LeEject 2 “Safety” Syringe and Needle System Receives FDA Clearance to Market
Posted on November 29, 2017
Posted on November 29, 2017
The LeEject 2 Syringe and Needle system has received the FDA clearance for sale. This unique system, protected by the US patent, differs from conventional dental syringe and needle systems because it allows the loading of the needles from the side portal and disposal of the needle without recapping and unscrewing.
The needle is secured by inserting it from the side and rotating the plastic sheath clockwise. The loading and unloading procedures of anesthetic cartridges are the same as the conventional dental syringe and needle system. The removal of the needle is very simple; by rotating the safeguard counterclockwise and inverting the syringe over a sharps container, and letting the needle fall into it, this eliminates the potential risk of recapping and unscrewing the contaminated needle. Interested readers are encouraged to visit the website, www.LeEject.com.
Dr. Alexander Lee, DDS, who has been overseeing the application process to the FDA for the past six years, commented that he is “very relieved and delighted at the same time.” During this time, he reflected that “[it] has been a total learning experience... when changes had to have been made in the syringe design by adding the plastic sheath, the self-aspiration claim had to be dropped, there was a change of filing agencies and I had to meet with several leading examiners from the FDA.
”The LeEject 2 system is safe, simple, and economical. Dr. Lee wants to concentrate on marketing towards dental schools, hygiene programs, and residencies by providing the systems at a reduced cost for them because inexperienced operators are more likely to sustain needle stick injuries.
Currently, OSHA prohibits recapping or removal of contaminated needles and other contaminated sharps unless the employer can demonstrate that no alternative is feasible. Because of the lack of alternatives in the market, recapping or needle removal must be accomplished using a mechanical device or a one-handed technique.
It has been shown that dental assistants are ten times more likely to sustain needle stick injuries than dentists. In that study, dental assistants have sustained needle stick injuries while cleaning instruments and trays, followed by changing a local anesthetic cartridge and recapping needles.
Although its ultimate success will be decided by the market this new addition to the dental syringe and needle system is welcomed by all dental professionals, especially those who want to protect themselves and their employees.
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