§ Dame Joan Vickers(by Private Notice) asked the Secretary of State for Social Services if he will make a statement concerning the death of five patients in Devonport Hospital following the discovery of contaminated fluid.
§ The Secretary of State for Social Services (Sir Keith Joseph)I have to report with great regret to the House the deaths of five patients at the Devonport Hospital. The whole House will feel the deepest sympathy, as I do, towards those who have been so tragically bereaved.
Last Saturday the doctors at the hospital confirmed their suspicion that these deaths might have a common link in that in each case an intravenous dextrose solution had been administered. These solutions had all been from the same sub-batch from the manufacturer, Evans Medical Ltd., of Speke.
The Senior Administrative Medical Officer of the South-Western Regional Hospital Board was informed on Saturday afternoon, and took immediate action to inform all hospitals in the region that bottles from that sub-batch were suspect and should not be used. He also informed the manufacturer, who at that stage believed that only the South-West Region would be involved, but, as a precaution, notified all his distributors that any stocks of the offending sub-batch should not be issued from their depots. Officers of my Department were also informed on Saturday, and they satisfied themselves that all hospitals in the South-West had been alerted.
Further information on Monday morning revealed that bottles from the same sub-batch could have been distributed to other regions. My Department immediately arranged for those regions to be alerted by telephone, and for nationwide publicity to ensure to the greatest possible extent that all bottles from the suspect sub-batch should be withdrawn from use.
Bottles of the dextrose solution from Devonport are being urgently examined bacteriologically by both the Public Health Laboratory Service and the Government Chemist. The results of these examinations will determine the next step 1244 to take to avoid any recurrence of this tragedy.
§ Dame Joan VickersI thank my right hon. Friend for his statement, and I ask him to offer our sympathy to those who are bereaved. Is he aware that since 1863 this hospital has performed excellent service to the community, and will he confirm that no blame attaches to the admirable and devoted staff? Have there been any similar incidents since 1966, when Evans Medical Limited had to recall 150,000 bottles of a similar liquid? What further action does my right hon Friend intend to take on this matter?
§ Sir K. JosephI welcome the tribute paid by my hon. Friend to the hospital and the staff. Since the incident in 1966 to which my hon. Friend refers, the firm concerned has been involved in no other incidents until now. A considerable tightening of precautions was made by the firm after the 1966 episode.
§ Dr. David OwenI extend my sympathy to the relatives of the people who have so tragically died. Will the right hon. Gentleman give the House a little more detail about the safety precautions that have been instituted in the firm since 1966? Will he assure the House that his Department has taken steps to ensure that the most stringent safety precautions are in force? Further, will he confirm or deny that the contaminated batch was delivered in May of last year? If it was, will a committee of inquiry be established to try to trace other deaths over the last few months which could be attributed to an infusion from the contaminated batch?
§ Sir K. JosephI understand that the likely cause of the 1966 contamination was faulty sealing of the bottle, and a more rigid specification was laid down for the rubber stopper and the application of the metal sealing ring. Improved manufacture and quality control procedures were introduced. Since then the Medicines Commission has come into being and is setting up an inspectorate which will watch quality control procedures. It is true that the batch was issued in April last year. I should like to leave the last part of the hon. Gentleman's question until I have considered the evidence available to me and decided what next should be done.
§ Mr. EmeryWill my right hon. Friend say what quality control he or his inspectorate has to prevent this sort of incident recurring? The quality control has obviously failed here and has led to fatalities. This is the second incident that has occurred within seven years involving the same firm. It must be apparent that action should be taken by his Department to ensure that this cannot happen again.
§ Sir K. JosephMy hon. Friend is right to focus attention on this point. My Department cannot possibly monitor every process of every product, but it exercises vigorous control over the sensible monitoring which a client should use. The new factor is the Medicines Commission, which is only at the beginning of its career. It also is setting up the nucleus of an inspectorate which will concern itself particularly with quality control.
§ Mrs. CastleMay I associate myself with the hon. Members who have expressed sympathy with the relatives of those who have died? In view of the importance of this issue, may I ask three questions?
First, does not this incident prove that a reputable brand name on a package is not a sufficient guarantee of the reliability of the product? Therefore, ought there not to be some form of routine testing of these products for which the right hon. Gentleman's Department should take responsibility? Can the right hon. Gentleman make quite clear what inspection takes place at present and what routine testing he intends to institute?
Secondly, at present when supplies come into a hospital there may not be a record of the batch number or the sub-hatch number on the invoice. This would make tracing difficult in an emergency situation such as this. Therefore, will the right hon. Gentleman issue instructions that all invoices should include the batch numbers or sub-batch numbers and that adequate records should be maintained of the product which a patient receives?
Thirdly, can the right hon. Gentleman tell us how far he has got in tracing the result of the batch? Will he put an embargo on all similar products of this company being used for this purpose until such time as the rest of the hatch has been traced?
§ Sir K. JosephI am sorry that I cannot give full answers to all the right hon. Lady's questions at this moment. She will be aware that the firm is naturally, in its own as well as the public interest, intensely jealous of its repute and good practice. Nevertheless, I have to be concerned with the quality control, and what I now have to study is the degree to which the Medicines Commission on the one hand and my Department on the other need to strengthen procedures. On that I cannot give a fuller answer until I have studied the lessons produced by this tragic episode.
I will certainly study the question about invoices. I think that they do carry a package number. I understand that 155 of the 600-odd bottles in this sub-batch have been recovered in the South-West Region up to now. I should like to consider the question of any embargo in the light of the answers I get from the Public Health Laboratory Service.
§ Dame Patricia Hornsby-SmithMay I associate myself with the expression of sympathy for those who have suffered bereavement in this tragedy? Is my right hon. Friend in a position to inform the House whether this was an error in the manufacture of the substance, or an error in the packaging, or whether some extraneous material was involved? Is my right hon. Friend yet in a position to guess where the fault lies in this unfortunate disaster, as quite obviously faulty fluid was being used on patients?
§ Sir K. JosephNo, I cannot give my right hon. Friend the answer to that question. I shall not be able to do so until I have the report of the Public Health Laboratory Service.
§ Mr. PardoeWhile associating myself with the hon. Lady the Member for Plymouth, Devonport (Dame Joan Vickers) both in sympathy with those affected and her remarks about the good work of the hospital, which serves part of my constituency, may I ask whether it is not normal practice for hospital laboratories to test incoming batches of this sort of substance? If that is not normal practice, should it not be?
§ Sir K. JosephI understand that it would not be practicable for hospitals to test samples from every product batch 1247 coming in, but the extent to which hospital procedures need to be reviewed will be one of the matters which I shall consider.
§ Dr. StuttafordHow long after the dextrose was administered did the first patient die? Can my right hon. Friend say what the organism was? If he cannot tell me, why not, because he has now had 48 hours in which to consider the matter?
§ Sir K. JosephI think the answer to the second question is reasonable, that I must wait for the examination by the Public Health Laboratory Service. I cannot answer the first question except to tell my hon. Friend that of the five deaths the first two were on 29th February and the last was on 2nd March; they were spread over those three days.
§ Mr. HefferCan the right hon. Gentleman tell us whether, after the fullest inquiries have been carried out, a report will be made available to hon. Members? Secondly, will he make absolutely clear that despite this very tragic event, Evans Medical Ltd. has a very good reputation? We in Liverpool feel very upset that the product should have emanated from a Liverpool factory. Will he make clear that this company has a very good reputation for these products?
§ Sir K. JosephI very much welcome the hon. Member's tributes to the firm concerned. In answer to the first part of his question, if my hon. Friend the Member for Plymouth, Devonport (Dame Joan Vickers) will be kind enough on a suitable date to put down a Question, I will give a written reply informing the House of the result of my inquiries.
§ Mr. PavittIn view of the importance of his statement about the Medicines 1248 Commission monitoring products, will the right hon. Gentleman undertake to make a statement of all the practical steps that will follow? Will he issue instructions that before dextrose is purchased in future it will be seen that the containers shall be of glass, as they used to be, because of bacteriological infection, whereas now many are made of plastic and other materials and infection is not easily spotted by the doctor when administering the drip?
§ Sir K. JosephI must not be taken as commenting in any way on the performance of the Medicines Commission. It is a new factor, and it is only just getting into action. I note the hon. Member's point about containers.