Revolution Medicals Safety Syringe and the Safety
Phlebotomy Device meet the “Desirable Characteristics of Safety Devices”
which include the following:
- The safety feature is an integral part of the device
- The safety device works passively (i.e. no activation is required by the user)
- The user can easily determine whether the safety feature is activated
- The safety feature cannot be deactivated and remains protective through disposal
- The device performs reliably
- The device is easy to use and practical
- The device is safe and effective for patient care
Based on the
engineering studies that have been conducted to date, the Company believes
that the licensed Safety Syringe and the licensed Safety Phlebotomy Device
can be manufactured at a cost that is approximately equal to the cost of
standard disposable syringes and standard phlebotomy devices.
Most of the safety
syringes that are currently available provide few safety benefits because
they require manual intervention to ensure safe operation. The safety
feature of these syringes generally consists of a shield or a sheath that
often requires the use of both hands to activate the safety device.
Although there are several retractable syringes currently available, they
rely on springs or rubber bands to retract the needle. Both of these
technologies have high malfunction rates, causing premature needle
retraction