Letters

Lessons of a hip failure

BMJ 1998; 316 doi: https://doi.org/10.1136/bmj.316.7149.1985a (Published 27 June 1998) Cite this as: BMJ 1998;316:1985

Registers of joint replacement operations should be set up

  1. Pat Riordan, Consultant in public health medicine,
  2. Graham Bickler, Director of public health,
  3. Cynthia Lyons, Public health specialist
  1. East Sussex, Brighton and Hove Health Authority, Lewes, East Sussex BN7 2PB
  2. Leicester Royal Infirmary, Leicester LE1 5WW
  3. Department of Epidemiology and Public Health, University of Leicester, Leicester LE1 7RH
  4. Northern General Hospital, Sheffield S5 7AU
  5. Cameron McKenna, Solicitors, London EC1A 4DD
  6. Department of Public Health, Sunderland Health Authority, Sunderland SR3 4AF

    EDITOR—Fickleness characterises the fashion industry. The fact that the introduction and use of hip prostheses in the United Kingdom should also be characterised by such whimsy is scandalous.1 The failure of the 3M Capital hip system and the difficulties in tracing and reviewing patients as a result bear witness to this. 2 3

    While we agree with the points made by Muirhead-Allwood in her editorial, she does not take the next logical step of requiring the establishment of a national hip prosthesis register. On the introduction of new prostheses and monitoring of outcomes, a register would provide a nationally coherent database recording preoperative, perioperative, and postoperative follow up information.

    It has been estimated that around 62 different replacement hip joints are available in Britain, manufactured by 19 different companies. Part of the problem in evaluating their effectiveness is the lack of high quality, prospective, comparative studies.4 A national register would provide the basis for scientifically well designed, statistically robust studies. Registers in Sweden and Norway collect a lot of relevant patient data and use these to allow adjustments for the effects of case mix when comparisons are made.

    We were provoked by the failure of the 3M Capital hip into ascertaining the national view of the need to establish a register and sent a UK-wide Epinet message to all directors of public health. The replies showed that several databases, audits, and research projects exist, but they are uncoordinated, geographically restricted, and, for some, strictly time limited. The overwhelming response was for the establishment of a national database to unite this research.

    In the light of the importance that the government attaches to clinical effectiveness and the establishment of clinical governance in trusts,5 we hope that this call for a national register is heard and acted on.

    References

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    Register exists in Trent region

    1. W M Harper, Professor of orthopaedic trauma surgery,
    2. K Abrams, Senior lecturer,
    3. R Elson, Consultant orthopaedic surgeon
    1. East Sussex, Brighton and Hove Health Authority, Lewes, East Sussex BN7 2PB
    2. Leicester Royal Infirmary, Leicester LE1 5WW
    3. Department of Epidemiology and Public Health, University of Leicester, Leicester LE1 7RH
    4. Northern General Hospital, Sheffield S5 7AU
    5. Cameron McKenna, Solicitors, London EC1A 4DD
    6. Department of Public Health, Sunderland Health Authority, Sunderland SR3 4AF

      EDITOR—Muirhead-Allwood calls for better regulation of the replacement hip industry in her editorial on the lessons to be learnt from the unacceptably high failure rate of the 3M Capital hip implant.1

      In the Trent region a register of all primary and revision hip and knee replacement operations was established in 1990. It has the cooperation of all orthopaedic surgeons in Trent and provides a confidential record that is available to individual surgeons. Capital Hips started to be implanted in the region in 1991, and implantation continued until 1995. Most of the implants were inserted in 1992 and 1993. Altogether 187 operations to implant a Capital hip were registered with the Trent study between 1991 and 1995. An increasing trend in revision operations was noticed in patients in whom the Capital hip had been implanted, with five revision operations in 1993-4 and 10 in 1996-7. Altogether, 16 revision operations for patients with Capital hips are registered with the database, giving an overall revision rate of 8.6% for these implants (95% confidence interval 4.5% to 12.5%); this is very high when it is considered that most of the implants were inserted in 1992 and 1993, and it contrasts with the five year revision rate for Charnley hip replacements implanted in Trent in 1990 of 3.0% (34/1132).

      The true effectiveness of a new implant can be assessed only if such databases are established across wide areas. We believe that new implants should not be used in regions unless a database is in place to monitor the results. It is only with the monitoring of such innovations in joint replacements that costly errors will not be made and advances can be judged against the performance of standard joint replacements as implanted by the average surgeon in the average hospital.

      References

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      Medical Device Regulations 1994 are now mandatory for all medical devices

      1. Christopher J S Hodges, Partner
      1. East Sussex, Brighton and Hove Health Authority, Lewes, East Sussex BN7 2PB
      2. Leicester Royal Infirmary, Leicester LE1 5WW
      3. Department of Epidemiology and Public Health, University of Leicester, Leicester LE1 7RH
      4. Northern General Hospital, Sheffield S5 7AU
      5. Cameron McKenna, Solicitors, London EC1A 4DD
      6. Department of Public Health, Sunderland Health Authority, Sunderland SR3 4AF

        EDITOR—Muirhead-Allwood argues that the introduction of a prosthesis must be regulated by a system analogous to that set up for drugs, involving extensive clinical trials, a licensing process, and postmarketing surveillance.1 This is almost precisely what will occur now, because on 13 June the Medical Device Regulations 1994 became mandatory for all medical devices, not just for prostheses. This new regulatory system will be introduced throughout Europe under directive 93/42/EEC and was described in detail by Ludgate and Potter in 1993.2

        The question, therefore, is not whether a system should be introduced but whether this new system is appropriately designed and will be appropriately operated and enforced. No doubt the regulators—principally in this case the Medical Devices Agency—and the European Commission, industry, and professionals will be able to consider the new system in the light of the facts of the problems with the 3M Capital hip as they emerge. On the basis of the limited information so far available from the press, I have confidence in the system as designed. I suspect, however, that improvements could be made in details of the postmarketing vigilance system for medical devices, although one should not jump to hasty conclusions from individual cases.

        References

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        Clinicians need to record name of manufacturer

        1. Wai-Ching Leung, Senior registrar in public health medicine
        1. East Sussex, Brighton and Hove Health Authority, Lewes, East Sussex BN7 2PB
        2. Leicester Royal Infirmary, Leicester LE1 5WW
        3. Department of Epidemiology and Public Health, University of Leicester, Leicester LE1 7RH
        4. Northern General Hospital, Sheffield S5 7AU
        5. Cameron McKenna, Solicitors, London EC1A 4DD
        6. Department of Public Health, Sunderland Health Authority, Sunderland SR3 4AF

          EDITOR—The hazard warning issued recently for the 3M Capital hip system by the Medical Devices Agency highlighted not only the need to regulate its use1 but also the importance for all clinicians who give drugs or implant medical devices of recording the batch number and the manufacturer of the products.

          Manufacturers are strictly liable for injuries caused by defects of products they supply if they are unreasonably dangerous to those who have used them. 2 3 However, if the manufacturer has notified the clinicians of potential defects but the clinicians are unable to identify the patients who have received the potentially defective devices and take immediate remedial action, the clinicians may be liable for damages resulting from the delay in corrective action being taken. Furthermore, if the clinicians are unable to identify the manufacturer during litigation—which may occur many years after the event—they stand in the shoes of the manufacturer and may become legally liable for the defective products. Clinicians should audit their records of all drugs given and devices implanted, such as intraocular lenses, hip and knee prostheses, and pacemakers.

          References

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