VA’s Double Standard: VA Recognizes Non-military Exposures as Risk Factors Despite the Lack of Scientific Proof

VA Media Relations officer Ndidi Mojay stated in a 2016 news article, “We would consider changing the way we process HCV air gun claims if available science indicated that there was some likelihood that contaminated air guns actually transmitted HCV.”

Currently VA acknowledges the nexus between Hepatitis C and jet injectors as “biologically plausible,” but refuses to comment any further on the issue. VA’s current stance on jet injectors does not preclude a veteran from obtaining service-connection but it does not guarantee it either. Decisions within the Veterans Benefits Administration have been inconsistent on jet injectors. Inconsistent Renderings in VA: Comparing Granted vs. Denied Jet Injector Claims

Yet the VA has recognized non-military exposures, such as intranasal cocaine use, tattooing and body piercing as risk factors for Hepatitis C despite the lack of scientific proof. From 2005 to the present, VA has even acknowledged the lack of scientific data for these exposures upon their website  (https://www.hepatitis.va.gov/provider/reviews/transmission.asp).

Jet Infectors - VA Hepatitis C Virus Transmission

“There are no conclusive data to show that persons with a history of exposures such as intranasal cocaine use, tattooing or body piercing are at an increased risk for HCV infection based on these exposures solely. It is believed, however, that these are potential modes of HCV acquisition in the absence of adequate sterilization techniques.”

Despite the lack of “conclusive data,” these exposures are listed as recognized risk factors upon VA’s website (https://www.hepatitis.va.gov/provider/reviews/screening.asp).

Jet Infectors - VA Hepatitis C Screening

VA has long held a double standard by recognizing non-military exposures as risk factors for Hepatitis C despite the lack of scientific proof. Yet jet injectors, which were widely used within the military, will not be recognized officially as a risk factor until scientific evidence emerges.

This is a double standard that benefits the Department of Veterans Affairs and not the people it was created to serve—veterans.

However, despite VA’s enigmatic stance, several things remain certain:

  • VA has unofficially acknowledged the nexus within its memorandum and by the mere granting of service-connection in a substantial number of cases.  Military Jet Gun Injections Transmitted Hepatitis: an assessment of VA claims
  • The evidence citing an association between Hepatitis C and jet injectors has emerged, it is now a question of whether or not the VA will acknowledge the evidence.

Footnote:
The above VA links have been archived and can be accessed here:

https://web.archive.org/web/20171015144741/https://www.hepatitis.va.gov/provider/reviews/transmission.asp
https://web.archive.org/web/20171015145220/https://www.hepatitis.va.gov/provider/reviews/screening.asp

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PCNFIs Fail to Prevent Contamination

Protector cap needle free injectors (PCNFI) were intended to be the safer mode of jet injection. The idea of placing a protective barrier between the patient’s skin and reusable nozzle allowed for the safety regulators sought and the expediency consumers wanted. As the timeline will show the concept of PCNFIs, although innovative, failed safety-testing and was abandoned as a means of administering immunizations.

Currently, several PCNFI devices are used as medical instruments. These devices are being used consecutively upon a single patient to administer anesthesia and medicine. As long as these devices are adequately sterilized through autoclaving before being used on a subsequent patient they pose no threat in the transmission of pathogens.

Am-O-Jet______________________________________________________________________________
1995
Robert Harrington, the former President and CEO of Vernitron Medical Products which previously owned Ped-O-Jet, creates the American Jet Injector company. He uses an identical design of the Ped-O-Jet to create the Am-O-Jet injector (FDA, 1999), which came in an electric model and a non-electric foot-pedal model.

1996 July
Am-O-Jet receives FDA 510(k) premarket approval on July 26th of 1996 (FDA, 1996).

1996 October
Harrington attends the CDC/WHO conference on jet injector safety and introduces his Am-O-Jet injector as a viable option for mass jet injection (Fields, 1996).

1997 May
Harrington attends the WHO/CDC conference on jet injector safety and announces plans to conduct safety-trials utilizing his Am-O-Jet injector. In the plan for one such trial, the Am-O-Jet would be used upon 1,000 Brazilian military recruits. After each injection the ejectate of the subsequent “shot” would be sent to United Kingdom’s Public Health Laboratory Service for testing (WHO, 1997). However, this field trial never used the Am-O-Jet or a protector cap. The study used Ped-O-Jet injectors owned by Brazil’s Ministry of Health. Moreover, the study used civilian volunteers infected with Hepatitis B and Hepatitis C and not military recruits.

1997 November
Keystone Industries conducts a product recall on the Ped-O-Jet over liability concerns that the device could transmit blood-borne pathogens. Article – Ped-O-Jet Withdrawal Letter to DoD Over Risk of Disease Transmission

1999
Harrington speaks at a FDA panel discussion on jet injector safety. “What is the future of Am-O-Jet’s high workload injectors? We believe in a traditional reusable nozzle, reusable work path. We’re continuing the production of that model,” said Harrington, who refuses to believe any safety risk exists with Ped-O-Jet / Am-O-Jet injectors (FDA, 1999). Moreover, Harrington outright lies, stating the device was used correctly within the U.S. military for 35-years and no evidence exists to the contrary. Article – Improper Military Jet Injections

2000
Am-O-Jet undergoes a Small Business Innovative Research Phase I project in conjunction with Dr. Bruce Weniger of the CDC, and Dr. James Sweat from the University of Florida. This safety-test replicated and expanded upon a previous safety study on jet injectors. Five different experiments were conducted in this series, including use of a plastic disposable nozzle. Within this study a saline solution was injected into a pig with the Am-O-Jet. The subsequent “shot” was fired into a vial and the ejectate was assessed for contamination using an ELISA (i.e., a highly sensitive test to detect albumin). Results of the study were not adequately reported although backsplash and contamination were observed (Sweat et al., 2000).

“We have detected contamination well above current levels that we would consider indeterminate or uninterpretable,” said Dr. Weniger (FDA, 1999). In other words, the researchers found rates of contamination were significant.

The results of Sweat and colleagues study were not fully published. Presumably Mr. Harrington did not wish to reveal results which would implicate his jet injector. Following this study, development of the Am-O-Jet was abandoned.

FELTON INTERNATIONAL___________________________________________________________
1998
Felton International, a jet injector developer and manufacturer, bought the rights to 17 Russian jet injectors from the Chemical Automatics Design Bureau of Voroenzh, Russia and MedEquipment. The BI-100 jet injectors utilize a protector cap between patients (Leon & Loskutov, 2005; Weniger, 2013).

2002 September
Felton Int. conducts three field evaluations for a prototype protector cap needle-free injector in Senegal. The device, which was shaped like a gun, was found to be bulky and hard to handle. In conjunction with PATH, the device’s grip was redeveloped into a “torch” grip design (Zehrung, 2003).

2003
Felton Int. receives an award from the U.S. Army for $119,570.00 to conduct a Phase I study on the development of a needle-free jet injection system. “The Phase I effort comprises detailed pharmacokinetic studies and preliminary and detailed device design. The fabrication of a size appropriate injector for test rodents will also be undertaken in Phase I.” (SBIR, 2003a).

Felton Int. receives a second award from the U.S. Army for $688,615.00 to conduct a Phase II study of their prototype jet injector.

The second phase of this project will consist of the following three tasks: 1) Develop and quantify a prototype needle-free injector. This task includes product, environmental and human safety testing. A protector cap will be used to prevent pathogen transfer between patients; 2) Conduct trials on non-human primates to determine the percent of enzyme delivered, the peak level of enzyme activity and the duration of the enzyme at that level; 3) Determine the efficacy of this enzyme as a bioscavenger by exposing injected rodents to OP or pesticides; and 4) Deliver a prototype injector to the Army for chemical warfare studies (SBIR, 2003b).

Felton goes on to state their overall goal:

The overall goal of this project is to provide the Army with a system to allow rapid injection of the enzyme into soldiers in the event of a chemical attack on the battlefield. In order to achieve this goal, the usability, safety and efficacy of the device will be proven. For the military, this device would allow rapid injection of troops prior to a potential chemical exposure. In this situation, troops should be injected 12 hours prior to possible exposure and re-injected weekly as long as the threat continues(SBIR, 2003b).

2003 November
Felton Int. presented a prototype protector-cap needle-free injector at the Joint Service Scientific Conference on Chemical & Biological Defense Research.

2004
PATH conducts an in vitro fluorescein test upon the HSI-500. Use of fluorescein dye made any contamination visible. Results of this test showed contamination upon the protector-cap but no contamination within the ejectate (FDA, 2005).

2004 August – October
Felton Int., in conjunction with PATH, conducted a pilot study at Huntington Medical Research Institute Liver Center in Los Angeles, California. The study assessed the safety of the prototype HSI-500, a protector-cap needle-free injector, upon 5-15 civilian volunteers who had a high titer of Hepatitis B. The aim of the study was to detect HBV within the ejectate following an injection into a HBV-carrier and to assess injection site bleeding (Zehrung, 2004). Results of the pilot study found no contamination, and led to the approval and development of a larger scale study in 2006 (Kelly et al., 2008).

2005 October
Felton Int. presented a prototype protector-cap needle-free injector to the Department of Defense Research. The presentation, titled Reintroducing High Workload Needle Free Jet Injectors to the US Military Medical Community, displayed the HSI-500 PCNFI device (Leon & Loskutov, 2005). The device was also known as the JIMI which was an acronym meaning Jet Injector for Mass Immunization.

2006 July – October
Felton Int. and PATH conducted a large-scale study upon the safety of the HSI-500. The study was conducted in Beijing, China among HBV-positive adults. Despite the cap’s design to prevent cross-contamination, “the study ended early because the PCNFI failed to prevent contamination in the first batch tested (8.2% failure rate). The injections were very well tolerated, with most followed by no bleeding (81.2%) or mild bleeding (7.8%).” Data collected also found moderate bleeding (0.5%).

Most shockingly, the published data demonstrates but the researchers failed to discuss, that cross-contamination of HBV occurred without any visible bleeding at the injection site. In 7 out of the 17 injections that tested positive for cross-contamination researchers observed no visible bleeding at the injection site (see Table 1 within the study). This indicates that cross-contamination of blood-borne viruses successfully occurred within microscopic levels of blood not visible to the human eye (Kelly et al., 2008).

Following this study any development and testing upon the HSI-500 (JIMI) was abandoned. PCNFIs were deemed unsafe for administering immunizations upon consecutive patients.

Since Felton International (now Pulse Needle-Free Systems) received funding from the U.S. Army, I reached out to the company to further clarify if at anytime was the HSI-500 or any other of their devices utilized upon any military personnel. Ed Stevens, the company’s President stated, “No, that study never involved military personnel.  (It was not a human study.) Felton/Pulse devices were never used on U.S. military personnel, and now our products are only used on animals.”

Conclusion____________________________________________________________________________
Two publicized PCNFIs both failed to prevent contamination. The Am-O-Jet, a Ped-O-Jet that allowed a protector cap to cover the nozzle, failed to prevent cross-contamination in a laboratory trial on pigs (Sweat et al., 2000). Another PCNFI, the JIMI injector also known as the HSI-500, showed promising results in a pilot study at Huntington Medical Center, although later failed to prevent cross-contamination of hepatitis B in a field trial in China (Kelly et al., 2008). Further development of PCNFI devices for administering immunizations were abandoned and the industry focused on development of disposable-cartridge jet injectors for administering immunizations.

References:

  • (FDA, 1996) Food & Drug Administration. 510(k) Premarket Notification: American Jet Injector Corp. – K962017. Accessible at: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K926017.
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (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.
  • (Leon & Loskutov, 2005) Leon NJ & Loskutov AY. Reintroducing High Workload Needle Free Jet Injectors to the U.S. Military Medical Community. Presentation to Department of Defense Research. 1 October 2005.
  • (SBIR, 2003a) Small Business Innovation Research. Felton International: Developing Human-Compatible Needleless Delivery Systems for Administering Bioscavengers – Phase I. 2003. Accessible at: https://www.sbir.gov/sbirsearch/detail/165599.
  • (SBIR, 2003b) Small Business Innovation Research. Felton International: Developing Human-Compatible Needleless Delivery Systems for Administering Bioscavengers – Phase II. 2003. Accessible at: https://www.sbir.gov/sbirsearch/detail/165601.
  • (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, 2013) Weniger BG. Jet Injection Bibliography. 11 July 2013.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]
  • (Zehrung, 2003) Zehrung D. PATH’s Experience from Jet Injector R&D and Field Assessment in Developing Countries. Presentation for Innovative Administration Systems for Vaccines. Rockville, Maryland. 18 December 2003.
  • (Zehrung, 2004) Zehrung D. Jet Inject for Mass Immunization: Design Update and Safety Testing Strategy. Presentation for Global Vaccine Research Forum. 10 June 2004.

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Impact of CDC’s 1993-94 Unpublished Study – Part II

Following Grabowsky and colleagues evaluation of the Ped-O-Jet, officials within the CDC initiated meetings to discuss the risks of multi-use nozzle jet injectors (MUNJI).

1995 CDC / WHO Meeting – Review the Safety of Jet Injectors
In November of 1995, the CDC and World Health Organization (WHO) gathered for a meeting in London titled, Review the Safety of Jet Injectors. Those present were CDC and WHO experts on device safety, vaccine safety, and laboratory testing. Amongst the attendees were Dr. Robert Chen of the CDC, John Lloyd of the WHO, Dr. Peter Hoffman from the United Kingdom’s Public Health Laboratory Service, and a representative from PATH (Fields, 1996). Dr. Chen had previously been involved in CDC’s safety testing of the Med-E-Jet and Ped-O-Jet (Chen).

The goal of this meeting was to rewrite the safety standards for all jet injector devices. CDC and WHO both agreed, the “risk of cross infection must be zero” (PATH, 1996). The CDC explained this “zero tolerance” level means “no contamination should be detectable on any reusable surface of the deice that comes into direct or indirect contact with the patient’s skin” (Fields, 1996). Both agencies agreed for these devices to be attractive to consumers, they should remain “competitive with [the] current price of autodestruct syringes.” Moreover, both agencies recommended that jet injectors should be regulated and undergo testing to ensure safety performance (PATH, 1996).

WHO announced that Dr. Peter Hoffman of the UK’s Public Health Laboratory Service would be overseeing “the design and implementation of a new laboratory safety test to evaluate all injectors against this new standard” of zero tolerance (Fields, 1996).

1996 CDC & WHO Conference – Jet Injectors for Immunization, Current Practice and Safety, Improving Designs for the Future
In October of 1996, members of CDC’s National Immunization Program along with the WHO extended the discussion on jet injectors to include various health agencies, manufacturers, and consumers. The goal of this meeting was for all involved parties to discuss the safety of existing jet injectors and to develop more stringent specifications for the development of a new generation of jet injectors. Amongst the attendees of the meeting were CDC researchers Dr. Robert Chen and Walter Bond, as well as Dr. Glaucus de Souza Brito from the Brazilian Ministry of Health, former Ped-O-Jet CEO Robert Harrington and the current owners of Ped-O-Jet, Keystone Industries.

Walter Bond, who was a part of all three of CDC’s jet injector studies, served as an expert panelist on jet injector safety. “Existing jet injectors, such as Ped-O-Jet,” stated Bond, “are not particularly easy to contaminate, but once they are contaminated, they can indeed transmit disease” (Fields, 1996).

Also during the meeting, the committee identified the need for additional safety testing. “Examining ejectates from Ped-O-Jet vaccinations given to new military recruits in the U.S.…would represent best-use circumstances for the jet injector,” concluded the committee (Fields, 1996). However, in the following year Keystone Industries informed the Department of Defense (DoD) of its intent to withdraw and stop manufacturing the Ped-O-Jet over risk of cross-contamination. Consequently, in December of 1997 DoD stopped using all MUNJI devices, including the Ped-O-Jet. The study, which intended to examine the ejectates of Ped-O-Jet vaccinations from military recruits, was never conducted.

The 1996 joint CDC/WHO meeting also identified several countries had allowed jet injector devices to be grandfathered-in and thus bypass safety regulations.

During the Atlanta meeting in October 1996 it became clear that jet injectors in the United States, U.K., France and Italy had been ‘grandfathered in’ without national regulatory controls. The reason for this appeared to be the long history of use of jet injectors without recorded mishap.

The Food and Drug Administration of the United States informed the Atlanta meeting that they intend to review the status of jet injection devices with a view to develop such regulation in the near future (WHO, 1997).

The CDC/WHO conference led to further discussions about jet injector safety within CDC and WHO, initiated discussions within the FDA, and would later prompt the manufacturer of Ped-O-Jet to withdraw it’s product from the Department of Defense.

These subsequent discussions have been outlined within the following articles:

References:

  • (Chen) Chen, Robert. Curriculum Vitae. Accessed January of 2015.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (PATH, 1996) PATH. Low-workload Jet Injectors For Vaccine Delivery: 1987-1996. Program for Appropriate Technology in Health. 18 September 1996. pp. 1-5.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]

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CDC Evaluates the Risk of Multi-Use Nozzle Jet Injectors

Following the 1996 CDC/WHO conference, CDC continued to evaluate and engage in discussions on the risks of multi-use nozzle jet injectors (MUNJI). The timeline below shows the reports, conferences, and one collaborative study in which CDC investigated MUNJI devices. The timeline also shows a shift in CDC’s stance on jet injectors, from viewing MUNJI devices being permissible in dire situations to MUNJI’s being inherently unsafe and discouraging their use altogether.

1999 CDC Reports MUNJIs Pose Medium Risk in a JAMA article
In a 1999 Journal of the American Medical Association article by Rebecca Voelker is the revelation that the CDC viewed jet injectors with a reusable nozzle that was not swabbed between patients as a medium risk for cross-contamination (Voelker, 1999).
Therefore, even before the publishing of subsequent research on jet injector safety which demonstrated it did not matter if the nozzle was swabbed or unswabbed (i.e., Hoffman et al., 2001; Hoffman et al., unpublished; Sweat et al., 2000), the CDC viewed MUNJIs as a medium risk.

1999 Voelker - Eradication Efforts Need Needle-Free Delivery- CDC Diagram- Reusable nozzle is a medium risk

(Voelker, 1999)

2000 Am-O-Jet Fails Safety Test
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 had an identical design to the Ped-O-Jet. This study tested the potential for cross-contamination via the Am-O-Jet amongst calves and pigs. The design of the study replicated previous in vivo jet injector studies (Sweat et al., 2000). Dr. Bruce Weniger of the CDC and coauthor of the study stated, “We have detected contamination well above currently [sic] levels that we would consider indeterminate or uninterpretable” (FDA, 1999). In other words, the researchers found the rates of contamination were significant.

2002 (Feb. 8) CDC Report – General Recommendations on Immunization
CDC urged the use of MUNJI devices to be limited only in dire situations and when other, safer methods are not viable. The report stated,

Efforts are under way for the research and development of new high-workload JIs using disposable-cartridge technology that avoids reuse of any unsterilized components having contact with the medication fluid pathway or patient’s blood…the use of existing multiple-use-nozzle JIs should be limited . . . [and] considered when the theoretical risk for bloodborne disease transmission is outweighed by the benefits of rapid vaccination with limited manpower in responding to serious disease threats (e.g., pandemic influenza or bioterrorism event), and by any competing risks of iatrogenic or occupational infections resulting from conventional needles and syringes… (CDC, 2002).

CDC’s shift to dire use only was a minuscule step forward from the agency’s warning eight-years prior, which noted if jet injectors became contaminated there is a risk for disease transmission (CDC, 1994).

2002 (Sept 16) CDC & WHO Meeting – Consultation on MUNJI Safety Evaluation
CDC and WHO hosted a meeting at CDC Headquarters in Atlanta to discuss the safety of MUNJI devices. Amongst the invited attendees were WHO, CDC, FDA, USAID, PATH, International Vaccine Institute, and members of academia. During this time, the CDC endorsed the use of MUNJI devices in dire situations until disposable-cartridge jet injectors became standardized (Weniger, 2005).

2004 (March 30) WHO & CDC Meeting – Consultation on MUNJI Safety Evaluation
WHO and CDC hosted a subsequent meeting on jet injector safety at WHO Headquarters in Geneva, Switzerland. The goal of this meeting was to establish criteria for a new generation of jet injector devices. The attendees attempted to answer several important questions relating to the matter of cross-contamination. Questions such as: “How infectious is blood? How do we measure it? How do you model the risk? What level of risk is acceptable?” (FDA, 2005).

The attendees were in agreement that a fraction of a picoliter can transmit infection. This conclusion was far different from the previous, widely-accepted yet unofficial belief that Hepatitis B is transmissible in 10 picoliters of blood or greater (FDA, 2005).

The attendees deemed it was inappropriate to make health officials decide what was an “acceptable” level of risk from using MUNJIs (Weniger, 2005). The objective of the health industry is not to contemplate risk but to sustain life and improve health.

The attendees questioned the relevance of prior animal models and recommended all future jet injector safety trials use human HBsAg carriers and the most sensitive PCR assays for detecting contamination within ejectates (Weniger, Jones & Chen). The use of Hepatitis B surface antigen (HBsAg) was not purely to assess if Hepatitis B is transmissible via jet injection but to use HBsAg, a highly infectious pathogen, as a threshold in evaluating safety. The idea being if a highly infectious pathogen is transmissible than that model of jet injector is unsafe.

Most importantly, during this meeting the CDC finally decided to abandon its attempt in developing safer MUNJI devices and discouraged the use of all MUNJI devices under any circumstance (Weniger, 2005).

2004 (May 25-26) Seventh Annual Conference on Vaccine Research
Dr. Bruce Weniger, of CDC, summarized the downfall of MUNJI devices within his poster presentation at the Seventh Annual Conference on Vaccine Research. Dr. Weniger wrote, “The U.S. military withdrew them [MUNJIs] in 1997, and WHO and CDC now caution against their use” (Weniger, 2004).

2004 (June 8-10) WHO Conference – Fifth Global Vaccine Research Forum
At WHO’s Proceedings of the Fifth Global Vaccine Research Forum, Dr. Weniger again stated the risks and hazards of multi-use nozzle jet injectors. “Subsequent bench studies of it [Med-E-Jet] and the more common Ped-O-Jet indicated that their nozzles could become contaminated with hepatitis B virus and pose a risk for transmission between consecutive vaccines” (WHO, 2005).

2005 MUNJIs Are “Inherently Unsafe”
Dr. Bruce Weniger, of the CDC, believed MUNJIs were inherently unsafe.

MUNJIs are inherently unsafe. Their re-use without intervening sterilization of fluid pathways which may be exposed to patient blood or tissue fluid violates established principles that apply to other critical medical devices.

One cannot rely of the absence of documented cases of disease transmission beyond the California outbreak.

It is unlikely that routine post-marketing surveillance would link sporadic cases to prior MUNJI use (Weniger, 2005).

2006 (Dec. 1) CDC Report – General Recommendations on Immunization
CDC reported disposable-cartridge jet injectors overcame the risks of cross-contamination posed by MUNJIs. “In the 1990s, a new generation of JIs was introduced with disposable cartridges serving as dose chambers and nozzle. With the provision of a new sterile cartridge for each patient and correct use, these devices avoid the safety concerns for multiple-use-nozzle devices” (CDC, 2006a).

2006 CDC Report – Needle-free Intradermal Influenza Study
CDC stated MUNJIs are “inherently unsafe.”

Safety concerns arose over multi-use-nozzle jet injectors (MUNJIs)…which use the same nozzle to inject consecutive patients without intervening sterilization. A hepatitis B outbreak in the mid 1980s caused by one MUNJI as well as other published and unpublished studies of this and other devices, indicated blood and tissue fluid containing pathogenic agents could be transmitted among patients. This led to discontinuation and recommendations against their use in public health, and market removal in 1997 of the most common device, the Ped-O-Jet®.

Since the 1990s, a new generation of safer disposable-cartridge jet injectors (DCJIs) have appeared. DCJIs avoid the inherently unsafe design of MUNJIs, since the disposable cartridge has its own sterile orifice and nozzle and is discarded between patients (CDC, 2006b).

2011 (Jan. 28) CDC Report – General Recommendations on Immunization
CDC reiterates the risks and hazards of jet injectors.

Jet injectors that use the same nozzle for consecutive injections without intervening sterilization were used in mass vaccination campaigns from the 1950s through the 1990s; however, these were found to be unsafe because of the possibility of bloodborne pathogen transmission and should not be used (CDC, 2011).

1999 – 2006 CDC’s Needle-Free Injection Technology Webpage
From 1999 to 2006, the CDC had an entire webpage devoted to needle-free injection technology. Although the site, http://www.cdc.gov/nip/dev/jetinject.htm, has since been long taken down. The webpage once provided links to reports from international and government health agencies containing information about the risks and hazards of jet injectors and links to Department of Defense websites that detailed the withdrawal of the devices by one manufacturer and the discontinuation of their use by the military. Fortunately through web.archive.org this webpage along with a substantial number of its reports were archived. CDC’s jet injector webpage can be accessed here.

Conclusion
CDC discouraged the use of multi-use nozzle jet injectors only after a protracted investigation and numerous meetings. CDC first investigated the safety of jet injectors in 1977, and actively investigated MUNJI devices from 1993 to 2004. Their ultimate decision, to discourage MUNJI use under any circumstance, was long overdue considering their partners at the WHO discouraged the use of MUNJIs six-years earlier.

It is important to note that although up until 2004 the CDC endorsed the use of MUNJIs in dire emergencies, the devices had not actually been used in a mass vaccination campaign within the United States. MUNJIs were last used in public in 1997 during a meningitis outbreak at Michigan State University (Paneth et al., 2000) and within the U.S. military on December 9th of 1997 (DoD, 1997). Whereas the WHO was quick to abandon MUNJI technology, the CDC wished to keep the devices as a contingency plan. It is my opinion that the agency’s reluctance to abandon the technology was ill-considered as it delayed the inevitable and prevented any seroepidemiological studies on prior MUNJI use.

Unequivocally, CDC’s jet injector studies demonstrated MUNJIs pose a risk in transferring blood-borne pathogens between patients. Since 2004, CDC has viewed MUNJIs as “inherently unsafe,” and has repeatedly discouraged their use.

Yet to date, CDC Headquarters in Atlanta has never listed multi-use nozzle jet injectors as a risk factor in transmitting blood-borne pathogens, even despite the high prevalence of Hepatitis C amongst those who had the greatest exposure to mass jet injector inoculations—Vietnam era veterans.

References:

  • (CDC, 1994) Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 43:(RR-1):7–8, 1994.
  • (CDC, 2002) Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP) and the American Academy of Family Physicians (AAFP). Morb Mortal Wkly Rep February 8, 2002;51 (No. RR-2): 1-35.
  • (CDC, 2006a) Center for Disease Control and Prevention. Recommendations of the advisory committee on immunization practices-(ACIP). Morb Mortal Wkly Rep. 55:(RR-15), 2006.
  • (CDC, 2006b) Centers for Disease Control and Prevention. Needle-free Intradermal Influenza Study. CDC-ISO-4785. 5 March 2006.
  • (CDC, 2011) Centers for Disease Control and Prevention. Recommendations of the Advisory Committee on Immunization Practices-ACIP. Morb Mort Wkly Rep. Vol. 60. No. 2. 28 Jan. 2011.
  • (DoD, 1997) Memorandum: Jet Hypodermic Injection Units. Philadelphia: Defense Logistics Agency. 9 December 1997.
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.
  • (Hoffman 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).
  • (Paneth et al., 2000) Paneth N, Kort EJ, Jurczak D, Havlichek DA Jr, Braunlich K, Moorer G, Vanderjagt D, Sienko D, Leiby P, Gibbons C. Predictors of vaccination rates during a mass meningococcal vaccination program on a college campus. J Am Coll Health. 2000 Jul;49(1):7-11.
  • (Sweat et al., 2000) Sweat JM, Abdy M, Weniger BG, Harrington R, Coyle B, Abuknesha RA, Gibbs EP. Safety testing of needle free, jet injection devices to detect contamination with blood and other tissue fluids. Ann NY Acad Sci 2000;916(31):681-682.
  • (Voelker, 1999) Voelker R. Eradication Efforts Need Needle-Free Delivery. JAMA May 26, 1999;281(20):1879-1881.
  • (Weniger, 2004) Weniger BG. Trends, challenges and opportunities for jet injection technology (presentation). National Foundation for Infectious Diseases. Seventh Annual Conference on Vaccine Research. 25-26 May 2004. Arlington Virginia.
  • (Weniger, 2005) Weniger B. Safety of Multi-use-nozzle Jet Injectors (MUNJIs) for Bloodborne Pathogen Cross-contamination (draft). Conference Notes. 7 August 2005.
  • (Weniger, Jones & Chen) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods.
  • (WHO, 2005) WHO. Proceedings of the Fifth Global Vaccine Research Forum. WHO/IVB/05.09. 2005.

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WHO Assesses the Safety of Jet Injectors

Following the 1996 CDC/WHO conference, the WHO actively engaged in meetings and conducted further evaluations on the safety of multi-use nozzle jet injectors (MUNJI). During this time, WHO continued to discourage the use of MUNJI’s under any circumstance. The timeline below shows the reports, conferences, and studies in which the WHO investigated MUNJI devices.

1986 WHO Report – Selection of Injection Equipment for the Expanded Program on Immunization
In October of 1986, the World Health Organization (WHO) changed its policy on the use of jet injectors. The policy change was the direct result of a hepatitis outbreak due to the use of a MUNJI device. WHO’s highly publicized statement said,

Until further studies clarify the risks of disease transmission associated with jet injectors, general caution in their use is recommended (WHO, 1986).

Their use should be restricted to special circumstances where the use of needles and syringes is not feasible because of the large numbers of persons to be immunized within a short period of time (WHO/UNICEF, 1987).

1995 WHO Requests the Help of Dr. Peter Hoffman
In 1995, the World Health Organization requested the help of Dr. Peter Hoffman of United Kingdom’s Public Health Laboratory Service. Dr. Hoffman was brought on to create a model to detect whether low, but infectious, volumes of blood were being transferred via various jet injectors (Fields, 1996). In a personal interview with this author in 2013, Hoffman stated,

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

This would mark WHO’s first investigation into the safety of multi-use nozzle jet injectors.

1995 CDC & WHO Meeting – Review the Safety of Jet Injectors
CDC met with WHO in London in 1995 to rewrite the safety standards for all jet injectors. Also present for the meeting were Dr. Hoffman and a representative from PATH. CDC and WHO both agreed the safety standard for jet injectors should be raised to a “zero tolerance” level (Fields, 1996). This meeting subsequently led to a CDC/WHO conference on jet injector safety in 1996.

1996 CDC & WHO Conference – Jet Injectors for Immunization, Current Practice and Safety, Improving Designs for the Future
CDC and WHO invited various health agencies, manufacturers, and consumers to discuss the safety of jet injectors. The goal of this meeting was for all involved parties to discuss ways in achieving a zero-risk jet injector.

During the conference Dr. Hoffman gave a presentation titled, Animal-model Assessment of Jet Injector Safety, in which he described a laboratory investigation for testing cross-contamination from jet injectors (Fields, 1996).

1996 WHO Discourages Use of Jet Injectors
WHO unofficially reversed its 1994 policy and advised against the use of jet injectors under any circumstances. The change in policy resulted from fears of spreading blood-borne pathogens, such as Hepatitis B, Hepatitis C, and HIV with Ped-O-Jet injectors during a massive meningitis outbreak in Nigeria in 1996 (Mohammed et al., 2000). However, this policy change was not widely publicized until 1998 (Fields, 1996). Article – Nigeria Forced to Use Ped-O-Jet Injectors in 1996 Despite Fears of Spreading Hepatitis and AIDS

1997 Hoffman’s Initial Investigation of Med-E-Jet
Hoffman’s initial laboratory investigation in 1997 tested the volume of contamination after a Med-E-Jet injector administered an injection into calves. Working with Dr. Hoffman and the WHO was Dr. RA Abuknesha from King’s College, London. Dr. Abuknesha developed an enzyme-linked immunosorbent assay (ELISA) to detect Human Serum Albumin, which was used as a marker to detect blood within the ejectates from the jet injectors (FDA, 1999; Friede, 2003). Results from this investigation showed systemic contamination of the ejectate (WHO, 1997). At the time, Hoffman and WHO concluded,

the path of contamination may have been reflux within the jet stream. This could possibly have occurred at the end of the shot when the liquid pressure at the nozzle of the injector dies to a level lower than that of the liquid column within the skin and subcutaneous tissue of the animal…The implication of these results is that, for jet injection to be safe, the entire fluid path must be changed between injections (WHO, 1997).

While it is true that the enzyme-linked immunosorbent assay (ELISA) is used to detect Human Serum Albumin (HSA) and HSA is found within blood, saliva, and skin cells, it is also true that the researchers took extensive precautionary measures to avoid any false positives within the data.

1997 WHO & CDC Conference – Steering Group on the Development of Jet Injection For Immunization
Hoffman’s initial findings of the Med-E-Jet were presented at the conference. Members were also informed that contamination was believed to be due from an undesirable phenomenon called retrodgrade flow. The consensus at the conference was other jet injectors, such as the Ped-O-Jet, should be evaluated to see if they succumb to retrograde flow as well. Further laboratory and field trials were planned. Also, members agreed in pursuing development of zero-risk devices, such as disposable-cartridge jet injectors (WHO, 1997).

1998 (March 25) WHO Conference – Technet Consultation
At a conference in Copenhagen, WHO presented preliminary findings of it’s laboratory investigation by Hoffman and colleagues. “The results so far obtained with three injector models show that there is an unacceptable level of downstream contamination, irrespective of whether the nozzle is discarded after each injection” (WHO, 1998a). Preliminary analysis of the Ped-O-Jet found 29 percent of the samples (29 out of 100) contained more than 10 picoliters of blood. The Medivax, protector cap needle-free injector, found a 31 percent contamination rate (11 out of 35 samples). The Med-E-Jet found a 72.7 percent contamination rate (16 out of 22 samples). The researchers further speculated contamination was the result of retrograde flow which “probably [occurs] at the end of the injection when the internal pressure of the injector drops” (WHO, 1998a).

Based upon these findings WHO stated,

Multidose, needle-free injectors with a reusable fluid path should only be used for immunization if they pass standard WHO safety tests. On this basis the latest evidence suggests that none of the models that have been tested [i.e., Ped-O-Jet, Med-E-Jet & Medivax] in the laboratory can be used for immunization” (WHO, 1998a).

This is worth repeating. The most widely used jet injector in the world, the Ped-O-Jet, did not pass WHO’s safety test and therefore cannot be used for administering immunizations. This would also mean the Ped-O-Jet should never have been used.

During this conference WHO officially discouraged the use of jet injectors under any circumstance and recommended the use of needles and syringes. “Until safe needle-free injectors are identified through independent safety testing, only needles and syringes should be used for immunization” (WHO, 1998a).

1998 (October) WHO Report – Safety of Injections
For the first time, WHO publishes warnings against the use of multi-use nozzle jet injectors. “Needle-free injectors designed for use with multi-dose vials and with a multiple-use fluid path should not be used for immunization. These injectors have an inherent risk of bloodborne disease transmission,” stated the report (emphasis added) (WHO, 1998b).

1998 (October) Ped-O-Jet Field Trial in Brazil
In October of 1998, WHO conducted a simulated field trial with Ped-O-Jet injectors to assess the degree of blood transmission via multi-use nozzle jet injectors. The investigation was a collaborative effort between WHO, the Brazilian Ministry of Health and Dr. Hoffman. The field trial administered saline injections to patients infected with Hepatitis B and Hepatitis C in the Brazilian cities of São Paulo and Belém (Hoffman et al., 2000). The researchers replicated de Souza Brito’s 1992 study but used a new ELISA method for detecting the presence of occult blood (Hoffman et al., unpublished).

In the first test, volunteers received a saline injection with a Ped-O-Jet injector, immediately followed by three subsequent shots into three test tubes. Covering the top of each test tube was a plastic film which was “used to replicate the effect of skin as a barrier to contamination transfer.” The ejectates within these three test tubes were assayed. These subsequent shots represented what the following three persons standing in the vaccination line would have received. The researchers were assessing if blood would be cross-contaminated to subsequent vaccinees when the nozzle of the jet injector was not swabbed (Hoffman et al., unpublished; Hoffman et al., 2000).

Positive samples were defined as any ejectate containing 10 picoliters of blood or more. Results for the first test, when the nozzle was not swabbed, found 13 out of 117 (11.1%) of the samples collected after the first inoculation had greater than 10 picoliters of blood. Results of the second “shot” found 4 out of 117 (3.4%) of the samples were positive and the third “shot” found no contamination (Hoffman et al., unpublished; Hoffman et al., 2000).

In the second test, immediately following an injection the nozzle of the Ped-O-Jet was swabbed with a piece of cotton soaked in ethyl alcohol. Three subsequent shots were fired into three test tubes and the ejectates were assayed.

Results of the second test, when the nozzle was swabbed, found 9 out of 117 (7.7%) of the samples collected after the first inoculation had greater than 10 picoliters of blood. Results of the second “shot” found 3 out of 117 (2.7%) of the samples were positive and the third “shot” found no contamination (Hoffman et al., unpublished; Hoffman et al., 2000).

These results signify several findings: 1) 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. This undesirable phenomenon is known as retrograde flow. The researchers stated, “This trial has confirmed previous laboratory modeling carried out by the same investigating team in London, showing that significant blood contamination can be transferred by jet injectors” (Hoffman et al., unpublished).

2) Once the Ped-O-Jet became contaminated it remained contaminated up to the following two subsequent injections.

3) Cross-contamination occurred despite the presence of visible bleeding at the injection site. “Blood contamination did not seem to correlate with the rapidity or profundity of bleeding at the injection site, nor with individual injectors used,” said the researchers.

In 29 samples more than 10 picoliters of blood was cross-contaminated via the Ped-O-Jet. In 14 out of the 29 positive samples, there was no visible bleeding at the injection site. Out of these 14 instances where no visible bleeding was observed, 11 samples were first shots and 3 samples were second shots (Hoffman et al., unpublished). These findings indicate that despite the lack of any visible bleeding at the injection site the Ped-O-Jet became so grossly contaminated that transmission of a relevant volume of blood occurred into the subsequent two injections.

Dr. Martin Friede, from WHO’s Initiative for Vaccine Research, described the significance of Hoffman’s findings at a 2005 FDA panel discussion on jet injector safety. Dr. Friede stated,

The devices that we have seen without a protection cap, we have data from the calves and the data from the Hoffman study in Brazil to show that frequent contamination of the ejected did take place. And that contamination was clearly of a level of blood that we are convinced can carry disease. So the devices which do not have a protection cap which are to be used for giving intramuscular injection we are convinced that these carry a significant risk (emphasis added) (FDA, 2005).

The field trial took cautionary measures to avoid false positives from the use of Human Serum Albumin (HSA) as a marker for detecting blood, since HSA is also found within saliva and skin cells. “Throughout this work, great care was exercised to exclude extraneous contamination with human serum albumin (HSA),” said Hoffman. “Operators wore face masks and gloves whilst handling unsealed specimen vials and during sample collection.” Moreover, measures were in place for assessing any pre- and post-injection HSA contamination which would have altered the data (Hoffman et al., unpublished).

2001 Hoffman et al. Publish Findings on Jet Injector Safety
Hoffman and colleagues finally published the results of their laboratory investigation in 2001. Four different types of jet injectors were analyzed: Ped-O-Jet/Am-O-Jet, Medivax, Jet2000, and Med-E-Jet. The Am-O-Jet was an identical design to the Ped-O-Jet device (American Jet Injector; Weniger & Papania, 2008). Two of the jet injectors–Medivax and Jet2000–were prototypes.

“All injectors tested transmitted significant (over 10 pl) volumes of blood; the volumes and frequency of contamination varied with injector” (Hoffman et al., 2001). These findings were astonishing. If 10 picoliters is a sufficient amount of blood for transmitting blood-borne pathogens then this value (i.e., 10 pl) can be used as a threshold level in determining a contamination rate amongst the sampling of jet injectors. Results found the Ped-O-Jet had a 34.2 percent contamination rate. The Med-E-Jet had a 97.4 percent contamination rate. The two prototype injectors were also found to transmit relevant amounts of blood. The Medivax had a 95.8 percent contamination rate. The Jet2000, which had a single-use plastic protector cap that protected the reusable nozzle, had a 42.0 percent contamination rate.

In an extended sampling, the Med-E-Jet nozzle was wiped with alcohol between subsequent injections. Results found a lower contamination rate than in the initial series where the nozzle head was not wiped. In other words, there was still contamination even after the nozzle was swabbed. These results demonstrate when the nozzle is swabbed only superficial contamination is removed and sterilization of the internal fluid pathways is neglected.

The results also found a significant number of samplings consisted of greater than 50 picoliters of blood. The Ped-O-Jet had a 16.6 percent contamination rate at this higher threshold. The Med-E-Jet had a 85 percent contamination rate. The Medivax had a 85.4 percent contamination rate. The Jet2000 had a 20.1 percent contamination rate (Hoffman et al., 2001).

Hoffman’s laboratory investigations took cautionary measures so as to not let HSA alter the data of the ELISA. “Stringently applied protocols” were utilized which included the need for “an extremely clean environment.” Injection sites of calves were cleansed twice with methanol. Vaccinators rinsed their hands with ethanol before handling a jet injector and bulk reagents (Hoffman et al., 2001).

Another limitation of the ELISA method is the necessity for diluting a sample that has been frozen. Daya Ranamukha-arachchi, a molecular biologist at the Office of Science at the Center for Devices and Radiological Health within the FDA, stated, “Under cold storage conditions serum albumin can bind to collection tubes…so you have to go through a series of dilutions in order to get within the dynamic range of detection” (FDA, 2005). Through this method some of the quantity of contamination can be lost.

Dr. Hoffman estimated a 30 to 50 percent loss of blood within the samples of his study. “Freezing solutions with low concentrations of proteins causes loss of detectable protein, probably due to the absorption of surfaces. We estimate…losses of analyte of around 30 – 50 %, and so our results are underestimates of blood contamination” (Hoffman et al., 2001).

Hoffman and colleagues (2001) concluded cross-contamination occurred because the newly deposited jet stream in the skin had developed a pressure greater than the declining pressure in the jet injector causing a backwards flow. This backwards or rather retrograde flow of fluid—and now blood and bodily fluids—shoots back into the internal fluid pathway of the jet injector.

2004 (March 30) WHO & CDC Meeting – Consultation on MUNJI Safety Evaluation
WHO and CDC hosted a subsequent meeting on jet injector safety at WHO Headquarters in Geneva, Switzerland. The goal of this meeting was to establish criteria for a new generation of jet injector devices. Attendees of the meeting came to a consensus on several points: 1) A fraction of a picoliter can transmit infection, thus making the 10 picoliter threshold irrelevant (FDA, 2005). 2) No level of risk is acceptable with the use of MUNJIs. Therefore jet injectors need to show they pose zero-risk to vaccinees (Weniger, 2005). 3) Previous animal models are irrelevant in assessing the risk for humans (Weniger, 2005). Future jet injector safety trials should use human HBsAg carriers and use the most sensitive PCR assays for contamination within ejectates (Weniger, Jones & Chen). The PCR assay is a more sensitive assay than the ELISA, a difference of ~3 picoliters and ~13 picoliters, respectively.

2005 (Aug 9) FDA Hearing – MUNJI Safety
WHO partook in a panel discussion on jet injectors at the FDA. Dr. Martin Friede, of the WHO, gave an in depth discussion on the risks of jet injectors and stated WHO’s ultimate position on MUNJIs. “The determination of the safety of MUNJIs is the responsibility of national regulatory agencies. WHO will not determine the safety. This is the responsibility of the national regulatory agencies,” said Friede (FDA, 2005).

WHO was willing to investigate and report its findings on MUNJI devices and even openly discourage against their use. However, ultimately the WHO did not want to get involved within any national regulatory determination.

Conclusion
The WHO was always quick to restrict and warn against the use of multi-use nozzle jet injectors. The agency was actively involved in investigating MUNJIs for many years before respectfully bowing-out in 2005. It is my belief that a more prominent position by the WHO would have been to conduct epidemiological studies evaluating the risks of MUNJIs used in mass vaccination campaigns.

For an agency, such as the WHO, to publish numerous studies throughout the 1960s and 1970s on how MUNJIs were a better way for administering immunizations and to subsequently investigate the risks of cross-contamination by MUNJIs throughout the 1990s then it would be logical and moral for the WHO to investigate how many people became infected with a blood-borne pathogen after receiving immunizations with MUNJI devices.

References:

  • (American Jet Injector) American Jet Injector, Lansdale, PA; 19446-4520, USA; amojet@aol.com (the Am-O-Jet™ is an exact design of the out-of-patent Ped-O-Jet® device).
  • (FDA, 1999) Food and Drug Administration. General Hospital & Personal Use Devices panel: open session. Department of Health and Human Services Meeting. Rockville, MD. 2 August 1999.
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (Friede, 2003) Friede M. Safety Evaluation of Re-designed Multi-Use-Nozzle Jet Injectors (presentation). Innovative Administration Systems for Vaccines Conference, Rockville, Maryland. 18-19 December 2003.
  • (Hoffman et al., 2000) Hoffman PN, Abuknesha RA, Andrews NJ, Brito de Souza G, Carrasco P, Weckx LY, Moia LJMP, Silva AEB, Lloyd J. Avaliação de segurança em injetores à pressão para vacinação no Brasil. Centro de Vigilância Epidemiológica (CVE) Boletim Informativo. July 2000;15(57):3-5.
  • (Hoffman et al., 2001) Hoffman PN, Abuknesha RA, Andrews NJ, Samuel D, Lloyd JS. A model to assess the infection potential of jet injectors used in mass immunization. Vaccine 19 (2001): 4020-4027.
  • (Hoffman 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).
  • (Mohammed et al., 2000) Mohammed I, Abdussalam N, Alkali AS, Garbati MA, Ajayi-Obe EK, Audu KA, Usman A, Abdullahi S. A Severe Epidemic of Meningococcal Meningitis in Nigeria, 1996. Royal Society of Tropical Medicine and Hygiene, 2000 (94): 265-270.
  • (Weniger, 2005) Weniger B. Safety of Multi-use-nozzle Jet Injectors (MUNJIs) for Bloodborne Pathogen Cross-contamination [draft]. Conference Notes. 7 August 2005.
  • (Weniger, Jones & Chen) Weniger BC, Jones TS, & Chen RT. The Unintended Consequences of Vaccine Delivery Devices Used to Eradicate Smallpox: Lessons for Evaluating Future Vaccination Methods.
  • (Weniger & Papania, 2008) Weniger BG, Papania MJ. Alternative Vaccine Delivery Methods [Chapter 61]. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357-1392.
  • (WHO, 1986) WHO/EPI. WHO/UNICEF Joint Guidelines. Selection of Injection Equipment for the Expanded Programme on Immunization. 1986. WHO/UNICEF/EPI.T5/ 86.27597.
  • (WHO/UNICEF, 1987) WHO/UNICEF. Expanded Program on Immunization-Joint WHO/UNICEF Statement on Immunization and AIDS. 1987. pp 18-19.
  • (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]
  • (WHO, 1998a) World Health Organization. Technet Consultation. Expanded Programme on Immunization. Conference 16-20 March 1998. Copenhagen. WHO/EPI/LHIS/98.05.
  • (WHO, 1998b) World Health Organization. Safety of injections in immunization programmes: WHO recommended policy. Geneva: World Health Organization, Global Programme on Vaccines and Immunizations, document WHO/EPI/LHIS/96.05, Rev. 1, Oct 1998;1-11.

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Impact of CDC’s 1993-94 Unpublished Study – Part I

CDC’s third evaluation into multi-use nozzle jet injectors created a cataclysmic change within the agency. No longer were jet injectors viewed as risk-free. The benefits these devices previously provided within mass immunization campaigns were now being thwarted by a growing fear of transmitting infectious viruses.

As a direct result of the investigation by Grabowsky and colleagues, CDC immediately issued a new, heightened warning on the risks of using multi-use nozzle jet injectors. The warning within the MMWR General Recommendations on Immunization, dated the 28th of January 1994 preceded Grabowsky filing his unpublished draft with CDC in April of 1994. The CDC warning stated,

The multiple-use nozzle jet injector most widely used in the United States (Ped- O-Jet) has never been implicated in transmission of bloodborne diseases. However…laboratory studies in which blood contamination of jet injectors has been simulated have caused concern that the use of multiple-use nozzle jet injectors may pose a potential hazard of bloodborne-disease transmission to vaccine recipients. This potential risk for disease transmission would exist if the jet injector nozzle became contaminated with blood during an injection and was not properly cleaned and disinfected before subsequent injections. The potential risk of bloodborne-disease transmission would be greater when vaccinating persons at increased risk for bloodborne diseases such as HBV or human immunodeficiency virus (HIV) infection because of behavioral or other risk factors (emphasis added) (CDC, 1994).

The wordage within this report demonstrates CDC viewed the results of the Med-E-Jet and Ped-O-Jet were significant. For instance, breaking down the above sentence in bold will help clarify. “Laboratory studies [references CDC’s in vitro experiments on the Med-E-Jet and Ped-O-Jet] in which blood contamination of jet injectors [plural, thus referring to more than one brand of device] has been simulated have caused concern that the use of multiple-use nozzle jet injectors may pose a potential hazard of bloodborne-disease transmission.” Herein the CDC acknowledged results from both of these devices “caused concern” over transmission. It is also interesting to note the CDC acknowledged the potential that all “blood-borne” pathogens could be transferred via jet injection. Although Hepatitis C was known of during the time of this report, as Dr. Grabowsky had stated this was before universal precautions were instituted, not much was yet known about Hepatitis C, and CDC was investigating these risks on a disease by disease basis, so Hepatitis C was not intentionally omitted.

While CDC casted warnings concerning the risks of jet injectors, the agency also acknowledged the speed and cost-efficient benefits the devices brought to mass vaccination campaigns. With a reluctance in completely abandoning the technology the report also discussed ways the CDC believed consumers could minimize the risks associated with these devices.

Multiple-use nozzle jet injectors can be used in certain situations in which large numbers of persons must be rapidly vaccinated with the same vaccine, the use of needles and syringes is not practical, and state and/or local health authorities judge that the public health benefit from the use of the jet injector outweighs the small potential risk of bloodborne-disease transmission. This potential risk can be minimized by training health-care workers before the vaccine campaign on the proper use of jet injectors and by changing the injector tip or removing the jet injector from use if there is evidence of contamination with blood or other body fluid. In addition, mathematical and animal models suggest that the potential risk for bloodborne-disease transmission can be substantially reduced by swabbing the stationary injector tip with alcohol or acetone after each injection. It is advisable to consult sources experienced in the use of jet injectors (e.g., state or local health departments) before beginning a vaccination program in which these injectors will be used. Manufacturer’s directions for use and maintenance of the jet injector devices should be followed closely (CDC, 1994).

In the following years, CDC researchers spoke-out, warning of the risks posed by multi-use nozzle jet injectors. Dr. Bruce Weniger was the former Lead Researcher on Vaccine Technology within the CDC and one of—if not thee—leading expert on jet injection technology. Weniger compared CDC’s studies of the Med-E-Jet from 1986 and Ped-O-Jet from 1994. To recap, the jet injector nozzle was artificially contaminated and then fired into a vial. The ejectate fluid in the vial represents what would have been injected into the next person in the vaccination line. The data below shows the number of samples which tested positive for Hepatitis B surface antigen.

10- Weniger Slide Comparing CDC's Jet Injector Studies
(Weniger, 2003)

Dr. Weniger stated,

Comparing both the Med-E-Jet involved in the outbreak, in red on the right, with a Ped-O-Jet, in green on the left, they [CDC] were able to detect substantial proportions of the next injections from both devices, regardless of whether they followed manufacturer recommendations to swab or wipe the nozzles with acetone or alcohol before the next injection. As you can see, 38% and 6% of next injections with the Ped-O-Jet contained HBV, unswabbed or swabbed, respectively, compared to 80% and 64% of the outbreak-associated Med-E-Jet (emphasis added) (Weniger, 2005).

Indeed results of the Ped-O-Jet found rates of contamination lower than the Med-E-Jet, but contamination was exhibited nonetheless. As Dr. Weniger stated, CDC detected substantial proportions of Hepatitis B surface antigen within ejectates from both devices.

Former Deputy Director of CDC’s Hepatitis Laboratories Division Martin Favero, who had previously remained silent, voiced his concerns of jet injectors within a 1998 paper, titled, Potential for Cross-Contamination With Needleless Injector. Favero, along with his coauthor Pugliese, wrote,

Medical devices that are used on patients in fields containing potentially
infectious body fluids can become contaminated and transmit infectious agents to other sites on the patient or to other patients if the devices are not properly cleaned and sterilized or disinfected after each use. One such device is the needleless, or jet, injector, which is used widely in medicine and dentistry to deliver local anesthetic in procedures such as bone marrow aspirations, lumbar punctures, and cutaneous and intraoral injections (Pugliese & Favero, 1998).

Next Article –  Impact of CDC’s 1993-94 Unpublished Study – Part II

References:

  • (CDC, 1994) Centers for Disease Control and Prevention. General Recommendations on Immunization: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morb Mortal Wkly Rep 43:(RR-1):7–8, 1994.
  • (Pugliese & Favero, 1998) Pugliese G., MS Favero. Potential for Cross-Contamination with Needleless Injector. Infection Control and Hospital Epidemiology. Nov. 1998. pg. 850.
  • (Weniger, 2003) Weniger BG. Jet Injection of Vaccines: Overview and challenges for mass vaccination with jet injectors. Innovative Administration Systems for Vaccines (conference). Rockville, Maryland, USA, 18-19 December 2003.
  • (Weniger, 2005) Weniger B. Safety of Multi-use-nozzle Jet Injectors (MUNJIs) for Bloodborne Pathogen Cross-contamination [draft]. Conference Notes. 7 August 2005.

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Brazilian Government Notes Risk of Ped-O-Jet Injectors: Prompts Investigations by CDC and WHO in the Early 1990s

The Brazilian Ministry of Health implemented safety testing upon Ped-O-Jet injectors in the late 1980s and early 1990s. The investigation was intended to uphold the safety of jet injectors but rather discovered the most widely-used device, the Ped-O-Jet, was a safety risk.

In 1987, a Measles Control Program was initiated within the São Paulo region of Brazil. A total of 8.7 million children aged nine-months to fourteen years were vaccinated with Ped-O-Jet injectors. Despite a hepatitis outbreak at a Los Angeles clinic with a Med-E-Jet injector, the healthcare workers in São Paulo believed the Ped-O-Jet was different and posed no risk (de Souza Brito, 1996).

The Brazilian Ministry of Health conducted a study to assure the safety of the Ped-O-Jet during routine military vaccinations in 1991 (de Souza Brito, 1996). The study aimed to answer three questions:

  1. What is the frequency of visible bleeding at the site of jet injection in the skin?
  2. What is the frequency of occult blood in the next vaccine shot dose?
  3. Is there any correlation between visible bleeding and occult blood of the next dose?

Glacus de Souza Brito and his fellow researchers led the investigation. It was observed amongst three vaccination sites the percent of vaccinees who bled immediately after the Ped-O-Jet was removed ranged from 2.2 to 23.3 percent. The average percent of bleeders was 3.6 percent (104 out of 2885). The researchers found “instantaneous bleeding took place after injection in a significant proportion of cases and that there was therefore a risk of downstream infection of subsequent subjects” (WHO, 1998).

The presence of blood prompted researchers to asses the possibility of cross-contamination. The subsequent shot after administering a vaccination was fired into a vial and analyzed. Amongst the three vaccination sites results detected blood within 0.2 to 6.6 percent of the ejectates, with the average being one percent (28 cases out of 2885 vaccinees).

The researchers found, “there was little to no correlation between visible bleeding and detection of occult blood in the successive vaccine doses. Only one person had both” (de Souza Brito et al., 1994; de Souza Brito, 1996). This finding is significant. There was no visible bleeding at the injection site in 27 out of 28 of the ejectates which contained blood, indicating blood transferred within microscopic levels not visible to the human eye.

Dr. Martin Friede of the WHO later noted, the researchers used blood detection stripes which can only detect around 2,000 picoliters of blood and therefore failed to detect blood within levels lower than 2,000 picoliters. The results demonstrated one percent of the ejectates contained 2,000 picoliters of blood (FDA, 2005). Therefore, the results found blood was being cross-contaminated via the Ped-O-Jet within volumes which could contain infectious viruses like Hepatitis B and Hepatitis C.

In 1992 a mass Measles Vaccination Campaign was launched across the entire country of Brazil. The government purchased 10,000 Ped-O-Jet injectors to vaccinate an estimated 50 million children between the ages of nine-months to fourteen years within a month period. During this mass vaccination campaign, a possible hepatitis B outbreak by Ped-O-Jet injectors was investigated but no statistical association was found. However, despite these findings the Brazilian government found the Ped-O-Jets were unsafe and stopped using the devices (Fields, 1996; de souza Brito, 1996).

These investigations by de Souza Brito were significant in raising safety concerns of jet injectors amongst the WHO and CDC. By 1994, Dr. de Souza Brito collaborated with researchers at the CDC to further investigate the inherent risks of Ped-O-Jet injectors. CDC Retests the Safety of Jet Injectors in 1993-94

References:

  • (de Souza Brito, 1996) de Souza Brito G. Multi dose jet injectors and safety aspects in Brazil. CDC & WHO Meeting on Jet Injectors. Atlanta, October 2-3, 1996. (communication paper).
  • (de Souza Brito et al., 1994) de Souza Brito G, Chen RT, Stefano IC, Campos AM, Oselka G. The risk of transmission of HIV and other blood-born diseases via jet injectors during immunization mass campaigns in Brazil. 10th International Conference on AIDS, Yokohama, 7-12 August 1994;10(1):301 (abstract no. PC0132, http://www.aegis.com/conferences/10wac/pc0132.html).
  • (FDA, 2005) FDA. General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. August 9, 2005. 35th Conference. Washington, D.C.
  • (Fields, 1996) Fields R. Participation in Meeting: Jet injectors for immunization; current practice and safety; improving designs for the future. WHO/CDC Meeting. Atlanta, GA. 2-3 October, 1996. Available at: http://pdf.usaid.gov/pdf_docs/PNABZ997.pdf.
  • (WHO, 1998) World Health Organization. Technet Consultation. Expanded Programme on Immunization. Conference 16-20 March 1998. Copenhagen. WHO/EPI/LHIS/98.05.

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Types of Military Jet Injectors

Throughout the decades, various brands of jet injectors were used within the Armed Forces. Each brand of jet injector used upon our military personnel has been documented in scientific journals as producing blood at the injection site and most importantly has documented blood contamination upon the jet injector nozzle and internal fluid pathways. Several studies have even highlighted the risk of jet injectors transmitting hepatitis. Herein are the jet injector models used within the Armed Forces and accompanying scientific studies citing blood contamination and risk of hepatitis.

The following multi-use nozzle jet injectors were used throughout the U.S. Armed Forces:

Ped-O-Jet: Research Documented Presence of Blood & Risk of Hepatitis

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Military Jet Injectors: Press-O-Jet

Jet Infectors - Press-O-Jet

Background Info
The Press-O-Jet was the first high-speed multi-use nozzle jet injector ever to be developed. The device was developed by researchers at Walter Reed Army Institute of Research in collaboration with Z & W Manufacturing Company of Wickliffe, Ohio. Z & W patented the Press-O-Jet in 1952. Sometime thereafter Press-O-Jet was acquired by the Scientific Equipment Manufacturing Corporation of Larchmont, New York. In 1965, the device was sold-off to the Parker Hanifin Corporation (www.parker.com).

Press-O-Jet was used amongst both military and civilian populations between 1952 and the early 1960s.

Military Usage
Multi-use nozzle jet injectors were invented at the request of the U.S. Armed Forces. Around 1951, the Armed Forces Epidemiological Board’s Commission on Immunization requested the Army Medical Service Graduate School to develop “jet injection equipment specifically intended for rapid semiautomatic operation in large-scale immunization programs” (Warren et al., 1955). Within the following year the Graduate School developed a series of models. Between 1952 and 1954, researchers at Walter Reed Army Institute of Research and Z&W Manufacturing Company had constructed a working prototype, known as the Press-O-Jet.

During the Press-O-Jet’s clinical testing, it was widely used on military personnel. A review of the literature found in 1954, 1,685 soldiers at Fort Meade and in the Military District of Washington, D.C. received a typhoid vaccination (Star-Democrat, 1954; Warren et al., 1955), and another 1000 recruits stationed at Fort Knox were vaccinated for smallpox with the Press-O-Jet (Elisberg et al., 1956). From 1955 to 1956, the Press-O-Jet administered 20,145 influenza vaccinations at Naval Air Station at Norfolk (Anderson et al., 1958). The scientific literature also vaguely noted the Press-O-Jet administered 1,440 influenza vaccinations to military personnel (Benenson, 1959).

Numerous photographs and newspaper articles have documented the Press-O-Jet being used within the U.S. Armed Forces. These photos, provided by the National Archives and Records Administration, show the Press-O-Jet being utilized within the military in 1955.

Jet Infectors - Press-O-Jet NARA (a)
(National Archives and Record Administration photo no. 366-P5-55-3318).

Jet Infectors - Press-O-Jet NARA (b)
(National Archives and Record Administration photo no. 306-P5-55-3313).

The caption on the backside of these images reads:

Wash., D.C. A new needle-less, automatic, multiple-dose jet “gun” for mass vaccine injections is being tested at Walter Reed Army Medical Center. The new inoculation mechanism gives promise that someday the Army’s soldier’s may receive quick and practically painless inoculation. Here Army doctor sided by Army nurse inoculates a soldier with the inoculation “gun” as other soldiers wait their turn. Source: Intern’l News S1276260 2/20/55 copy msg”.

In 1954, Walter Reed Medical Center tested the Press-O-Jet upon military personnel as documented in this newspaper article. (Star-Democrat. Painless Shot. 28th May 1954. pg. 35)

Jet Infectors - Star Democrat - Press-O-Jet

In this photograph, the Press-O-Jet was tested on patients at the Bacteriology Research Laboratory within the Armed Forces Institute of Pathology around 1955. (NCP 013106-13) (Otis Historical Archives, National Museum of Health and Medicine, Silver Spring, Maryland)

Jet Infectors - Press-O-Jet Bacteriology Research Laboratory

This newspaper article, captured below, reveals the Press-O-Jet was developed by Dr. Joel Warren and his colleagues within the United States Army and tested upon military inductees.

Rome News Tribune, Rome, Georgia
February 18, 1955

New Vaccine “Jet Gun” May Replace Needles

CHICAGO (INS)—“Watch the needle,” the familiar cry of inductees to their buddies as they lined up for vaccination shots, may soon take its place in military history alongside the out-dated “man the halyards” and “saddle up.”

Four United States Army Researchers have developed a needleless automatic, multiple-dose jet “gun” for mass vaccine injections at induction centers and embarkation points.

They claim their injector, which operates with an automatic cocking device like a machine gun, although not completely painless, hurts considerably less than the old-style “needle-with-an-outboard-motor-on-it” of World War II fame.

The researchers say “in an appreciable number of cases, persons report no pain at all.”

Writing in the current journal of the American Medical Assn, published in Chicago, Dr. Joel Warren of Walter Reed Army Medical Center in Washington, describes how the needle-free gun shoots a tiny jet of vaccine right through the skin under some 250 pounds of pressure.

The pressure comes from a spring-driven piston pump. Each injection takes about one second.

After the operator triggers off each “shot,” a hydraulic pump re-cocks the gun. Since no needle is used there is no need for sterilization after each shot.
In trial runs, a total of 1,685 Army inductees were vaccinated daily with the US Army’s standard triple typhoid vaccine.

Each inductee got a jet injection in one arm and a regular needle tetanus injection in the other arm at the same time administered by a “highly-trained” corpsman.

The report concluded the trial “substantiated” hopes that jet injection is “a promising procedure potentially useful in many military and civilian situations that require immunization or medication of large numbers of people in a short time.”

Dr. Warren was joined by Frank Ziberl, Arthur Kish and Louis Ziherl, all of Cleveland, in the gun development.

Presently, the National Museum of Health and Medicine, formerly known as the Army Medical Museum, proudly displays the Press-O-Jet within their military medical exhibit. The caption below the display reads, “By the Vietnam War, injectors distributed vaccines and medications on a large scale. The Walter Reed Army Institute of Research prototyped this example.”

Jet Infectors - Press-O-Jet Museum Display

Research Documented Presence of Blood & Risk of Hepatitis
Numerous scientific studies have documented the presence of blood at the injection site and upon the jet gun nozzle following Press-O-Jet injections. One of these studies, even warned of the risk of transmitting hepatitis within the early days of jet injection.

  • Warren and colleagues (1955) administered the triple typhoid vaccine using the Press-O-Jet to 1,685 Army inductees. Bleeding at the injection site of these military personnel were observed. In several instances the researchers noted the jet stream lacerated the patient’s skin when the proper injection technique was not followed.
  • Lipson and colleagues (1958) found bleeding at the injection site when using the Press-O-Jet injector. Lipson was studying the antibody response after administering the poliomyelitis vaccine by jet injection. He observed after administering two doses of vaccine to 34 children that “there was frequently a small amount of leakage of vaccine from the puncture site in both groups, accompanied occasionally by a small amount of blood.” Moreover, Lipson observed blood on the nozzle of the jet injector in two instances. So out of 68 injections visible contamination of the nozzle occurred two times. This equates to 3 percent of the injections. Lipson wrote, “Although the risk of transmitting the virus of hepatitis is slight, it does exist; and in using this instrument care should be taken to avoid accidental contamination with blood or tissue juices” (emphasis added).
  • Anderson, Lindberg and Hunter (1958) observed a large-scale military field trial conducted upon sailors stationed at Naval Air Station in Norfolk, Virginia. The mass influenza vaccination campaign administered 20,145 injections with a Press-O-Jet injector between 1955 and 1956. Sailors were vaccinated at a rate of 734 injections per hour. The researchers observed bleeding at the injection site of sailors and in several cases the jet stream lacerated sailors’ arms due to an improper injection technique by corpsmen.
  • Following the mass Salk Polio vaccination campaign, which was the first major field-trial of jet injectors, Dr. Robert Hingson reported jet injectors produced bleeding and ecchymosis at the injection site. The campaign used the Press-O-Jet amongst other jet injector devices (Hingson et al., 1957).
  • Elisberg, McCown and Smadel (1956), who wanted to use jet injectors for mass smallpox vaccinations, assumed “since no needle is used, contamination of the instrument by such blood-borne microbial agents as malaria or serum hepatitis is avoided and frequent sterilization of the jet injection apparatus is unnecessary.” Yet Elisberg, McCown, and Smadel not only observed bleeding following a jet injection, they illogically thought if the device was removed immediately the patients would be safe. Weniger and Papania (2008) reported Elisberg, McCown and Smadel’s study used the Press-O-Jet.

Acknowledgements
Special thanks to the National Archives and Records Administration for their assistance.

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.
  • (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.
  • (Hingson et al., 1957) Hingson RA, Davis HS, Bloomfield RA, Brailey RF. Mass inoculation of the Salk polio vaccine with the multiple dose jet injector. GP [General Practice] 15:94–96, 1957.
  • (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.
  • (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.
  • (Weniger & Papania, 2008) Weniger BG, Papania MJ. Alternative Vaccine Delivery Methods [Chapter 61]. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357-1392.

© Jet Infectors, 2016 – 2020
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Military Jet Injectors: Hypospray Multidose

Jet Infectors - Hypospray Multidose

Background Info
The Hypospray Multidose, was a multi-use nozzle jet injector manufactured and marketed by the Robert P. Scherer Corporation of Detroit, Michigan (www.rpscherer.com).

The Hypospray Multidose model was used in both civilian and military populations between 1952 and the early 1970s.

Jet Infectors - Hypospray Multidose Jet Injector

Military Usage
Within the U.S. Armed Forces, the Hypospray Multidose emerged during the late 1950s. The photograph below, shows Lawrence E. Blackman of Darlington, South Carolina receiving the first typhus shot with a Hypospray Jet Injector at Fort Gordon in Georgia on August 26th of 1959. Mr. John R. Gordon, a representative of R.P. Scherer Corp., administers the shot. Major Sergeant Edward Sammons from the Post Surgeon’s Office observes.

Jet Infectors - Hypospray Multidose 1959 Fort Gordon
(Photo by Roy C. McManus. Post Sig Photo Lab, Fort Gordon, GA).

The Windward Marine, the newspaper for U.S. Marine Corp Air Station at Kaneohe Bay, Hawaii, documented the introduction of the Hypospray. The 1960 article, showcased below, demonstrates the Hypospray Multidose being used upon a fellow soldier.

Jet Infectors - 1960 USMC Hawaii - Hypospray Multidose

(Windward Marine, US MCAS Kaneohe Bay, April 29, 1960)

Here is a recruit receiving an immunization with the Hypospray Multidose at Fort Leonard Wood in 1967.

Jet Infectors - Hypospray Multidose Fort Leonard Wood 1967

Presently, one of the few existing Hypospray Multidose jet injectors is on display at the Public Health Museum in Tewksbury, Massachusetts.

Public Health Museum - Hypospray Multidose
(Public Health Museum, July 24, 2017)

Research Documented Presence of Blood & Risk of Hepatitis
Numerous studies have documented the presence of blood when using the Hypospray Multidose. One of these studies, even warned of the risk of transmitting hepatitis via jet injection.

  • The mass Salk Polio vaccination campaign was the first major field-trial of jet injectors. Dr. Robert Hingson, who had been a major contributor to the development of jet injection technology, reported during the mass Salk Polio vaccination campaigns that jet injectors produced bleeding and ecchymosis at the injection site. This campaign used several jet injectors including the Hypospray Multidose Jet Injector (Hingson et al., 1957).
  • Kutscher and colleagues (1962) noted bleeding at the injection site when using the Hypospray Multidose. The researchers also noted that the skin could become lacerated if the vaccinator failed to abide by the correct injection technique stated by the manufacturer. The researchers also noted, “If the patient’s arm is held on the hip with arm muscles tensed, the Hypospray may not penetrate the muscle and 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.

Most shockingly, in spite of the presence of blood, Kutscher cited as one of the advantages of jet injection technology was the “diminution of the problem of instrument sterilization.” Diminution is defined as a reduction in the size, extent, or importance of something. Therefore, Kutscher is stating not having to sterilize the jet injector as often as the sterilizing of needles and syringes is an advantage. The lack of sterilization leaves the possibility for cross-contamination of blood and diseases. Kutscher does state, “The Hypospray unit itself is not sterilized although the head can and should be disinfected” (Kutscher et al., 1962) but this does not guarantee the device is actually sterile. If he is reporting splash back, lacerations from improper injection technique, and bleeding at the injection site then more than just the head of the jet injector needs to be sterilized.

  • In 1967, Dr. Sol Rosenthal studied the transference of blood by various inoculation devices amongst school children. “The ever expanding, mass skin-testing and vaccination programs, the newer methods of inoculation, and the mounting incidence of viral hepatitis prompted this study,” said Rosenthal. “It was reasoned that if the detection of the transference of erythrocytes (hemoglobin) or serum could be assayed, one might infer that the parenteral hepatitis agent would likewise be transferred” (Rosenthal, 1967).

Rosenthal compared the use of syringes to the Hypospray Multi-dose K-3 jet injector. He found the presence of enough blood capable of contaminating the next child in 1.2 percent of cases with syringes and in 17 percent of cases on the injector nozzle. This is worth reiterating, in 1967 Rosenthal raised concern when he found there was enough blood detected on the jet injector nozzle to transmit blood-borne pathogens (Rosenthal, 1967; Weniger & Papania, 2008).

  • Gross and colleagues studied a mass vaccination campaign of children within the County of Los Angeles which used Hypospray Multidose jet injectors. These researchers found, “A drop of blood or vaccine following an injection was encountered less than 12 percent of the time” (Gross et al., 1970).
  • German researchers, Horn, Opiz and Schau (1975), found through their investigations of the Hypospray Multidose that the risk of cross-contamination to subsequent patients was not only possibly but a concern which needed to be addressed. Horn warned of the risk of spreading hepatitis via jet injection:

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 (emphasis added) (Horn, Opiz & Schau, 1975).

References:

  • (Gross et al., 1970) Gross PA, Grigsby SF, Kogan BA, Heidbreder GA. Jet injector: appraisal of its use in a local setting. Am J Public Health Nations Health. Sep 1970;60(9) 1839-1844.
  • (Hingson et al., 1957) Hingson RA, Davis HS, Bloomfield RA, Brailey RF. Mass inoculation of the Salk polio vaccine with the multiple dose jet injector. GP [General Practice] 15:94–96, 1957.
  • (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, et al. 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 54:418–420, 1962.
  • (Rosenthal, 1967) Rosenthal SR. Transference of blood by various inoculation devices. Am Rev Respir Dis. October 1967; 96(4):815-819.
  • (Weniger & Papania, 2008) Weniger BG, Papania MJ. Alternative Vaccine Delivery Methods [Chapter 61]. In: Plotkin SA, Orenstein WA, Offit PA, eds. Vaccines, 5th ed. Philadelphia, PA: Saunders (Elsevier); 2008;1357-1392.

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Fair Use Notice (17 U.S.C. § 107)