September 21, 2017
The Department of Defense’s (DoD) ban on the use of multi-use nozzle jet injectors was swift and well documented. Although, the documents were later removed and, in one case, destroyed by law after five years. Thankfully through Dr. Weniger, web.archive.org, and talented researchers these documents have been saved. For the first time, the change within DoD’s vaccination protocols, from the fall of multi-use nozzle jet injectors to the rise of disposable-use cartridge jet injectors is thoroughly outlined.
Keystone Industries acquires the assets and trademarks of Ped-O-Jet from a bankrupt sale.
1996 Oct. 2-4
John Stengel, Production Manager of the Ped-O-Jet at Keystone Industries, attends a joint meeting by CDC and WHO to discuss the safety and improvement of jet injectors. A CDC expert stated, “Jet injectors, such as Ped-O-Jet, are not particularly easy to contaminate, but once they are contaminated, they can indeed transmit disease” (Fields, 1996).
1997 Mar. 18-19
Members of Keystone Industries attended a WHO meeting to further discuss the safety and design of jet injection devices for mass immunizations. Several studies were presented which documented the Ped-O-Jet indeed became contaminated and thus posed a safety risk. For example, “studies in Brazil with PED-O-JET have shown that under field conditions the ejected vaccine was positive for occult blood by urine dipstick” (WHO, 1997)
The Armed Forces Epidemiological Board made a site visit to the Marine Corp Recruit Depot at Parris Island and observed mass jet injections using Ped-O-Jet injectors. AFEB reported, “jet injector nozzle’s were frequently contaminated with blood, yet sterilization practices were frequently inadequate or not followed.” 1999 AFEB – Report Citing Bloody Jet Injectors and Lack of Sterilization
1997 Nov. 20
As a direct result of the CDC and WHO conferences, Chairman and CEO, Fred Robinson, of Ped-O-Jet International notifies the Department of Defense by letter that due to safety concerns Ped-O-Jet injectors should no longer be used. “Until such studies conclude than [sic] no risk is present for blood borne disease transmission, we strongly urge the Armed Forces to discontinue use of the product,” wrote Mr. Robinson. Keystone Industries Withdrawal Letter
1997 Dec. 5
The DoD Medical Materiel Quality Control Program issues a product recall notice stating Ped-O-Jet injectors, both electrical and foot-pedal models, should no longer be used within the U.S. Armed Forces. 1997 Automatic Jet Hypodermic Injection Units:Withdrawal (DPSC 970147) MMQC-97-1169
1997 Dec. 9
Colonel Joel Lamy of the Defense Logistics Agency’s Medical Quality Assurance System Device Alert issues a memorandum to the staff director of the Defense Medical Standardization Board declaring all jet injector devices, no matter the brand or model, be discontinued. “The use of these products, regardless of manufacturer, be discontinued until assurances of their safety are received. In light of the possible serious consequences and the letter from Ped-O-Jet, this is considered the best course of action. We are also suspending issue of these items from the depot.” 1997 (Dec 9) DoD – Defense Logistics Agency – Jet Hypodermic Injection Units copy
1997 Dec. 11
During the Armed Forces Epidemiological Board’s meeting, the Board discussed the use of jet injectors for delivering certain vaccines within the Armed Forces and in light of the DoD withdrawal, the board initiated a review of jet injector safety.
1998 Jan. 9
The Armed Forces Epidemiological Board, after reviewing jet injector safety, issued a memorandum noting the risk of cross-contamination and encouraged the use of newer technology jet injectors in which “the part of the device that comes into human skin contact is disposable.” Here the AFEB was referring to the Biojector 2000, which is a disposable cartridge jet injector.
AFEB further added “At those sites or situations where jet injectors are continuing to be used, A memorandum be issued, effective immediately, reviewing: 1) Proper device use and disinfection. 2) That standardized training in the above be completed by all persons using such devices.”
Also within this memorandum, the AFEB noted no active prospective surveillance studies have been performed to uphold the safety record of jet injectors. 1998 (Jan 9) AFEB- Recommendation on Jet Injectors
1998 January 30
The DoD Medical Materiel Quality Control Program issues a follow-up notice stating all jet injectors are not to be used within the U.S. Armed Forces. 1998 (Jan 30) Automatic Jet Hypodermic Injection Units MMQC-98-1019
1998 April 15
The Armed Forces Epidemiological Board held the Infectious Disease Subcommittee Meeting in Norfolk, Virginia to discuss the safety of jet injectors. Dr. Bruce Weniger of CDC’s National Immunization Program gave an overview of jet injection and discussed safety issues (Weniger, 2013). The meeting, which was initially open to the public, was later closed “due to the fact that material of a proprietary nature” was being discussed (Federal Register, 1998).
1998 April 20
Navy Bureau of Medicine and Surgery updates its Immunization Requirements and Recommendations manual prohibiting the use of jet injectors. 1998 (April 20) DoD- BUMED 6230-incomplete version
1998 April 28
The AFEB encouraged the development of newer jet injection technology. (Multi-use nozzle jet injectors were initially designed by Walter Reed Army Institute of Research, so this was a call for the DoD to reinvent the technology). AFEB also recommended newly developed jet injector prototypes undergo testing to ensure the safety of patients. 1998 (Apr 28) AFEB- Recommendation on Jet Injectors
1998 April 29
The Secretary of the Navy implements an Anthrax Vaccination Program. The vaccination plan stated, “Jet injector immunization devices will not be used to administer anthrax vaccine.” 1998 (April 29) DoD- Anthrax Vaccination Implementation Plan
1998 Nov. 3
The DoD Medical Materiel Quality Control Program informs that Connaught Pharmaceutical was discontinuing large multi-dose vials of vaccines due to discontinuation of Ped-O-Jets. Connaught supplied yellow fever, meningococcal and tetanus-diphtheria vaccines. These vials “require[d] use of jet injector apparatus that is no longer recommended as an appropriate vaccination method.” 1998 (Nov 3) DoD MMQC-98-1248
1998 Nov. 25
Navy Bureau of Medicine and Surgery authorized the use of the Biojector 2000, a disposable-cartridge jet injector. “Biojector 2000 Injection Management System is authorized for use in Navy and Marine Corps activities for immunization, administration to service members and other beneficiaries. At this time, no other hypodermic jet injector system is FDA approved-this is required prior to consideration for BUMED authorization.” 1998 (Nov 25) Navy Bureau of Medicine DoD Memo
Biojector Medical Technologies in conjunction with the U.S. Naval Research Center implemented a Phase I Human Trial upon military personnel. The trial administered a malaria DNA Vaccine with the Biojector 2000. This disposable-cartridge jet injector eliminates the risk of previous multi-use nozzle jet injectors (Bioject, 1999).
Between October 2003 and October 2004, the U.S. Military heavily used the Biojector 2000 to administer mass immunizations of recruits and within military hospital settings, as documented within the slide below.
As noted within the above DoD documents multi-use nozzle jet injectors were banned in 1997. Since then, any jet injector used within the Department of the Navy required FDA approval first. The only FDA approved jet injector during this time period was the Biojector 2000, a disposable cartridge jet injector.
Although protector cap needle-free jet injectors (PCNFI) underwent safety testing after 1997 there is no evidence to demonstrate PCNFIs were used within the military.
The true historical account of jet injectors demonstrates multi-use nozzle jet injectors were banned within DoD in 1997 and the vaccine vials for such devices were discontinued shortly thereafter. The fact that MUNJI devices were never used again demonstrates the seriousness and danger with which DoD viewed these devices. The fact that these documents were removed and destroyed at the earliest date by law demonstrates culpability on the part of U.S. Armed Forces.
- (Bioject, 1999) Bioject Medical Technologies, Inc. U.S. Navy Reports Positive Preliminary Results with Biojector(R) 2000 Device In Phase I Malaria DNA Vaccine Trial. PR Newswire. 21 December 1999. Available at: http://www.prnewswire.com/news-releases/us-navy-reports-positive-preliminary-results-with-biojectorr-2000-device-in-phase-i-malaria-dna-vaccine-trial-77728422.html.
- (Federal Register, 1998) Federal Register. Department of the Army: Armed Forces Epidemiological Board. U.S. Government Printing Office. 13 April 1998; 63(70): 17995.
- (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.
- (Lynam, 2003) Lynam K. Feedback From the Field: Needle-free Injection Use in Large Scale Immunization Campaign. Presentation at Innovative Administration Systems for Vaccines Conference. Rockville, MD. 18 December 2003.
- (Weniger, 2013) Weniger BG. Curriculum Vitae. November 2013.
- (WHO, 1997) World Health Organization. Steering group on the development of jet injection for immunization. May 14, 1997. [draft]