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Frequently Asked Questions

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.

  1. 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.
  2. 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.
  3. 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.
  4. The device must be disposed of in a designated sharp receptacle.

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 one-use-only limitations.

 

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.

  • SafetyTip™ 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.
  • SafetyTip™ can be used easily under low light conditions such as those in outdoor night emergencies.
  • SafetyTip™ 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 specialty needles.
  • SafetyTip™ is simple and intuitive to use, which reduces training costs and minimizes accidents and non-compliance.
  • SafetyTip™'s square base section provides positive gripping for assembly and disassembly, and the needle is covered at all times.
  • SafetyTip™ does not require assembly of multiple separate parts for use with the needle.
  • SafetyTip™ fits both plains tapered and treaded tapered luers and hubs, as well as other handles and hubs.
  • SafetyTip™ is equally useful to left and right-handed operators.
  • SafetyTip™ opens and closes with one hand, and can be closed by flipping the sheath shut against any hard surface.
  • SafetyTip™ 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.
  • SafetyTip™ can be opened and closed an unlimited of times.
  • SafetyTip™ 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 way.
  • SafetyTip™ 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 damage it.
  • Whether open or closed, the sheath allows fluid discharge from the needle.
  • SafetyTip™ 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 safety sheath.

 
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 is K993125.

 
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 SafetyTip™'s advantages?

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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