only on the company's production of infusion fluids. The embargo still bites on that production and will continue to do so until we have agreed with the firm about its new procedures. As for inspection, the report makes it plain that no pattern of inspection will guarantee the country against occasional incidents. Only application to duty by all levels of management and staff and by people in the distribution and use chain can save the country from future incidents. It means that we have 1581 to tighten up procedures at every stage in the process. I agree that on this occasion further damage was prevented by the timely vigilance of hospital staff. I am discussing with the professions the degree to which we can increase the training and vigilance of all hospital staff concerned. But I fear that there is no easy way out by way only of an inspection system. An inspection system must be part, but only part, of our safety measures.
§ Dr. Miller
Will the right hon. Gentleman accept that it is not quite such an easy matter to produce sterile solutions as one would imagine but that it is not impossible? Does he agree that it is tragic for someone to have reached the stage of recovering from a serious illness only to die because of an awful catastrophe of this kind? Does he agree also that it is equally a terrible tragedy from the point of view of the medical profession? However, since the offending fluid was actually septic at the time that it left the laboratory and did not become septic during its transit to or its being deposited at the hospital, will he turn his mind to the testing of it before it is used? I do not suggest that it should be done immediately before use. But could batches of infusion be tested several days before they are used, making sure that the storing of them in hospitals is done in conditions which will keep them sterile?
§ Sir K. Joseph
This is the third time that the hon. Gentleman has made this point to me. I must now promise him that I shall pass that suggestion to the Medicines Commission for consideration.
§ Dr. David Owen
I join the congratulations to members of the staff at Devon-port Hospital for their remarkable skill in picking up the early signs of this. Will not the right hon. Gentleman agree, however, that the most alarming part of this report is not brought out in it? It is that in May, 1971, 666 bottles of this sub-batch were dispatched to various parts of the country, that only 155 have been traced, and that a third of them were found to be contaminated. That seems to indicate that some 511 bottles of the sub-batch have not been traced. It is reasonable to expect that a third of them may have been contaminated. We are dealing, therefore, with a potential tragedy which 1582 may involve 170 bottles of contaminated fluid that has been used already, and no one has known about it. Is not it right that the committee should have spent some time looking at this rather more worrying aspect as well as at the small number of cases at Devonport, in view of the wider implications for the whole distribution system?
§ Sir K. Joseph
The evidence is that the other bottles were probably used with no ill-effects. The batch all went to that region.
§ Mr. Carter-Jones
I thank the right hon. Gentleman for his prompt action in this matter, and I think that both sides of the House will agree he has been very forthcoming. However, will the right hon. Gentleman agree that this incident may result in a setback to progress in medicine? As his Department is the prime buyer, cannot he monitor the whole system of medicines?
§ Sir K. Joseph
That is the idea behind the Medicines Act, under which licensing will shortly come into force. Much can be done through control by way of licensing. However, the report reminds us that no human system of inspection that would be practicable can possibly catch every error and, therefore, that the country must be able to depend upon the procedures and the diligence of all elements in the chain.
§ Mr. Robert Hughes
Does not the right hon. Gentleman consider that urgent action is necessary to establish an inspectorate? I accept that no amount of inspection can guarantee success, but it could guarantee that the equipment in use is of the highest standard and that it is kept maintained to that standard. Bearing in mind that the report refers to the quality of management, does the right hon. Gentleman consider that perhaps bad management might be regarded as criminal negligence when lives are at stake?
§ Sir K. Joseph
That last question is not for me. But in considering the inspectorate process I shall seek to learn much from this report.
§ Mr. Pavitt
Does the right hon. Gentleman's reference to the Medicines Commission mean that this matter will be 1583 examined by the Committee on the Safety of Drugs? Will the right hon. Gentleman look at the machinery operating in relation to this kind of problem? With regard to inspection at the point of delivery in hospitals, which is a long and complicated question, when the right hon. Gentleman comes to make a further announcement, will he give the House more details about how this can be pursued effectively throughout all our regional hospital board areas?
§ Sir K. Joseph
I do not anticipate having to make another statement to the House. The Medicines Commission is pursuing the subject of this report by way of a special committee which will make an interim report to me in due course.