The new ClearCut™ S Safety Series safety scalpel is a disposable surgical incisional instrument used during cataract surgery. The patented retractable blade guard protects doctors and nurses from accidental sharps injuries; reducing injuries and minimizing the potential spread of infectious disease. Intuitive single-handed activation enables protection with minimal change to typical workflow.

During cataract surgery, the surgeon is working with his eyes glued to a binocular microscope and is handing scalpels and other sharps very quickly between him/her and an assistant, for a set of cuts that only take a few seconds to perform. The primary challenges included:
• design of an easy to use, self-evident, ergonomic and reliable mechanism
• clear tactile, visual and audible feedback as to the state of the guard
• accomplishing objectives with a minimum of parts
• designing for high volume manufacturing and assembly

The intent of this project was to improve safety in the operating room. From sharp injuries to sterilization and contamination, the tool needed to address the wellbeing of surgeons, their staff and patients. A big part of this required the team to carry out human factor research & analysis.

Additionally, as an extension of their reputable ClearCut™ incisional platform, the project needed to maintain certain manufacturing processes. Our integrated team of industrial designers, research and engineers optimized the design for efficient manufacturing and over all user friendliness.

The design team implemented extensive user research throughout the process. From user testing, interviews and competitive reviews the design team ensured all safety concerns were properly addressed. The new line of scalpels provides benefits to users, patients and the manufacturer:

For the user
• easy to understand and use with a prominent activation button, accessible with either thumb or pointer
• one handed
• anti-roll features that keep the tool oriented face up on the prep table so the markings indicating the type of device can be very clearly seen
• non-slip grip features to keep the device firmly in hand / for precise control
• a cylindrical cross section so the device can be easily rolled in the finger tips to the proper orientation for use
• color coded trigger buttons for blade identification within the family of tools
• flexible design that can accommodate a number of different hand positions that surgeons will routinely use for actuation, with forefinger or thumb
• common handle / shield assembly to accommodate the full range of blades – this provides common fit and feel across the product line
• clear safety shield for visual confirmation of blade type

For the patient
• shield protects the blade from becoming dull or ragged enabling more accurate incision
• minimizes the chance of incident between the ophthalmologist and assistants so the procedure is uninterrupted
• provides a safer, more sterile environment for the patient, limiting the chance for infectious disease transfer from medical staff to patient

For the manufacturer
• compliant with existing osha regulations for safety devices
• improves profitability through higher average selling prices and market share gains

Cataract surgery is a high volume procedure so speed is critical, and safety is paramount (for patient & medical staff). More than 3 million cataract surgeries are performed in the U.S. each year. And with each procedure performed with traditional scalpels, there is risk of accidental sharps injury while passing the scalpel from assistant to surgeon.

The CDC estimates that there are “between 600,000 and 800,000 needlesticks and other percutaneous injuries that occur among healthcare workers annually.” The primary benefit of the device is to assure safety to the physician, nurses and assistants handling the device minimizing the potential for infection from inadvertent scalpel cuts. The ease of use, and intuitiveness, of the device are such that the safety features they employ are likely to be much more routinely used in ophthalmic surgery. ClearCut provides significant safety features while maintaining the precision and price point the market demands.