Mission_CSTD_Packet_3419

IV Medication
Safe Handling Systems

Easy-to-use needlefree systems for the safe preparation
and administration of IV medications

The enclosed materials were created for Mission Health

November 28, 2016

Dear Mission Health System;
ICU Medical is pleased to be recognized as a potential partner with Mission Health System in your effort
to bring safety to Pharmacy and Nursing. ICU has been at the forefront developing Closed System Transfer
Devices (CSTDs), and is uniquely positioned to provide meaningful solutions to support our partners’
needs. ICU holds the market leading position for CSTDs at the bedside, where nurses prefer the easy to
use, passive safety design of the ChemoClave® system. However, through our research work with
Pharmacists and Technicians, we developed and launched the ChemoLock® CSTD in early 2015, which
employs a membrane-to-membrane, single-motion, “click to lock” design. Our unique ability to combine
the preferences of both Pharmacy and Nursing into a single, standardized system is what sets ICU Medical
apart from the alternatives.

ICU Medical’s CSTDs incorporate passive safety design features into every component, including bonded
and locking mechanisms that ensure compliance with NIOSH and USP <800>. For example, both the
Spiros® Closed Male Luer and ChemoLock Injector, when attached to a syringe, create a non-removable
connection in order to prevent accidental disconnects and the risk of a drug spill. Other unique features
include the availability of multi-packs and procedure kits, which save valuable technician time while
reducing packaging waste, preserving shelf space, and reducing costs.

Furthering our innovative product portfolio, ICU offers the Diana™ Automated Drug Compounding System,
which helps high-volume facilities safely compound medications while reducing the risk of repetitive
stress injuries commonly associated with pharmacy compounding. With Diana, facilities can increase
efficiencies for high volume or difficult to fill preparations, such as chemotherapy, ambulatory pumps, or
stock bags of reconstituted medications. Also included, is a preview of our next generation Diana
Compounding System, which is due in the beginning of 2017. This system offers remote verifications by
employing an embedded camera in the mixing module that can wirelessly communicate compounding
information to a tablet located outside of the cleanroom for pharmacy review.

ICU Medical sincerely thanks you for this opportunity to help your facility improve hazardous drug handling
safety and reach compliance with USP <800>. ICU Medical welcomes further discussion and an opportunity
to share our unique capabilities with the selection committee.

Sincerely,

Alison Burcar
Vice President, General Manager Infusion Systems
 

951 Calle Amanecer, San Clemente, CA 92673 > 949.366.2183 > 800.824.7890 > www.icumed.com

ChemoLock®

Needlefree Closed System Transfer Devices (CSTD)

The rst needlefree CSTD to receive FDA 510(k) Safely Administer
clearance for both pharmacy compounding (ONB)
and patient administration (FPA) applications. The ChemoLock system is simple and intuitive to ensure compliance
and improve patient and nurse safety.
Safely Prepare
Safely Dispose
Stay safe and in compliance with recommended guidelines during the
preparation of hazardous drugs thanks to the ChemoLock system’s The ChemoLock system remains mechanically closed all the way through
mechanically and microbiologically closed needlefree system. disposal, to help eliminate potential drug exposure to you
or the environment.
Safely Transport

The ChemoLock system prevents leaks and spills during the
transportation of hazardous drugs from pharmacy to nursing,
while also protecting the sterility of the patient preparation.

Safe Handling

Starts in the Pharmacy

ChemoLock’s needlefree “click to lock” membrane-to-membrane
design ts seamlessly into your workflow to help you minimize
exposure to hazardous medications and maintain drug sterility.

ChemoLock’s intuitive and easy-to-use system locks with an audible click, ensuring
a safe and secure connection has been made to minimize exposure to hazardous
drugs and protect the patient preparation from external contamination.

> Designed to completely capture hazardous drug vapor
> Snaps together with a single motion and an audible click
> Eliminates the potential for dangerous needlestick injuries

The ChemoLock system’s easy-to-use needlefree “click to lock” technology maintains a
closed system throughout the entire safe handling process to keep you in compliance
with industry safe handling guidelines.

©2016 ICU Medical Inc. | M1-1574 Rev. 01 800.824.7890 | www.icumed.com

ChemoClave®

Needlefree Closed Systems and Closed
System Transfer Devices

ChemoClave uses intuitive, luer-based technology to help
you cost-e ectively minimize exposure to hazardous drugs
and comply with recommended guidelines.

Safely Prepare Safely Administer

The ChemoClave system maintains a mechanically and microbiologically The ChemoClave system makes it safer for you and your patients by
closed needlefree system during the preparation of hazardous drugs to preventing accidental disconnects to minimize drug exposure without
help keep you safe and comply with recommended guidelines. having to change any standard nursing protocols.

Safely Transport Safely Dispose

By maintaining a closed system with bonded and locking mechanisms, The ChemoClave system remains mechanically closed all the way
ChemoClave helps you prevent leaks and spills during the transport of through disposal to eliminate potential drug exposure to you or the
hazardous drugs from pharmacy to nursing. environment.

Safely Administer
Hazardous Drugs

ChemoClave uses intuitive, nursing preferred, luer-based
technology to help you minimize exposure to hazardous drugs.

The easy-to-use ChemoClave system maintains a needlefree mechanically
and microbiologically closed system to eliminate the potential for dangerous
needlestick injuries while helping keep clinicians safe from exposure to
hazardous drugs.

> Easy-to-use system requires no assembly of components

> Generates less biohazardous waste1

> Costs less to implement than competing systems1

Used in conjunction with other safety precautions, ICU Medical CSTDs help keep you in
compliance with OSHA, NIOSH, ASHP, ISOPP, ONS, APHON, and USP <800>.

1Barnachea L, Lee T, Gitler J, Saria M. Presented at the California Society of Health System Pharmacists (CSHP), November 4, 2011. 800.824.7890 | www.icumed.com

©2016 ICU Medical Inc. | M1-1573 Rev. 01

DianaTM

Hazardous Drug Compounding System

Introducing the rst user-controlled automated compounding
system for the safe, a ordable high-volume preparation
of hazardous and non-hazardous drugs.

User-Controlled Automation Closed System Assures Safety

Cost-e ectively keep pharmacists and technicians in control of the Maintain drug sterility while protecting clinicians from exposure to
compounding process from beginning to end. hazardous drugs and accidental needlesticks.

Reduce the Risk of Repetitive Stress Injury Increase E ciency and Reduce Waste

Free up pharmacists and technicians from many of the repetitive motions Improve workflow e ciency while reducing drug waste by extracting
required during preparation and reconstitution. every drop of drug from every container.

Automate Your Workflow

With Breakthrough Sterile

Drug Compounding Technology

Designed to t the way you work today, the Diana system is
safe, easy, intuitive, and accurate.

Diana reduces hazardous drug exposure, maintains drug sterility, and
minimizes physical stress to pharmacists and technicians—while costing less
than high-volume manual compounding with closed system transfer devices.

> User-controlled automated system for repeatable accuracy
> Minimizes repetitive motion stresses
> Helps maintain drug sterility

Learn how Diana can help you reduce exposure to hazardous drugs while minimizing
physical stress to pharmacists and technicians.

©2016 ICU Medical Inc. | M1-1581 Rev. 01 800.824.7890 | www.icumed.com

Coming Soon!

Introducing the New DianaTM Automated
Compounding System with Remote Verification

The Diana system combines automated compounding with a remote verification system
to help maximize the safety and efficiency of the compounding process.

> Remotely verify compounding procedures > Comply with USP <800> CSTD guidelines
> Avoid wrong drug errors > Create photographic compounding logs
> Easily fits in a 3-ft. hood > Track lot numbers and expiration dates

©2016 ICU Medical Inc.  |  M1-1602 Rev. 01 800.824.7890  | www.icumed.com

Clinical Evidence: ChemoLock

Studies Evaluating Environmental Contamination

Evaluation of FDA-Cleared ONB Closed-System Transfer Devices Utilizing
Cyclophosphamide as a Marker

Michael Koraleski, Pharm.D*, Firouzan ‘Fred’ Massoomi, Pharm.D*, Matt Zock+
*Nebraska Methodist Hospital, Omaha, Nebraska ; +RJ Lee Group, Inc., Monroeville, PA
The results of this study suggest that the ChemoLock system was effective in preventing detectable surface contamination during three separate
trials of simulated compounding activities with known amounts of cyclophosphamide.

Evaluation of ICU Medical’s ChemoLock™ and ChemoClave® Systems Using Methotrexate (MTX) as a Marker

Conducted at RJ Lee Group, Inc., Greene County, PA
The results of this study demonstrate that the ICU Medical ChemoLock and ChemoClave systems are substantially equivalent when used by a
trained pharmacist in preventing detectable surface contamination during three separate trials of simulated compounding activities with known
amounts of MTX.

pH Liquid Integrity Test of FDA-Cleared ONB Closed-System Transfer Devices

Carolyn Pfeifer, Pharm.D.; Patrick Fuller, Pharm.D., University of Nebraska Medical Center, Omaha, NE Michael Koraleski,
Pharm.D.; Firouzan ‘Fred’ Massoomi, Pharm.D., Nebraska Methodist Hospital, Omaha, NE
Data from this study comparing ChemoLock, PhaSeal, and traditional needle/syringe compounding methods suggests that CSTDs are necessary
for safe preparation of hazardous drugs as the needle and syringe method failed to contain all three pH solutions within the transfer process. The
PhaSeal product improved solution containment but had two failed manipulations in a relatively small sample size. The ChemoLock product had no
litmus paper color changes and no visible droplets evident during manipulations.

Studies Evaluating Vapor Containment

Assessment of ChemoLock Closed System Transfer Device for Vapor Containment in Accordance with NIOSH
Draft Protocol

Data on File at ICU Medical Inc., San Clemente, CA
Test results show that ChemoLock System was effective in preventing 70% isopropyl alcohol (IPA) vapor, as well as hazardous drug vapor from
paclitaxel and etoposide during simulated compounding and administration procedures.

Studies Evaluation Mechanically & Microbiologically Closed Systems

Microbial Ingress Study for ChemoLock™ Devices

AAIPharma Services Corp
Results of this seven-day microbial ingress study using four bacterial strains and ten activations per device show ChemoLock prevents the transfer
of environmental contaminants, including bacterial and airborne contaminants, into the system.

Studies Evaluating Chemical Compatibility

ChemoLock Chemical Compatibility

Data on File at ICU Medical Inc., San Clemente, CA
The ChemoLock products are manufactured using the same chemical resistant plastics as the ChemoClave products, and will provide equivalent
compatibility. All test results demonstrate that the ChemoClave products were compatible with common therapeutic classes of drugs for a minimum of
24-hours and a maximum of 28-days for multi-use drugs.

©2016 ICU Medical Inc.   |  M1-1592 Rev. 02

Clinical Evidence: ChemoClave

Studies Evaluating Environmental Contamination

Evaluation of surface contamination with cyclophosphamide following simulated
hazardous drug preparation activities using two closed-system products

Soe e S, Rickabaugh K, J Oncology Pharm Practice: 2010; Aug.10

Results show both ChemoClave and PhaSealTM systems, when operated properly, are similarly e ective in minimizing surface contamination. Work
practice and procedures regarding product operation appeared to be important factor in hazardous drug containment and needle safety when
using PhaSeal, but not when using ChemoClave, which requires fewer steps and is needlefree.

Evaluation of ICU Medical’s ChemoLock™ and ChemoClave® Systems Using Methotrexate (MTX) as a Marker

Conducted at RJ Lee Group, Inc., Greene County, PA

The results of this study demonstrate that the ICU Medical ChemoLock and ChemoClave systems are substantially equivalent when used by a trained
pharmacist in preventing detectable surface contamination during three separate trials of simulated compounding activities with known amounts of MTX.

Dirty Little Secrets: Hazardous Drug Contamination at the Chairside

Hodges L., Caskey C. Section on Hematology and Oncology/Environmental Health and Safety Department, Wake Forest University School of Medicine

In this study, ChemoClave was shown to be e ective in eliminating accidental exposure to hazardous drugs and decreasing levels of surface
contamination at the point of administration. ICU Medical’s Spiros® closed male luer, when placed at the end of a syringe or IV tubing, can prevent
leakage or accidental discharge during and a er administration as the Spiros automatically self-seals when disconnected and only opens when
attached to a female needlefree connector.

Studies Evaluation Mechanically & Microbiologically Closed Systems

Microbial Ingress Study for ChemoClave Devices

Report of a study commissioned by ICU Medical Inc. and conducted by AAIPharma Services Corp.

Results of this seven-day microbial ingress study using four bacterial strains and ten activations per device show ChemoClave prevents the transfer
of environmental contaminants, including bacterial and airborne contaminants, into the system.

Studies Evaluating the ChemoClave System On Exposure to Hazardous Drugs, Blood and
Complications Relating to an Open System

Reducing Hazardous Drug Exposure: Are All Closed Systems Created Equal?

Karen Sachse, MSN, RN, CPON, CNS-BC, Margaret Perry, BSN, RN, CPHON, CPN, and Radha Rohatgi, Pharm D,
BCOP, Hematology and Oncology, Children’s National Medical Center, Washington, DC.

Following a spike in hazardous drug exposure due to spills resulting from disconnects between CSTDs and administration tubing, Children’s National
Medical Center in Washington DC initiated a performance improvement process to resolve this issue and better protect sta , patients, and families. An
interdisciplinary team conducted a systematic review and implemented interventions to reduce hazardous drug exposure in the Cancer and Blood
Disorders unit. Results of the study show that the Spiros closed male luer proved to be an e ective solution for reducing disconnects and the potential
for dangerous exposure to hazardous drugs and blood, and complications related to an open system. The small size of the Spiros also made it ideal for
use on pediatric patients, increasing patient and family satisfaction.

Studies Evaluating Chemical Compatibility
ChemoClave Chemical Compatibility

Data on File at ICU Medical Inc., San Clemente, CA

All test results demonstrate that the ChemoClave products were compatible with common therapeutic classes of drugs for a minimum of 24-hours and
a maximum of 28-days for multi-use drugs.

©2016 ICU Medical Inc. | M1-1593 Rev. 01

 
 

FDA Clearance: ChemoClave® and ChemoLock™ Closed System
Transfer Devices (CSTD)

The ChemoClave Closed System Transfer Device (CSTD) products and their components have been FDA
cleared in the following 510(k) documents: ChemoClave® Cytotoxic Medication Preparation and Delivery
System Ko81361; and Spiros® K070532. Each of these clearances fell under one or more of the following
classification codes: FPA (set, administration, intravascular), LHI (set, i.v. fluid transfer), and FMF (syringe,
piston).
The ChemoLock Closed System Transfer Device (CSTD) products and their components have been FDA
cleared in the following 510(k) document: ChemoLock Closed System Drug Transfer Device K131549. This
clearance is under the ONB (Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer
System) and the FPA (set, administration, intravascular) categories.
The FDA ONB code was created in 2013 to better categorize products that are intended to be used for the
safe handling of hazardous drugs and ICU Medical is currently in the process of filing the existing
ChemoClave products under the code. All other 510(k)s such as the FPA (set, administration,
intravascular), LHI (set, IV fluid transfer), or FMF (syringe, piston) that are cleared with other systems are
all current, active and sufficient for the legal Marketing and Sale of the products they relate to.
Thank you again for your interest, if there are further questions or concerns, please visit our website at
www.icumed.com or contact the corporate offices at 949-366-2183 or 800-824-7890.

951 Calle Amanecer, San Clemente, CA 92673 > 949.366.2183 > 800.824.7890 > www.icumed.com

Hazardous Drug Preparation

Using ChemoLock Vial Spikes and Injector on Syringe

Vial Spike

Vented Vial Spike, 13mm (CL-72)
Allows for access to small vials with 13 mm closures

Universal Vented Vial Spike (CL-70) 1
Large vent offers better flow rates and reliability 2
3
Vial Spike, 20mm (CL-80S)
External balloon equalizes pressure for reconstitution 4
5
Closed Male Injector 6

ChemoLock Injector (CL2000S) 7
For use on a syringe 8
9

10mL

800.824.7890 | www.icumed.com

Dedicated Pump Set 100 -
75 -
Using ChemoLock Bag Spike, Injector and Port 50 -
25 -
Bag Spike mL

Bag Spike with Additive Port (CL-13) Patient
For use on any solution container
800.824.7890 | www.icumed.com
Closed Male Injector

ChemoLock Injector (CL2000S)
For use on administration set

Administration Component

ChemoLock Port (CL2100)
For use on patient IV line

Secondary Set Administration 100 - 100 -
75 - 75 -
Using ChemoLock Secondary Set, Injector and Port 50 - 50 -
25 - 25 -
Secondary Set mL mL

30” Secondary Set with Integrated ChemoLock Patient
Port Drip Chamber and Bonded ChemoLock
Injector (CL3511) 800.824.7890 | www.icumed.com

Closed Male Injector

ChemoLock Injector (CL2000S)
For use on administration set

Administration Component

ChemoLock Port (CL2100)
For use on patient IV line

Secondary Set Preservation Administration

Using ChemoLock Bag Spike, Secondary Set, Injector and Port

Bag Spike 100 - 100 -
75 - 75 -
Bag Spike (CL-10) 50 - 50 -
For use on any solution container 25 - 25 -
mL mL
Secondary Set

40” Secondary Set with In-line Drip Patient
Chamber and 2 ChemoLock Injectors (CL3520)
800.824.7890 | www.icumed.com
Closed Male Injector

ChemoLock Injector (CL2000S)
For use on administration set

Administration Component

ChemoLock Port (CL2100)
For use on patient IV line

IV Push Administration

Using ChemoLock Injector on a Syringe and Port

100 -
75 -
50 -
25 -
mL

Closed Male Injector

ChemoLock Injector (CL2000S) 1
For use on syringe 2
3
Administration Component 4
5
6
7
8
9 10 mL

ChemoLock Port (CL2100)
For use on patient IV line

Patient

800.824.7890 | www.icumed.com

Dedicated Pump Set

Using ChemoLock Bag Spike and ChemoClave Spiros Closed Male Luer

100 -
75 -
50 -
25 -
mL

Bag Spike

Bag Spike with Additive Port (CL-13)
For use on any solution container

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

Secondary Set Administration

Using ChemoLock Hybrid Secondary Set and ChemoClave Spiros Closed Male Luer

100 - 100 -
75 - 75 -
50 - 50 -
25 - 25 -
mL mL

Secondary Set

30” Secondary Set with Integrated ChemoLock
Port Drip Chamber and Bonded Spiros (CL3011)

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

Secondary Set Preservation Administration

Using ChemoLock Secondary Set and ChemoClave Spiros Closed Male Luer

Bag Spike 100 - 100 -
75 - 75 -
50 - 50 -
25 - 25 -
mL mL

Bag Spike (CL-10)
For use on any solution container

Secondary Set

40” Secondary Set with In-line Drip
Chamber, ChemoLock Injector and Spiros (CL3020)

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

Hazardous Drug Preparation

Using ChemoClave Vial Spikes and Spiros Closed Male Luer on Syringe

Vial Spike

Vial Spike, 13mm (CH-62)
Allows for access to small vials with 13 mm closures

Universal Vented Vial Spike (CH-70) 1
Large vent offers better flow rates and reliability 2
3
Universal Vial Spike (CH-80)
External balloon equalizes pressure for reconstitution 4
5
Closed Male Luer 6

Spinning Spiros (CH2000S) 7
For use on a syringe 8
9

10mL

800.824.7890 | www.icumed.com

Dedicated Pump Set 100 -
75 -
Using ChemoClave Bag Spike and Spiros Closed Male Luer 50 -
25 -
Bag Spike mL

Bag Spike with Additive Port (CH-13)
Dedicated lumen for direct access to solution bag

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

Secondary Set Administration

Using ChemoClave Secondary Set and Spiros Closed Male Luer

100 - 100 -
75 - 75 -
50 - 50 -
25 - 25 -
mL mL

Secondary Set

30” Secondary Set with Integrated Clave Drip
Chamber and Bonded Spinning Spiros (CH3011-C)

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

Secondary Set Preservation Administration

Using ChemoClave Bag Spike, Secondary Set and Spiros Closed Male Luer

Bag Spike 100 - 100 - 100 -
75 - 75 - 75 -
Bag Spike (CH-10) 50 - 50 - 50 -
For use on any solution container 25 - 25 - 25 -
mL mL mL

Secondary Set

40” Secondary Set with In-line Drip
Chamber and 2 Spinning Spiros (CH3020)

Closed Male Luer

Spinning Spiros, Red Cap (CH2000S-C)
For use on administration set

Patient

800.824.7890 | www.icumed.com

IV Push Administration

Using Spiros Closed Male Luer on a Syringe

100 -
75 -
50 -
25 -
mL

Closed Male Luer 12
3
Spinning Spiros, Red Cap (CH2000S-C) 4
For use on syringe 5
67
8
9 10 mL

Patient

800.824.7890 | www.icumed.com

ICU Medical and You:

A Commitment to Clinical Support and Education

We’ll be with you every step of the way as you implement our hazardous drug safe handling
solutions into clinical practice. In doing so, we will work closely with your clinical teams to create
a variety of training aids and reference tools tailored specifically to your facility protocols.

Custom In-service Videos

Access product demonstrations on demand with our customized in-service video
libraries. These online video libraries allow you to stream videos from your computer
or mobile device, or download them to watch offline.

Step-By-Step Instructional Posters

Ensure that your staff is comfortable using our products at all times with step-by-step,
customized product reference posters. These posters are designed to give your teams
a quick reference tool when in the pharmacy, or on the nursing floor.

Live Training With Clinical Specialists

Get hands-on product training from our team of experienced clinical specialists. These
specialists work closely with your facility to understand existing clinical protocols and
help your teams effectively integrate our ICU Medical safe handling solutions.