What is the SafetyTip™ Safety Needle?
SafetyTip™ is a patented, state-of-the-art
user-friendly medical hypodermic needle device with
an integral safety sheath. SafetyTip™ prevents
needle-stick injuries while providing healthcare
workers with a simple and high-quality tool.
SafetyTip™'s key function is to replace the
obsolete, separately capped needles in use on
catheters, IV assemblies, prefilled cartridges,
vacutainer-style phlebotomy sets, hypodermic needles
and other needle devices. Both separately capped and
other self-capping devices on the market require
two-handed interaction with the apparatus after use
and before disposal. This two-handed interaction
dramatically increases the risk of needle-stick
injury and subsequent infection to the health care
worker. By contrast, SafetyTip™ allows efficient
one-handed uncapping and recapping of the needle.
How is SafetyTip™ used, step by step?
The SafetyTip™ safety needle is packaged and
shipped in a sterile package.
- The package
is easy to open, and the needle is simple to
attach to the various receiving instruments-just
like a standard needle. SafetyTip™ also comes
pre-attached to a disposable syringe.
- The operator
then simply flips SafetyTip™'s safety sheath
open by pulling back on the lip at the top of
the sheath, or by pinching the sheath just above
the hinge so that the sheath snaps out of the
retaining catches on the hub of the needle.
Click to see video.
- To recover
the needle, the operator may flip the device
shut with one finger, or by pressing the sheath
back in place against a hard surface; the
retaining catches on the hub of the needle lock
the flanges securely in place. Either of these
closing methods is performed one-handed.
- The device
must be disposed of in a designated sharp
SafetyTip™ can be opened and closed any number of
times, allowing an operator to load a medication,
close the sheath temporarily, then expose the needle
again for use as required. This flexibility supports
widespread acceptance of the device, as SafetyTip™
does not frustrate the operator by imposing
What are SafetyTip™'s advantages over other
products and methods?
SafetyTip™ has numerous advantages over
conventional needle devices and over all other
safety needle devices. Existing anti-needle-stick
systems are either expensive, complex, difficult to
assemble or disassemble safely, require extensive
training, or are limited in their applications.
is a niche product that fills a specific market
need. It is less expensive and easier to use
than other safety needle products on the market.
can be used easily under low light conditions
such as those in outdoor night emergencies.
can be used with most classes of needle devices.
- One sheath
size fits A lengths and diameters of needle up
to 1.75", and could be as long as 3" for
is simple and intuitive to use, which reduces
training costs and minimizes accidents and
square base section provides positive gripping
for assembly and disassembly, and the needle is
covered at all times.
does not require assembly of multiple separate
parts for use with the needle.
fits both plains tapered and treaded tapered
luers and hubs, as well as other handles and
is equally useful to left and right-handed
opens and closes with one hand, and can be
closed by flipping the sheath shut against any
can be closed with one hand the moment the
needle is removed from the patient's skin. The
operator's hands remain behind the sheath and
away from the needle as the device is closed.
can be opened and closed an unlimited of times.
stays open in any position without impeding the
operator's visibility or use. The device allows
accurate placement and penetration into the
patient's skin or the target-receiving device
with full needle-tip visibility at all times.
- When open,
the safety sheath stays out of the operator's
is effective before, during, and after needle
use. The device remains safe during transport
and after disposal.
- The safety
sheath does not touch the needle and cannot
- Whether open
or closed, the sheath allows fluid discharge
from the needle.
design allows adaptation for use as a
double-ended vacutainer needle. The design is
also ideal for blood gas kits.
- The disposal
volume SafetyTip™ requires is the same as that
for conventional needle devices, which helps
control disposal costs.
What is new about SafetyTip™?
The sheaths of many safety needle patents are
slotted, have some sort of pin hinge or living
hinge, and require some means of holding the sheath
in place over the needle. Most of these devices
physically engage the needle itself in order to
remain shut. SafetyTip™ avoids this common flaw by
employing a simple catch mechanism to secure the
Does SafetyTip™ have it FDA 510-K?
Yes, the U.S. Food and Drug Administration has
issued the 510-K, regulatory Class 11. 510(k) Number
What is the patent status of SafetyTip™?
SafetyTipTM Needle was granted a PRC (Peoples
Republic of China) Patent # 97,246,193 in December
2000. SafetyTipTM Needle, the U.S. Patent #
6,575,941 awarded on June 10, 2003, is a Single Use
Only product. Patents have also been approved in
numerous other countries worldwide. SMSI owns the
sole license to manufacture and market this patent.
Have tests been conducted to confirm
Yes, during the testing that was part of the
FDA's 510-K process, experienced health care workers
operated the device and confirmed that SafetyTip™'s
advantages over conventional needle devices and
other safety products are significant. The health
care professionals felt that being able to close
SafetyTip™ with a quick, one-handed motion was a
distinct and unique benefit. In addition, the health
care workers who tested the device liked SafetyTip™
's simplicity and ease of use, similarity in size
and functionality to standard needles, and the
multiple closure cycles permitted by the device.
Furthermore, users found that the square section
imparted additional leverage for assembly and
disassembly, which added to the safety and
convenience of the device.
The SafetyTip™ design specifically allows
compliance by the user, it does not force
compliance. For this reason as well, the device
receives excellent reviews from the health care
workers who have had the opportunity to use this
safety needle. The SafetyTip™ helps clinicians to
protect themselves against accidental needle-sticks
in a pro-active and convenient way. Because it
permits the user maximum flexibility in how the
device is utilized, the SafetyTip™ enjoys very high
acceptance rates among health care professionals.
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