POST 00420E : NEEDLE-FREE INJECTOR FOR MASS IMMUNIZATION CAMPAIGN

POST 00420E : NEEDLE-FREE INJECTOR FOR MASS IMMUNIZATION CAMPAIGN Follow-up on Posts 00405E, 00408E, 00411E and 00417E A Call to the International Public Health Community by the Needle Free Team at PATH 31 January 2002 ___________________________________________________________________________ The Needle Free Team at PATH completely supports full field safety trials to address the issue of cross contamination. It is for this reason that we have asked the international public health community to weigh in on this issue. Field trials (such as those conducted in Brazil) are currently being discussed with WHO, however it is important for the community to agree with the final protocol once it is available for comments and input. The BI-3M application was submitted to the USFDA at the request of WHO, in order to determine the extent by which the FDA would consider contamination and safety issues. We now ask the international public health community to guide final determination of safety with regard to this device. The target applications for this technology are mass immunization campaigns in the developing world, where additional factors need to be considered beyond what an industrial nation like the USA would consider. With regard to the comparison with the Ped-O-Jet®, the injector design has a completely different nozzle to patient interface. There is NO direct contact between the nozzle orifice and the injection site in the skin, but rather there is a single use, auto-disable barrier "cap" with a thin film barrier placed in between the nozzle orifice and injection site. As the injection stream passes from the nozzle orifice into the protector cap, it passes first through the film barrier, creating a hole slightly larger than the injection stream itself. The injection stream then passes through several millimeters of air space (contained within the cap) before entering the skin. The possibility of contaminants retracing the path through the protector cap (including the small hole in the barrier film) is remote. Darin Zehrung ----------------------------------------------------------------------------- All members of the TechNet21 e-Forum are invited to send comments on any posting or to use the forum to raise a new discussion or request technical information in relation to immunization services. Starting in January 2002, TechNet21 e-Forum will have 3 language versions: English, French and Spanish. The comments made in this forum are the sole responsibility of the writers and do not in any way mean that they are endorsed by any of the organizations and agencies to which the authors may belong. ----------------------------------------------------------------------------- CONTRIBUTIONS: Contributions to: or use your reply button! The TechNet21 e-Forum welcomes new subscribers who are involved in immunization services. SUBCRIBE: To subscribe, send an e-mail to: Leave the SUBJECT area BLANK, do not type anything. In the body text, just write: Subscribe TECHNET21E Surname Name Do not use any accents in your name and surname. UNSUBSCRIBE: To unsubscribe, send an e-mail to: Leave the SUBJECT area BLANK, do not type anything. In the body text, just write: Unsubscribe TECHNET21E ------------------------------------------------------------------------------ ARCHIVES New archives of posted messages starting with 1 November 2001 is accessible to all TechNet21 subscribers. To view the archives: http://listes.ulaval.ca/listserv/archives/technet21e.html Archives for postings between 17 August 1998 and 31 October 2001 can be found at the following web site for download starting 1 December 2001. http://www.who.int/vaccines-access/Vaccines/Vaccine_Cold_Chain/Technet Archives for files (documents) are under revision to clean old documents and drafts that are already replaced with new ones, and will be made available soon at the same site. http://www.who.int/vaccines-access/Vaccines/Vaccine_Cold_Chain/Technet ----------------------------------------------------------------------------- The World Health Organization and UNICEF support TechNet21. The TechNet21 e-Forum is a communication/information tool for generation of ideas on how to improve immunization services. It is moderated by Claude Letarte and is hosted in cooperation with the Centre de coopération internationale en santé et développement, Québec, Canada (http://www.ccisd.org) -----------------------------------------------------------------------------