Faulty Design Created Inherent Risk – Part 5

Jet Injectors = Jet Infectors

January 17, 2016

Kelly and colleagues tested the potential cross-contamination of the hepatitis B virus via a protector cap needle-free injector (PCNFI). This newly improved design was supposed to eliminate the previous risks and hazards imposed by the multi-use nozzle jet injectors by placing a single-use plastic cap over the nozzle of the device. The study utilized the HSI-500 injector which consisted of a protector cap made of four coaxial orifices that the jet stream had to penetrate before continuing unimpeded to the patient’s skin. “The series of four coaxial orifices is designed to reduce retrograde passage of infectious material from the injection site onto the nozzle.”

The following slides, provided by Felton International, demonstrate the theory behind this technology.

hsi-500-slide-1hsi-500-slide-2hsi-500-slide-3hsi-500-slide-4hsi-500-slide-5

Jet injections were given to hepatitis B carriers in Beijing, China. The photo below captured the injections.

Kelly study- HSI-500 JIMI_Injection

Despite the cap’s design to prevent cross-contamination, “the study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate). The injections were very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding (7.8%).” Data collected also found moderate bleeding (0.5%).

Most shockingly, the published data demonstrates but the researchers failed to discuss, that cross-contamination of HBV occurred without any visible bleeding at the injection site. In 7 out of the 17 injections that tested positive for cross-contamination researchers observed no visible bleeding at the injection site (see Table 1 within the study). This indicates that cross-contamination of blood-borne viruses successfully occurred within microscopic levels of blood not visible to the human eye.
The study also demonstrated retrograde flow allowed blood-borne pathogens to permeate the single-use protector cap and enter the jet injectors internal fluid pathway.
Lastly, Kelly noted there was “no significant viral destruction from passing HBV through the injector.” This means that the virus, after undergoing retrograde flow from the human into the jet injector at a high velocity, through the four coaxial orifices that make-up the protector cap, and then being ejected again, was not destroyed but still alive and infectious.

Faulty Design Created Inherent Risk – Part 6

Acknowledgments:
Special thanks to PATH for supplying a paid copy of this study.

References:

  • (Kelly et al., 2008) Kelly K, Loskutov A, Zehrung D, Puaa K, LaBarre P, Muller N, Guiqiang W, Ding H, Hu D, Blackwelder WC. Preventing contamination between injections with multi-use nozzle needle-free injectors: a safety trial. Vaccine (2008) 26, 1344-1352.

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