HC Deb 11 June 2002 vol 386 cc1213-4W
Mr. Nicholas Winterton

To ask the Secretary of State for Health (1) upon whose recommendation, and for what reasons, disposable instruments were introduced for use in hospital operating theatres in England; what tests were carried out on the new disposable instruments; from which manufacturers the disposable instruments were sourced; what procedures were established to monitor the introduction and use of the instruments; and if he will make a statement; [56502]

(2) for what reasons deaths and adverse incidents resulting from the use of disposable operating instruments do not have to be reported; how many deaths have been reported and over what period; if complications resulting from use of disposable instruments have been related to specific manufacturers; and if he will make a statement; [56504]

(3) on what date a surgeon first complained to the authorities about the quality of the newly introduced disposable operating instruments; and how many complaints have been made since then; [56503]

(4) what steps his Department has taken to identify and contact parents and relatives of patients who have suffered adverse incidents in hospital operating theatres as a result of the use of disposable instruments who were not informed of their use at the time of the operations; and if he will make a statement. [56505]

Mr. Lammy

The move to single use instruments for tonsil and adenoid surgery was part of the Department's strategy to reduce the risk of transmitting variant Creutzfeldt Jakob Disease (vCJD) through surgical instruments. This was in accordance with advice received from the Spongiform Encephalopathy Advisory Committee (SEAC).

When the tenders for the contract were returned, a visual inspection of the instruments offered by all suppliers was undertaken. Once specific suppliers had been short-listed, their products were sent out to randomly selected ear, nose and throat surgeons to be used during operations. After each operation, the surgeons were asked to complete an evaluation form. The results of this evaluation were used during the selection of the successful suppliers. There are five companies on the National Health Service Purchasing and Supply Agency's framework agreement for single use instruments. They are:

  • Meditech Systems Ltd
  • B=H Surgical Instrument Makers
  • Rocialle Medical Ltd.
  • Trust Sterile Services
  • Axis Medical Ltd

We believe that there are other manufacturers of single use instruments who supplied products direct to NHS trusts, outside the Agency's framework agreement.

In October 2001, the Department sent a questionnaire to all members of the British Association of Otorhinolaryngologists to ask their opinion of the single use instruments. As a result of the comments made, minor alterations were made to the product specification of some products, such as mouth gags.

The medical devices regulations require device manufacturers to demonstrate that their devices meet essential safety requirements prior to placing them on the market. The safety and performance of devices in service is monitored by a mandatory vigilance system. Manufacturers are obliged to inform the competent authority (in the UK this is the Medical Devices Agency (MDA)) when an incident has occurred, involving their device, which may have caused a death or serious injury or which has the potential to cause death or serious injury.

In addition, the MDA also operates a voluntary user reporting system for users to report any adverse incident involving a medical device. The MDA first received an adverse incident report from a user in April 2001. Since then, the MDA has received reports of incidents concerning all the manufacturers listed above. The MDA has identified from its adverse incident database a total of 125 reports in relation to non-powered instruments, (108 prior to December 2001). 24 reports have also been received relating to powered instruments (diathermy). Each incident has been investigated in conjunction with the device manufacturers and appropriate action taken. One death has been formally reported to the MDA. We are aware of a second, which is presently under investigation.

There are possible risks in all surgical procedures. Therefore, before each operation, the clinician should explain the risks involved and any alternative treatment, to allow the patient or their family to give informed consent to the surgery. Tonsil and adenoid surgery is a relatively low risk operation, but where adverse incidents occur they are treated on a case by case basis by the NHS trust where the operation took place. Patients who have had their tonsils removed with single use instruments should not be concerned of any long-term effects following the surgery.