Impact of CDC’s 1993-94 Unpublished Study – Part II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

 

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

 


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