FAQ

1 

Why do hospitals need a safety scalpel?

Because the traditional blade poses a risk and is the second largest cause of stab wounds.

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What is it about the scalpel blade that makes it unsafe?

The point of the blade can result in accidental stab/needle stick wounds and is the cause of most injuries.

A recent study published by the American College of Surgeons titled, ‘Increase in Sharps Injuries in Surgical Settings Versus Nonsurgical Settings After Passage of National Needlestick Legislation’ reported the following data relating to sharps injuries:

Of the top three devices that cause sharps injuries, suture needles, scalpels, and disposable syringes , the majority of injuries occur near the beginning of the use-disposal cycle—that is, during use, while passing the device, or between steps of a multi- step procedure. Injuries during these early phases accounted for 83.5% of suture needle injuries, 69.8% of scalpel blade injuries, and 51.9% of injuries from disposable syringes.

These findings are significant because they reveal that scalpel blade injuries cannot be prevented by safety scalpels currently available on the market, because these scalpels are loaded with a sharp tipped blade. Safety scalpels currently available are designed to prevent injuries when passing scalpels hand to hand and NOT when the scalpel is being used in a surgical procedure.

It is imperative that we recognize this and use scalpels that prevent injuries, not only during passing, but also during use.

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What percentage of surgeons, currently use a Safety Scalpel?

Approximately 5 % in OR. The arguments of the surgeons that they need a weighted scalpel and that the active parts of the safety scalpel pose an additional risks have been proven to be real issues behind the poor conversion rate of healthcare facilities to safety scalpels.

4 

What else can hospitals do to prevent sharps injuries?

The CDC and OSHA both recommend that safer work place practices such as not passing sharps from hand to hand and instead using a pre determined zone or tray for placing and retrieving sharps, need also to be institutionalized.

For example, it is not enough that we drive cars designed for safety but that we also drive safely.

5 

So what needs does the SAFhandleTM reusable scalpel metal handle and SAFhandleTM Safety blade system meet?

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The SAFhandleTM reusable scalpel metal handle and SAFhandleTM safety blade system meets the performance and safety needs of the Surgeons, Nursing Staff and Hospitals.

The SAFhandleTM reusable scalpel metal handle is a fully stainless steel handle with the EXACT shape and dimensions of the traditional scalpel handle and meets the need of the Surgeon for a weighted scalpel that does not require a change in technique. Additionally it enhances cutting performance.

It has been redesigned so that it is safer to load the blade and to remove the blade WITHOUT touching the blade meeting a very important safety need of the Nursing Staff.

The SAFhandleTM safety blade is a blade that has a rounded tip rather than a pointed tip as recommended by the CDC in its workbook on Sharps Injuries Prevention, AORN and also by EPINET in the their Sharps Injury Prevention Checklist. The rounded tip of the blade has been designed so that accidental stab wounds will not usually result in a sharps injury.

This common sense design minimizes the risk of injuries during use, while passing the device, or between steps of a multi- step procedure.

Since the size of the handle and blade is the exact same as that of traditional scalpels, inventory space in hospitals will be the same. The cleaning methods of handles, disposal containers, counting trays etc all will be the same. All these factors will be an important for Hospitals to manage their costs.

6 

Are there any additional advantages to the SAFhandleTM reusable scalpel metal handle and SAFhandleTM Safety blade system?

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Whilst the RIB back blade is not a stated need of surgeons there is an overwhelming preference for the RIB back blade. The RIB back blade is not sharper than blades of other makes. It just feels sharper-sharpness is perceived and cannot be measured objectively. It feels sharper because the Surgeon is able to apply more pressure on it and because it does not deflect as much when cutting hard tissues. Other blades, in comparison feel flimsier.

The SAFhandleTM scalpel handle will reinforce and strengthen blades and greatly enhance cutting action and control, due to its innovative blade holding and locking system. The lock prevents the possibility of the blade being dislodged due to a sudden movement or a collision.

Current designs of Scalpels do not meet the needs for Arthroscopy and OSHA has accepted that traditional scalpels may be used. The Arthroscopists use a No. 11 blade to make a stab incision (we cannot therefore make a round tipped No.11 blade) and when pulling the blade out, often will twist it. This is when the blade will break because blades have been designed for limited lateral pressure.

The SAFhandleTM reusable scalpel metal handles has been designed so that the blade deflection is reduced to a minimum and a much higher lateral pressure can be applied to the blade.

7 

Are there similar products available in the market ?

Blunt tip suture needles (the largest cause of sharps injuries) are already available. Blunt tip suture needles are recommended and approved by the OSHA, NIOSH, CDC, American College of Surgeons and AORN amongst others. Multiple studies have reported the effectiveness of blunt-tip suture needles in decreasing percutaneous injuries. A Centers for Disease Control and Prevention (CDC) study of suture needles in gynecologic surgery found a statistically significant reduction of injury rates when blunt-tip suture needles were used.

We are convinced that round (blunt) tip scalpel blades will also contribute to a statistically significant reduction of scalpel injury rates.

8 

What are DiamantineTM High Performance scalpel blades? What benefits do they provide?

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DiamantineTM High Performance Safety Blades are manufactured to precise angles; the cutting edge is coated with a diamond like material which is biocompatible and highly corrosion resistant, using an environmentally friendly process. The are available in three variants
(a) safety round tip blades (b) conventional Blades (c) extra strong conventional blades. 

This DiamantineTM specification enhances initial sharpness, strength and sharpness retention and will particularly meet the needs of Orthopedic and Plastic Surgeons. Laboratory testing shows significant performance improvements over the best conventional scalpel blades.

Combined with the SAFhandleTM safety reusable scalpel handle, these high performance blades will provide optimum performance and safety. 

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