Faulty Design Created Inherent Risk – Part 6

Jet Injectors = Jet Infectors

January 23, 2016

To conclude this series, Darlow was seeking epidemiological cases of viral hepatitis as a means of assessing whether jet injectors actually transmitted blood-borne diseases. Due to extenuating circumstances that are unique to the hepatitis C virus a lack of epidemiological cases would be expected during Darlow’s time. For instance, hepatitis C was not even identified as a disease. During the 1970s researchers speculated there was another strain of hepatitis and referred to it as non-A, non-B hepatitis, but otherwise hepatitis C would not be identified until 1989.

Second, during the onset of infection hepatitis C is most often asymptomatic, meaning there are no observable signs or symptoms. Those infected that do experience symptoms of decreased appetite, fatigue, nausea, muscle or joint pains, and weight loss would not think to attribute these general symptoms to the unknown and unidentified hepatitis C virus; especially within a military population that is subjugated to rigorous exercise and harsh conditions. Symptoms within a military population would have been, and in fact were, misdiagnosed or unreported. Soldiers were told to “toughen-up” rather than seeking an infirmary. Therefore military medical records are most often negative for any signs or symptoms of hepatitis C.

Chronic symptoms of hepatitis C do not appear for ten- to twenty-years later. Fast forwarding ten- to twenty-years and what do we observe amongst our now veteran population? Numerous diagnoses of hepatitis C, non-A, non-B hepatitis, and hepatic abnormalities. The epidemiological cases that Darlow sought have now emerged.

Fast forward another twenty-years and over 100 cases have recognized a jet injector as a probable source of a veterans hepatitis C infection. 53 cases solely recognized the jet injector was the veterans’ only risk factor for hepatitis C. Meanwhile, hundreds of veteran-claimant cases are still working their way through the court and adjudication process and hundreds of other cases have been nefariously and wrongfully denied. (See my post, A Twenty-One Year Assessment of the Nexuses Between Jet Injectors and Blood-Borne Pathogens Via Veteran Affairs Court Cases).
Moreover, a tactic admission by jet injector manufacturers emerges. In an old news article, Linda D’ Antonio, spokeswoman for the now defunct Association of Needle-Free Injection Manufacturers, stated “With the older style jet-injection devices, it was possible for blood to be drawn back into the nozzle…that blood then could be passed to the next person” (Snowbeck, 2001). Here an industry trade association made-up of 19 jet injector manufacturers, whose aim was to “promote understanding and advancement of needle-free injection technology, provide news and communication, and represent the industry to regulatory and technical standards organizations and the public” (CDC, 2006) admits to inherent design faults that permitted the transmission of blood and blood-borne pathogens between subsequent recipients.
Unequivocally, jet injectors widely-used within the United States armed forces transmitted hepatitis C.
The proof of the pudding is, in fact, in the eating.

References:

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

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.”
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%).

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
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.

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.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Faulty Design Created Inherent Risk – Part 4

Jet Injectors = Jet Infectors

January 17, 2016

Suria and colleagues (1999) investigated a multiple-use nozzle jet injector, known as the Syrijet, made from the same manufacturer as the Ped-O-Jet. This in vitro study assessed the transference of microbial pathogens among patients and whether skin cells could contaminate the internal components of the Syrijet during the injection process. Results found the jet injector nozzle became contaminated after being in contact with a contaminated injection surface. Moreover, due to the retrograde flow (i.e., Backwards flow) of the injection process contaminates had entered the internal components of the jet injector. The study found the larger the ejection volume the greater the internal components were contaminated. Suria concluded, “Although autoclaving is the only way to ensure sterilization of this device, frequent cleaning of the ejection surface during clinical use minimizes the risk of cross-patient bacterial transfer.” Although Suria also warns swabbing the nozzle of the jet injector does not remove the internal contamination.

Reference:

  • (Suria et al., 1999) Suria H, Van Enk R, Gordon R, Mattano LA Jr. Risk of cross-patient infection with clinical use of a needleless injector device. Am J Infect Control. 1999 Oct; 27(5):444-7).

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Faulty Design Created Inherent Risk – Part 3

Jet Injectors = Jet Infectors

January 17, 2016

Retrograde Flow
P.N. Hoffman, a scientist at the Laboratory of Hospital Infection in London, studied the risks and hazards of jet injectors at the request of the World Health Organization. In a personal interview, Hoffman recalled his study by saying:

I was part of a team studying a small range of jet injectors, trying to establish general truths rather than study specific injectors. I was observing whether there were any problems of blood transmission between sequential recipients of injections rather than trying to fix any specific problem (Hoffman, 2013).

Hoffman assessed the potential of cross-contamination via jet injectors amidst low volumes of blood detection. Hoffman’s calf study assessed four different types of jet injectors. He promised manufacturers he would not disclose the brand names of the devices tested but would only identify them by their unique characteristics (Hoffman et al., 2001). I,however, have deciphered which injectors were used: Ped-O-Jet/Am-O-Jet, Medivax, Jet2000, and Med-E-Jet. The Am-O-Jet is an identical design to the Ped-O-Jet device (American Jet Injector; Weniger & Papania, 2008). Two of the jet injectors (i.e., Medivax and Jet2000) were prototypes.
Hoffman found, “All injectors tested transmitted significant (over 10 pl) volumes of blood; the volumes and frequency of contamination varied with injector” (Hoffman et al., 2001). 10 picoliters (pl) of blood, which is not visible to the human eye, is an accepted threshold for transmitting the Hepatitis B virus, and has been used as the unofficial threshold for an impermissible amount of contamination.

In my interview, I asked Dr. Hoffman how much blood would be required to transmit the hepatitis C virus? Hoffman responded,

There is a greater knowledge base on hepatitis B than hepatitis C in this area. It is generally assumed that hepatitis C is about 10-times less infectious than hepatitis B. This means hepatitis C having a transmission volume starting at around 100 picolitres, but it is probable that a greater volume would usually be required (Hoffman, 2013).

Interesting, yet remember these values are still microscopic. Since my interview with Dr. Hoffman the transmissibility rates of viral hepatitis are still unknown and are left to professional opinion.
The National Institute of Health has helped me comprehend these figures. In response to my inquiry on the topic the NIH stated,

a picoliter is 10-12 or one trillionth the size of a liter…to put this in perspective, if a drop of blood were a microliter in volume, it would look no bigger than a period on this page. A picoliter would be a million times smaller (NIH, 2013).

The thought of infectious blood being so small makes me cautious of shaking someone’s hand or touching foreign objects.
Hoffman’s findings were astonishing. If 10 picoliters is a significant amount of blood for transmitting Hepatitis B then this value (i.e., 10 pl) can be used as a threshold level in determining a contamination rate amongst the sampling of jet injectors. Results found the Ped-O-Jet had a 34.2 percent contamination rate. The Med-E-Jet had a 97.4 percent contamination rate. The two prototype injectors were also found to transmit relevant amounts of blood. The Medivax had a 95.8 percent contamination rate. The Jet2000, which had a single-use plastic protector cap that protected the reusable nozzle, had a 42.0 percent contamination rate. In an extended sampling, the Med-E-Jet nozzle was wiped with alcohol between subsequent injections. Results found a lower contamination rate than in the initial series where the nozzle head was not wiped (Hoffman et al., 2001). In other words, there was still contamination even after the nozzle was swabbed. These results demonstrate when the nozzle is swabbed only superficial contamination is removed and sterilization of the internal fluid pathways is neglected.
The results also found a significant number of samplings consisted of greater than 50 picoliters of blood. The Ped-O-Jet had a 16.6 percent contamination rate at this lower threshold. The Med-E-Jet had a 85 percent contamination rate. The Medivax had a 85.4 percent contamination rate. The Jet2000 had a 20.1 percent contamination rate (Hoffman et al., 2001).
Hoffman remarked on the results in a journal article as “disappointing.” In studying the contamination of the jet injector, he identified a phenomenon which he termed “ballistic contamination.” This occurred because the newly deposited jet stream in the skin had developed a pressure greater than the pressure in the jet injector causing a backwards flow. This backwards or rather retrograde flow of fluid and now blood and bodily fluids shoots out of the skin and onto the jet injector nozzle and into the internal fluid pathway (Voelker, 1999).
So the question would arise, are these isolated incidents or natural phenomenon of the jet injection process?
Hoffman and colleagues found the retrograde flow was a natural phenomenon in the injection process. For all the naysayers let me use the Fair Use Law to the limits and quote Hoffman himself,

some of the liquid injected form[ed] a pocket below the injection site. This will be under maximum pressure towards the end of the injection process, before sufficient dispersion into surrounding tissues has occurred to release pressure. This will coincide with a lessening of pressure from the injector. When the pressure from the injector is exceeded by the back-pressure from the tissue pocket, backflow through the pathway in the skin created by the injector could occur. This liquid will contain blood from the destruction of small blood vessels during the injection process and can have different pathways after it has emerged from the skin according to the type of injector. Injectors that have direct skin contact will form a continuous fluid pathway between the skin and injector. As the outward pressure from the injector dies away at the end of an injection, back-pressure from the fluid in the tissue pocket will cause blackflow out of the skin to inside the injector’s fluid pathway (Hoffman et al., 2001).

Kale and Momin (2014) stated that during Phase 2 of the three-stage injection process there would be a backwards flow, where the jet spray would shoot back-out of the hole towards the jet injector. This would be an expected phenomena in every injection due to the continuous depletion of pressure where the volumetric rate of hole formation would eventually be less than the volumetric rate of the jet impinging the skin. This continuous decrease in pressure would create a retrograde, or rather backwards flow, whereupon the jet injector’s nozzle, internal fluid pathway and drug reservoir would become contaminated.
In remarking on Hoffman’s study, the World Health Organization stated, “The implication of these results is that, for jet injection to be safe, the entire fluid path must be changed between injections” (WHO, 1997).
The magnitude of Hoffman’s study called for further investigations. Hoffman’s findings were later replicated in published and unpublished studies by (1) the World Health Organization, (2) the São Paulo State Ministry of Health in Brazil, and (3) the University of Florida (Weniger, 2002).
(1) A 1997 report by the World Health Organization cited an unpublished in vitro study conducted by the Program for Appropriate Technology in Health (PATH), which assessed gross contamination upon the jet injector nozzle. The tests sought to detect contamination in three areas: 1) On the surface of the skin that was injected, 2) in down-stream inoculations between patients, and 3) upon the surfaces of the jet injector that had contact with skin. Contaminants were tested to a sensitivity level of one picoliter, or rather 10-6 milliliter. “Although these tests were not as sensitive as the PHLS tests [by Hoffman], they showed systematic contamination of both the ejectate and the internal fluid pathway.” That is to say there was enough blood to contain a blood-borne pathogen in both the ejectate (i.e., the dose the next vaccinee would receive) and within the jet injector (WHO, 1997).
(2) An unpublished Brazilian study, referred to above, tested older model multi-use jet injectors. In this study, a saline solution was injected into human subjects and then sequentially injected three times into three test tubes. The ejectates were tested to detect any blood contamination up to 10 picoliters. Dr. Martin Friede of the World Health Organization stated, “whether it was wiping with the nozzle or wiping without the nozzle, we had between 7 and 11 percent of the ejectates contaminated with blood” (FDA, 2005).
(3) Sweat and colleagues (2000) replicated and extended Hoffman’s study by testing the potential of cross-contamination of the Ped-O-Jet amongst calves and pigs. This study modeled all of the previous in vivo studies in that it injected a saline solution into a vaccinee (i.e., either a calve or pig) and then subsequently fired the ejectate into a vial. The subsequent injection represents what the next person or animal in line would receive.
“We have detected contamination well above current levels that we would consider indeterminate or uninterpretable,” said Dr. Bruce Weniger, a coauthor of this study (FDA, 1999). In other words, researchers found rates of contamination were significant.

Acknowledgements
I greatly thank Dr. Peter Hoffman for taking the time in answering my questions. I am also thankful for the Health Protection Agency of the United Kingdom for providing me with a paid copy of Hoffman’s study.

References:

  • (American Jet Injector) American Jet Injector, Lansdale, PA; 19446-4520, USA; amojet@aol.com (the Am-O-Jet™ is an exact design of the out-of-patent Ped-O-Jet® device).
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.
  • (Hoffman, 2013) Hoffman, PN. Personal communication. February 28, 2013.
  • (Kale & Momin, 2014) Kale TR, Momin M. Needle free injection technology – An overview. Innovations in Pharmacy. 2014, Vol. 5, No. 1, Article 148. pp. 1-8. Available at: http://z.umn.edu/INNOVATIONS.
  • (NIH, 2013) National Institute of Health. Personal Communication. September 4, 2013.
  • (Sweat et al., 2000) Sweat JM, Abdy M, Weniger BG, Harrington R, Coyle B, Abuknesha RA, Gibbs EP. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids. Ann NY Acad Sci 2000;916(31):681-682.
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA. 1999. Available at: https://web.archive.org/web/20010524044635/http://jama.ama-assn.org/issues/v281n20/ffull/jmn0526-2.html.
  • (Weniger, 2002) Weniger BG. Bifurcated needles vs. jet injectors for smallpox vaccination. ACIP. 2002-Jan-09: pp 1-8. [Draft].
  • (Weniger & Papania, 2008) Weniger BG, Papania MJ. Alternative Vaccine Delivery Methods [Chapter 61]. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357-1392.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Faulty Design Created Inherent Risk – Part 2

Jet Injectors = Jet Infectors

January 17, 2016

“Where is the proof?” you may question. Glad you asked.

Splash-Back was Inevitable
Samir Mitragotri, a chemical engineer at the University of California, visually captured the discharge of multiple-use nozzle jet injectors using high-speed microcinematography (Mitragotri, 2006). The photos in the following link demonstrate a close-up look at the jet injection process. Most importantly, notice in the images when the high velocity stream penetrates the skin there is extensive splash back.

Have a closer look (pun intended).

“The black region at the top of each image shows the outline of a jet injector with the protrusion in the centre showing the position of the nozzle,” said Mitragotri. “The black region at the bottom shows the outline of human skin.” The white space between the two black regions is a gap, approximately a few millimeters wide between the jet injector and human skin.

In the photo where the time equals 0, the jet injector has been activated.

By the time of 40 μs (i.e., Microsecond) the jet stream appears from the orifice and by 160 μs the jet stream makes initial contact with the skin. For reference purposes one microsecond equates to one millionth of a second.

From 280 μs to 1 ms (i.e., Millisecond) the penetration of the jet stream caused excessive splash back. Mitragotri stated, “The typical volume of the liquid splashed in the image at 400 μs is around 100 nl [i.e., Nanoliter] (Mitragotri, 2006).

The deposition of the liquid medicament between 2 to 5 milliseconds (ms) causes a wheal, or rather a bulge under the skin. This wheal will diminish over time as the ejected fluid absorbs into surrounding tissues.

Mitragotri’s photographic evidence leaves no dispute, during the natural injection process that was intended by the manufacturer, the nozzle frequently became contaminated. Thus, the jet injector became unsterile and therefore unsafe. Moreover, this evidence corroborates the testimonies of veterans who visually saw blood on the nozzle of the jet injector during their military mass vaccination campaigns.

References:

  • (Mitragotri, 2006) Mitragotri S. Current status and future prospects of needle-free liquid jet injectors. Nature Reviews Drug Discovery 5:543–548, 2006.

Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.

Fair Use Notice
In accordance with the Fair Use Law (17 U.S.C. § 107), copyrighted sources cited within this website are distributed without profit and are presented for educational, research, and in some cases critical analysis purposes. For these reasons authorization from the copyrighted holders has not been obtained. If you wish to use the copyrighted material for purposes that go beyond the Fair Use Law 17 U.S.C. § 107, you must obtain permission from the copyright owner.

Faulty Design Created Inherent Risk – Part 1

Jet Injectors = Jet Infectors

January 17, 2016

“The proof of the pudding is in the eating,” wrote H.M. Darlow. In the British physician’s 1970 letter-to-the-editor of a medical journal, he cited the lack of epidemiological cases of viral hepatitis to uphold the safety and sterility of jet injection technology. Darlow was quick to ascertain his professional opinion despite the notable asymptomatic feature of viral hepatitis and the emergence of non-A non-B hepatitis during his time. Darlow, like others, was so caught-up in the infatuation and hype of jet injection devices that he refused to acknowledge the risks and hazards.

Since Darlow’s letter-to-the editor the medical community has made great strives. Physicians have identified HIV in 1980 and hepatitis C in 1989. The asymptomatic progression of viral hepatitis (i.e., HBV and HCV) is now understood to last 10 to 20 years. The transmissibility of viral hepatitis is understood to be in picolitres, or rather traces of blood that are invisible to the human eye. Further studies have assessed the safety and sterility of jet injectors and have found results contrary to Darlows. Moreover, the advent of the Internet has allowed access to medical and scientific journals to nonprofessionals. No longer are studies hidden in journals only accessible to the privy of the academic elite. Now the truth-seekers can and will unveil the truth.

The proof of the pudding is, in fact, in the eating. However for Darlow it appears his pudding was served too early. Research on the safety and sterility of jet injectors has shown otherwise. In this series we will review scientific studies that have found the faulty design of multiple-use nozzle jet injectors created inherent risks.

References:

  • (Darlow, 1970) Darlow HM. Jet vaccination. British Medical Journal 4(734):554, 1970.

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Copyright Notice
© Shaun Brown and Jet Infectors, 2017. Veterans are encouraged to use these documents as evidence within their VA claims. Any other use and/or duplication of this material without express and written permission from this site’s author and/or owner is strictly prohibited. Excerpts and links may be used, provided that full and clear credit is given to Shaun Brown and Jet Infectors with appropriate and specific direction to the original content.