Author: Nova Szoka, MD
PenBlade by PenBlade, Inc. is registered as a Class 1 device with the FDA – registration number 3010780223.
PenBlade is a single-use safety scalpel with a retractable steel blade. The device activates like a click pen and retracts via a separate button near the front of the handle, allowing the user to sheath the blade without having to change grip position. PenBlade also contains a trimming groove which allows the user to cut sutures.
Following passage of the Needlestick Safety and Prevention Act in 2000, the implementation and acceptance of safety needles drastically decreased the rate of needlestick injuries, however healthcare workers largely rejected safety scalpel designs, leading to unchanged scalpel injury rates1. To date, only 15% of operating rooms use safety scalpels. Some of the barriers to safety scalpel adoption include poor ergonomics, cumbersome safety activation mechanisms, blade dullness, and low weight compared to traditional scalpels. The PenBlade device addresses these issues as the intuitive click-pen action uses existing muscle memory, the front-positioned release button retracts the blade without hand movement, the high quality stainless-steel blade provides superior sharpness improving blade control and minimizing pressure needed to cut structures, and the device weighs 50% more than similar safety scalpels.
For use in similar conditions as a traditional scalpel.
1 Jagger, J., Perry, J., Gomaa, A., & Phillips, E. K. (2008). The impact of US policies to protect healthcare workers from bloodborne pathogens: the critical role of safety-engineered devices. Journal of Infection and Public Health, 1(2), 62-71.