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 administration 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 evidence of 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 – 2018

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).

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, 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 – 2018
Fair Use Notice (17 U.S.C. § 107)

VA’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), known informally as VA’s “bible,” recognizes military jet injections as a possible risk factor for Hepatitis C transmission.

On December 16 of 2015, the Department of Veterans Affairs (VA) 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 VA’s latest guidance concerning jet injectors.

The change came about as VA 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 VA 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 VA viewed this mode of transmission as highly speculative. Overtime, the Board of Veterans Appeals had noticed in a substantial number of cases the only Hepatitis C risk factor veterans experienced were his or her military jet injections. This forced the VA to recognize the possibility of jet injector transmission in veterans’ claims.

Although not all VA staff have abided by the manual in recognizing this nexus and the VA has been reluctant to resolve this discrepancy, which is why it is necessary for you to learn how to use this manual to your advantage.

How To Use The Manual
VBA’s Adjudication Procedure Manual (M21-1) not only serves as VA’s recognition that Hepatitis C transmission via jet injectors is possible but also serves as VA’s guidance on handling such claims. Nowhere does the manual discredit the jet injector nexus. Therefore, any VA staff who fail to recognize this mode of transmission as a possible source of a veteran’s Hepatitis C are flouting the VA’s established opinion.

Pursuant to M21-1, 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).

The manual presents the information in a non-bias manner. This allows those who use the manual to follow the facts of each case without any side commentary by critics.

For example, one Veteran Law Judge remarked,

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 the fallacious opinions 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

Despite VA’s stance on jet injectors, some VA staff still openly disregard VA’s bible and refuse to believe the plausibility of jet injector transmission.

Fallacious Opinions By VA Staff
VA staff—whether a VA Examiner, VHA physician, BVA Law Judge, Adjudicator, etc.—have been letting their personal beliefs concerning jet injectors negatively impact the outcome of claims. Such fallacious opinions by VA staff have nothing to do with the merits of a veteran’s case. Listed below are several examples. Veterans, claimants, and Veterans Service Officers should ask the following questions when reviewing a jet injector claim.

  • Did the VA or its staff say the jet injector was not a recognized risk factor for Hepatitis C?

Staff claiming jet injectors are not a recognized risk factor fail to recognize VA’s position that this mode of transmission is “biologically plausible,” and pursuant to M21-1 jet injectors would be considered a “confirmed risk factor” with a medical nexus letter from a physician treating the veteran links the veteran’s Hepatitis C to jet injectors. Of course, the letter will need to include “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 hepatitis infection.”

Here is an example of this fallacious opinion: “The same VA examiner provided a September 2015 addendum opinion which resulted in the same conclusion. The examiner elaborated that the Veteran’s hepatitis C was less likely than not related to his service, to include air gun vaccination, as air gun vaccination is not considered a risk factor for hepatitis C” (BVA Citation # 1706152).

  • Did the VA or its staff claim since there was no needle there was no risk?

Staff claiming since there is no needle there is no risk is absurd. Within the jet injection process is the undesirable phenomenon of retrograde flow, in which the jet stream acted as a needle and at the end of the injection caused a backwards flow of vaccine, blood and bodily juices into the jet injector.

Here is an example of this fallacious opinion: A VA examiner “felt [it] was unlikely that the veteran would have gotten such infection from an air gun inoculation, since this method did not use a needle puncture” (BVA Citation # 113621). Herein the examiner does not recognize jet injectors as a possible risk factor because there is no needle. This examiner disregards the fact that VA believes there is a possibility of a nexus and let’s his personal opinion on jet injectors influence the claim, in which the claim was denied. The issue here is not the particulars of the veteran’s risk factors, but is about the personal beliefs held by VA staff on jet injectors.

  • Did the VA or its staff say there are no documented cases of such transmission, therefore, it is less than likely as not that the veteran acquired Hepatitis C by jet injectors?

Here is an example of this fallacious opinion: A VHA physician acknowledges the review of literature concerning jet injector transmission but erroneously refutes the likelihood because there were no documented cases of such transmission within the Department of Defense. This VHA physician failed to acknowledge that Hepatitis C was not identified until 1989, therefore how could there be any documented cases when these veterans served prior to 1989? The VHA physician failed to acknowledge that in 60 to 70 percent of cases Hepatitis C progresses asymptomatically. Therefore due to these extenuating circumstances there would not be any documented cases. Here is the quote for reference purposes.

In February 2016, a VA physician opined that there is no evidence that service members have acquired bloodborne infections (such as hepatitis B, hepatitis C, or human immunodeficiency virus) as a result of the use of jet injectors by the Department of Defense. The physician noted, however, that concerns about the safety of jet injectors prompted the Department of Defense to discontinue the routine use of jet injectors for vaccinations. The physician noted that jet injectors that use the same nozzle tip to vaccinate more than one person have been used worldwide since 1952 to administer vaccines when many persons must be vaccinated in a short period of time. The examiner noted that the jet injector developed and most widely used by the military has never been implicated in the transmission of bloodborne infections. However, there was a concern that the use of jet injectors may pose a potential risk for translating bloodborne infections to vaccine recipients. The examiner noted that there was an outbreak of hepatitis B caused by non-standard use of another type of jet injector in a civilian clinic. Lab studies from Brazil and the United Kingdom suggest that bloodborne transmission theoretically could occur with the use of jet injectors. The examiner noted that there have been no reported cases of cross-contamination of a veteran with the jet injectors used by the Department of Defense. The examiner opined that, since there have been no confirmed cases of hepatitis C or other bloodborne pathogen due to the use of a jet injector, it is less likely than not that the Veteran had chronic hepatitis, liver disease, diabetes mellitus, hypertension, COPD, or an acquired psychiatric disorder as a result of an air gun vaccination (BVA Citation # 1729780)

  • Did the VA or its staff claim the veteran’s Hepatitis C must be from some unidentifiable and unrecognized source?

Staff claiming jet injector transmission must be from an unidentifiable and unrecognized source is outright nefarious and fails to weigh the evidence already presented within the case.

Here is an example of this fallacious opinion: The examiner, who was a VA physician, weighed the veterans hepatitis C risk factors—which were accidental needle stick as a healthcare worker in the military and military jet injector inoculations—against statistical findings in medical studies. The VA physician assessed the likelihood that the veteran’s claim matched those studies. In so doing, the VA physician read that the risk of acquiring hepatitis C from a jet injector was less than 20 percent and in 20 percent of hepatitis C cases the risk is unidentifiable. He then attributed, based upon conjecture and not reality, that the cause must be from an unidentifiable risk. The VA physician gave no credence to the risk factors the veteran did experience and failed to recognize that the veteran may have been a part of the less than 20 percent who acquired hepatitis C from jet injector inoculations (BVA Citation # 0817607).

Here is another example: “In October 2013, a VA examiner opined it is less likely than not the Veteran’s Hepatitis C is related to service, including as a result of air gun vaccinations. He states it is speculative to consider contraction of Hepatitis C in such a manner, and the Veteran’s Hepatitis C more likely than not was contracted outside of military service. However, the examiner did not identify any post-service occurrences which caused the Veteran’s Hepatitis C. Instead, he simply states there are other causes which have either ‘not been recognized, recalled or shared by the Veteran.’” … The BVA rendered, “While the October 2013 VA examiner is competent to opine as to the etiology of Hepatitis C generally, the Board does not find his opinions persuasive. While the examiner indicates it is speculative to consider contraction of Hepatitis C due to air gun vaccinations, he in turn speculates other causes not supported by the evidence” (BVA Citation # 1616758).

  • Did the VA or its staff say there is no evidence within the veteran’s service medical records indicating that the veteran received immunizations with a jet injector?

Over the past year, staff have made the claim that there is no proof that the veteran received vaccinations via a jet injector. Indeed veterans’ service medical records only listed the vaccinations, including lot numbers, and did not list the mode of vaccination. However, the VA examiners failed to apply Layno v. Brown, 6 Vet. App. 465, 470 (1994), in which a veteran is competent as a layperson to testify on that which he or she has personal knowledge. Moreover, contemporaneous documents reveal certain types of vaccines were administered via jet injection. Military year books and photographs reveal jet injectors were routinely used in the administering immunizations.

Here is an example of this occurring: “In this case, the Board recognizes that the service medical treatment records do not indicate whether the Veteran received inoculations via air gun; however, the Board also finds that the Veteran is competent and credible regarding his report of the use of air gun injectors and regarding any other risk factors” (BVA Citation # 1756420).

Here is another example: “The Board observes that the veteran is competent to describe the manner in which he was inoculated during his period of active service because such an observation does not require specialized medical knowledge. Grottveit v. Brown, 5 Vet. App. 91, 93 (1993); Espiritu v. Derwinski, 2 Vet. App. 492, 494 (1992)” (BVA Citation # 0401390).

Such fallacious opinions are grounds for appeal.

Claims Must Be Viewed in Accordance with VA Policies and Procedures
VA regulation states, “…the evidence in each individual claim must be thoroughly and conscientiously studied by each member of the rating board in the light of the established policies of the Department of Veterans of Affairs…” (emphasis added) (38 C.F.R. § 4.6). Therefore pursuant to VA regulation, VA staff should leave their personal opinions at the door and view jet injectors based upon the guidance provided by the administration.

VA regulation also states, “Fairness and courtesy must at all times be shown to applicants” (emphasis added) (38 C.F.R. § 4.23). The veterans in the claims from which the first five above examples were drawn were not shown fairness. These veterans’ risk factors were not weighed based upon the merits of their cases. These claims were weighed based upon the personal opinions of VA staff and were erroneously denied.

The plausibility of jet injector transmission cannot be discredited. VA’s Manual for Disability Compensation recognizes jet injectors as a possible risk factor for Hepatitis C (M21-1, III.iv.4.I.2.e.). 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.

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

© Jet Infectors, 2016 – 2018

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 – 2018

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.

 

© Jet Infectors, 2016 – 2018
Fair Use Notice (17 U.S.C. § 107)

 

Faulty Design Created Inherent Risks – Retrograde Flow

Retrograde flow, also commonly referred to as black flow, is the undesirable phenomenon in which fluid, mixed with tissue cells, bodily fluid and blood, moves up the jet stream and enters the jet injector, contaminating the internal fluid pathway and drug reservoir.

The following illustrations demonstrate this concept. In the first image, the jet injector is actuated and the jet stream is emitted from the nozzle.

Jet Infectors - Retrodgrade Flow 1

In this image, the jet stream is deposited into the arm.

Jet Infectors - Retrograde Flow 2

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. The image below demonstrates the multi-directional flow, in which tissue cells, blood and bodily fluids, flowed into the jet injector orifice.

Jet Infectors - Retrograde Flow 3

 

And where is the evidence?

 

© Jet Infectors, 2016 – 2018

Jet Injector Manufacturers Acknowledge Retrograde Flow

Linda D’ Antonio, spokeswoman for the now defunct Association of Needle-Free Injection Manufacturers, stated in a news article, “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 to subsequent recipients.

Although this was not the only admission of a design flaw by the industry. Throughout the years, various manufacturers and engineers had acknowledged back flow, reflux, and back leak. All of these terms refer to retrograde flow.

Kenneth Dunlap acknowledged “flow back” within his 1991 patent for a disposable nozzle assembly jet injector. Dunlap stated,

In the case of the prior art needleless injectors heretofore described, during the administration of an injection, the fluid jet driven at high pressure through the patient’s skin may result in some minor amount of bleeding and because the nozzle assembly of the jet injector is pressed firmly against the skin at the moment of release and for a short time thereafter, there is a possibility that blood might flow back into the ejection orifice to contaminate the nozzle. As such, to avoid cross-contamination of blood between different patient’s being treated in a hospital or clinic situation, it would heretofore be necessary to disassemble the drug injector and sterilize those portions of the assembly that could conceivably retain contaminated blood (U.S. Patent 5062830).

Sergio Landua wrote about “blood reflux” within his 1998 patent for a disposable syringe jet injector.

It is considered that replacing the nozzle tip alone after each injection is not sufficient to guarantee complete elimination of cross contamination between patients, since by particles of blood reflux during the injection, viruses or pathogens may be carried on to the inside of the dose chamber, and therefore contaminate the following medication dose to be injected in the next patient (U.S. Patent 5782802).

Bruce Joseph Roser described “reflux flow” within his 2003 patent for a disposable injection device. Roser explained,

It appeared that high pressure occurring in the tissues, which were suddenly distended by the injection, coincided with falling pressure inside the jet injector. Ultimately, this caused a reflux flow or “sucking-back” of tissue fluid into the injector. Because of this serious drawback, single-use vials which insert into the mechanical injector were developed (U.S. Patent 6602222).

 

References:

  • (CDC, 2006) Centers for Disease Control and Prevention. Needle-free injection technology. Department of Health and Human Services. 12 September 2006. Accessible at: https://web.archive.org/web/20061225084649/http://www.cdc.gov/nip/dev/jetinject.htm.
  • (Snowbeck, 2001) Snowbeck C. Reviving an old technology for large-scale vaccination. Post-Gazette. 20 November 2001. Accessible at: http://old.post-gazette.com/healthscience/20011120hjet2.asp.
  • (U.S. Patent 5062830) Dunlap KW. “Dry Disposable nozzle assembly for medical jet injector.” United States Patent 5,062,830. 5 November 1991.
  • (U.S. Patent 5782802) Landau S. “Multiple use needle-less hypodermic injection device for individual users.” United States Patent 5,782,802. 21 July 1998.
  • (U.S. Patent 6602222) Roser BJ. “Disposable injection device.” United States Patent 6,602,222 B1. 5 August 2003.

© Jet Infectors, 2016 – 2018
Fair Use Notice (17 U.S.C. § 107)

Research Documented Retrograde Flow

Although the concept of retrograde flow may seem hard to believe, the phenomenon has been independently validated by various researchers from the USA, Netherlands, Russia, and England over the past 50 years. The phenomenon has been described in scientific literature with terms such as reflux, back flow and back leak.

Retrograde flow was initially observed in the first multi-use nozzle jet injector, the Press-O-Jet, during the 1950s. Elisberg, McCown and Smadel (1956) reported, the “backflow of inoculum mixed with the subject’s bodily fluids,” however it was their belief that “the precautionary quick withdrawal of the jet injection syringe immediately after the inoculation is finished prevents contamination of the nozzle with agents which might transmit a blood-borne infection.” Contrary to Elisberg, McCown and Smadel’s belief, subsequent research has shown prompt removal of the jet gun failed to stop cross-contamination within the half second it took to administer the vaccination.

Robert Hingson acknowledged a “back leak” of fluid within his 1963 paper in the Military Medical Journal. Hingson wrote, “Because of the need for readjustment by the tissues which so suddenly receive the 1 cc. injection, we recommend keeping the injector nozzle compressed tightly against the injected site for one second after injecting, to minimize back leak” (Hingson, Davis & Rosen, 1963). Hingson’s belief was the jet injector would act as a barrier, stopping the back flow of fluid, and give time for the fluid to absorb into the surrounding tissue. However, Hingson failed to test if the “back leak” would breach the nozzle orifice and contaminate the inside of the jet injector.

Dutch researchers observed retrograde flow during the 1980s. Brink and colleagues (1985) found cross-contamination of a highly infectious virus occurred within their study on mice despite the lack of visual bleeding at the injection site. The researcher’s hypothesized, “Probably the enormous tissue pressure caused a splashback of the injected fluid. This retrograde stream could be responsible for the transport of virus particles.” The researchers further stated investigations should be conducted to see if this phenomenon occurs in humans.

Russian researchers, Evstigneev and Lukin, noted retrograde flow within their investigations during the 1990s. The researchers wrote, “infection is possible because of retrograde flow of vaccine preparation which just has mixed with tissue liquid of a previous patient or taking into account a continuous contact of an injector head with patient’s skin during injection” (Evstigneev & Lukin, 1994).

Researchers from Kalamazoo College investigated the potential for cross-contamination with the Syrijet, a multi-use nozzle jet injector made from the same manufacturer as the Ped-O-Jet. In assessing the transference of microbial pathogens during the injection process, Suria and colleages (1999) found, “the degree of backflow and resulting contamination increased with increasing ejection volume setting, from lowest (0.06 cm3) to highest (0.30 cm3).” Suria observed the greater the volume the greater degree of internal contamination from retrograde flow. Suria also noted swabbing the nozzle of the jet injector did not remove internal contamination.

Joy Baxter and Samir Mitragotri both described the mechanical workings of jet injection in their 2006 paper. Baxter, a researcher for Unilever Research and Development, and Mitragotri, a chemical engineer at Harvard University, wrote, “Backflow of the jet is observed during hole formation if the volumetric rate of hole formation in the skin is smaller than the volumetric flow rate of the jet liquid into the skin” (Baxter & Mitragotri, 2006).

In October of 1998, the WHO 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. In fact, the researcher found retrograde flow was a natural phenomenon within the jet injection process and referred to it as “ballistic contamination” (Voelker, 1999). Hoffman thoroughly explained the process within his paper.

…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).

The Program for Appropriate Technology in Health (PATH) assessed the degree of contamination with jet injectors during the mid-1990s. The tests sought to detect contamination in three areas: 1) On the surface of the skin that was injected, 2) upon the surfaces of the jet injector that had contact with skin, and 3) in the ejectates, or rather the next dose fired. The tests “showed systematic contamination of both the ejectate and the internal fluid pathway” (WHO, 1997). Contamination of the internal fluid pathway could only have occurred due to either fluid suck-back or retrograde flow.

PATH redeveloped jet injectors to avoid the risk of cross-contamination by implementing a single-use protector cap to shield the jet injector from splash-back. However, as safety testing showed, the protector cap was not infallible. Kelly and colleagues (2008) found the Hepatitis B virus cross-contaminated through the protector cap and into the next dosage to be fired. Cross-contamination could only have occurred by the phenomenon of retrograde flow.

 

References:

  • (Baxter & Mitragotri, 2006) Baxter J, Mitragotri S. Needle-free liquid jet injections: mechanisms and applications. Expert Rev Med Devices Sep 2006;3(5):565-74.
  • (Brink et al., 1985) Brink PRG, van Loon AM, Trommelen JCM, Gribnau FWJ, Smale-Novakova IRO. Virus transmission by subcutaneous jet injection. J Med Microbiol. December 1985; 20(3): 393-397.
  • (Elisberg, McCown, & Smadel, 1956) Elisberg BL, McCown JM, Smadel JE. Vaccination against smallpox. Jet injection of chorio-allantoic membrane vaccine. J Immunol 1956;77(5):340-351.
  • (Evstigneev & Lukin, 1994) Evstigneev VI, Lukin EP. The safety of the jet (needle-free) injection. Military Medical Journal (Russia) Jul 1994; (7):38-39, 79.
  • (Hingson, Davis, & Rosen, 1963) Hingson RA, Davis HS, Rosen M. The historical development of jet injection and envisioned uses in mass immunization and mass therapy based upon two decades’ experience. Military Medicine 128:516–524, 1963.
  • (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.
  • (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.
  • (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).
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA May 26, 1999;281(20):1879-1881.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection, Geneva, 18-19 March 1997. Geneva: World Health Organization, Global Programme on Vaccines and Immunizations, document, 1997;1-37.

© Jet Infectors, 2016 – 2018
Fair Use Notice (17 U.S.C. § 107)

Faulty Design Created Inherent Risks – Splash-Back

Splash-back refers to contamination upon the nozzle of the jet injector. This undesirable phenomenon occurs when the jet stream impinges the skin during hole formation, in which debris—consisting of fluid, tissue cells, blood, and bodily fluid—splashes back onto the jet injector nozzle and possibly into the nozzle orifice.

Splash-back is more likely to occur when the nozzle orifice is not pressed firmly against the skin or with jet injectors that have a spacer which creates a gap in between the nozzle orifice and skin.

The following illustrations demonstrate the concept. In the first image, the jet injector is actuated and the jet stream is emitted from the nozzle orifice, as demonstrated with the blue arrow.

Jet Infectors - Splash-back 1

In this image, the jet stream penetrates the skin, initiating hole formation. This will cause debris, as mentioned above (fluid, tissue cells, blood and bodily fluids), to splatter, as demonstrated with the red arrow.

Jet Infectors - Splash-back 2

Since the nozzle of the jet injector is in the immediate splatter field it will become contaminated, as demonstrated below.

Jet Infectors - Splash-back 3

 

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

 

 

© Jet Infectors, 2016 – 2018

Research Documented Splash-back

Splash-back has been previously reported upon in scientific studies. A 1966 article titled, Vaccination by Jet Injection, published in the British Medical Journal stated, “There is no risk of cross-infection unless the face of the injector is contaminated with blood or tissue juices” (Anonymous, 1966). Although studies have demonstrated the nozzle of the jet injector indeed becomes contaminated during jet injection.

  • Hoffman and colleagues (2001) observed the nozzle and internal fluid pathway became contaminated during the jet injection process amongst several brands of jet injectors, including the Ped-O-Jet and Med-E-Jet. He termed this phenomena as ballistic contamination, whereupon the force of impact caused a release of pressure which expelled debris away from the site of impact (Voelker, 1999). With the jet injector being directly behind the site of impact it is a prime target to becoming contaminated.
  • Lipson and colleagues (1958) assessed if the antibody response to a poliomyelitis vaccine via jet injection would be comparable to needle and syringe. In the study, thirty-four children received two doses of polio vaccine via a handheld Press-O-Jet injector and twenty-seven children received one dose of vaccine by needle. Lipson stated, “We observed blood on the nozzle of the jet injector on two different occasions.” This means in 3 percent of the injections blood was observed on the jet injector nozzle, indicating the nozzle became contaminated due to splash-back.
  • Kutscher and colleagues (1962) warned of splash-back within their paper. “The Hypospray unit itself is not sterilized although the head can and should be disinfected,” stated the researchers. If the patient’s arm is not properly held “some portion of the injected material may rebound and not attain its target” (emphasis added). In other words the injected material would splash back onto the jet injector.
  • Dr. Sol Roy Rosenthal studied the transference of blood via the Hypospray Multidose jet injector amongst children at two schools. Observations from the first school found the jet injector produced “much bleeding.” Overall the study found in 17 percent of the vaccinations of school children there was enough blood on the jet injector nozzle to transmit blood-borne pathogens (Rosenthal, 1967).
  • Horn, Opiz and Schau (1975) observed splash-back through their investigations of the Hypospray Multidose and warned of the risk this posed in spreading hepatitis. Horn stated,

We were able to demonstrate by direct staining of material obtained from the nozzle, that this part of the injector becomes contaminated with material originating in human white blood corpuscles. These findings are very similar to those of Hughes with syringes and have an obvious implication in relation to the transfer of hepatitis virus by jet injectors (Horn, Opiz & Schau, 1975).

This research serves as evidence that the nozzle face of the jet injector becomes contaminated during the injection process.

 

References:

  • (Anonymous, 1966) Anonymous. Vaccination by Jet. Br Med J December 31, 1966: 1610.
  • (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.
  • (Horn, Opiz & Schau, 1975) Horn H, Opiz B, Schau G. Investigations into the risk of infection by the use of jet injectors. Health and Social Serv J 85:2396–2397, 1975.
  • (Kutscher et al., 1962) Kutscher AH, Hyman GA, Zegarelli EV, Dekis J, Piro JD. A comparative evaluation of the jet injection technique (Hypospray) and the hypodermic needle for the parenteral administration of drugs: a controlled study. Am J Med Sci 1962;54:418-420.
  • (Lipson et al., 1958) Lipson MJ, Carver DH, Eleff MG, Hingson RA, Robbins FC. Antibody response to poliomyelitis vaccine administered by jet injection. Am J Public Health 1958;48(5):599-603.
  • (Rosenthal, 1967) Rosenthal SR. Transference of blood by various inoculation devices. Am Rev Respir Dis. October 1967; 96(4):815-819.
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA May 26, 1999;281(20):1879-1881.

 

© Jet Infectors, 2016 – 2018
Fair Use Notice (17 U.S.C. § 107)