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.

© Shaun Brown and Jet Infectors, 2016 – 2017
Fair Use Notice (17 U.S.C. § 107)


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