Community Medical Foundation for Patient Safety

The Community of Competence™ and Foundation for Life

Evaluation of Medical Devices and Equipment

Members of our research team in clinical and biomedical engineering review the design and application of medical devices and equipment for efficacy and safety.  Items must be approved or cleared by the U.S. Food and Drug Administration (FDA) as a Class I, II or III device, accompanied with proper documentation and contract for evaluation.

Currently, we are evaluating the FDA device class 2 Sensokinetogram (SKG), a registered product of Red Oak Instruments, LLC,  for rapid, noninvasive screening of mild traumatic brain injury (mTBI) or concussion for military and  sports medicine applications.  The project is intended to improve triage and the earliest detection of  mTBI in the military and civilian theaters, such as battlefields and emergency medicine.  

Another medical device that is under evaluation for patient safety is the Yeescope™, a fully disposable, rigid laryngoscope (FDA  device class 1). Disposal laryngoscopes, widely used outside the U.S.,  may  significantly reduce and prevent cross-contamination and nosocomial infection among patients during surgery.

Both devices are registered with and cleared by the U.S. FDA  for domestic market and application.  For more information about evaluation of medical devices and our IRB process, please contact us.