Q. Can the ORLocate® system be used to track set level?
A. The ORLocate® system has a modular architecture and it can be customized to fit various customer requirements. Starting from a set level tracking solution in the sterile processing department and expanding to single instrument level tracking, adding a workstation in the operating room to provide reconciliation between the OR and the SPD, count instrument before and after the surgery, or even during the procedure and ranging up to a full solution that also tracks sponges. ORLocate® has an additional module that supports additional use cases such as peel-pack management, Loaned Sets Management, Centralized Sterilization Center serving multiple customers and more.
Q. Can the ORLocate® system be used to track instruments marked with barcode and\or 2D matrix?
A. The ORLocate® system equally supports barcode, 2D and RFID. Your ORLocate® workstation configuration will be customized to fit the required use-cases. At some sites we use a multi-scanner that can read all of the above markings.
Q. Is the ORLocate® solution ready for Unique Device Identification ("UDI")?
A. The ORLocate® system is designed to store the serial Global Trade Item Number (sGTIN) as well as GMDN and GIAI or GRAI identifiers. Our tags can contain additional info such as manufacturing date and GMDN, therefore, it fully supports all UDI requirements.
Q. Does the ORLocate® solution conform to GS1 standards?
A. Haldor is a GS1 industry partner and the ORLocate® system is GS1 compliant.
Q. What is the difference between passive RFID and active RFID?
A: Active tags are powered by a battery and can automatically broadcast a signal whereas passive tags do not have a power source and therefore rely on a reader to "wake-up” upon receiving RF energy emitted usually with close proximity.
Q. Is tagging with RFID more expensive than 2D matrix or Barcode?
A: The cost of laser marking a 2D matrix on a metal instrument is similar to the cost of attaching the Haldor proprietary tag. However, since the lifespan of our RFID tags is far greater than 2D marking due to the severe corrosive environment in sterile departments, the total cost of ownership of RFID tags is much lower. Marking an instrument with Barcode has an initial lower cost, but, it can not contain UDI level of details and the average lifespan is much shorter.
Q. What is the lifespan of the Haldor proprietary tag?
A: Haldor proprietary tags are designed to withstand the corrosive SPD conditions up to the average life expectancy of most surgical instruments and containers.
Q. What is the reading distance of passive RFID tags?
A: Haldor has several proprietary RFID tags and readers and each one were designed and optimized per specific use-cases:
1. Locating a tag left in an abdomen of a patient (attached to an instrument or a sponge) can be done from a distance of up 50 cm.
2. Counting with an HoveRead® was accommodated to a distance of 10 cm which makes sense while counting instruments and sponges in a tray or on a table.
3. Scanning of a S-Tag can be done from a distance of 5 cm.
4. Identifying a an instrument marked with the H-Tag via a Tool-Add (desktop) device is done from 2-3 cm to avoid mistaken ID.
In other words, we developed a match between a tag, a device and a specific use-case.
Q. Why does it make sense to tag instruments with passive RFID?
A. RFID is the only technology that:
1. Provides an ability to identify multiple items in a single scan.
2. Does not require aligning a line of sight between a device and the marking.
3. Support UDI and GS1.
4. Not vulnerable to dirt and scratches.
Q. How often do Retained Surgical Item ("RSI") incidents occurs with post-surgery patients?
A. Studies estimate that RSI incidents occur in 1 out of 1,500 intra-abdominal surgical cases each year in the USA, typically at least 2-4 cases per year in a mid-size hospital. ORLocate® is designed to reduce RSI risks, improve sterile processing productivity and accuracy and reduce time wasted in the OR over manual counting of instruments.
Q. How difficult is it to integrate the new equipment into the hospital and its regular protocols?
A. ORLocate® system supports the entire life-cycle of instruments from the preoperative continuum to sterile processing departments. Its modular architecture makes it easy to accommodate the system to specific hospital requirements, sterilization protocols and to automatically collect data from production floor equipment. We can customize the system to level of regulation enforced to maximize throughput without concession that will reduce quality and set accuracy.
Q. What is radio-frequency identification (RFID)? How does it work?
A. RFID technology uses RF to transfer identification and optionally additional data between a tag and a reader. Commonly there are active RFID tags equipped with a battery power source and smaller passive tags that rely on activation from a reader to be able to send data. The ORLocate® system can utilize both types of tags.
Q. Is the ORLocate™ system safe?
A. ORLocate® follows the World Health Organization’s Guidelines for safely using low
electromagnetic field exposure. The system has received clearance from the US Food and Drug Administration (FDA) and also received the CE certification. Haldor Advanced Technologies has developed an embedding and encapsulating method that uses bio-compatible materials to allow the RFID tags on the sponges and instruments to work with metal, heat or body fluids.
Q. Can ORLocate® RFID tags be added to any surgical instrument?
A. The RFID tag can be attached to any instrument with a 3 mm flat surface. ORLocate® affixes the tags to instruments securely and in a place and position that will not impact how instruments are routinely held or manipulated. The tags are secured in a way that will withstand sterilization, liquid and metal environments for the instrument's lifecycle.
Q. Can ORLocate® passive tags be attached to every surgical instrument?
A. Haldor RFID tag has a very small capsule. Our laser welding technology and methodology allows us to attache it to most metal surgical instruments. ORLocate® tags are welded to instruments securely while the welding point is selected to ensure minimal (if any) impact on instrument usability. ORLocate® equally supports the marking of items by 2D matrix of barcode. Such marking can be used for consumables such as surgical blades.
Q. Is the hospital required to purchase new instruments from Haldor?
A. No, Haldor can attach RFID tags to the hospital current inventory, usually done on-site using a mobile retrofit laboratory. Hospitals may continue to work with their current sponge suppliers, but may be required to purchase a type that is equipped with passive RFID tag.
Q. Will instrument makers be able to attach ORLocate® tags directly to new instruments at the point of manufacture?
A. The ORLocate® tags are unique but can be placed on instruments by the manufacturers if they are certified and authorized by Haldor Advanced Technologies under license, strictly conforming to the ISO 15693 standard.
Q. How does the presence of the ORLocate® RFID tags impact current sterilization practices?
A. ORLocate® tags do not impact sterilization or limit any current practices. Haldor Advanced Technologies has developed durable and resistant tags that can withstand extreme sterilization temperatures and conditions.
Q. Is there a limit to the number of instruments on the Mayo Tray or Back Tray?
A. The ORLocate® system devices can count every instrument placed on Mayo and Back Trays and counting over 100 instruments is done in seconds.