FAQ

How do ClearCount products work?

• An RFID chip smaller than a dime is placed in each sponge and provides a unique identification of the sponge.
• The unique ID allows the sponges to be individually accounted for both counting in before surgery and counting out. When counts do not reconcile, a SmartWand™ is used to locate the missing sponge in the patient or in the O.R.

How does the SmartSponge System^® work?

• 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.
• Sponges come out of the field and go directly into the SmartBucket™ one at a time or in larger quantities, where they are counted out.
• 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.

How does the SmartWand-DTX™ work?

• 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.
• The SmartWand-DTX can be used to verify manual counts by wanding over the sponges that have been counted before surgery.
• Sponges come out of the field and are counted out. The SmartWand-DTX can be used to verify the out-counts.
• If there is a discrepancy in counts, the patient is then scanned with the SmartWand-DTX 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.

What is ClearCount’s Never Event Warranty?

• ClearCount offers with all of its products, at no additional cost to the customer, a $2M Never Event Warranty if a retained sponge occurs if using the  ClearCount System as directed (see ClearCount for terms and conditions). This product liability package is offered with the backing of CNA, a $50B insurer, and covers a variety of costs typically not covered by product liability insurance, including redo surgery, legal fees, settlement costs, fines, and more.

• Virtually any size/type of sponge needed can be tagged, including all sizes of Laparotomy and Gauze products as well as many specialty sponges. If a string or loop can be attached to the sponge, ClearCount/Medline 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. Effort must be made to supplement manual counting through the electronic counting process if human error is to be prevented. The large majority of retained sponge incidents occur when the counts are believed to be reconciled (“false correct count”). If healthcare professionals only scan for detection 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.

Why use a system that detects? Isn’t counting enough?

• Counting alone does not reduce the O.R. delays associated with unreconciled counts: missing sponge/s must be found. A large multi-center trial recently showed that as little as a 30 minute delay can nearly double the risk of infectious complications – every minute counts. With a detection system, scans of the patient and the O.R. can be conducted quickly, often eradicating the need for an X-ray and the associated delays.

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 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.” Very few patients are of a size outside of the read range of the SmartWand.
• 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 verify that the wand is reading completely through the patient.

Does the SmartSponge System create an electronic record? How can the record be integrated into the patient case record?

• The SmartSponge System creates a complete record of each surgical procedure, creating a time stamp for each item when scanned in and counted out.   In addition it captures all wanding procedures, items seen during the wanding, whether it read the SmartTag, and any alerts and alarms encountered by the user.  It also captures whether the final count was reconciled and records the use of the administrator card.  This complete data record is captured and maintained within the system and is available for download.  On a day-to-day basis in the OR, the circulator simply records the unique case ID number in the electronic patient record.  This case number enables the ability to track back to the detailed surgical information should the need arise.

Is any patient identifiable information stored in the device?

• There is no patient identifiable information stored on the device or the tag.

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.  ClearCount  is pursuing research and development toward 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.

• The SmartSponge System and SmartWand-DTX reduce the time spent double-checking manual counts while they reduce the chance of human error. Unlike barcode systems, the ClearCount systems require no line of sight, so quick and accurate scans are effortless for staff.
• When it comes to detection, both systems offer the ability to speed the process of finding a missing sponge, either in the patient or within the O.R. This reduces delays associated with searching. Delays associated with waiting for X-rays are also eradicated when sponges are located using RFID detection.

The SmartSponge System is self-funding because it helps hospitals:

• Avoid costly litigation
• Eliminate unreimbursed surgical procedures
• Eliminate unnecessary X-ray costs
• Reduce risks to valued surgeons
• Avoid costly O.R. delays due to sponge miscounts or waiting for X-rays
• Leverage a platform for future protection, such as retained surgical instrument prevention
• Avoid concerns of financial risk, through the Never Event Warranty

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:

• Provides unique identification of every item
• Passive: Non emitting tag and contains no battery
• Small: RFID tag is smaller than the diameter of a dime
• No line-of-sight required to detect sponges
• Can count multiple sponges simultaneously
• Can not count the same sponge twice

Are ClearCount products 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.
• ClearCount announced FDA 510 (k) clearance of its SmartWand-DTX in February 2010.