All cochlear implants - update on immunisation recommendations

(All) risk of pneumococcal meningitis in cochlear implant patients. (MDA/2006/019)

Deadline (action underway): 17 April 2006

Deadline (action complete): 15 June 2006

Device

All cochlear implants.

Problem

Risk of pneumococcal meningitis in cochlear implant patients.

Update to immunisation recommendations.

Background

People with cochlear implants may have an increased risk of contracting bacterial meningitis. Abnormalities of the hearing organs may predispose some profoundly deaf individuals to greater meningitis risk and the presence of stimulation electrodes passing into the cochlea may present a route for the spread of infection which, if left untreated, may lead to bacterial meningitis.

In August 2002, the Medical Devices Agency issued a Device Alert (DA2002(09)) informing clinicians of the potential risk of pneumococcal meningitis in cochlear implant patients. At that time the Department of Health introduced the recommendation that all existing and prospective cochlear implant patients be given the pneumococcal vaccine.

In 2004, a UK study showed that although the risk of cochlear implant patients contracting bacterial meningitis remained low, the risk among implanted adults was slightly higher than for the general population2,3. A larger study of paediatric cochlear implant patients in the USA indicated an elevated risk in children4. These studies therefore indicated that patients fitted with cochlear implants may have an increased risk of contracting bacterial meningitis compared to the general population. The study carried out in the USA also indicated that patients who had cochlear implants with an intracochlear lead positioner had an increased risk of contracting pneumococcal meningitis in the first two years following implantation4. In the UK the incidence of infection had not been observed to differ between the available models of cochlear implant. Implants with a positioner are no longer available.

In August 2002 the Department of Health included coclear implant patients in the higher clinical risk groups for developing pneumococcal meningitis, who should be immunised against pneumococcal infection. In August 2004, the Department of Health further updated the immunisation recommendations for children aged between two and five years, and this advice was included in MDA/2004/046, which was issued by MHRA in September 2004.

Update

A recent study in the USA5 has now shown that the increased risk of developing pneumococcal meningitis persists beyond two years after implantation in cochlear implants that have a lead positioner. However, in the UK it remains the case that no increased risk has been observed between models with or without a lead positioner.

The Department of Health plans to further update the paediatric immunisation recommendations during 20066. For the latest immunisation advice, always refer to ‘The Green Book’.

Action

  • Note that the recommendations given in this update supersede the advice given in DA2002(09) on 7 August 2002 and MDA/2004/046 on 16 September 2004.
  • Ensure that existing and prospective cochlear implant patients have been immunised according to the Department of Health policy as outlined in ‘Immunisation Against Infectious Disease’ (‘The Green Book’).
  • Treat middle ear infections in existing and prospective cochlear implant patients promptly.

  • Ensure that existing and prospective cochlear implant patients have been immunised according to the Department of Health policy as outlined in ‘Immunisation Against Infectious Disease’ (‘The Green Book’)1.
  • Ideally, schedule cochlear implant surgery when patients are fully immunised in line with the recommendations given in the Department of Health immunisation programme. However, it is important that immunisation does not delay cochlear implantation.
  • Check for and treat middle ear infection before cochlear implant surgery. Consider the use of prophylactic antibiotics prior to implantation.
  • Diagnose and treat middle ear infections promptly in implanted recipients using the appropriate antibiotics.
  • Report all occurrences of meningitis incochlear implant patients to the Medicines and Healthcare products Regulatory Agency, providing details of the implant manufacturer and model and appropriate clinical data (including the immunisation status of the patient).

References

  1. Immunisation against infectious disease: HMSO 1996; ISBN 0-11-321815X, with replacement chapter 26 of ‘The Gree Book’ (Pneumococcal) issued in November 2005, available at www.dh.gov.uk.
  2. Cochlear implantation and meningitis in the UK. Report by the MRC Institute of Hearing Research August 2004, available at www.ihr.mrc.ac.uk/reports.
  3. Incidence of meningitis and of death from all causes among users of cochlear implants in the United Kingdom, Summerfield Q et al. J Public Health 2005; 27(1):55-61.
  4. Risk of bacterial meningitis in children with cochlear implants. Reefhuis J et al. N Engl J Med 2003; 349: 435-45.
  5. Bacterial meningitis among children with cochlear implants beyond 24 months after implantation. Biernath KR et al. Pediatrics 2006; 117(2);284-9.
  6. Planned changes to the routine Childhood Immunisation Programme. Chief Medical Officer Letter dated 08 February 2006, available at www.dh.gov.uk.

Action by

All clinicians who implant, manage or treat patients fitted with cochlear implants and those with prospective cochlear implant patients.

Distribution

  • NHS trusts in England - Chief Executives
  • Healthcare Commission (CHAI) - Headquarters
  • Primary care trusts in England - Chief Executives
  • Health Protection Agency (HPA) - Directors

Please bring this notice to the attention of all who need to know or be aware of it. This will include distribution by:

Trusts to:SABS liaison officers for onward distribution to all relevant staff including:

  • Audiology clinics
  • Clinical directors
  • Consultant microbiologists
  • Directors of cochlear implant units
  • ENT surgeons
  • Lead nurse infection control
  • Medical directors
  • Paediatric surgeons
  • Paediatricians

Health Protection Agency to:Directors for onward distribution to:

  • Consultants in communicable disease control
  • Health portection nurses

Healthcare Commission (CHAI) to:Headquarters for onward distribution to:

  • Clinics
  • Hospitals in the independent sector
  • Private hospitals
  • Private medical practitioners

Primary care trusts to:SABS liaison officers for onward distribution to all relevant staff including:

  • Directors of public health
  • General medical practitioners
  • Health visitors
  • Immunisation coordinators
  • Practice managers
  • Practice nurses

Contacts

Details of MHRA contacts for technical and clinical aspects.

Change of address or removal from address list for Healthcare Commission.

Immunisation queries:

in the first instance, these should be addressed to your local immunisation coordinator. Advice can also be found on www.immunisation.nhs.uk.

Enquiries about immunisation policy should be addressed to:

Dr Karen Noakes, Immunisation Policy, Monitoring and Surveillance, Department of Health, Room 506, Wellington House, 133-155 Waterloo Road, London SE1 8UG. Tel: 020 7972 4687, Fax: 020 7972 3989, E-mail: karen.noakes@dh.gsi.gov.uk

MHRA

Enquiries to the MHRA should quote reference number 20020708.025-8 and be addressed to:

Technical aspects:

Miss Katy Hopkins or Mr Peter M Solesbury, Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Tel: 020 7084 3176/3215 Fax: 020 7084 3106

E-mail:katy.hopkins@mhra.gsi.gov.ukpeter.solesbury@mhra.gsi.gov.uk

Clinical aspects

Mr Jonathan Plumb, Medicines & Healthcare products Regulatory Agency, Market Towers, 1 Nine Elms Lane, London SW8 5NQ

Tel: 020 7084 3128 Fax: 020 7084 3111

E-mail:jonathan.plumb@mhra.gsi.gov.uk

Change of address or removal from address list for Healthcare Commission

Healthcare Commission, Finsbury Tower, 103-105 Bunhill Row, London EC1Y 8TG

Tel: 020 7448 0842

E-mail: contacts@healthcarecommission.org.uk

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