>Protectus Hypodermic Safety Syringe >Intellectual Property >Competitive Advantages
The Protectus Safety Syringe (formerly SquareOne Safety Syringe), the Company's lead product, is a patented, automatically self-sheathing safety hypodermic syringe. The Protectus Safety Syringe is designed to reduce or eliminate the dangers of accidental needlestick injuries to healthcare workers who may be pricked, scraped or injected by a needle before or after it has been injected and withdrawn from patients potentially carrying infectious bloodborne microorganisms. The Company has received 510(k) permission from the US FDA to manufacture, market, and sell its Safety Syringe in the US. No other permissions are required to manufacture and market the device. Protectus Medical Devices is managed and operated by experienced and dynamic leaders who have pioneered the development of safe and effective medical devices.
The Federal Law, the Protectus Hypodermic Safety Syringe
and the FDA
The Federal Law:
In July 1999, California became the first state to require the use of "Self-Sheathing Needles". This law mandates the use of "engineering controls," such as those embodied in the Protectus Safety Syringe device. Federal legislation requiring healthcare employers to supply 'the best available safety devices,' similar to the California law, was passed and signed into law by the President of the United States and has been in effect since April 2001 (see Public Law 106-430).
The Protectus Medical Safety Syringe:
The Protectus Safety Syringe design meets all aspects of the functional definition of "Self-Sheathing" mandated by Federal Law and is designed to reduce or obviate all dangers of accidental needlestick injuries to healthcare workers who could be pricked, scraped or injected by a needle before or after it has been injected and withdrawn from patients and therefore potentially carrying infectious bloodborne microorganisms. The Protectus Safety Syringe design utilizes a spring-biased locking sheath that is/becomes automatically locked and safe if the user does not have or loses intentional control of the device. The device has a user-friendly slide collar lock that allows the syringe to be used in essentially the same manner as any standard syringe with little special training or in-service instruction.
The DIFFERENTIAL ADVANTAGES of the Protectus Safety Syringe over the competition that are of paramount importance to the users, decision-makers and employers are:
- The device is automatic, self-sheathing, requiring no intentional activation by the user.
- Has a permanent lock easily activated after injection.
- The needle can be changed or replaced safely without exposing an unprotected needle.
- Functions as a standard hypodermic syringe with its added safety features.
- One can safely transport the syringe without recapping the needle.
- The sheath maintains a barrier between the hands and the needle when not in use.
- The device cannot be locked with the needle exposed.
- The syringe is locked and safe if intentional control of the device is lost.
- The device is user-friendly and has shown strong acceptance in clinical trials.
- The syringe is fully compliant with federal and state laws and with the OSHA mandate.
- Use of the device provides immediate healthcare cost savings to the user institutions.
- The Protectus device is cost-effective.
The Protectus Safety Syringe Acceptance and Approval:
In full-comparison clinical trials, the efficacy of the Protectus Safety Syringe was clearly demonstrated and, on this basis, Protectus Medical has received permission from the FDA to market and sell the Protectus Safety Syringe as a Class II non-significant risk device. No further approvals are required from the FDA to market and sell this device.
In summary, Protectus Medical Devices, Inc. has developed a revolutionary, proprietary, patented design for a Safety Syringe that can be manufactured and sold at the low end of the safety syringe pricing spectrum. Based on the results of full-comparison clinical trials, the Protectus device has received the required 510(k) permission from the U.S. FDA to market and sell the device in the U.S. The Protectus Safety Syringe provides a tremendous marketing advantage over competitive devices, especially since Federal legislation now requires the use of safety syringes in all applications, particularly those that are automatic and self-sheathing.