Concern Over Use of Protector Cap Needle-Free Injectors

December 26, 2016

Jet Infectors embarked to answer one question-
Are Jet Infectors still being used today?

So far no such devices are being used to administer vaccinations. However, a preliminary investigation found discrepancies within needle-free literature which, in good faith, must be clarified.

Jet Infectors found protector cap needle-free injectors (PCNFI) are currently being used as medical instruments in a beauty clinic in Pretoria, South Africa.

The PCNFI device used in Pretoria is known as Med-Jet MBX. The device consists of a single-use disposable plastic cap which acts as a barrier in protecting the reusable nozzle, internal fluid pathway, and drug reservoir from foreign particles.

However, PCNFI devices do not eliminate the risk of disease transmission between consecutive patients. Therefore, it is imperative that the reusable nozzle, internal fluid pathway, and drug reservoir are autoclaved after use on each patient. These pieces are to be treated no different than any other surgical device in need of autoclaving.

Med-Jet MBX has been marketed worldwide for applications in dermatology, cosmetics and mesotherapy. Although the device is still awaiting FDA approval within the United States.

Med-Jet MBX is manufactured and distributed by Medical International Technologies (MIT Canada) of Saint-Laurent, Canada. Med-Jet MBX, nor MIT Canada, have ever been implicated in any outbreak. An Internet search found no complaints against Med-Jet or MIT Canada whatsoever.

Jet Infectors reached-out to Karim Menassa, President and CEO of MIT Canada who was pleasant and forthcoming about his products.

“Our user manual clearly states that the reusable portion of the fluid path must be sterilized before injecting any patients,” said Mr. Menassa. “For example, Dr. Benohanian has purchased several reusable fluid paths and sterilizes after every patient.”

Although here lies some confusion and thus the sole reason for publishing this article. A paper published by Antranik Benohanian M.D. and Danielle Brassard M.D., both of Saint-Laurent, Canada and fond advocates of the Med-Jet MBX, does not state the device must be autoclaved after being used on each patient.

“Multiple injections could still be performed on a same patient, but not on a subsequent patient unless the anticontaminant disposable device is changed to avoid cross contamination,” wrote Benohanian and Brassard (2010).

Herein the authors attribute the anticontaminant disposable device as being the protector cap and is distinguished separately from the jet injector. Nowhere was it stated the reusable components of the jet injector were to be autoclaved in between patients.

The authors reiterated, “When the tip of the nozzle comes in direct contact of the skin, the risk of cross-contamination may occur. This requires the replacement of the disposable nozzle with a sterile one before using the injector on a subsequent patient.”

Safety testing by Kelly and colleagues (2008) found a PCNFI device, manufactured by PATH and Pulse Needle Free Systems, USA, failed to prevent contamination past the protector cap barrier. In 8.2 percent of the samples, Hepatitis B was found to have gone through the protector cap and into the internal components of the jet injector. Most startling, researchers observed no visible bleeding at the injection site in 7 out of the 17 injections that tested positive for cross-contamination of the Hepatitis B virus.

At this time it remains unclear how the beauty clinic in Pretoria is using the jet injector. When asked about sterilization procedures, the beauty clinic failed to respond and ceased all further communication.

Med-Jet MBX and other PCNFI devices can be used safely as medical instruments. Although it is important for users to know replacing the disposable cap does not sterilize the jet injector. The device must be autoclaved before being used on each patient.

PCNFI devices are not to be used in administering vaccinations.

If you know of a Jet Infector currently being used please fill-out the form on the following link.

References:

  • (Benohanian and Brassard, 2010) Benohanian A, Brassard D, “Needle-Free Jet Injection Revisited”, Review Report, 2010.
  • (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.

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