Foley catheters are soft, plastic or rubber tubes that are placed transurethrally into the bladder to provide continuous drainage and relief when there is urinary retention, to monitor urine output for critically ill patients, to manage urination during surgery, and to provide end-of-life care. However, these indwelling catheter’s can increase the patient’s risk of death due to urinary tract infection itself or from complications (such as C. difficile associated diarrhea) that occur in response to antibiotics used to treat CAUTIs. For this reason, Foley catheters are recommended by the Centers for Disease Control and Prevention and the Infectious Diseases Society of America to be placed using sterile (aseptic) technique. Unfortunately, it is very challenging to maintain sterility throughout the multi-step procedure required for placement, particularly for females due to anatomic location of the female urethra and need for retraction of the external female genitalia (vulva) and common medical comorbidities such as obesity, edema, osteoarthritis and acute medical conditions such as altered mental status that impact the challenge of obtaining and maintaining correct positioning to enable sterile catheter placement.
The device, F3 is anticipated to be a single-use, sterile, disposable device that would be used to aid the sterile placement of transurethral urinary catheters (commonly known as Foley catheters) for Female patients. It is anticipated to be produced using a combination clear plastic and silicone. The basic version of the device has 2 core purposes and elements:
1) Labia separator: The device would have flared wings on bilateral sides to physically but atraumatically retract the labia major and minora tissues, enabling better visualization and access to the urethral meatus where the Foley catheter is placed.
2) Perineal shield: the posterior shield of the device covers the perineal tissues including the anus to prevent contamination of the sterile catheter with bacteria (particularly gastrointestinal bacteria).
1) The addition of lighting on the device such as a small LED light positioned to optimize visualization of the urethra during placement of the Foley catheter.
2) Easy-access to attached antimicrobial swabs used to cleanse the vulvar skin to create the sterile field needed for urinary catheter placement.
3) Small handle to assist initial placement, secure positioning, and in device removal after the urinary catheter has been inserted and secured.
4) Attachment for indwelling catheter to be loaded in a position that is helpful for guiding appropriate catheterization of the urethral meatus.
• Aid sterile insertion of transurethral Foley urinary catheters
• Female pelvic examinations
• Improved adherence to aseptic technique for female patients
• Fewer catheterization attempts needed before successful sterile placement of indwelling urinary catheter
• Improved patient comfort with Foley catheter placement by reducing the number or duration of catheterization attempts required
• Reduced rates of catheter-associated bacteriuria or infection, particularly for “early” catheter-associated urinary tract infections (<48 hours after placement).