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Qualitative Clinical Studies on the SafetyTip™ Needle

As the Director of clinical trials for Safety Medical Supply International, Inc., I completed clinical trials of our SafetyTip™  product line at Harvard Medical facilities. These trials included phlebotomists, nurses and physicians with 95 participants in the study. There was over 90% positive response regarding preference of SafetyTip™  over their conventional needles.

Qualitative Results Summary:

100% of the participants preferred the Safety Tip over their conventional needles

96% preferred the SafetyTip™ over their other safety needles, and emphasized the user friendliness of the device. The other 4% noted no real difference aside from a general favorable experience and greater ease.

  • 100% found the needle device to be secure and stable with filling and evacuation of the syringe.
  • 100% found the devise to be operator friendly.
  • 100% found the technique easy to master.
  • 100% enjoyed the overall sharpness of the needles, especially when compared to conventional needles.
  • 96% said that they would recommend SafetyTip™  for clinics, labs, and hospitals; 4% did not comment on recommending.
  • 98% noted the security for one-handed shielding; 2% felt that they would be more secure with added usage.
  • 100% found the device to have ease of transport prior to use.
  • 100% enjoyed the ease of both assembly and disassembly.

The following summarized reports of clinical trials should also be of interest because of the diversification of the subjects in the study.

  1. According to a clinical trial  administered by Keith Crawford, M.D., PhD a senior research scientist at CBR Institute of Biomedical Research, the phlebotomists evaluated the needles with regard to stability of packaging, esthetics, ease of assembly, ease of use, needle sharpness, and reliability of cap and hinge unit. In every category, there was a 90% or better response in regard to ease of assembly, disassembly, and transport, user friendliness, stability and security of the product, as well as needle and cap quality. Over 90% preferred the SafetyTip™ over the conventional syringe and would highly recommend it to health care organizations.
  2. According to the paramedic/EMT group trial conducted by Christopher George (paramedic 853158), the trial highly recommended SafetyTip™  products with over 92% feeling secure with the products in emergency situations, stressing the ease of use, the stability and reliability of the products, the ease of assembly and disassembly, the sharpness of the needle, and the ease of transport. An overall unanimous endorsement was made for SafetyTip™  products in emergency situations where reliability and ease of use is always an issue. Its use in critical care settings was especially lauded. Over 92% said that they would be willing to recommend the needles to other hospitals, clinics, and labs. George says, "I just wanted to thank you for your SafetyTip™ syringes. I work as a paramedic and if it was not for your syringe's safety mechanism I would have been stuck by the syringe. I was treating a patient with very bad CHF (Congestive Heart Failure) and the patient needed to be intubated. The patient need to be given Versed to relax her slightly so I would be able to intubate her while she was seated in full-fowler's position. I drew the Versed up in a SafetyTip™ syringe and then after giving it I was able to place the safety mechanism and then because I was in a moving ambulance placed it next to the tech-seat on the shelf. I then had to stand up to intubate the patient. After placing the tube however I went and sat back down, directly on the needle. The needle had fallen off the shelf while I was intubating her and if it was not for the safety mechanism on your syringe I would have suffered a needle stick injury. I just wanted to say thank you for your product, and I would recommend it to all health care professional.."
  3. In a clinical trial performed within the gastrointestinal/internal medicine department at the Newton Wellesley Hospital. Headed by Carla H. Ginsburg, M.D., M.P.H., the study over a two month period, reported an overwhelming endorsement for SafetyTip™ , particularly with their concern with needle stick injuries and their serious consequences. In every category of evaluation, there was over 90% positive response, and summarized their findings by stating  "This group is extremely positive about the Safety Medical Products and look forward to their widespread use in preventing needle stick injuries".

Michael A. Greenwald, M.D. Clinical Trial Investigator

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