1. Is SafeBoard considered a restraint?
Code 42 CFR 482.13(e)(1)(i)- A restraint is defined as any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely.” Interpretive Guidelines 482.13(e)(1)(i)(C)- A medically necessary positioning or securing device used to maintain the position, limit mobility, or temporarily immobilize the patient during medical, dental, or surgical procedures is not considered a restraint.” Therefore, SafeBoard is not considered a restraint.
2. How does SafeBoard limit incidence of infection?
SafeBoard is a single patient use device. After each procedure, if cuff becomes soiled it can be switched out. The device is attached to the patient, the extremity is then sterilized or cleaned (depending on procedure) to be used for the sterile procedure or other vascular access procedures. If applied correctly prior to extremity sterilization, there is no room for risk of infection. SafeBoard eliminates the "holder", therefore less medical personnel at bedside for a procedure, minimizing infection further.
3. How does the inflated cuff work when threading a guidewire and PICC catheter beyond the cuff? Does it need to be deflated during procedure?
SafeBoard is designed specifically for upper leg or upper arm placement for ultrasound guided PICC/Midline/PIVs and the cuff is attached below the level of insertion, therefore would not interfere with threading a guide wire or catheter. However the inventor suggests to deflate cuff through sterile drape/towels as soon as practical, even if only partially during completion of procedure. Once deflated, cuff still provides stabilization to extremity wile waiting on xray for placement verification.
4. How does the cuff keep the patient from rotating the extremity on the board?
If you have ever had your blood pressure taken you will know that rotating your extremity while the cuff is inflated is extremely difficult and requires great strength that babies/children under 3 years of age do not possess.
5. Are there any risks to injury such as fracture or other pressure related injuries based on the use of this device?
The safety of this device has been the number 1 priority throughout the design, development, and prototyping phases. SafeBoard has been used safely on over 260 patients ranging in age from 0 days- 10 years with no adverse events.
6. Are there safeguards on the pressure used to inflate the cuff? Is it possible to over-inflate the cuff?
SafeBoard has gone through extensive pressure testing on all sizes to determine minimum working pressure to stabilize the extremity. Those pressures have been incorporated into a pressure relief valve into the existing manual release in order to prevent over inflation of the cuff. This allows the operator/inserter to only inflate to a safe pressure and prevent unwanted adverse events related to circulation.
7. Does the device actually keep the extremity still in an agitated young child? What about the rest of the patient's body?
SafeBoard will allow for some movement of the extremity in the agitated child but is a tool that can reduce movement in comparison to medical adhesives and a "holder" that can possibly interfere with your sterile and working field. The rest of the patient's body and extremities are stabilized with a blanket as a swaddle or papoose. The inventor also encourages maximum comfort measures to be utilized appropriate to age and development including but not limited to; topical anesthetics, oral sucrose, nonnutritive sucking, swaddling, and distraction. Topical anesthetic is used local to the site of insertion to decrease pain and discomfort. Oral sucrose and nonnutritive sucking have been shown to help alleviate pain for newborns undergoing painful procedures. Child life specialists should also be utilized when available to help reduce distress in pediatric patients during medical procedures.