HC Deb 16 April 1993 vol 222 c743W
Mr. Flynn

To ask the Secretary of State for Health (1) what percentage of orthopaedic hand operations carried out in the last 14 years have required revision;

(2) what percentage of knee replacement operations carried out in the last 14 years have required revision.

Mr. Sackville

It is not possible to identify precisely what proportion of operations required revision, but in 1989–90 and 1990–91 respectively, an estimated 6.3 per cent. and 5.3 per cent. of knee joint replacements were revisions. Equivalent information for hand operations is not available.

Mr. Flynn

To ask the Secretary of State for Health what plans she has to introduce a national register of knee replacements and revisions to provide an accurate measure of revision rate.

Mr. Sackville

I refer the hon. Member to the reply that I gave him on 14 April at column610.

Mr. Flynn

To ask the Secretary of State for Health which knee replacement implants which have been used in the NHS in the last 14 years have(a) the highest success rate and (b) the highest failure rate.

Mr. Sackville

Information on the outcome of knee replacement operations is not available centrally. It is the responsibility of clinicians to give advice to patients on the various types of knee implants available, based on the needs of the patient.

Mr. Flynn

To ask the Secretary of State for Health what tests are carried out on knee replacement implants before they can be marketed.

Mr. Sackville

There are no statutory requirements for the marketing of knee replacement implants.

Since 1986, knee implants have been controlled by the voluntary Department of Health manufacturer registration scheme, which requires that new designs should undergo appropriate testing prior to their release for general sale. There are currently 23 registered manufacturers of knee implants and the vast majority of these products implanted in the United Kingdom are from registered sources.

From 1 January 1995, the European Directive on Medical Devices will place the control of knee implants on a formal statutory basis, and manufacturers will be required to submit details of manufacturing and design to third party assessment.