Ped-O-Jet Withdrawal Letter to DoD Over Risk of Disease Transmission

Jet Injectors = Jet Infectors

May 21, 2016

After six years of searching and multiple Freedom of Information Act Requests to multiple DoD agencies, I finally found the withdrawal letter from the manufacturer/owner of the Ped-O-Jet to the DoD. (Previously other websites have wrongfully accredited my find and used this information without my consent. This FOIL Response Letter predates any postings by other websites and will clarify all matters as who is the correct promulgator).

In a 1997 letter, Keystone Industries informed the Department of Defense of its intent to withdraw and stop manufacturing the Ped-O-Jet, the most widely used jet injector in the world, over risks of cross-contamination.

In 1996 and again in March 1997, the Center for Disease Control and the World Health Organization held a meeting to discuss the topic of mass inoculation. Many organizations and nations had representatives at these meetings. The Armed Services of the United States and FDA attended these meetings, as well as a Colonel Bancroft and other representatives of the Armed Services. In 1997, this group participated and was responsible for the development of a report entitled “Steering Group on the Development of Jet Injection for Immunization”. One of the topics in the report discussed the potential risk of blood borne disease transmission where a multiple use jet injector is used…as a result of these findings set forth in the report, we will discontinue producing and servicing the Ped-o-Jet at this time.

We believe that further studies would be aquired to ensure that the Ped-o-Jet is a safe method for administering mass injections. Until such studies conclude than no risk is present for blood borne disease transmission, we strongly urge the Armed Forces to discontinue use of the product” (Ped-O-Jet, 1997).

One interesting find is the manufacturer listed all military bases that had bought a Ped-O-Jet within the four years prior to the discontinuation.

Do not be dissuaded by the letter’s statement that “Ped-O-Jet has never had a reported case of cross contamination.” As I always state, actions speak louder than words. If the manufacturer was not concerned about cross-contamination then they would not have discontinued their device. Furthermore also take into account that other jet injector manufacturers redesigned their devices to eliminate the risks of cross contamination, for instance Bioject and their disposable-cartridge jet injector (DCJI) models. However, the owner’s of Ped-O-Jet consciously choose not to do this. Could it be to avoid being liable for a hazardous device? If Ped-O-Jet made a DCJI it would mean the company acknowledges their MUNJIs are hazardous.

Robert Harrington, once former CEO over the Ped-O-Jet before Keystone acquired it,
said at a FDA hearing,

[The letter] inform[ed] them [Department of Defense] that the product Ped-O-Jet was unsafe, could easily be contaminated, and that Keystone no longer would be responsible for the safety and efficacy of the product if it continued to be used by the government. The direct result of this letter was an immediate ban of all high workload jet injectors by the U.S. Department of Defense (FDA ,1999).

Here is the the withdrawal letter in its entirety –Keystone Industries Withdrawal Letter.

References:

  • (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.
  • (Ped-O-Jet, 1997) Ped-O-Jet withdrawal letter to Department of Defense. DPSC-970147. 1997.

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