Medication Safety

CLOSED-LOOP MEDICATION ADMINISTRATION

Overview

Safe Label System helps meet ISMP Guidelines, including eliminating the use of handwritten labels in the perioperative/procedural areas and including a machine-readable code (e.g. barcode, RFID) on all syringe and infusion labels by 2025.

Other benefits:

Award-winning, FDA Class II medication safety device
Audible and visual verification of the drug name and concentration act as a second set of eyes at preparation
Helps eliminate the top three medication errors made in the operating room: vial/ampoule swaps, mislabeling and syringe swaps
To date, it’s used in 15,000+ operating rooms in over 1,000 of the world’s leading hospitals and has helped to prevent more than 1.9M medication errors¹

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Safe Label System (SLS) Support and Resources

Product Literature
Support Documentation
Warranty
FAQs

SLS FAQs

Q: Is this Safe Label System designed for medical usage in the operating room?

A: Yes, the system was designed for use in the operating room. It includes a medical grade (safety compliant) power supply and has been designed such that it can be cleaned with disinfectants without any risk of damage to the system

Q: Are the labels created by the Safe Label System compliant with National Safety Patient Goals NPSG.03.04.01 of The Joint Commission

A: Yes, the labels are engineered to conform to the American Society of Anesthesiologists (ASA) color guidelines and contain all elements required by the National Safety Patient Goals of The Joint Commission (TJC). It is also compliant with ISO standard ISO 26825 and ASTM 4774.

Q: Can labels printed on the Safe Label System be written on with a standard ball point pen?

A: Yes, the labels can be written on with both a ball point pen and felt tip pens. No special pen is required.

Q: What elements are included on the labels created by the Safe Label System?

A: The labels are properly color coded according to the ISO standard ISO26825 and ASTM 4774.). The labels may include:

medication name (with configurable Tall Man lettering) and concentration
dilutions and diluents
preparation date/time, expiration date/time
identification of the preparer (i.e., preparer’s initials)
site-specific warnings and messages.

Q: What other types of labels can be printed with the Safe Label System?

A: The Safe Label System can print labels for IV lines, invasive monitors and other operating room needs on-demand. The labels are configurable by the site.

Q: What is the bar code printed on the label used for?

A: The barcode can be used to integrate with an Anesthesiology Information Management System (AIMS), a Bar Coded Medication Administration system (BCMA), a broader hospital information system such as an EHR, or a waste assay system for drug diversion.

Q: What are the benefits of using the Safe Label System with an AIMS?

A: Additional safety features available when integrated with an AIMS may include:

Automatic identification and announcement of each syringe to be administered
Automatic documentation of the date/time when a drug was administered
Warnings for expired syringes
Warnings for patient allergies or adverse drug interactions

Q: Will Codonics provide the barcode information to different AIMS companies so that they can support it or is it exclusive to specific vendors?

A: Yes, Codonics will provide the barcode information and sample labels to AIMS, BCMA and EHR companies upon request for their integration of the system. Currently supported AIMS vendors include Epic, Cerner, Plexus, iMDSoft and Tosho.

Q: Can the Safe Label System’s formulary database be customized for specific hospital formularies?

A: Yes, the Safe Label System includes a customizable formulary database. This database can be customized to specify all the details of the label (name to be displayed, concentration, Tall Man lettering, color, etc.).

Q: Who manages the Safe Label System’s formulary database?

A: The architecture of the Safe Label System is similar to that of a Smart Pump. We expect that all sites will assign a pharmacist or drug librarian to manage the database just like they do for their Smart Pumps.

Q: Does the Safe Label System’s formulary support pre-defined combinations of drugs?

A: Yes, the Safe Label System can support combinations of drugs. These must be defined in the system’s formulary and a custom bar code defined for the combination. If prepared “on the fly” then a blank label must be prepared and completed by the clinician.

Q: How is the Safe Label System’s formulary database updated?

A: The formulary database in the Safe Label System may be updated manually by inserting a USB drive containing the update into each unit or the system may be updated remotely via network (Ethernet or Wi-Fi).

Q: What is the bar code reader on the Safe Label System used for?

A: The bar code reader on the system is used to scan the bar code on drug vials and ampoules. The bar code tells the Safe Label System all of the pertinent information on the drug including manufacturer, manufacturing location date, etc. This information is used in preparing a label with the Safe Label System. In addition, the information is used to identify recalled and/or expired drugs.

Q: What happens if a drug vial is scanned that is not in the formulary?

A: The Safe Label System will alert the user visually and audibly that the drug was not recognized and will allow the user to print a blank label that can be completed by hand and used for labeling the syringe.

Q: Is the speaker volume on the Safe Label System adjustable?

A: Yes, the speaker volume can be adjusted or muted.

Q: Is the brightness of the Safe Label System’s touch screen adjustable?

A: Yes, the touch screen brightness can be adjusted.

Q: Can the Safe Label System be mounted on a cart or anesthesia boom?

A: The system has been designed for mounting on carts and booms. Codonics sells a variety of shelves, arms and wall mounts for the system. In addition, the base of the system has a VESA compliant mounting pattern so that standard mounts can be used. Additional information on VESA can be found at www.vesa.org.

Q: What types of consumables are required for the Safe Label System?

A: The system uses two consumables, a multi-color ink cartridge and a label roll. The ink cartridge should last approximately one month depending upon the colors used (Typical usage is 5-10 labels per procedure, 6 procedures per day, 5 days per week). The label roll contains 1,000 labels.

The labels used in the system are specially engineered to comply with stringent medical guidelines and requirements. The labels have a plastic base so that they do not tear and can be dipped in alcohol and other liquids without degradation in image quality. In addition, they have a special adhesive that ensures that they do not peel or curl for at least 24 hours.

Q: How will the user know that the consumables on the Safe Label System are low?

A: The system will tell the user that the ink is low on the user interface with a warning message and then will provide another message, as well as not print labels, when empty. The label rolls have a color mark on the label’s liner indicating that the media is low when only a few days’ supply is left. This is similar to the red indicator used on a cash register.

Q: Is there a cutter in the Safe Label System to support cutting and dropping of the labels?

A: Yes. This is a standard feature of the product.

Q: Can the SLS be managed over a network?

A: Yes, the SLS can be managed over a network either via Ethernet or Wi-Fi. All SLS systems to be managed must have the same version of software installed on each of them.

Q: What network interfaces does the SLS support?

A: An Ethernet interface is standard on each SLS. An optional Wi-Fi interface is also available. The Wi-Fi interface is compatible with 802.11ac.

Q: Is Gigabit Ethernet supported?

A: SLS550i supports Gigabit Ethernet (1000Base-T).

Q: What Wi-Fi “encryption” protocols does SLS Support

A: Encryption ensures that communications between the SLS and the Wi-Fi access point are secure and equipment scanning the radio waves cannot decode the data sent over Wi-Fi frequencies. The SLS supports:

None [default]
WEP
WPA PSK (Personal Security Key)
WPA Enterprise
WPA2 PSK
WPA2 Enterprise

Q: What Wi-Fi “authentication” protocols does SLS Support?

A: Authentication protocols are used to validate a user or piece of equipment is allowed to interact with the network. This is commonly with a series of “certificates” that are files with secure data that identify the equipment to the network. Authentication can also be done by assigning special usernames and passwords to the equipment or by a combination of certificates and passwords. SLS supports the following protocols:

This is commonly done or performed with a series

PEAP (Protected Extensible Authentication Protocol) “also known as PEAPv0” is a proprietary protocol which was developed by Microsoft, Cisco and RSA Security.
EAP-TLS (Extensible Authentication Protocol – Transport Layer Security) is an older standard that was created by Microsoft and accepted by the IETF as RFC 2716: PPP EAP TLS Authentication Protocol. This is a very common protocol used in enterprise applications.

Q: Does the SLS Ethernet interface use the same encryption and authentication as the Wi-Fi interface?

A: No. The SLS does not support encryption or authentication over Ethernet. Often, a hospital will disable an Ethernet port that is not being used or only allow equipment with a specific Ethernet address (MAC address) to be plugged into the port.

Q: Can both the Ethernet and Wi-Fi network interfaces be active simultaneously?

A: Yes. Both interfaces can be configured and used at the same time.

Q: Does the Safe Label System support both Static and DHCP IP addresses?

A: Yes. The network settings of both the Ethernet and Wi-Fi interfaces are independently configurable from the Utilities menu of the SLS touch screen to use either Static or DHCP IP addresses.

Q: Can I buy an off-the-shelf USB Wi-Fi interface for the SLS?

A: No. The SLS is a medical device with hardware and software designed and validated by Codonics. Only use Codonics supplied hardware and software. Use of unauthorized hardware or software will invalidate Codonics’ warranty and support. A Feature Key is required to enable the Wi-Fi interface on the SLS.

Q: Can the SLS report a problem over the network?

A: Yes. The Email Notification program and the Device Manager on the Administration Tool can be used to monitor the status of SLS systems on the network.

Q: Can the SLS be virus scanned over the network?

A: No. The SLS only allows remote network connections from other Codonics software tools such as the SLS Administration Tool and the SLS Email Notification program. This is a security feature to prevent unauthorized programs from accessing or changing software on the unit.

Note: The SLS uses Linux and various other security measures which substantially reduce the risk of the system being compromised by a virus or malware.

Q: Can virus scanning software be loaded onto the SLS from the USB port on the unit?

A: No. The SLS will only boot and install official Codonics SLS operating software on a Codonics supplied USB drive. The SLS will not boot or install software from any other USB drive.

Q: Is there any way to eliminate a virus from the SLS?

A: Yes. In the unlikely event that an SLS gets a virus, reinstalling the operating software from a Codonics supplied USB drive will completely reinitialize the system. You should also reload the formulary if you suspect the SLS had a virus.

Q: Is SLS data being transferred over the network secure?

A: Yes. All connections to the SLS use SSL (Secure Sockets Layer) and can only be established from Codonics software tools using a password that is assigned by the site. This prevents other programs from connecting to the SLS. Additionally, all software and formulary packages are encoded in a proprietary format with a digital signature to prevent unauthorized software or data from being installed on the SLS. This applies to packages that are installed over the network or from the USB drive on the SLS.

Q: Are network transfers to the SLS fast?

A: Yes. A typical formulary is significantly less than 50MB and can be transferred from the Device Manager on the Administration Tool to the SLS in a couple of minutes. A network with many SLS systems can deploy a formulary to 50+ systems in less than 1 hour. If the hospital network is very busy, it may require more time.

Q: Will installing a new formulary interrupt a provider using the SLS?

A: No. Formularies will only be installed when no users are logged into the system. If a user is logged in, the formulary will be received and stored by the SLS until the user logs out. After the user logs out, the front panel will provide a notice that a formulary is going to be installed and give the user a chance to defer the installation.

Q: Will I know if a formulary successfully installed on an SLS?

A: Yes. The Email Notification program can be configured to alert you of successful or failed formulary installations. Also, the Device Manager on the Administration Tool can be used to check status and the version of the formulary on all SLS devices.

Q: Will the SLS continue to function if the network connection is lost?

A: Yes. The SLS is designed to run without a network connection. The network is primarily used to simplify installation of formularies and provide centralized monitoring of the SLS units. A network connection is not required to use the SLS.

Q: Will the AT Device Manager tell me if the network connection is lost?

A: Yes. The Device Manager on the Administration Tool will indicate any SLS unit that is not responding on the network and indicate the device is Offline. The software, formulary and configuration version information will not be displayed while the unit is not accessible on the network.

Q: Is an external scanner available for the SLS so that I can scan items that are too large to put under the scanner?

A: Yes, an optional tethered hand scanner is available for the SLS that will allow the user to scan with either the integrated or external scanner.

Q: Is it possible to scan the syringes labeled with the SLS before the medication is administered in order to confirm the correct syringe was selected?

A: Yes, with Administer Mode, an optional feature (requires an Administer Mode feature key) the user can scan a label prepared on the SLS and the system will present the user with the drug name and concentration as well as check the expiration status of the syringe.

Q: Can I use the labels prepared on the SLS with a BCMA system?

A: Yes, labels prepared with the SLS can be used with BCMA systems. The 1D and 2D bar code label contains the drug code number of the medication and systems like Epic can be configured to read the bar code.

Q: What are the system requirements for the Administration Tool software and Email Notifier software?

A: The current released Administration Tool software 2.6.1 requires the following requirements:

Administration Tool software 2.6.1

Medication Safety

Overview

Other benefits:

Interested in Learning More?

Safe Label System (SLS) Support and Resources

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