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  3. Wednesday, 16 January 2002
POST 00411E : NEEDLE-FREE INJECTOR FOR MASS IMMUNIZATION CAMPAIGN Follow-up on Posts 00405E and 00408E 16 January 2002 _________________________________________________________________ Bruce G. Weniger (mailto:bgw2@cdc.gov ) of the National Immunization Program at the Centers for Disease Control and Prevention (CDC) offers us a very documented opinion on the needle-free injector. ____________________________________________________________________________ This is feedback invited in follow-up to the posting about FDA's recent 510(k) "premarket notification clearance" for the BI-3M needle-free jet injector manufactured by the Chemical Automatics Design Bureau (http://www.fas.org/spp/civil/russia/kbkha.htm and http://www.inspacemedia.com/english/info/industrylinks/2001/006.shtml) in collaboration with Felton Medical International (http://www.feltonmedical.com/) and PATH (http://www.path.org/technos/ht_measles_elim_inject.htm). "Clearance" of an injector device under the 510(k) route is far less strenuous than an FDA "premarket approval" for a device (see: http://www.fda.gov/cdrh/devadvice/3122.html#link_4). The former permits U.S. sales solely on the basis of being "substantially equivalent" to an existing legally-marketed predicate device (http://www.fda.gov/cdrh/devadvice/314.html#contents). But the presumed predicate device -- the multiple-use-nozzle Ped-O-Jet® -- aroused concern in the mid-1990s from a Brazilian study which detected blood in in-vitro ejectates collected during routine vaccination campaigns of humans (http://www.aegis.org/pubs/aidsline/1994/dec/m94c3258.html). In 1997, it was withdrawn voluntarily from the market by its manufacturer (Keystone Industries, Inc.) because of liability fears, leading to a U.S. Department of Defense recall from military use (see: http://www.cdc.gov/nip/dev/jetinject.htm#policies). Multiple-use-nozzle injectors have undergone published (Hoffman et al, Vaccine 2001;19:4020-4027) and unpublished safety evaluation model testing in cows, pigs, and humans in the UK, US, and Brazil. The method assays for picoliter concentrations of blood (>20 pL/mL), which is theoretically capable of transmitting hepatitis B infection, based on one titration study in an HBsAg-carrier chimpanzee. The sensitivity, specificity, and relevance to humans for these evaluations remain unvalidated. Nevertheless, for all devices studied to date, blood was detected at levels within reliable segments of their calibration standard curves in one or more ejectates collected during series of up to approximately 100 in vivo injections. The recent 510-k clearance of the BI-3m should not be interpreted to represent a "clean bill of health" for this multiple-use-nozzle device. It simply means the FDA considers it to be equivalent to a Ped-O-Jet® in efficacy and safety. >From FDA's regulatory perspective, Ped-O-Jets are still legally marketable in the U.S. WHO currently recommends that the Ped-O-Jet® and similar devices NOT be used until their safety is demonstrated (http://www.who.int/vaccines-documents/DocsPDF/www9665.pdf). In contrast, an FDA "pre-market approval" -- for which the BI-3M was not submitted and did not receive -- would require a much more rigorous demonstration of both efficacy (which is not in any doubt) AND safety (http://www.fda.gov/cdrh/devadvice/316.html#contents). In granting its "clearance", the FDA made no thorough assessment of the safety of the device with regard to the potential for transmission of bloodborne pathogens between consecutive vaccinees. Given the cloud of concern surrounding multiple-use-nozzle jet injectors, the public health vaccination community should insist that all multiple-use-nozzle injector devices undergo careful regulatory scrutiny, i.e., a full "pre-market approval" by the FDA, or an equivalent process in other countries. Also, the full studies of their safety and efficacy in support of approval should be published in peer-reviewed journals, and thus permit the public health agencies and organizations likely to use them to make their own judgements based on the evidence. Bruce G. Weniger Assistant Chief for Vaccine Development Vaccine Safety and Development Branch National Immunization Program Centers for Disease Control and Prevention ------------------------------------------ Postal Mail: 1600 Clifton Road (E-61) Atlanta, GA 30333 USA Couriers: 12 Corporate Boulevard Atlanta, GA 30329 USA ------------------------------------------ Tel: [+1] 404-639-8779 Fax: [+1] 404-639-8834 bgw2@cdc.gov http://www.cdc.gov/nip/dev ----------------------------------------------------------------------------- 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. 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