SAFhandle™ : Preventing the Unpreventable

The SAFhandle™ safety scalpel system is a logical re-engineering of the conventional scalpel blade and handle- designed to achieve the optimum balance between employee safety and the effective delivery of optimal healthcare while mitigating costs. It consists of:

The SAFhandle™ safety blade is a passive device with a round-tip instead of a sharp-tip to prevent accidental stab wounds. Round-tipped blades are identified as an example of engineering controls to prevent needlestick injuries by CDC, AORN and EPINET.

The SAFhandle™ reusable metal handle safety scalpel is a stainless steel handle with the exact shape, dimensions, weight, grip and balance of a conventional scalpel which Surgeons prefer and allows them to focus on patient care.

The engineering control of the innovative handle/blade fitment locking system allows hands free removal of blade, in compliance with OSHA¹ and CDC requirements² and dispenses with the need for blade remover devices. The lock prevents the possibility of the blade being dislodged due to a sudden movement or a collision.

PROTECTION DURING USE WITH ENHANCED PERFORMANCE
The SAFhandle™ safety scalpel system will exceed the cutting performance of conventional scalpels due to the innovative blade fitment and locking system which reinforces and strengthens the blade and greatly enhances cutting action and control. Surgeons will be delighted with its precise and robust cutting action and the confidence it inspires.

OSHA AND FEDERAL REGULATION COMPLIANCE
The system provides an easy to use and cost effective solution for OSHA and federal regulation compliance.

MEETING YOUR TEAMS NEEDS
In addition to protection during use, the features of the system meet the needs of surgeons, nursing staff, risk management and materials management.

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REFERENCES: ¹OSHA-In situations where an employer has demonstrated that the use of a scalpel with a reusable handle is required … the blade removal must be accomplished through the use of a mechanical device or a one-handed technique [29 CFR 1910.1030(d)(2)(vii)(B)]. ²CDC, Workbook for Designing, Implementing and Evaluating a Sharps Injury Prevention Program.

	For the Surgeon
	1. A stainless steel handle with centimeter scale that weighs and feels like a conventional handle, requiring no change in technique. 2. SAFhandle™ exceeds the cutting performance of conventional scalpels due to the innovative blade fitment system which greatly strengthens the blade and enhances cutting action. 3. Suitable and safe for Arthroscopy. 4. A complete range of carbon and stainless steel blades available.

	For the Nursing Staff
	1. Round-tippped blades protect against accidental stab wounds. 2. Innovative fit and lock system is safe and easy to load the blade. Protects against sudden movements and collisions 3. No change in aseptic technique. 4. Hands free technique for removal of blade. 5. Blade remover units not required. 6. Requires very little training.

	For the Risk and Materials Managers
	1. No increase in inventory space needed. 2. No increase in volume of sharps waste. 3. Sharps disposal containers, counting trays, methods and equipment for cleaning handles and handling methods require no change. 4. Durable stainless steel handle with extended life. 5. Provides an easy and cost effective way to comply with OSHA standards and federal regulations

Blade sizes: SAFhandle™ safety (round-tip) blade sizes: 10, 15, 20, 21, 22, 23 and 24. Conventional No.11, 12, 12D and 15C scalpel blades are compatible with SAFhandle™ reusable metal handles.

Handle sizes: SAFhandle™ reusable metal handles with centimeter scale in sizes No. 3, 4, 3L and 4L.

Materials: SAFhandle™ safety blades are available in surgical grade carbon and stainless steel. The SAFhandle™ handles are assembled in India using components and surgical grade steel made in Germany.

Packaging: The SAFhandle™ safety blades are available in cartons with 3 unit boxes of 50 blades each. The SAFhandle™ reusable scalpel metal handles are packed in a unit box of one handle. Each carton contains 6 unit boxes.

Fitment: The SAFhandle™ safety blades are compatible with the SAFhandle™ reusable scalpel metal handle as well as conventional scalpel handles conforming to ISO 7740:1985 standards. SAFhandle™ reusable metal handles are compatible with most conventional blades. Reinforced- back blades are not compatible.

Sterilization: SAFhandle™ safety blades are sterile. SAFhandle™ metal handles are supplied non- sterile.

Standards: Standards: BS 2982:1992, ISO 7740:1985, ISO 7153-1:1991, EN 10088-3:2005

Cleaning and Sterilization of Handles: Cleaning and Sterilization of handles manual, washer-disinfector and ultrasonic cleaning methods and sterilization by steam autoclave.

Recommendations: It is recommended that the SAFhandle™ safety scalpel system be used in conjunction with work practice controls by OSHA and CDC.

OSHA and Federal regulation compliance: The system provides an easy to use and cost effective solution.

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Recommendations: It is recommended that the SAFhandle™ safety scalpel system be used in conjunction with Work Practice Controls such as neutral zones, as recommended by OSHA, AORN, CDC and ACS.

Warning: Used sharps are contaminated. Disease may occur from injury. Handle carefully. Refer to OSHA, AORN, CDC or other local standards setting organization guidelines.

Disclaimer: Should only be used by persons who are trained in the use of the product.