The 131st Annual Meeting (November 15-19, 2003) of APHA

Abstract #67856

Samantha D Wilson, RN, BScN, MHSc¹, Shelley L Deeks, MD, MHSc, FRCPC¹, Susan G Squires, RN, BScN, MSc¹, Fred Lapner, MD, FRCPC², Damian Kakwaya, MSc³, Irwin Hinberg, PhD², Barbara Harrison, RN³, Attar S Chawla, PhD², Tara Tucker, MD, FRCPC⁴, and Arlene S King, MD, MHSc, FRCPC¹. (1) Population and Public Health Branch, Health Canada, Tunney's Pasture, Building #6, PL 0603E-1, Ottawa, ON K1A 0K9, Canada, (2) Medical Devices Bureau, Health Canada, PL 0301H1, Tunney's Pasture, Ottawa, ON K1A 0K9, Canada, (3) Health Products and Food Branch Inspectorate, Health Canada, 3155 Willingdon Green, Burnaby, BC V5G 4P2, Canada, (4) Marketed Health Products Directorate, Health Canada, 2932 Baseline Rd, Ottawa, ON K1A 0K9, Canada

In July 2002, Health Canada (HC) became aware of a possible association between receipt of a cochlear implant (CI) and development of bacterial meningitis. At that time, approximately 30 cases had been reported in Europe and the USA, and one case had been reported in Canada. Approximately 2000 CI devices have been implanted in Canada.

The investigation of this public health issue necessitated the establishment of a Cochlear Implant and Meningitis Working Group with representation from HC branches responsible for medical device regulation, compliance, and health promotion and protection. The investigation has included a health hazard evaluation, enhanced surveillance of bacterial meningitis and a retrospective cohort study of CI recipients in Canada. The Working Group requested that Canada's National Advisory Committee on Immunization (NACI) evaluate the need for immunization recommendations specific to CI recipients.

As of 1 February 2003 there have been 6 reported cases of bacterial meningitis among CI recipients in Canada. The cohort study is ongoing and results will be available in November 2003.

NACI has recommended that all cochlear implant recipients and those considering cochlear implantation should be considered at high risk for invasive pneumococcal disease and invasive Haemophilus influenzae type b disease and should be vaccinated according to schedules for individuals at high risk. Persons with cochlear implants were not considered at high risk for invasive meningococcal disease.

The collaborative approach used in this investigation is unique and has resulted in a more comprehensive investigation into this complex public health issue.

Learning Objectives:

• At the conclusion of this session, the participant will be able to:
• 1)Recognize the benefits of a collaborative approach to investigating complex public health issues.
• 2)Articulate the roles of field investigators, medical device regulators, public health inspectors and federal epidemiologists in the investigation of a complex public health issue.
• 3)Identify public health action to reduce cochlear implant recipients' risk of bacterial meningitis.

Keywords: Public Health Agency Roles, Medical Devices

Presenting author's disclosure statement:
I do not have any significant financial interest/arrangement or affiliation with any organization/institution whose products or services are being discussed in this session.