Critiquing CDC’s Review of the Literature

Within CDC’s 1986 investigation the administration conducted a review of the literature on jet injector safety. A review of the literature is a section within a paper that recognizes previous studies and articles that relate to the topic being investigated. The CDC’s review of the literature within their 1986 CDC report and also within their 1990 study stated the outcomes of jet injector studies. However, both failed to appropriately consider the limitations and differences of these studies. For instance:

  • British researcher H.M. Darlow found within his 1970 investigation, there was slight detection of radioactive labeled human serum on the nozzles of Port-O-Jet injectors. Despite the fact that he found contamination, he stated “icteric tragedies have been conspicuous by their absence,” meaning there lacked epidemiological evidence, at the time, to support the existence of a problem with hepatitis. Darlow assumed there was no real risk since recipients of the jet injector were not reporting any adverse health affects (Darlow, 1970). However, Darlow’s view does not account for the asymptomatic progression of serum hepatitis.
  • Black and colleagues (1978) found, after replicating Darlow’s experiment, no detection of radioactive human serum on the nozzle of a Med-E-Jet. Within the researchers in vitro investigation they administered injections into tissue infiltrated with radioactive isotope. The researchers concluded, “In the demonstrated absence of contamination with blood or tissue fluid, the risk of spreading hepatitis appears remote” (Black et al., 1978). Yet the 1985 outbreak by a Med-E-Jet injector has proven otherwise.
  • Abb, Deinhardt and Eisenberg (1981) found the injection sites and nozzle of a Ped-O- Jet were negative for Hepatitis B associated antigens after administering inoculations to two hepatitis B positive patients. However, Abb and colleagues rendered their opinion on a minuscule sample size. Moreover, the researchers failed to conduct the most critical test in determining cross-contamination by failing to test the ejected fluid for Hepatitis B antigens.
  • In 1985, Peter Brink and his colleagues studied the risk of virus transmission via jet injection. These researchers from the Netherlands assessed the degree of contamination after administering jet injections to mice chronically infected with lactic dehydrogenase (LDH) virus, a highly infectious pathogen. Results found 16 out of 49 (33%) mice became infected with the LDH virus after receiving injections from a Med- E-Jet injector. Most shockingly, researchers observed “post-injection bleeding was relatively uncommon,” occurring in only two out of 49 (4%) of the mice. Assuming the two bleeders were amongst the mice who became infected with LDH, indicates at least 14 out of 16 (88%) of the mice became infected despite the lack of visual bleeding. This is worth repeating, even though there was no visible bleeding during or after the jet injection, transmission of a highly infectious pathogen still occurred. This study demonstrates cross-contamination of highly infectious virus within microscopic levels via jet injection.
  • Brink and colleagues concluded transmission occurred when excessive tissue pressure after the the delivery/dispersion phase of injection caused retrograde flow of the liquid medicament that had mixed with skin tissues, blood, and the LDH virus. This retrograde flow is thought to be responsible for carrying the virus in the reverse path of the injection, out the injection site and contaminating the nozzle orifice of the jet injector. Brink stated until further investigations into the safety of jet injectors are conducted, “it might be justifiable to screen for HBsAg when a patient belongs to a high risk group, or to abandon the jet and give the treatment with individual syringes and needles” (Brink et al., 1985).
  • Brink and colleagues noted how several of the above investigations differentiated. Several studies—such as, Darlow (1970) and Abb and colleagues (1981) only delivered intracutaneous jet injections which were shallow injections and elicited less splash back. These studies used an intradermal nozzle, which acted as a spacer to achieve a shallower vaccination within the layers of tissue just under the skin. Therefore, these studies posed a lesser risk and produced negative to minimal contamination than deeper subcutaneous injections, as in Brink’s study, which required direct contact of the jet injector’s nozzle and the vaccinee’s skin. Brink had written, “the investigations cited above were designed to exclude the risk of transmission of virus infection by intracutaneous jet injections. However, subcutaneous jet injections might have a higher risk of contamination, because of the direct contact between skin and nozzle” (Brink et al., 1985).

Failing to note the above differences led readers to assume that the studies referenced were equivalent comparisons. As we have shown these studies were not comparable as they used an intradermal nozzle and were shallower injections which produced less splash-back.

Moreover, it is interesting to note that CDC’s review failed to mention the administration’s investigation of the Ped-O-Jet in 1977. It can not be said that the CDC didn’t know of its previous safety-testing conducted within the agency since Walter Bond, a CDC microbiologist, served in both investigations.

References:

  • (Abb, Deinhardt & Eisenburg, 1981) Abb J, Deinhardt F, Eisenburg J. 1981 The risk of transmission of Hepatitis B virus using jet injection in inoculation. Journal of Infectious Diseases 144: 179.
  • (Black et al., 1978) Black J, Nagle CJ, Strachan CHL. Prophylactic low-dose heparin by jet injection.Br Med J 8 July 1978;2(6130):95.
  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission bysubcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (CDC, 1986) Centers of Disease Control. Epidemiologic Notes and Reports Hepatitis B Associated with Jet Gun Injection — California. MMWR 1986;35(23):373-376
  • (Darlow, 1970) Darlow HM. Jet vaccination. British Medical Journal 4(734):554, 1970.

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1981 Navy Corpsman Manual Blatantly Acknowledges Contamination within the Military’s Mass Immunizations

In a stark admission, a 1981 Navy Hospital Corpsman Training Manual recognized the likelihood of contamination when mass jet injector vaccinations are done in haste and procedures are not properly followed.

The manual recalls the infamous assembly line inoculations where jet injectors used within boot camps and training facilities.

“The most common method of mass immunization is through the use of ‘shot lines.’ You will undoubtedly remember this practice from boot camp.”

The manual then blatantly acknowledges,

“When immunizations are administered on a mass scale, the tendency to shortcut recommended procedures increases the likelihood of contamination and improper administration.”

As the evidence of record before and after the publication of this manual has shown, the “shortcut[s]” or rather procedures typically not followed by corpsmen were:

Next let’s look at the word contamination as it relates to mass jet injector immunizations. The use of this word in this 1981 manual can only be associated with blood or serum contamination as evidenced by contemporaneous documents.

Department of Defense directives also associated the word contamination with blood and serum.

  • A Navy Bureau of Medicine directive, dated November 1, 1995, stated in regards of jet injectors, “injector nozzles, visibly contaminated with blood must be dismantled, changed, and sterilized.” (emphasis added) (DoD, 1995)
  • A Navy Bureau of Medicine directive, dated January 3, 1996 and titled “Dental Infection Control Program,” defined contaminated as, “Contaminated. The presence or reasonably expected presence of blood or other potentially infectious material on an item or surface.” (emphasis added) (DoD, 1996)

As the evidence presented above has shown, the military’s high volume immunizations with jet injectors were conducted in haste and the procedures outlined by the manufacturer and the military were not followed. According to this 1981 Navy Corpsman Manual, these “shortcuts,” increased the likelihood of contamination of the injector, and thus, exposed military personnel to cross-contamination of blood and blood-borne pathogens.

The entire manual can be accessed here.

1981 navy hospital corpsman training manual

References:

• (Lipson et al., 1958) Lipson MJ, Carver DH, Eleff MG, et al. Antibody response to poliomyelitis vaccine administered by jet injection. Am J Public Health 48:599–603, 1958.

• (DoD, 1995) Department of Defense. Immunizations and chemoprophylaxis (aerospace medicine). Air Force Joint Instruction 48-110; Army Regulation 40-562’ BUMEDINST 6230.15; CG COMDTINST M6230.4E. By Order of the Secretaries of the Air Force, Army, Navy, and Transportation. 1 November 1995. 14 pages (U.S. G.P.O.: 1995-404-407:20140).

• (DoD, 1996) Department of Defense. Dental Infection Control Program. BUMEDINST 6600.10A CH-2, BUMED-631. 3 January 1996. 58 pages.

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Walter Reed Army Medical Center Training Manual Exposes Risks and Faults of Ped-O-Jet

A Walter Reed Army Medical Center Handbook from 1985 gave an in depth discussion on the proper jet injection technique for prospective Immunization Specialists. The text, Allergy-Clinical Immunology Training Manual, is a conglomeration from previous instructions in corpsman manuals, the Ped-O-Jet manual, and lessons learned from frequent usage. The text sheds light on what the Department of Defense (DoD) knew about jet injectors during the height of their usage.

The digitized text can erroneously be read at face-value posing a risk of spreading misinformation by nefarious actors or illicitly used in third-world nations. Here we will go through the information in the manual and show the errors in thinking, comments which show cross-contamination, and juxtaposition the manual with current knowledge on the risks and hazards of multi-use nozzle jet injectors.

manual cover

The manual emphasizes using proper technique and maintenance of the jet injector gun.

Improper maintenance and assembly will damage the device, cause faulty operation, and result in contamination of the vaccine. Improper injection technique will injure the recipient’s skin and will fail to deliver the required dosage of vaccine. Prerequisites for learning the use of the jet injection apparatus include:

e. Recognizing that any of the following are indications of faulty maintenance, faulty operation, or faulty injection technique:

( 1 ) Off-center or irregular wheals at site of injection.

( 2 ) Lacerations or bleeding at the site of injection.

( 3 ) Incomplete shots as evidenced by large drops of vaccine remaining on the skin surface.

(Allergy-Clinical Immunology Training Manual, 1985, page 45-2)

Potential for Bleeding 
The manual repeatedly stresses the potential for bleeding, beyond the warning cited above:

If the injection site bleeds cotton gauze should be firmly applied to the area. (Allergy-Clinical Immunology Training Manual, 1985, page 45-3)

Incomplete injections or excessive bleeding will result if injector is not held against the site long enough. (Allergy-Clinical Immunology Training Manual, 1985, page 45-9)

These cautions for bleeding represent ideal usage and not real life conditions. During actual military usage bleeding was common, as evidenced by the testimonies of veterans and evidenced within the links below:

1992 Navy Report Documenting Ped-O-Jet Injections Caused Soldiers to Bleed Vanishes

1995 Film Captured Bleeding During Mass Military Jet Injections

1999 AFEB – Report Citing Bloody Jet Injectors and Lack of Sterilization

Erroneous Claims on Safety
The greatest threat posed in the Manual is the claim that the device is safe. The manual states,

Large numbers of personnel can be processed rapidly with minimal hazard of transmitting infection when the jet injector is used. (Allergy-Clinical Immunology Training Manual, 1985, page 45-2)

Here the DoD minimizes the risk of cross-contamination as a “minimal hazard of transmitting infection.” Yet minimal hazard is not the same as no hazard. The language follows DoD’s longstanding modus operandi of acknowledging the possibility of transmission and then minimizing the likelihood.

The manual further states,

Since the piston, front end assembly, and the feed needle are sterilized at the end of every day’s use, there is little chance of contamination. (Allergy-Clinical Immunology Training Manual, 1985, page 45-2)

The sterilization of the jet gun at the end of the day does nothing to stop cross-contamination during the mass vaccination of 100 to 300 vaccinees within that day. DoD backs this preposterous claim by stating in the following sentence,

Even though the nozzle is not sterilized between recipients, there has been no evidence of serum contamination or transmission of disease. (Allergy-Clinical Immunology Training Manual, 1985, page 45-2)

Yet this is not true. In 1959, Abram Benenson, the co-inventor of the Ped-O-Jet, and researchers at Walt Reed Army Institute of Research conducted safety testing on the Ped-O-Jet. The researchers concluded “the problem of hepatitis has been minimized” after “the presence of less than 15 gammas of human serum” was detected on the nozzle of the Ped-O-Jet (Benenson, 1959). In 1959, the risk of cross-contamination existed but was minimized by the researchers. Therefore, it is incorrect for this 1985 manual to state no serum contamination existed when evidence existed to the contrary.

Note: Since 1959, greater advances in science have been made. As Jet Infectors has previously written, the results [of Benenson’s study] were unable to detect any contamination using the assays available during that era…the science of the late 1950s could not detect contamination within such microscopic levels, and most importantly, no tests existed to detect viral hepatitis.

It was true there was no evidence of disease transmission at the time of the manual’s publication in April of 1985. Yet the DoD never implemented any seroepidemiological study, nor active surveillance program following jet injector immunizations. Of course, they would not find what they were not looking for.

Interestingly, days before publication of this manual an outbreak from jet injector usage came under investigation by the Long Beach Department of Health (March 1985) (CDC, 1986) and a laboratory study implicating jet injector transmission was published (March 1985) (Brink et al., 1985).

Moreover, the DoD’s assertion that there was no evidence of blood or disease transmission conveniently ignores the fact that the DoD knew of the risk of cross-contamination by fluid-suck back when it was raised by inventor Aaron Ismach in 1959  and were still attempting to overcome the risk of fluid-suck in the Ped-O-Jet as outlined within their 1967 military specification.

The manual itself even inconspicuously acknowledges the phenomenon of fluid-suck back when it cautions against foreign particles entering and clogging the nozzle. The manual states,

Every attempt has been made to prevent foreign matter from entering the unit and plugging the jet nozzle. If plugged, the tip may be cleared through the use of the cleaning wire provided…A damaged nozzle will seriously affect the proper operation of the injector. If nozzle opening is enlarged or leading edges of the opening is made ragged, excessive bleeding may result. (Allergy-Clinical Immunology Training Manual, 1985, page 45-7)

What is the foreign matter? The word foreign, in this regard, is defined as coming or introduced from outside. The vaccine is the only matter expected to be involved in the jet injection. The vaccine comes from within and not outside. So what is the foreign matter that comes from outside and enters the jet nozzle? Maybe it is backsplash of vaccine after impinging the skin? Blood? Skin from the creation of hole formation? Any foreign matter entering the unit should have been recognized as contamination, in which case the Ped-O-Jet was not sterile.

The wise critic may retort if the jet gun is clogged then there is no cross-contamination because the gun is in need of repair. However, this point misses the mark. The jet injector has been propagated as being a safe method of vaccination that is impervious to cross-contamination. If the jet injector were impervious then no foreign matter could infiltrate the jet nozzle. Yet here is acknowledgement within a DoD manual warning foreign matter is capable of such infiltration.

Said differently, either the Ped-O-Jet is impervious to cross-contamination as propagated by the DoD or the Ped-O-Jet is susceptible to being infiltrated as the DoD has warned, but it cannot be that both hold truth. Here the former is a puffing statement minimizing the risks of jet injectors and the latter a stark admission of reality—jet injectors were susceptible to becoming contaminated and capable of cross-contaminating.

The full manual can be viewed here.

References:

• (Allergy-Clinical Immunology Training Manual, 1985) Allergy-Clinical Immunology Training Manual, Volume II. Walter Reed Army Medical Center, April 1985. Fourth Edition. pp. 45-1 – 45-10.

• (Benenson, 1959) Benenson AS. Mass immunization by jet injection. In: Proceedings of the International Symposium of Immunology, Opatija, Yugoslavia, 28 September—1 October 1959 (International Committee for Microbiological Standardization, Secton of the International Association of Microbiological Societies). Zagreb: Tiskara Izdavackog zavoda Jugoslavenske akademije; 1959;393–399 [Library of Congress QW 504 I60p 1959].

• (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, SmaleNovakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.

• (CDC, 1986) Centers of Disease Control. Epidemiologic Notes and Reports Hepatitis B Associated with Jet Gun Injection — California. MMWR 1986;35(23):373-376.

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1995 Film Captured Bleeding During Mass Military Jet Injections

A 1995 military film has recently resurfaced and is the second piece of incriminating evidence concerning military jet injections. The film, shown below, shows communal vaccinations being performed upon Air Force recruits at Lackland AFB. Most importantly though the film captured blood running down the arm of a recruit and corroborates the testimonies of thousands of veterans.

The video shows recruits being paraded past three jet injection stations. Each station administered a different vaccine. Each recruit held a cotton swab in his right hand, as shown below. This swab was used for wiping any blood or excess vaccine after each completed the firing line. Also notice the corpsman in this screenshot is looking away as he administers a shot.

Protocol dictates that when administering multiple jet injections to administer the consecutive injection above the previous vaccination so that the nozzle of the gun is not contaminated with any discharge from the vaccination site.

The photos below show a third vaccination being administered above a previous injection. This “previous injection” is evident by blood running down the recruit’s arm. This also means the jet injector that administered that previous injection is contaminated with blood. Also note that the corpsmen seem unfazed at the presence of blood during the jet injections. They didn’t clean the blood. They didn’t stop the line to swap-out the Ped-O-Jet with a sterile one.

Throughout the process, each vaccinator disregarded proper procedures and instructions: The corpsmen placed their hand on the recruits’ arms but failed to pull the recruits’ skin tightly so that the injection would be properly received. There was no swabbing of the nozzles in between injections to lessen the risk of contamination, and the corpsman failed to swap the bloody Ped-O-Jet with a sterile one. Yet despite the military’s disregard for safety procedures on recruits, the corpsman took safety precautions upon themselves by wearing latex gloves.

This film shares a lot of similarities to a 1963 film previously reported upon. The 1963 military footage captured jet injector vaccinations of Army recruits and documented blood beading on a recruit’s arm. Both films show assembly-line inoculations in which recruits received three consecutive vaccinations via jet injectors. The films also show the nozzles of the guns were not wiped, the injections were performed improperly and hastily. But most importantly, both films documented the presence of blood during the vaccinations and uphold the testimonies of countless veterans.

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Revisiting Ismach’s 1959 Patent Reveals Ped-O-Jet was Unsterile

Aaron Ismach’s invention of the Automatic Jet Hypodermic Injection Apparatus, more commonly known as the Ped-O-Jet, attempted to overcome the risk of transferring hepatitis during mass immunizations. Although a review of his 1959 patent demonstrates the risk was not eliminated.

Patents contain an abundance of information. Amidst the detailed description about the uniqueness of the invention, a patent describes specific problems the invention intends to resolve.

Ismach proclaimed, “One of the outstanding benefits conferred by the invention in helping to prevent hepatitis or other cross-infection, is that if operation of the jet injection device is commenced in a sterile condition, the gun will maintain its own sterility” (Ismach, 1962).

Although this would also mean if the device failed to “maintain its own sterility” then it failed “to prevent hepatitis or other cross-infection.” This point is further upheld by Ismach stating, “the danger of cross-infection is almost completely avoided” (emphasis added) (Ismach, 1962). Ismach never declared the risk of cross-infection was completely avoided. He could not proclaim his own device was risk-free so he minimized the danger, as evidenced within this patent.

As the patent shows, Ismach believed the risk of transferring hepatitis was contingent upon whether the device became unsterile during the vaccination event.

Did the jet injector ever become unsterile? From Ismach’s patent, we can ascertain that yes, jet injectors, including his Ped-O-Jet device, were frequently unsterile.

Ismach claimed that his invention is “free from danger of sucking fluid back from a patient either during or after the firing cycle is completed so that the danger of cross-infection is almost completely avoided” (emphasis added) (Ismach, 1962).

Here Ismach subtly discloses that after the jet injector was fired there was fluid—whether splash-back of vaccine, blood, or tissue cells—upon the nozzle orifice. Any fluid upon the nozzle following an injection should have been recognized as contamination and thus the device was unsterile.
“Sucking fluid back…after the firing cycle” = Fluid Suck-Back
Ismach proclaimed that his invention was free from sucking fluid back after the firing cycle. He declared that failure to prevent fluid suck-back allows for “cross-infection” and states cross-infection is dangerous. Here Ismach was describing the undesirable phenomenon, so appropriately termed as fluid suck-back.

However, subsequent research has revealed the Ped-O-Jet was no exception to fluid suck-back.

  • The Department of Defense recognized the Ped-O-Jet was capable of sucking fluid back within a 1967 military specification. The specification alluded that conducting a performance test upon every Ped-O-Jet would remove any defective devices. “On cocking the gun, there shall be no drawback of fluid at the jet nozzle,” stated the specification (DoD, 1967; DoD, 1975). However, the performance test conducted was inadequate as it only evaluated fluid suck-back based upon a limited set of parameters and did not represent real life use of the device.
  • In 1977 researchers within the CDC’s Hepatitis Laboratories Division in Phoenix, Arizona, independently—and secretively—assessed the safety of Ped-O-Jet injectors. In their observations, a drop of fluid was observed on the nozzle orifice after firing an injection. “The drop would disappear (back into the injection nozzle head) in 3 to 5 seconds if the gun was held vertically or the drop would disappear immediately if the gun was cocked in a horizontal position” (CDC, 1977). These investigations represented real-life use of the Ped-O-Jet.

The CDC concluded that “disappearance of the fluid drop are common during clinical use of the jet injector” (CDC, 1977). Therefore fluid suck-back was not evidence of a defective device but of an inherent problem with the Ped-O-Jet in general.
“Sucking fluid back…during firing cycle” = Retrograde Flow
Ismach proclaimed that his invention was free of sucking flood back during the firing cycle. Ismach stated, there was “no danger of cross-infection, since nothing but the inoculating fluid itself penetrates beneath the skin of the patient” (Ismach, 1962). Yet the phenomenon of retrograde flow disproves this claim.

  • In October of 1998, the World Health Organization conducted a simulated field trial to assess the degree of blood transmission via Ped-O-Jet injectors. Swabbing the nozzle of the Ped-O-Jet did not eliminate but only slightly reduced the degree of contamination. This finding indicates contamination was present inside the injector’s internal fluid pathway, beyond the reach of swabbing the nozzle, due to retrograde flow (Hoffman et al., unpublished).
  • Hoffman also found retrograde flow within his laboratory investigations of four different jet injectors. A Ped-O-Jet device, renamed as the Am-O-Jet, was apart of this investigation. Hoffman found retrograde flow was a natural phenomenon within the jet injection process. Hoffman stated,

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).

Hoffman’s research revealed that despite the fact that there was no needle, there was transference of blood from the patient into the internal components of the jet injector. His research spotlighted the multidirectional flow between the patient and jet injector during the end of the injection process.
Ismach Knew Seriousness of Hepatitis
In 1959, Ismach was cognizant of the risk and seriousness of hepatitis. He knew that hepatitis could be transmitted by people who appear to have no symptoms. “It is possible for a patient to be a carrier of hepatitis and capable of seriously infecting another patient with the disease, although the carrier himself may show none of the symptoms associated with hepatitis” (Ismach, 1962).

Yet despite acknowledging the asymptomatic features of hepatitis Ismach minimized the risk of such transmission via jet injection. Remember Ismach stated, “the danger of cross-infection is almost completely avoided” (Ismach, 1962).
Conclusion
As Jet Infectors has shown throughout this review, the jet injector became contaminated in number of ways. Whether through contamination upon the nozzle orifice, fluid suck-back, or retrograde flow, it seems slight that this device ever remained sterile. Ismach’s claims to the safety of his invention do not carry any weight and amount to nothing more than puffing statements. The risk of transmitting Hepatitis B and Hepatitis C via jet injectors, including the Ped-O-Jet, is not merely theoretical or biological plausible but was in fact real.
References:

  • (CDC, 1977) CDC. DHEW Memorandum: Informal Quarterly Report of October-December 1977. From: Special Investigations Section (Petersen NJ, Bond WW, Carson LA) to: Deputy Director (Favero MS), Hepatitis Laboratories Division, Phoenix, AZ (unpublished).
  • (DoD, 1967) Department of Defense. Military specification: hypodermic injection apparatus, jet, automatic. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-36505, 12 June 1967.
  • (DoD, 1975) Department of Defense. Military specification: hypodermic injection apparatus, jet, foot operated. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-37084, 11 June 1975.
  • (Hoffman et al., unpublished) Hoffman PN, Abuknesha RA, Andrews NJ, Brito GS, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. A field trial of jet injector safety in Brazil. (unpublished).
  • (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 immunisation. Vaccine. 16 July 2001;19(28-29):4020-4027.
  • (Ismach, 1962) Ismach, Aaron. “Multi-dose jet injection device.” United States Patent 3,057,349. 9 October 1962. Accessible here.

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VA Correspondence Recognizes Jet Injectors as Possible Risk Factor for Hepatitis C

August 20th, 2018
In August of 2017, Jet Infectors brought several discrepancies to members of the House Committee on Veterans’ Affairs for review. The Committee felt our inquiry deserved a response from VA. By October, a top official within the Veterans Benefits Administration (VBA) responded but failed to appropriately address our questions. The letter did, however, uphold that top officials within the VBA recognize jet injectors as a possible risk factor for acquiring the Hepatitis C Virus (HCV).

“…despite the lack of any scientific evidence to document transmission of HCV with air gun injectors, VA acknowledges this as a possible risk factor for developing HCV,” stated Laurine Carson, the Acting Deputy Director for VBA’s Compensation Service.

Mrs. Carson went on to state,

“…a medical report linking HCV to air gun injectors must include a full discussion of all potential modes of transmission for an individual Veteran and a rational as to why the examiner believes the air gun injector was the source of the Veteran’s hepatitis infection. VA examiners review all evidence of record to include medical evidence and lay statements to provide an opinion regarding a nexus between the disability and an event, injury or disease incurred during active duty service.”

“Rating decisions which determine service connection are then made by weighing all evidence of record based on the Veteran’s specific circumstances. Since each decision is made on a case-by-case basis, there are differences in outcomes in decisions made by the Board of Veterans’ Appeals (BVA).”

So why is this important?

The Carson letter, along with VBA’s Adjudication Procedure Manual (M21-1), demonstrates top officials within VBA are consistently recognizing jet injectors as a risk factor for Hepatitis C. Nowhere within Mrs. Carson’s response, nor within M21-1, is the jet injector nexus questioned or doubted. Therefore, the plausibility of jet injector transmission cannot be discredited by VA staff.

When reviewing a claimant’s case, VA staff must acknowledge transmission via jet injectors as a possible mode of transmission, must accept a veteran’s contention that he or she was vaccinated via a jet injector, and then thereafter, the evidence of the case can be weighed and a determination on the claim made. A determination can only be made based upon the evidence on record. Any VA staff claiming the veteran’s Hepatitis C is likely the result of an unidentified risk factor are failing to appropriately weigh the evidence presented within the claim. Such fallacious statements should not be given any merit. If such fallacious statements are given evidentiary weight then the claimant should appeal.

2017 (October 6) VBA response letter from Carson
PDF copy here.

© Jet Infectors, 2016 – 2021

1967 Military Specification Reveals DoD Was Cognizant of Fluid Suck-Back & Bleeding With Military Jet Injectors

August 1st, 2018

Recently obtained military documents reveal that during the 1960s the Department of Defense knew of an ongoing problem with jet gun injectors and attempted to remedy the issue. These documents reveal that the military believed if the manufacturer conducted a performance test on every jet injector any defective devices would be removed and jet injections would be safe. However, as this article will demonstrate, jet injectors were not safe, the performance test conducted was inadequate, and an undesirable phenomenon called fluid suck-back was not a defect but a common occurrence within all devices.

In 1967 the Department of Defense (DoD) created a military specification for the most widely used jet gun injector in the U.S. military. The specification came six-years after jet injectors were standardized throughout the Armed Forces (Army, 1961) and thirteen-years after the first prototype was used upon military personnel (Star-Democrat, 1954; Warren et al., 1955).

A military specification, as defined by the Government Accountability Office, is a document describing “the physical and/or operational characteristics of a product.” Military specifications generally state the DoD’s requirements, dimensions, standards, and objective(s) of a product. The specification then serves as a contract between a manufacturer and the DoD on the degree of quality with which the product is to be built.

Here the specification serves as evidence on what the DoD knew about jet injectors and how they perceived to overcome defects within these devices. The contents within this first jet injector specification from 1967 disclosed two startling bits of information: (1) Jet injectors posed a threat of sucking any fluid on the nozzle orifice back into the gun, and (2) jet injectors induced bleeding.

Specification Acknowledged Fluid Suck-Back
“On cocking the gun, there shall be no drawback of fluid at the jet nozzle,” states the 1967 specification document for the Automatic Jet Hypodermic Injection Apparatus (DoD, 1967). The 1975 specification document for the non-electric version known as the Ped-O-Jet reads verbatim (DoD, 1975).

These documents were referring to the undesirable phenomenon known as fluid suck-back, in which any fluid or blood resting on the nozzle is sucked back into the orifice of the jet injector and contaminates the next dosage to be fired.

The 1967 specification reveals the DoD viewed fluid suck-back as a defect and assumed conducting a performance test on every jet injector would isolate and remove faulty devices. Although this strategy was only the latest approach at trying to remedy a longstanding problem.

Fluid Suck-Back: A Longstanding Problem for the DoD
As we have written elsewhere:

During the mid- to late-1950s, researchers within the Department of Defense (DoD) became cognizant of the undesirable phenomenon of fluid suck-back. The observation prompted researchers at Walter Reed Army Institute of Research along with engineers at the Medical Equipment Development Laboratory at Fort Totten (MEDL) with the task of remedying the problem. By 1959, the DoD developed a new multi-use nozzle jet injector (MUNJI) that was intended to be an improvement over previous models. The device was called the Automatic Jet Hypodermic Injection Apparatus, or more commonly known as the Ped-O-Jet.

Lt. Colonel Abram Benenson, who oversaw the use of jet injectors within the DoD, acknowledged the collaborative work that birthed the Ped-O-Jet in a 1959 paper:

“[S]ince July 1957, we [Benenson and Lt. Col. Robert Lindberg] have been responsible for the development of jet injectors for immunization. Our field and laboratory studies depended on the efforts and support of Captain Adrain D. Mandel and Mr Charles E. Buckler; engineering support was furnished by the Medical Equipment Development Laboratory, Fort Totten, New York, where the basic principle was improved into the current multidose jet injector” (emphasis added) (Benenson, 1959).

Aaron Ismach, the inventor of the Ped-O-Jet and a civilian engineer at MEDL, reported that previous multi-use nozzle jet injectors of the 1950s allowed for fluid suck-back. In his December 14th, 1959 patent, Ismach stated, “unlike most earlier hypodermic jet injection guns, the instant invention is free from sucking fluid back from a patient either during or after the firing cycle is completed so that the danger of cross-infection is almost completely avoided” (Ismach, 1962). The Press-O-Jet would be one of the “earlier hypodermic jet injection guns” that Ismach was referencing.

Ismach’s patent specifically acknowledged the potential of fluid suck-back occurring when cocking the gun but states a ball check valve, located within the nozzle head, prevents this from happening. “The ball check valve 44 serves to prevent the entry of any air or suckback of any fluid during the loading cycle of the vaccine pump…” (Ismach, 1962).

From Ismach’s assertion the issue of fluid suck-back clearly rests upon the efficacy of the ball check valve. To gain an understanding of how Ismach improved upon the ball check valve, Jet Infectors compared the patents of the Press-O-Jet and Ped-O-Jet. One noticeable difference stood out—the ball check valve on the Ped-O-Jet was spring-loaded to help keep it shut. The Press-O-Jet did not contain a spring.

However, if the spring-loaded ball check valve had resolved the issue of fluid suck-back, as Ismach proclaimed, it would not have received mentioning within this specification. Said differently, if the problem was remedied it would not have been brought-up eight-years after Ismach claimed to have fixed the issue in his patent. Therefore, it can be said with confidence that the DoD was still observing fluid suck-back within the Automatic Jet Hypodermic Injection Apparatus (Ped-O-Jet).

Critics may claim, if every device had to pass a performance test then the faulty devices would have been removed from stock. Although this depends on the quality with which the performance test was conducted and is based upon the assumption that fluid suck-back indicated that the device was defective. Was the performance test valid and thorough? Was fluid suck-back evidence of a defect within a particular device?

Performance Test was Inadequate
The performance test outlined within the specification was inadequate for several reasons. First, the premise of this test was completely faulty. Within the sentence “upon cocking the gun, there shall be no drawback of fluid at the jet nozzle,” is the subtle revelation by DoD that fluid was present on the surface of the nozzle. The presence of fluid on the nozzle orifice after an injection posed no threat in a performance test but during actual use could serve as a mode of cross-contamination when the nozzle is pressed against the arms of multiple patients. Any vaccine or blood resting upon the nozzle orifice would be cross-contaminated to a subsequent person. Therefore, any fluid on the exterior nozzle after an injection should have been recognized as contamination.

Second, the performance test only evaluated fluid suck-back based upon a limited set of parameters, which were outlined within the military specification. For instance, the specification stated:

  • “The injection apparatus shall be mounted in a test jig designed to fire the apparatus at the rate of 1200 shots per hour” (DoD, 1967). Therefore the device was stationary, held vertically, and fired at a rate of once every three seconds.
  • “The unit under test shall fire at least 250 1 cc shots and 500 1/2 cc shots of water continuously without failure at the rate of 1200 shots per hour” (DoD, 1967).
  • “On cocking the gun, there shall be no drawback of fluid at the jet nozzle” (DoD, 1967). To pass the test, every time the gun was cocked, the device could not suck any fluid on the nozzle orifice back into the device.

This test failed to assess if fluid suck-back occurred under other circumstances. For instance, was fluid suck-back observed when the gun was cocked in a horizontal position, as opposed to just the vertical position as mentioned in the performance test? Or what about the human factor? Did fluid suck-back occur when the gun was being moved up and down and back and forth by the operator during real-life conditions, as opposed to just being tested in a stationary jig? For these reasons, the performance test was inadequate as it failed to assess the jet injector under real-life conditions.

Subsequent research conducted outside of the military did evaluate the above questions. In 1977 researchers within the CDC’s Hepatitis Laboratories Division in Phoenix, Arizona, independently—and secretively—assessed the safety of Ped-O-Jet injectors. In their observations, a drop of fluid was observed on the nozzle orifice after firing an injection. “The drop would disappear (back into the injection nozzle head) in 3 to 5 seconds if the gun was held vertically or the drop would disappear immediately if the gun was cocked in a horizontal position” (CDC, 1977). These investigations represented real-life use of the Ped-O-Jet and did not use any jig.

The CDC concluded that “disappearance of the fluid drop are common during clinical use of the jet injector” (CDC, 1977). Therefore fluid suck-back was not evidence of a defective device but of an inherent problem with jet injectors in general.

Although the wise critic may retort that the stipulation “every time the gun was cocked it could not suck any fluid back” is pretty comprehensive. Yet this is a faulty conclusion. This is not a question of if contamination occurred but how. For instance, if the gun was cocked while held horizontally, fluid suck-back occurred immediately. Or without even cocking the gun, fluid suck-back was found to occur in 3 to 5 seconds if the gun was held vertically. If the gun was fired within 3 seconds, fluid suck-back may not have occurred but there was still contamination on the nozzle orifice. Regardless of whether contamination was on the external nozzle orifice or within the internal fluid pathway, the jet injector was unsterile.

Second, arguing whether fluid suck-back occurs when held vertically or horizontally or within or beyond three seconds is ultimately pointless when subsequent research has identified contamination occurring during the jet injection process. Whereas fluid suck-back occurs in between injections, an undesirable phenomenon called Retrograde Flow occurs during the injection.

As we have stated in our section, Faulty Design Created Inherent Risks, near the end of jet injection process, the pressure of the jet stream impinging the skin would be less than the pressure of the fluid deposited within the newly constructed hole in the vaccinee’s arm. Since the jet stream was too weak to further deepen the hole, it moved backwards and flowed out of the hole and back into the jet injector. This would be an expected phenomenon in almost every jet injection due to the continuous depletion of pressure.

Still critics may say, this was a performance test, not a clinical test. What did the clinical test find?

Glad you asked.

Clinical Tests
The military specification required clinical testing of the jet injector to be conducted to ensure its safety. The specification stated,

Clinical Tests. The government will arrange for the clinical testing of the hypodermic injection apparatus on patients using one of the preproduction samples in order to insure the proper functioning of the sample, including injecting with a minimum of whealing or bleeding and other characteristics described herein (emphasis added) (DoD, 1967).

Somewhere unbeknownst to us there exists a military document or study that conducted a clinical test on patients to uphold the safety of the Automatic Jet Hypodermic Injection Apparatus, as described above. It is unclear if this document still exists or where it might be located. It also is unclear if the “government,” that is the Defense Personnel Support Center, conducted this assessment, if it was outsourced, or if prior studies conducted by the DoD, Centers for Disease Control or World Health Organization were deemed acceptable.

Despite whatever the clinical test stated, we know with certainty the device was not safe. At the time, blood detection was very primitive and the clinical test would not have been capable of identifying low, yet infectious levels of blood. For this reason, the results of the clinical test would have been underreported or have given false negatives. For instance, if a 1959 safety test conducted by Walter Reed Army Institute of Research was used as the clinical test then the results would have been underreported. Moreover, blood-borne pathogens such as Hepatitis C and HIV were unknown in 1967. Without a means of testing viruses not yet known to the human race transmission would have gone undetected.

In our analysis of the this military specification, we have already acknowledged numerous safety hazards, such as: the presence of contamination on the outside of the jet nozzle; the ball check valve did not prevent fluid-suck back from occurring; the performance test, which was to remove defective devices, was inadequate and did not evaluate real life conditions; subsequent research found the internal components of the jet injector became contaminated due to a process called retrograde flow, and now we read that the specification acknowledged the presence of blood during the jet injections.

Specification Acknowledged Jet Injectors Induced Bleeding
“The government will arrange for the clinical testing…in order to insure the proper functioning of the sample, including injecting with a minimum of whealing or bleeding” (emphasis added) (DoD, 1967).

Here the military openly acknowledged bleeding during the vaccination campaign. Yet most shockingly, the DoD did not state there shall be no bleeding during usage but a “minimum of…bleeding.” The DoD’s 1970 specification for the intradermal nozzle attachment recognized bleeding as a distinctive attribute of the injection: “The injection shall produce a pronounced wheal and shall be characterized by a minimum of bleeding and skin trauma” (emphasis added) (DoD, 1970). Clearly the DoD found minimal bleeding to be acceptable with jet injection but failed to quantify what constituted as a “minimum” of bleeding within any of the specifications.

The presence of any blood should have warranted safety precautions to be implemented by the DoD. Indeed knowledge on blood-borne pathogens was limited in 1967. However, the risk of contracting hepatitis from blood was known of during this time. “It is possible for a patient to be a carrier of hepatitis and capable of seriously infecting another patient with the disease, although the carrier himself may show none of the symptoms associated with hepatitis,” wrote Ismach in his 1959 patent for the Automatic Jet Hypodermic Injection Apparatus (Ismach, 1962). Despite acknowledging the danger of hepatitis, Ismach minimized the risk of such transmission via jet injection.

Yet the Eli Lilly & Company appropriately recognized the risk of transmitting hepatitis via jet injectors. In 1962, five years before publication of the first jet injector specification, the company issued a warning on the product insert of its influenza vaccine, which stated: “If the nozzle becomes contaminated with blood or serum, it should be replaced or resterilized before further use to prevent the transmission of serum hepatitis virus or other infectious agents from one person to another” (Eli Lilly & Co., 1962).

Nowhere within any specification did the DoD caution against the risk of transmitting hepatitis when the jet injector became contaminated with blood. Why the DoD failed to implement the same level of safety precautions as a pharmaceutical company will be a question forever unanswered.

In the Years Following…
In the years following this first jet injector specification, several amendments and notices were issued, as noted below:

Here is the original 1967 military specification for the Automatic Jet Hypodermic Injection Apparatus.

Amendment 1, issued on October 31st of 1972, cannot be found. Whatever alterations were made are unknown.

Amendment 2, issued in 1974, made several alterations. The most critical of the changes was suspending the clinical test requirement. No longer was the Automatic Jet Hypodermic Injection Apparatus mandated to undergo clinical testing but only subjugated to testing “if deemed necessary” (DoD, 1974).

In 1978, the DoD had published a military specification for the creation of an Automatic Jet Hypodermic Injection Apparatus training device. The device could be used to train military personnel in administering antidote for nerve agents without the actual antidote attached (DoD, 1978). A working jet injector would not suffice for training purposes because if the jet injector is dry-fired, meaning it is fired without any liquid medicament, the device would become damaged.

It is noteworthy to include, in light of the CDC implicating a multi-use nozzle jet injector in the transmission of Hepatitis B at a weight reduction clinic in 1985, the DoD should have requested another clinical test on the Automatic Jet Hypodermic Injection Apparatus to be conducted. However, no documents have ever surfaced indicating any such follow-up testing was ever performed.

In 1988, the specification underwent a process called validation, in which the specification was reviewed to determine if the document was current and accurate. Notice 1 stated in its entirety, “Military Specification MIL-H-36505, dated 12 June 1967, has been reviewed and determined to be current” (DoD, 1988). However, the documented failed to describe the processes involved. Also, there was no mentioning of any updated clinical testing to ensure the safety of the technology during the validation process.

In 1994, the DoD issued Notice 2 which stated in its entirety, “Military Specifications MIL-H-36505, dated 12 June 1967 and MIL-H-36505 (2), dated 19 July 1974 is hereby cancelled without replacement” (DoD, 1994). During the 1990s, the DoD had noticed the vast amount of military standards created unnecessary restrictions as well as increased costs. Following Secretary of Defense William Perry’s memorandum in 1994, the DoD rescinded a lot of specifications opting instead for the use of industry standards. Despite the cancellation of this specification, the DoD still used the Automatic Jet Hypodermic Injection Apparatus until December 5th of 1997 when the device was pulled due to safety concerns.

Conclusion
Jet Infectors review of the Department of Defense’s military specification for the most widely used jet injector within the U.S. military demonstrates that changes to the ball check valve in 1959 were insufficient in alleviating the risk of cross-infection and that the military was still attempting to remedy the issue of fluid suck-back in 1967.

The performance test, which attempted to remedy the issue, only assessed for fluid suck-back on a limited set of parameters and failed to assess real life conditions. The DoD failed to see that fluid suck-back was not a defect but an inherent problem and thus frequently occurred. The DoD also failed to identify any fluid on the outside of the nozzle as contamination. For these reasons the specification was inadequate.

Subsequent research has shed light on another inherent fault of jet injector technology. In administering the jet injection an undesirable phenomenon called retrograde flow allowed for blood and bodily juices to flow back into the internal components of the gun during the injection. This was a cataclysmic breach of sterility.

Furthermore, the clinical test would not be capable of identifying the transference of low but infectious volumes of blood and could not test for blood-borne pathogens, such as Hepatitis C, which would not be identified until 22-years later.

On two occasions the DoD failed to retest the safety of jet injectors: Once after a hepatitis outbreak implicated a multi-use nozzle jet injector in 1985 and again during the validation of this specification in 1988. The DoD should have requested updated clinical tests to be performed to ensure the safety of those vaccinated.

It is indisputable, the DoD, the largest consumer of jet injectors, repeatedly failed to appropriately assess the safety of these devices.

References:

  • (Army, 1961) Department of the Army. Annual Report of the Surgeon General United States Army Fiscal Year 1961.
  • (Benenson, 1959) Benenson AS. Mass immunization by jet injection. In: Proceedings of the International Symposium of Immunology, Opatija, Yugoslavia, 28 September—1 October 1959 (International Committee for Microbiological Standardization, Secton of the International Association of Microbiological Societies). Zagreb: Tiskara Izdavackog zavoda Jugoslavenske akademije; 1959;393–399 [Library of Congress QW 504 I60p 1959].
  • (CDC, 1977) CDC. DHEW Memorandum: Informal Quarterly Report of October-December 1977. From: Special Investigations Section (Petersen NJ, Bond WW, Carson LA) to: Deputy Director (Favero MS), Hepatitis Laboratories Division, Phoenix, AZ (unpublished).
  • (DoD, 1967) Department of Defense. Military specification: hypodermic injection apparatus, jet, automatic. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-36505, 12 June 1967. Accessible here.
  • (DoD, 1970) Department of Defense. Military specification: nozzle, automatic, jet hypodermic injection apparatus. Defense Supply Center, Phil-Troop Support/ Medical Items of Supply. MIL-N-36667, 19 March 1970. Accessible here.
  • (DoD, 1974) Department of Defense. Military specification: hypodermic injection apparatus, jet, automatic. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-36505 (2), 19 July 1974. Accessible here.
  • (DoD, 1975) Department of Defense. Military specification: hypodermic injection apparatus, jet, foot operated. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-37084, 11 June 1975. Accessible here.
  • (DoD, 1978) Department of Defense. Military specification: hypodermic auto-injector, demonstration. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-T-37923, 31 October 1978. Accessible here.
  • (DoD, 1988) Department of Defense. Military specification: hypodermic injection apparatus, jet, automatic. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-36505 (2), Notice 1, 22 August 1988. Accessible here.
  • (DoD, 1994) Department of Defense. Military specification: hypodermic injection apparatus, jet, automatic. Defense Supply Center, Phil-Troop Support / Medical Items of Supply. MIL-H-36505 (2), Notice 2, 31 August 1994. Accessible here.
  • (Eli Lilly & Co., 1962) Eli Lilly and Company. Influenza Virus Vaccine Polyvalent (Types A and B) [vaccine product insert; 03516, 80:12, PA 1787 AMP]. Indianapolis, IN: Eli Lilly and Company; December 28, 1962;102.
  • (Ismach, 1962) Ismach, Aaron. “Multi-dose jet injection device.” United States Patent 3,057,349. 9 October 1962.
  • (Star-Democrat, 1954) Star-Democrat. Painless Shot. 28th May 1954. pg. 35.
  • (Warren et al., 1955) Warren J, Ziherl FA, Kish AW, Ziherl LA. Large scale administration of vaccines by means of an automatic jet injection syringe. JAMA 157:633–637, 1955.

© Jet Infectors, 2016 – 2021
Fair Use Notice (17 U.S.C. § 107)

VBA’s Adjudication Procedure Manual (M21-1) Recognizes Jet Injectors as a Possible Risk Factor

July 5, 2018

The Veterans Benefits Administration’s Adjudication Procedure Manual (M21-1 Manual), informally known by many as VA’s “bible,” recognizes military jet injections as a mode of transmission for Hepatitis C.

On June 12 of 2015, the Veterans Benefits Administration (VBA) rescinded the infamous 2004 VBA Fast Letter 211 (04-13) concerning jet injectors, by incorporating similar provisions within the Adjudication Procedures Manual. See M21-1, III.iv.4.I.2.e. Although many VA staff still cite the Fast Letter, the manual has become VBA’s latest guidance concerning jet injectors.

The change came about as VBA updated it’s bible / manual. No information was added or omitted but simply put into a chart form, as shown below.

M21-1 Immunization with a jet air gun injector

Although, certainly the rhetoric in which the VBA presents this mode of transmission has changed. Whereas the Fast Letter (04-13) viewed jet injector transmission with a speculative nature, the manual acknowledges the nexus as possible. When the Fast Letter was published in 2004, less than a handful of claims implicating jet injectors had been granted; so at the time the VBA viewed this mode of transmission as highly speculative. Overtime, the VA had noticed in a significant number of cases that military jet injections were the only Hepatitis C risk factor veterans experienced. This forced the VBA to recognize the possibility of jet injector transmission in veterans’ claims.

Although not all VBA staff have abided by the manual in recognizing this nexus, which is why it is necessary for you to learn how to use this manual to your advantage.

How To Use The Manual
The M21-1 Manual is an internal VBA manual containing provisions which instruct and guide adjudicators within VA Regional Offices on how to process a claim. The intentions of the manual are to guide staff so that claims are processed accurately and with consistency. To be clear, the manual recognizes laws, rules and VBA provisions, although the provisions in and of themselves do not impose or set forth any laws or rules. The provisions listed within M21-1 Manual, however, are binding upon VBA staff (i.e., Adjudicators within VA Regional Offices)—see footnote below describing the authority given to the M21-1 Manual. The manual is only binding upon VBA staff and holds no authority within the Board of Veterans Appeals.

In regards to jet injectors, the M21-1 Manual not only recognizes jet injector devices as a possible of mode of transmission for Hepatitis C but also serves as VBA’s guidance on handling such claims. Nowhere does the manual discredit the jet injector nexus. Therefore, any VBA staff who fail to recognize this mode of transmission as a possible source of a veteran’s Hepatitis C are flouting the VBA’s instruction and guidance.

Pursuant to the M21-1 Manual, jet injectors would be considered a “confirmed risk factor” in a veteran’s claim when “a medical report linking hepatitis to air gun injectors…include[s] a full discussion of all potential modes of transmission and a rationale as to why the examiner believes the air gun injector was the source for the [veteran’s] hepatitis infection” (M21-1, Part III, Subpart iv, 4.I.2.e; M21-1, Part III, Subpart iv, 4.I.2.j).

Veterans and claimants filing a jet injector claim should cite the M21-1 Manual. The above paragraph should be included into the claim along with a supporting nexus letter from the treating physician and/or gastroenterologist.

If the VA Regional Office has denied the claim and has failed to cite the manual’s recognition of jet injector transmission then the veteran / claimant should file an appeal. Failure by the examiner or rater to consider the manual’s recognition of this mode of transmission as being biologically plausible is grounds for appeal. Despite the fact that the Board of Veterans Appeals is not bound by M21-1 provisions, veteran law judges often refer to the manual and often examine the thoroughness of the examiner and rater’s rationale. When a Veteran’s Law Judge has found a rationale to be incomplete he or she will either 1) not to give any weight to that opinion or 2) will remand the case for reconsideration.

Here is one example in which a Veteran Law Judge remanded a case on such grounds. The Veteran Law Judge noted the manual’s recognition of the jet injector nexus:

Under M21-1 III.iv.4.I.2.e, Risk Factors for HBV and hepatitis C, the Manual instructs that the “risk factors for the development of [hepatitis B (HBV)] and hepatitis C are similar,” and that the evidence favoring risk factors for hepatitis C infections includes immunization with a jet air gun injector (BVA Citation # 1607862).

In this case, the VA had previously viewed the veteran’s contention that she acquired Hepatitis C from her military jet injections as frivolous. On appeal the veteran cited the manual’s recognition of this nexus. The Board of Veterans Appeals court agreed that the evidence was not viewed in light of the guidance provided within the manual. “[T]he VA examiner did not discuss the VA’s finding that ‘despite the lack of any scientific evidence to document transmission of hepatitis C with air gun injectors, it is biologically possible.’” The case was remanded so that an accurate, non-biased medical opinion could obtained. Herein is a perfect example on how to use the manual to counter a fallacious opinion by VA staff.

As mentioned above, the VBA Manual states, “Risk factors for the development of HBV and HCV are similar.” Since the transmission of Hepatitis B by jet injectors has been documented, it is plausible, logical and acceptable to deem Hepatitis C transmission would occur via this route despite the lack of any documented cases. Below is a snapshot from the manual.

M21-1 HBV and HCV Risk factors are similar

Here is the relevant section of the M21-1 Manual concerning jet injectors. Veterans, claimants, and Veteran Service Officers are encouraged to use this within their claim. 

Despite VBA’s stance on jet injectors, some VBA staff still openly disregard VA’s bible and refuse to believe the plausibility of jet injector transmission. If a claim was denied and the VA did cite M21-1’s recognition, the veteran / claimant should question the rational given within the denial letter to see if the opinion is fallacious. How should veteran’s counter such fallacious opinions by VA staff?

Footnote:
VBA M21-1 Manual is binding upon all VBA staff. Therefore, since the M21-1 Manual lists jet injectors as a risk factor, VBA staff are not permitted to discredit or question the plausibility of jet injector transmission. VBA staff must consider and weigh jet injectors as a source of infection within a veteran’s claim.

  • Gray v. Secretary of Veterans Affairs, No. 16-1782 (Fed. Cir. 2018)

“[t]he VA consolidates its [internal] policy and procedures into one resource known as the M21-1 Manual.” Disabled Am. Veterans v. Sec’y of Veterans Affairs, 859 F.3d 1072, 1074 (Fed. Cir. 2017) (“DAV ”). The M21-1 Manual “is an internal manual used to convey guidance to VA adjudicators.”

And,

the Manual is “not binding on anyone other than the VBA [Veterans Benefits Administration] employees” and, in particular, does not bind the Board of Veterans Appeals (“Board”). Maj. Op. ––––; see also Carter v. Cleland, 643 F.2d 1, 5 (D.C. Cir. 1980) (noting the Manual’s binding effect on VA adjudicators); Office of Gen. Counsel, U.S. Dep’t of Veterans Affairs, Op. Prec. 7-92, Applicability of VA Manual M21-1, Part 1, Paragraph 50.45, 1992 WL 1200482, at *2 cmt. 4 (Mar. 17, 1992) (same).

  • Carter v. Cleland, 643 F.2d 1, 6-8 (D.C. Cir. 1980) states, “Guidelines contained in the VA’s manual are admittedly binding on the Administration’s adjudication officers.”
  • Office of Gen. Counsel, U.S. Dep’t of Veterans Affairs, Op. Prec. 7-92, Applicability of VA Manual M21-1, Part 1, Paragraph 50.45, 1992 WL 1200482, at *2 cmt. 4 (Mar. 17, 1992)

VA Manual M21-1 is issued by the Chief Benefits Director and its provisions are intended to provide uniform “procedures for the adjudication of claims for pension, compensation, dependency and indemnity compensation, accrued amounts, burial allowance and servicemen’s indemnity.” See Adjudication Procedure Manual, M21-1 Foreword. The procedures set forth in this manual are intended to be binding only upon VA officials within the Veterans Benefits Administration (VBA) who are responsible for initially adjudicating claims for benefits. See M21-1, paragraph 1.01. Generally, BVA is not bound by this manual. 38 U.S.C. § 7104 (c). 38 C.F.R. § 19.102 (b); Carter v. Cleland, 643 F.2d 1, 6-8 (D.C. Cir. 1980).

  • 38 C.F.R. § 19.5, Criteria governing disposition of appeals.

In the consideration of appeals, the Board is bound by applicable statutes, regulations of the Department of Veterans Affairs, and precedent opinions of the General Counsel of the Department of Veterans Affairs. The Board is not bound by Department manuals, circulars, or similar administrative issues.

  • 38 U.S.C. § 7104 (c) “The Board shall be bound in its decisions by the regulations of the Department, instructions of the Secretary, and the precedent opinions of the chief legal officer of the Department.”

© Jet Infectors, 2016 – 2021

Faulty Design Created Inherent Risks – Fluid Suck-Back

Fluid suck-back refers to any fluid or blood upon the nozzle being sucked into the orifice of the jet gun injector and contaminating the drug reservoir which holds the next dosage to be fired. Fluid suck-back occurs after the injection has been administered.

This undesirable phenomenon is likely due to a combination of the unit being pressurized and a faulty ball check-valve which created a vacuum at the end of the injection.

The following illustrations demonstrate this phenomenon.

Jet Infectors - Fluid Suck-back 1Jet Infectors - Fluid Suck-back 2Jet Infectors - Fluid Suck-back 3

And where is the evidence?

© Jet Infectors, 2016 – 2021

Research Documented Fluid Suck-back

During the mid- to late-1950s, researchers within the Department of Defense (DoD) became cognizant of the undesirable phenomenon of fluid suck-back. The observation prompted researchers at Walter Reed Army Institute of Research along with engineers at the Medical Equipment Development Laboratory at Fort Totten (MEDL) with the task of remedying the problem. By 1959, the DoD developed a new multi-use nozzle jet injector (MUNJI) that was intended to be an improvement over previous models. The device was called the Automatic Jet Hypodermic Injection Apparatus, or more commonly known as the Ped-O-Jet.

Lt. Colonel Abram Benenson, who oversaw the use of jet injectors within the DoD, acknowledged the collaborative work that birthed the Ped-O-Jet in a 1959 paper:

“[S]ince July 1957, we [Benenson and Lt. Col. Robert Lindberg] have been responsible for the development of jet injectors for immunization. Our field and laboratory studies depended on the efforts and support of Captain Adrain D. Mandel and Mr Charles E. Buckler; engineering support was furnished by the Medical Equipment Development Laboratory, Fort Totten, New York, where the basic principle was improved into the current multidose jet injector” (emphasis added) (Benenson, 1959).

Aaron Ismach, the inventor of the Ped-O-Jet and a civilian engineer at MEDL, reported that previous MUNJIs of the 1950s allowed for fluid suck-back. In his December 14th, 1959 patent, Ismach stated, “unlike most earlier hypodermic jet injection guns, the instant invention is free from sucking fluid back from a patient either during or after the firing cycle is completed so that the danger of cross-infection is almost completely avoided” (Ismach, 1962). The Press-O-Jet would be one of the “earlier hypodermic jet injection guns” that Ismach was referencing.

Ismach’s patent specifically acknowledged the potential of fluid suck-back occurring when cocking the gun but states a ball check valve, located within the nozzle head, prevents this from happening. “The ball check valve 44 serves to prevent the entry of any air or suckback of any fluid during the loading cycle of the vaccine pump…” (Ismach, 1962).

From Ismach’s assertion the issue of fluid suck-back clearly rests upon the efficacy of the ball check valve. To gain an understanding of how Ismach improved upon the ball check valve, Jet Infectors compared the patents of the Press-O-Jet and Ped-O-Jet. One noticeable difference stands-out—the ball check valve on the Ped-O-Jet was spring-loaded to help keep it shutt, while the Press-O-Jet did not contain a spring.

The patent for the Press-O-Jet states, “Return flow of the inoculant through the bore 23 of plunger 22 is prevented by means of ball check valve 25.” Yet, the patent also notes that the ball check valve merely rests between two spaces without any reference of a spring: “A gasket 34 is interposed between the nose 33 and the end of plunger 22 and acts both as a seal and also as a retainer for the ball 25” (emphasis added) (Ziherl, 1958).

The diagram from the Press-O-Jet patent shows the ball check valve (number 25) resting between two partitions with no zigzagged line to indicate a spring.

Press-O-Jet ball check valve #25

(Ziherl, 1958)

Whereas the patent for the Ped-O-Jet clearly states the ball check valve is spring-loaded. “The ball check valve 44 serves to prevent the entry of any air or suckback of any fluid during the loading cycle of the vaccine pump, but the spring pressure on this valve 44 is light enough to be easily overcome during the firing or ejection cycle of the vaccine pump” (Ismach, 1962).

The diagram from the Ped-O-Jet patent shows the ball check valve (number 44) is retained by a spring, as indicated by the zigzagged line.

Ped-O-Jet Ball Check Outlet Valve #44

(Ismach, 1962)

The lack of spring-loaded ball check valve could be the reason the DoD had observed the Press-O-Jet to improperly work at times. “The failure of the ball check valve in the forward end of the plunger system to seat properly causes the gun to deliver less than the measured dosage and requires a metal lathe to gain access to the ball valve” (Anderson et al., 1958).

Even if the ball was properly seated within the counterbore the lack of resistance from a spring could account for the systemic fluid suck-back observed by Ismach.

The question now becomes did the spring-loaded ball check valve within the Ped-O-Jet prevent fluid suck-back?

As subsequent research reveals, the Ped-O-Jet still succumbed to fluid suck-back. Ismach’s assertions were nothing more than puffing statements.

  • In 1977, CDC’s Hepatitis Laboratories Division conducted safety testing on the Ped-O-Jet. The researchers observed a drop of fluid remained on the injector nozzle after firing and would disappear back into the nozzle orifice within 3 to 5 seconds. The researchers concluded, “These manipulations causing disappearance of the fluid drop are common during clinical use of the jet injector” (CDC, 1977).
  • Weniger, Jones and Chen recalled CDC’s 1977 investigation of the Ped-O-Jet, stating, “After injections, they [CDC] observed fluid remaining on the Ped-O-Jet nozzle being sucked back into the device upon its cocking and refilling for the next injection (beyond the reach of alcohol swabbing or acetone swabbing).”
  • In 1994, the CDC retested the safety of the Ped-O-Jet. After artificially contaminating the underbelly of a shaved rabbit with Hepatitis B surface antigen (HBsAg), a sterile Ped-O-Jet was placed upon the site and administered an injection. The subsequent injection was fired into a vial and tested for HBsAg. The results found the ejected fluid of the next shot fired was positive for HBsAg in 19 out of 50 (38%) of the samples (Grabowsky et al., 1994). Cross-contamination of HBsAg from the skin surface to the ejectate of the subsequent shot was due to either fluid suck-back or retrograde flow.
  • The CDC collaborated with American Jet Injector Corporation and the University of Florida to test the safety of the Am-O-Jet, a MUNJI device. The Am-O-Jet was an identical design of the Ped-O-Jet. Within this study the researchers admit the check-valve had been redesigned; thus further implicating the inherent design faults of previous Ped-O-Jet models. It is noteworthy to add, the researchers found rates of contamination were significant with the Am-O-Jet (Sweat et al., 2000).

These reports document that jet injectors—including the most widely used jet injector, the Ped-O-Jet—allowed contaminates upon the nozzle orifice to be sucked into the internal fluid pathway and infect the next dosage to be fired. Despite attempts to resolve the problem with the ball check valve, fluid suck-back still occurred and has been continuously reported upon through-out the past 60-years.

References:

  • (Anderson, Lindberg, & Hunter, 1958) Anderson EA, Lindberg RB, Hunter DH. Report of large-scale field trial of jet injection in immunization for influenza. JAMA 167:549–552, 1958.
  • (Benenson, 1959) Benenson AS. Mass immunization by jet injection. In: Proceedings of the International Symposium of Immunology, Opatija, Yugoslavia, 28 September—1 October 1959 (International Committee for Microbiological Standardization, Secton of the International Association of Microbiological Societies). Zagreb: Tiskara Izdavackog zavoda Jugoslavenske akademije; 1959;393–399 [Library of Congress QW 504 I60p 1959].
  • (CDC, 1977) CDC. DHEW Memorandum: Informal Quarterly Report of October-December 1977. From: Special Investigations Section (Petersen NJ, Bond WW, Carson LA) to: Deputy Director (Favero MS), Hepatitis Laboratories Division, Phoenix, AZ (unpublished).
  • (Grabowsky et al., 1994) Grabowsky M, Hadler SC, Chen RT, Bond WW, de Souza Brito G. Risk of transmission of hepatitis B virus or human immunodeficiency virus from jet injectors and from needles and syringes. Unpublished manuscript draft, dated January 3, 1994.
  • (Ismach, 1962) Ismach, Aaron. “Multi-dose jet injection device.” United States Patent 3,057,349. 9 October 1962.
  • (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.
  • (Weniger, Jones & Chen) Weniger BG, Jones TS and RT Chen. “The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Future Vaccination Methods.” National Center for Immunization & Respiratory Diseases. [Poster Presentation].
  • (Ziherl, 1958) Ziherl, Frank. “Multiple Injection Inoculator Instrument.” United States Patent 2821193. 28 January 1958.

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