FAQ
Frequently Asked Questions about the RF Surgical Detection Systems.What is the detection range of the RF Surgical Detection System™?
Is the scanning wand disposable or reusable?
Is the scanning mat reusable and what is the estimated life of the mat?
What is warranty on the RF Assure Detection Mat and Blair-Port Wand®?
Does the RF Assure Detection Mat need to be sterilized?
How is the RF Assure Detection Mat sanitized?
Can the wand be re-sterilized?
What does it cost to use the system in an average surgical case?
Is the energy source harmful to the patient or clinical staff?
Does the system count sponges?
How does the system help rectify miscounts?
Is there anything in the OR that could trigger a false detection?
If the sponge count is correct should the patient still be scanned?
Should the system be used on every surgical case?
Will OR procedures need to be altered to use the system?
Will RF Surgical provide assistance during a system evaluation and implementation?
What types of sponges, gauze and towels are available with the system's RF tag?
Will the RF Surgical Detection System™ detect instruments?
Does the console have UL approval?
Can the RF Assure Detection Mat be used along with bean bags?
Is RF Detection technology suitable for Bariatric cases?
What is the detection range of the RF Surgical Detection System™?
The system is rated to detect tagged objects at 16 inches from wand or mat under typical OR conditions. Detection range has been measured over 22". Range can be affected by environmental conditions.
Is the scanning wand disposable or reusable?
Both. The wand is packaged sterile and can be used as either a single use device or reused with a sterile drape. Under normal reuse conditions (see Directions for Use) the estimated life of the wand is one year.
Is the scanning mat reusable and what is the estimated life of the mat?
Yes, the RF Assure Detection Mat is fully reusable and under normal use conditions (see Directions for Use) the estimated life of the mat is one year.
What is warranty on the RF Assure Detection Mat and Blair-Port Wand?
The RF Assure Detection Mat and Blair-Port Wand come with a one year manufacturer's warranty.
Does the RF Assure Detection Mat need to be sterilized?
No, the RF Assure mat rests directly on top of the surgical table pad but under the O.R. table covers/drape.
How is the RF Assure Detection Mat sanitized?
The RF Assure Detection Mat should be sanitized in the same way as a typical surgical table mattress following existing OR sanitation protocols.
Can the wand be re-sterilized?
No, the wand cannot be re-sterilized or reprocessed. Wands intended for reuse must be covered with a sterile drape when removed from the sterile package using sterile/aseptic technique. See Directions for Use for cleaning and care instructions.
What does it cost to use the system in an average surgical case?
Using the reusable Blair-Port Wand® and RF Assure Detection Mat, the system averages under $15 per surgical case. RF Surgical provides the system console at no charge to hospitals, so the only ongoing expense is the cost of the wand, detection mat and RF tagged sponges, gauze and towels.
Yes, hospitals that have implemented the RF Surgical Detection System™ are listing system disposables as a patient charge item similar to a post operative x-ray.
Is the energy source harmful to the patient or clinical staff?
No, scanning involves a micro burst of energy much less than that produced by a small color TV or Bovie instruments. The system has received the IEC 60601-1 and IEC 60601-1-2 Certification for Medical Electrical Equipment Safety.
Does the system count sponges?
No, the system is not a counting mechanism. It was designed to detect RF tagged sponges, gauze and towels left behind in patients before closing procedures, thereby preventing a dangerous and costly medical error. The system adds an extra measure of safety to manual counting procedures established by the AORN and individual hospitals.
How does the system help rectify miscounts?
If the final count is off and the patient has already been scanned and cleared, the wand can be used to help locate missing sponges and gauze in other areas, such as in the garbage or under drapes. This may help to rectify counts, thus eliminating the potential need for an x-ray and extended anesthesia time.
Is there anything in the OR that could trigger a false detection?
Clinical experience with the system in over 100 hospitals has shown minimal false positives. Tagged sponges, gauze and towels should be removed from the scanning field. See DFU cautions.
If the sponge count is correct should the patient still be scanned?
Yes. According to studies, 80% of retained surgical sponges occur when sponge counts are erroneously thought to be correct. To optimize OR safety, every patient involved in an open cavity surgery or an OB procedure should be scanned using the RF Surgical Detection System™.
Should the system be used on every surgical case?
Hospital policy will determine protocol. However, all patients involved in open cavity surgeries or OB procedures should be scanned because these are statistically the types of cases where retained objects have occurred after counts were thought to be correct.
Will OR procedures need to be altered to use the system?
No. One of the advantages of the RF Surgical Detection System™ is that it is non-disrupting during closing procedures, unlike computerized counting systems. Proper scanning can be done within 45 seconds with minimal impact on OR procedures.
Will RF Surgical provide assistance during a system evaluation and implementation?
Yes, RF Surgical has certified clinical specialists dedicated to assist customers on evaluations and throughout implementations. Also we offer free online training modules for those customers looking to certify new users.
What types of sponges, gauze and towels are available with the system's RF tag?
To fulfill diverse OR needs, our RF tags are embedded in a variety of lap sponges including 4 x18, 12 x 12, 18 x 18, 8 x 36, and 18 x 36, as well as 4 x 4 and 8 x 4 gauze, and standard OR towels(Green, Blue, White). All are available in sterile packs and custom procedure trays from leading distributors. Additional disposables are being evaluated for tag attachment.
Will the RF Surgical Detection System™ detect instruments?
Not currently, a development program is underway to include instrument detection.
Does the console have UL approval?
The console has been tested by CSA and is approved to the appropriate medical Standards for CSA and UL (C22.2 606.1 and UL 60601-1 / UL 60601-1-2).
Can the RF Assure Detection Mat be used along with bean bags?
Yes, bean bags will have no negative effect to the performance of the detection mat. The detection mat has been shown to be effective when patient positioning devices are used. See DFU for more information.
Lab testing and clinical studies have shown no negative effects in using electrode gel pads. (See manufacturer's direction for use)
Is RF Detection technology suitable for Bariatric cases?
Yes, in fact according to surgical literature, BMI is one of the risk factors associated with retained surgical items. RF Detection technology has been proven to mitigate the risk of having a retained sponge in over 1,000,000 surgical procedures, including bariatric cases.
Can RF Detection technology be used in Vaginal Deliveries?
Yes, about a third of all retained surgical sponges are associated to uncomplicated vaginal deliveries. When the genital tract is packed post-delivery and the packing is kept in place beyond the immediate recovery period (one to two hours after delivery), the risk for a retained surgical sponge is high and can result in serious health complications for the patient. A quick scan using RF Detection Technology can help mitigate the risk of having a retained surgical sponge post partum.
Can RF Detection technology be used in C-Sections?
Yes, C-sections can require many sponges and the need for cavity packing. A quick scan using RF Detection Technology can help mitigate the risk of having a retained surgical sponge prior to wound closure.