FDA Reviews Jet Injector Safety

Following the 1996 CDC/WHO conference, the FDA initiated a hearing to review the safety of multi-use nozzle jet injectors (MUNJIs). The timeline below shows FDA’s two hearings on jet injector safety, which eventually led to the development of a guidance document.

 

1999 FDA Hearing – Guidance Development For Jet Injectors
In August of 1999, the FDA held its first ever hearing on jet injector safety. The purpose of the panel discussion was to develop a guidance document and identify regulatory standards to help improve the jet injection industry. Amongst the attendees were members of the FDA, Dr. Bruce Weniger of the CDC, PATH, and several jet injector manufacturers.

Dr. Charles Edmiston, associate professor of surgery at Medical College of Wisconsin, served as Chairman of the panel discussion. Dr. Edmiston stated, “we need to keep abreast of how this technology may actually be responsible for transmitting infections in the future, like hepatitis C.” (FDA, 1999).

The panel heard presentations on jet injector use over the last fifty-years, and forty-years of research demonstrating the risk of transmitting infectious pathogens.

Only one attendee upheld the safety of MUNJIs. Robert Harrington, former CEO and President over the Ped-O-Jet, shouted from the audience, “It was used by the Army for 35 years and it [the jet injector nozzle] was always wiped. Never had an issue. Good tracking system. And there’s nothing recorded in the world that says that it wasn’t wiped.” Jet Infectors has since presented evidence demonstrating Mr. Harrington’s comments were outright lies. (See article – Improper Military Jet Injector Vaccinations)

At the conclusion of the conference, the panel gave two recommendations: 1) To continue post market surveillance on the use of MUNJI devices. Post market surveillance monitors the safety of a device, such as a jet injector, after it has been released for public use. 2) To explore creating a standardized method for testing the safety of jet injectors (FDA, 2005a).

Despite the in depth discussions no regulatory changes or guidance document resulted from this conference.

 

2005 (Aug 9) FDA Hearing – MUNJI Safety
The FDA held a second hearing on the safety of MUNJI devices. The meeting was a long overdue extension of the first conference.

Present were members of various departments within the FDA, also Dr. Martin Friede from the WHO, representatives from PATH and other industry consultants and organizations. [Dr. Weniger of the CDC was scheduled to attend but had to cancel.]

The primary focus of the meeting was to “discuss and make recommendations on methods to assess the potential of disease transmission by multiple-use nozzle jet injectors” (Federal Register, 2005), which was one of the recommendations given at the 1999 hearing.

The hearing had been the most comprehensive discussion yet on the risks of MUNJI devices. Dr. Friede of the WHO gave an explicit presentation on the inherent design faults of MUNJIs, presented numerous studies that evaluated cross-contamination and addressed how those studies upheld to later advances in science (FDA, 2005a).

The panelists also addressed pertinent questions such as the adequate volume of blood for transmitting viruses and whether an acceptable level of risk exists when using MUNJIs (FDA, 2005b). Many of the questions had already been discussed within a WHO/CDC meeting held in 2004 but were reiterated for the FDA panel members.

No conclusions were reached by the end of the hearing. The FDA advisory committee did not release a draft guidance on jet injectors until 2009.

 

2009 FDA Draft Report – Draft Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
In 2009, the FDA published a draft guidance on needle-free devices for public review and comment. The publication was the first ever guidance document for needle-free devices. Previously multi-use nozzle jet injectors circumvented regulatory standards. Devices developed prior to the 1976 regulation of medical devices were “grandfathered” onto the market. Jet injectors developed after the enactment of the 1976 law cleared regulation on the basis that they were substantially equivalent to multi-use nozzle jet injectors already on the market (Weniger & Papania, 2013). These loopholes allowed MUNJIs to bypass safety testing in the past.

FDA’s draft document served as an instruction manual for those submitting a pre-market application for needle-free devices. The document discussed design features, construction materials, performance testing, sterility issues and product labeling. Applicants finally knew what information the FDA wanted in order to be granted pre-market approval of a prototype.

The draft document acknowledged the risk of cross-contamination with jet injectors and advised against development of such reusable devices. The FDA stated,

Disease transmission may result from cross-contamination in reusable needle-free injectors, e.g., Multi-Use-Nozzle Jet Injectors (MUNJIs). There is a potential for disease transmission when blood contamination of the fluid path or injectable product occurs during a previous injection. Contamination can occur on the skin-contacting surface of the injector or inside the injector from splash-back. It is also possible that the replaceable cap may become contaminated…FDA generally recommends against developing injectors that require between-use cleaning of any component in or around the fluid path (FDA, 2009).

 

2013 FDA Report – Guidance for Industry and FDA Staff: Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products
In June of 2013 the FDA published its final version of the guidance document for needle-free devices. FDA received several comments on the 2009 draft guidance, which led to several changes.

One such change was the heightened language in the section cautioning against the use of multi-use nozzle jet injectors due to the risk of cross-contamination. The final version stated,

The vast majority of injectors are approved or cleared for single patient use. In general, multi-patient use injectors (e.g., reusable needle-free Multi-Use-Nozzle Jet Injectors) raise significant concerns for the risk of blood born pathogen and skin contaminant transmission from patient to patient. For example, there is a potential for disease transmission when blood contamination of the fluid path or the injectable product occurs during a previous injection. Contamination can occur on the skin-contacting surface of the injector or inside the injector from splash-back. It is also possible that the replaceable cap may become contaminated. In addition, in-between use cleaning of any component in or around the fluid path may result in contamination (emphasis added) (FDA, 2013).

Here the FDA clearly advises against the use of multi-use nozzle jet injectors due to significant concerns of cross-contamination of blood-borne pathogens between patients.

 

Conclusion
FDA’s 1999 and 2005 hearings eventually led to the development of a guidance document for premarket submissions of needle-free devices. Ultimately the FDA discouraged the use of MUNJIs due to “significant concerns” of blood-borne disease transmission. By 2013 disposable-cartridge jet injectors were standardized for administering immunizations.

Following the 1999 hearing, the FDA was to continue post market surveillance of MUNJIs devices. Personally, I question how involved was this post-market surveillance. It is my presumption that the FDA only assessed complaints filed under their reporting system known as MedWatch. The FDA should have been in communication with the Department of Defense and Department of Veterans Affairs to inquire if soldiers and veterans, who were the largest population subjected to jet injectors, had experienced any adverse effects or if any large outbreaks, such as Hepatitis C, had emerged.

Lastly and most interestingly, despite the vast amount of information presented on the inherent risks of MUNJIs within these two hearings, the FDA never sought a ban on MUNJI devices. In 2013, I sought clarification on this issue. The FDA stated,

According to FDA’s updated communication on the use of jet injectors to deliver vaccines, data to support their safety and effectiveness have not been submitted to the FDA for evaluation. However, the FDA has not “banned” them. [Full copy of letter here.]

One would wonder, if a medical device has been discouraged due to significant concerns why not impose a ban?

 

References:

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


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