ClearCount Medical Solutions

FAQ

How does the SmartSponge^® System work?

An RFID chip smaller than a dime is placed in each sponge and provides a unique identification of the sponge.
Before the operation, a SmartTag™ is placed under the patient in close proximity to the surgical site. This will provide feedback to the user that the SmartWand™ is reading through the patient to the surgical table when a scan is performed to locate a sponge.
As sponges come out of the field, they can go directly into the SmartBucket™ one at a time or in larger quantities.
Following the surgical procedure, the counts are reconciled. If there is a discrepancy in counts, the patient is then scanned with the SmartWand which quickly identifies any remaining sponges.
A green light on the SmartWand handle confirms the wand is reading all the way through the patient to the surgical table. A red light illuminates if a sponge has been detected. Visual and audible notification is also provided on the display screen of the SmartBucket.
After all sponges are accounted for, the user retrieves a final report. This can be printed automatically or sent to the hospital’s medical records system via an HL7 interface.

What size/types of Sponges are available?

Virtually any size/type of sponge needed can be tagged, including all sizes of Laporotomy and Gauze products as well as many specialty sponges. If a string or loop can be attached to the sponge, ClearCount can incorporate an RFID tag! Please provide your Sales Consultant with a list of types needed.
Surgical Towels are also available.

Can the sponges be put in my existing sterile kits/trays?

Yes. All sponges are available in bulk non-sterile form to any kit manufacturer.

Why use a system that counts? Isn't detection enough?

Detection-alone does not address the possibility of miscounts. The large majority of retained sponge incidents occur when the counts are believed to be reconciled ("false correct count"). If healthcare professionals only scan when there is an un-reconciled manual count, the majority of retained sponges may be missed. Only a system that counts and detects will address human error associated with manual counting as well as assist in locating a sponge that is correctly determined to be missing.

What happens if a tag fails or is damaged?

Each tag is checked by the tag manufacturer before shipping. Additionally, each tag is checked after it is sewn in to the sponge. The final safety check is performed by the user prior to being introduced into the case. The scan "in" of the sponges validates the tag is working properly. If a tag were to be damaged or missing, the system will inform the user to discard the package of sponges. This ensures when counts are performed all tags/sponges in the SmartBucket will be counted. When a scan of the patient is performed using the SmartWand, the user can be confident the RFID tag is functioning properly.
The tags have been designed and tested to withstand snare and crush tests (i.e. being clamped during a surgical procedure).

Can the SmartWand or SmartBucket read other RF tags (i.e. badges, keys, etc)?

Because ClearCount utilizes RFID technology, the system is not susceptible to false positive reads from any other tags.

How far can the SmartWand read?

Read range is a function of the size of the wand. ClearCount's standard SmartWand can read approximately 17". An oversized wand for larger read ranges is also available.

How do I know I am reading through the patient?

With the placement of a SmartTag on the OR table under the surgical site, the user is provided with notification of being in range by a green "In-Range" indicator on the handle of the SmartWand. This validates that the wand is reading through the patient. The SmartBucket screen also displays a message notifying the user that the wand is "In Range."
In the event that a SmartTag is not placed under the patient, the SmartWand can still be used. The user will not, however, be able to validate that the wand is reading completely through the patient.

Is case information available to be printed out?

Yes, an optional printer can provide a paper receipt indicating the results of the “Final Count” before a case is ended. This receipt can then be placed into the chart.
Additionally, the device can export the data in an HL7 format directly to the hospital’s electronic charting system.
If a printout or interface is not requested, the device prompts the user to record the unique Case ID # at the end of the case in the patient’s chart, to be referenced in the future if needed.
All case data can be stored on the device and downloaded/backed up by the hospital Biomedical or IT department.

Is any patient identifiable information stored in the device?

What happens when there is an incorrect number of sponges in a package?

When the user attempts to scan in a package of sponges with an incorrect number of sponges in a pack, the device will provide an error message notifying them to discard the bad package of sponges. It will NOT allow them to scan these sponges into the procedure.

What are the advantages of the SmartSponge System versus other systems/technologies?

The SmartSponge System reduces wasted OR time spent resolving count discrepancies.
The SmartSponge System is a platform for the future. In the future, we will be introducing modules for tracking other surgical items as well as other patient safety features.
The SmartSponge System eliminates X-Ray costs associated with the effort to locate a sponge that may have been left behind in the surgical site.
Finally, avoidance of retained surgical sponges protects your facility from costly litigation.

Why RFID?

RFID is a proven and safe technology and has been used for the past 20 years in applications such as recording financial transactions, toll booth collections management, as well as many security and inventory solutions.

Benefits of RFID include:

Is the SmartSponge System approved by the FDA?

The SmartSponge System obtained FDA 510(k) clearance in November of 2007. It is the first FDA cleared solution to combine the benefits of counting and detection of surgical sponges.