Mission Statement

Discovery of HIV and increased awareness of hepatitis B and C has led OSHA to issue the Blood borne Pathogens (BBP) Standard in 1991 to protect healthcare workers in the U.S. The BBP Standard includes the idea of universal precautions, requiring employers to provide personal protective equipments and medical safety devices such as retractable needles, and implement work practice controls, and banned recapping such as hypodermic syringes. Prior to this, physicians and dentists did not wear gloves for routine exams and treatments.

The Needlestick Safety and Prevention Act of 2000 has urged healthcare workers and the industry to seek out these medical safety devices. Hypodermic syringes, angiocath needles, and other needles for blood sampling were disposable, yet problems arose with the disposal process, and needlestick injuries were still occurring. Medical safety devices were mostly hypodermic syringes, angiocath and others, in which needles could be either retracted or re-sheathed for safe disposal.

The current dental aspirating syringe and the disposable needle have been in use for more than fifty years and have served the profession well up to now. The method of detaching needles from the syringe, i.e., recapping and unscrewing the needles, has been a problem for dental professionals for some time. Because there has been a lack of better alternatives, OSHA and CDC still recommend recapping by one handed scoop technique or using a recapping device in dentistry despite its own danger of recapping.

In a research article, it has been shown that dental assistants (75%) have sustained needlestick injuries more than dentists (7%) and hygienists (18%), and 86% of the injuries among assistants were due to the syringe needles. Dental assistants have sustained most of the injuries while cleaning instruments and trays (24%), followed by changing a local anesthetic cartridge (19%) and recapping a needle (18%). (Shah, SM. et al.; Percutaneous injuries among dental professionals in Washington State, in BMC Public Health 2006, 6:269)

Physicians and nurses routinely dispose of the medical sharps by themselves. Why do dentists delegate the disposal of the needles to assistants? Presumably, because disposing the used needles is cumbersome, non-essential, and time consuming. This is the problem associated with the current dental syringe and needle system. Recapping is not the only issue, but the whole disposal process has to be safe, simple and easy for everyone to reduce needlestick injuries.

What is the worth of your safety? When you buy the LeEject 2 syringes and needles, you are not just buying needles; you are buying safety and convenience for you and your staff.

There are dental professionals who have contracted serious diseases by needle stick injuries. I intend to help the victims with the profits from the LeEject 2 system sales since I have there myself.

Let's keep our workplace safe. Let us be more aware of potential dangers.

We are committed to reducing needlestick injuries by designing safer dental devices, as well as through education and prevention.

The Safety Shot Cartridge Syringe and Needle System

Our innovative idea of loading the needle from the side port was developed quite some time ago and initial samples were made. We first pursued attempts to license the system, but a lack of responses from manufacturers led to abandoning the idea of licensing.

After a long pause, contract manufacturing was decided upon. The search for a manufacturer who would commit to a novel and unproven product was a long process. Then, contract negotiations and building mutual trust took some time. There were numerous revisions, refinements and discussions about quality control for the syringe and needle models.

The U. S. Food and Drug Administration (FDA) application process is a long process and saw many adjustments. The basic design of the syringe was changed by adding the plastic sheath to secure the needle, the agency used for filing with the FDA was changed, and the leading examiner of this product at the FDA was replaced during the process. The claim of self aspiration was dropped during the FDA application and self-aspirating syringes are no longer available in the US market.

Alexander Lee, DDS

Dr. Alexander Lee had a vision of the LeEject system and has been working to bring this product to market.He attended the University of Michigan, for both his undergraduate degree and dental school. After spending some time in private practice of general dentistry, he completed the oral and maxillofacial surgery residency at the Montefiore Medical Center, Bronx, NY.He maintains oral surgery practices, is married, has three children, and lives in New Jersey.

President’s Message

"Our goal of reducing the needlestick injuries in the dental community is real and important, and hopefully many people can benefit from the Safety Shot system including the developing countries."

The first needlestick injury I have sustained happened more than twenty years ago when I was an oral surgery resident. I was called in to evaluate facial trauma on a patient who was involved in a motor vehicle accident and had sustained multiple injuries. When I got to the ER, there was a young patient who was intoxicated on alcohol, combative. Four point restraints were placed on this patient, there were contusions and lacerations in the facial area, medical history was still being obtained, chest x-ray was being filmed... A nearby ER nurse said, "Don't just stand there. Start an IV line or something." I had proceeded to start an IV line. As I stuck an angiocath on his arm, the patient jumped and I stuck myself with the same needle. This was the time before the CDC came out with protocols for the needle stick injury, and hepatitis C was known as non-A, non-B hepatitis. The first level trauma center can be an intimidating place, especially for those who just started their residency.

The second needlestick injury I had sustained happened a few years after my residency. We were extremely busy that day and behind schedule. The bloody instruments on the trays were just piling up no matter how fast the assistants worked. We were nearly running out of sterile instruments. I was compelled to help to put away some instruments on the trays. Underneath the bloody gauzes, there was an uncapped needle. As I was recapping the needle, I stuck myself. This was the time before the one hand scoop technique was taught or recapping devices were available. Afterward, I came across friends who also had sustained needlestick injuries and were undergoing mental anxiety.

It has been over 10 years since the concept of the LeEject system has been conceived and the first prototypes were made. Making the LeEject system commercially available was thought to be the remaining challenge. The prototypes were shown to the US manufacturers of the syringes and dental needles. My personal health problems, family priorities, and setbacks in the dental practice prevented me from moving on. Eventually the lack of responses prompted me to find other manufacturers overseas who shared my dream and could manufacture the products at reasonable costs. Financing the moldings and the new assembly line was a big step to take. After the initial batches, these products had to be re-designed and modified until they were satisfactory. Marketing this new innovative product is also challenging. In this unchartered course, it has been difficult to maintain enthusiasm despite delays and disappointments.

Several people have contributed to the design and modifications of the needle and syringe system. Initially, it would have been impossible without the help of my patent lawyer, Mr. Chris Garvey. I appreciate the needle and syringe manufacturers on their tireless supports despite the several modifications. Also, I owe appreciation to the advertising firm, Crebrand, and MDI Consultants, especially Ms. Maria Griffin, who has been helping us with the FDA application. The next contributor would be the FDA team who has asked many valid questions, and the process helped us to prepare revisions and modifications. Lastly, I appreciate the many evaluators who have raised many valid points and we have tried our best to meet those questions and criticisms. We are grateful that we had the chance to modify and upgrade the LeEject system.

Few U.S. dental schools are willing to evaluate and use the system. On the other hand, the responses from the dental hygiene programs have far exceeded our expectations and many are waiting for immediate use. We have set aside 10,000 syringes and 500,000 needles to be distributed to US dental schools and hygiene programs, free of charge after FDA clearance. The FDA is trying to protect dentists and hygienists from possible human errors in using the LeEject system, and we are trying to protect the dental healthcare professionals from the preventable needlestick injuries. The major US distributors have shown interest in carrying the LeEject system and we have made sales in other countries and are making strong progress to sell in Europe. After May 2013, the EU countries are banning the recapping of the used needles.

Our goal of reducing the needlestick injuries in the dental community is real and important, and hopefully many people can benefit from the LeEject system including the developing countries.

We started this business in May of 2011 and we made some progress. Currently, we are working on other projects such as a safer and easier delivery of injectable drugs, new different formulas of local anesthetics for dentistry, and new areas that cannot be disclosed at this time. Rather than drawing up drugs and labeling from the vials and ampules, the empty cartridge and needle can be discarded together. The cartridges and the plastic syringes, which can be color coded, would reduce human errors, save time and medical wastes, especially for busy OR's and ER's. For the local anesthetics in dentistry, wouldn't it be nice if we could come up with a formula where the numbness would disappear after one hour and have a wide margin of safety? For a prolonged procedure, dentists could use a local anesthetic, which has rapid onset, long duration and good hemostasis.

We are "staying hungry and foolish" as the late Steve Jobs advised.