A Medical Device Daily

The FDA has issued a statement saying that a new Centers for Disease Control and Prevention (CDC; Atlanta)/FDA study has shown that children with cochlear implants with a positioner remain at increased risk of bacterial meningitis caused by Streptococcus pneumoniae beyond 24 months post-implantation.

Cochlear implants with a positioner, a rubber wedge used to position the implant, were manufactured only by Advanced Bionics (Valencia, California). None have been implanted since July 2002, following a warning issued by the FDA identifying the association between the implant positioner and meningitis (Medical Device Daily, July 26, 2002/Aug. 16, 2002).

The new study, published in the February issue of Pediatrics, followed the same cohort of children identified in an earlier study for an additional two years. After 24 months post-implantation, children with cochlear implants with a positioner continue to be at greater risk of developing bacterial meningitis than children with cochlear implants without a positioner or children in the general population. Six children developed meningitis after 24 months post-implantation.

The FDA said that the findings “underscore the importance of continued monitoring and prompt treatment of bacterial infections” in this group.

The original warning was launched by the finding that 26 of more than 4,000 children with the implant and positioner developed meningitis.

The agency said it is still not known whether the risk of meningitis in patients whose implants have a positioner might be reduced if the implant were removed or replaced by a model without the positioner. “Any potential benefits of explantation surgery must be weighed against the risks for operative complications, including perioperative meningitis,” the agency said, noting insufficient information to support a recommendation for elective explanting of devices with a positioner.

The CDC also repeated its recommendations, first issued in 2003, concerning the administration of vaccines to cochlear implant patients, with or without the positioner, available on its web site, www.cdc.gov/nip/issues/cochlear/cochlear-gen (MDD, Aug. 1, 2003).

Early signs of meningitis include high fever, headache, stiff neck, nausea or vomiting, discomfort looking into bright lights, and sleepiness or confusion.

In some of the meningitis cases reported to the FDA, cochlear implant recipients had signs of middle ear infection (otitis media) prior to surgery or before the meningitis developed. For this reason, healthcare providers should diagnose and treat otitis media promptly in patients with cochlear implants, the agency said. And prophylactic antibiotic treatment should be considered, perioperatively, in children receiving cochlear implants.

The original CDC/FDA article on this topic was published in the July 31, 2003, issue of The New England Journal of Medicine, and the original FDA Notification on the Risk of Bacterial Meningitis in Children with Cochlear Implants was updated Sept. 25, 2003.

The 2003 CDC/FDA study assessed the risk of meningitis among 4,264 children under the age of 6, when implanted. Focus of the investigation was young children because they account for the majority of known meningitis cases and the group receiving most of the cochlear implants. The study was unable to determine how the positioner might increase the risk of developing meningitis.

AdvaMed lauds U.S./Korea trade effort

Stephen Ubl, president and CEO of the Advanced Medical Technology Association (AdvaMed; Washington), recently issued a statement endorsing the decision by the U.S. and the Republic of Korea to launch negotiations for a free trade agreement (FTA). “AdvaMed applauds the leadership of U.S. Trade Representative Ambassador Portman and Korean Trade Minister Kim Hyun-chong as they begin this process,” he said.

The statement termed Korea “a significant market for advanced medical technology,” adding that “a comprehensive FTA with Korea that addresses technical barriers to trade and reimbursement issues – as well as tariffs on goods, intellectual property rights, investment and services – would expand our members' export opportunities and bring tangible economic benefits to the U.S. and Korea.”

Ubl's statement concluded: “The successful conclusion of an FTA between our two countries can also further promote trade liberalization efforts regionally and globally. AdvaMed stands ready to support the FTA negotiating effort.”

HHS, Institute Pasteur in flu accord

The U.S. Department of Health and Human Services (HHS) and Institut Pasteur (IP; Paris) reported that they have agreed to carry out joint activities, beginning in Southeast Asia, to strengthen global capacity to detect influenza viruses that could have the potential to trigger a human pandemic.

A memorandum of understanding, signed by HHS Deputy Secretary Alex Azar, deputy secretary of HHS, and Professor Alice Dautry, president of IP, establishes an HHS/IP Working Group to oversee the development of collaborative projects, to include:

  • Building capacity in terms of surveillance, epidemiological investigation, testing, diagnosis and control of infectious disease in countries affected by, and at risk for, the spread of the H5N1 influenza strain.
  • Exchanging technical expertise to foster rapid response to disease threats.
  • Disseminating public information on infectious disease, including in local languages in developing countries.

“The Avian flu and respiratory diseases have been our constant concern, especially in the Pasteur Institutes in the Asian region,” Dautry said, “We have laid a heavy focus on them since 2004.”

Azar termed IP “an internationally respected research institute with . . . an impressive global network of institutes.”

Institute Pasteur is a nonprofit foundation dedicated to the prevention and treatment of infectious diseases through biological research, education and public health activities.

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