FOCUS ON: Oncology Systems

Transcription

1 FOCUS ON: Oncology Systems

2 Delivering Excellence Focused and committed In to Oconology helping you Infusion deliver Therapy From Preparation To Administration Excellence in Powerful medications used in cancer treatments are critical to patient care, but they Oncology also pose a safety risk to patients and healthcare IV workers. Therapy At ICU Medical, our focus is on delivering safe, efficient and cost-effective oncology systems that fit seamlessly into your workflows, and help you keep pharmacists, clinicians, and patients safe from hazardous drug exposure. Powerful medications used in cancer treatments are critical to patient care, but they also pose a safety risk to healthcare workers. At ICU Medical, our focus is on delivering safe, efficient, and cost-effective See how our focus can help you: oncology systems that fit seamlessly into your workflows and help you keep pharmacists and clinicians safe from hazardous drug exposure from preparation Enhance to Patient administration. Safety Enhance Patient Safety Improve Clinical Efficiency Maximize Profitability Improve Clinical Efficiency Maximize Profitability

3 Preparation with ChemoLock & ChemoClave CSTDs for USP <800> Compliance Complete Line of Diluents and Containers for Preparation of Oncology Admixtures Helping you keep healthcare Automated Compounding and Remote Verification with the Diana Workflow System workers safe from hazardous drug exposure and comply with USP <800> Enhance Safety Only ICU Medical lets you keep a closed system from beginning to end* Patient Administration with ChemoLock and ChemoClave CSTDs for USP <800> Compliance Complete IV-EHR Interoperability with ICU Medical MedNet Infusion Documentation to Deliver Charge Capture with ICU Medical MedNet * Plum 360 provides a closed system when using the PlumSet with Clave secondary port and a closed system transfer device Plum 360 Infusion Pump with Unique Air Management Technology Track preparation data with automated pharmacy compounding and ensure accurate dosing with smart pump programming infusion technology. Maintain a closed system that enhances end-to-end safety and helps to comply with USP <800>. Improve Efficiency Simplify the compounding process with automated compounding with remote verification and click to lock CSTD technology. Improve nursing efficiency with infusion pumps featuring unique air management and IV-EHR interoperability, along with easy-to-use luer-based CSTDs. Reduce chair time by delivering two compatible medications simultaneously at independent rates through a single line. Maximize Profitability Improve financial performance by maximizing reimbursement with accurate infusion documentation and reducing chair time with concurrent medication delivery. Minimize CSTD and IV set costs by reducing components at each step.

4 In Pharmacy We design our products to align with your existing workflows, helping you reduce medication errors and streamline the flow of data from pharmacy to nursing. Safety Efficiency Profitability Complete Line of Diluents and Containers for Preparation 0f Oncology Admixtures Complete Line of Diluents and Container Sizes Empty Admixture Containers DEHP-Free Containers Available ChemoLock and ChemoClave CSTDs for USP <800> Compliance Reduce Exposure to Hazardous Drugs Easy-to-Use Closed Systems Save Costs with Multipacks and Speciality Kits Maintain Sterility of Drug Vial The Diana Compounding Workflow System for Increased Efficiency Remote Verification Integrated CSTDs Accuracy without the Use of Gravimetric Scales Automated Ambulatory Cassette Filling and Air Removal

5 In Nursing We reduce steps while helping you improve safety, letting you focus on your patients. Safety Efficiency Profitability ChemoLock and ChemoClave CSTDs for USP <800> Compliance Sets with Prebonded CSTDs Cost-Effective CSTD Implementation Easy-to-Use CSTDs Full IV-EHR Interoperability with ICU Medical MedNet Smart Pump Programming Automated Start/Stop Time Capture Alarm Forwarding Plum 360 Infusion Pump with Unique Air Management Technology Reduce Air-in-Line Alarms Automated Backpriming Reliable Secondary Delivery Data You Can Trust Enhance Medication Safety with ICU Medical MedNet Unmatched Drug Library Compliance Comprehensive Reports Industry-Leading Cybersecurity Deliver Medications as Ordered ICU Medical offers two CSTD solutions to meet your needs

6 Enhance safety with compounding and infusion system technology that connects to your EHR Maintain drug vial sterility for up to ICU Medical s easy-to-use closed system transfer devices (CSTDs) and automated compounding workflow 7 Days extension of your electronic health record (EHR), helping you reduce medication errors, increase patient system are designed to help you minimize exposure to hazardous drugs and comply with USP <800>. Our smart infusion systems with ICU Medical MedNet safety software and full IV-EHR interoperability act as an safety, and streamline the flow of data from pharmacy to administration. Maximize safety and maintain a closed system from preparation through administration with easy-to-use USP <800> compliant CSTDs* The ChemoLock system s locking mechanism eliminates unsafe disconnects, helping you meet NIOSH requirements and comply with USP <800> CSTD guidelines. Track preparation data and enhance accuracy with IV workflow technology and automated pharmacy compounding that connects to your EHR Connecting the Diana compounding workflow system to your EHR lets you maintain an accurate record of each preparation, ensuring greater accuracy than manual compounding. Automated compounding with Diana has been shown to provide compounding accuracy of ±1% 1 Ensure accurate dosing with smart pump programming technology and maintain a closed system with air management pump technology* ICU Medical CSTDs pass the NIOSH protocol2 Evaluating a Closed System Transfer Device Based on NIOSH Performance Test Protocol, NIOSH Docket Number 288-A, CDC ICU Medical MedNet IV safety software helps you eliminate potentially catastrophic dosing errors associated with manual programming, while our proven Plum 360 infusion system helps you reach up to 98% drug library compliance. Plum 360 is the only infusion system to allow automated backpriming to remove air from the line without disconnection, helping you maintain a closed system throughout drug delivery. Plum 360 eliminates the risk for common secondary setup errors, which have been shown to occur in 48% of secondary infusions. Andrew Szkiladz, PharmD, BCPS, BCOP, Baystate Health, Springfield, MA; Fred Massoomi, PharmD, FASHP, Visante, Inc., Omaha, NE; Shawn Hegner, PharmD, UCHealth-Northern Colorado, Loveland, CO Background Methods Results No peer accepted performance standard currently exists for closed system transfer devices (CSTDs). As such, NIOSH researchers along with healthcare industry representatives and individual researchers are developing a performance test protocol for CSTD. While the original protocol was only applicable to barrier-type CSTD, the second iteration of the protocol is applicable to both barrier and air-cleaning types of CSTD. Changes to the original protocol include the use of a new surrogate whose vapor pressure is more representative of current hazardous drugs as well as the use of desorption tubes to be analyzed by TD-gas chromatography-mass spectrometry (TD-GCMS). The protocol as outlined by NIOSH Docket Number 288-A, CDC was used for the evaluation of the CSTD. Propylene glycol diluted in a 10:1 ratio in water and a stainless steel thermal desorption tube was used to collect vapor or liquid. The air pump flow rate was set to 50ml/min with a task time of 5 minutes. Detection of Propylene Glycol outside of a Closed System Transfer Device The objective was to evaluate the ICU Medical ChemoLock CSTD with two different vial adaptor technologies based on the NIOSH draft test protocol, NIOSH Docket Number 288-A, CDC , which is intended to challenge a CSTD s ability to function as a closed system that restricts drug mass (vapor or liquid) from crossing the system boundary and escaping into the surrounding environment. The two vial adapter technologies tested included: 1. A barrier technology that utilizes an external balloon designed to equalize pressure in the vial and limit the escape of hazardous drug particles and air. AIR-CAPTURE BARRIER Task 2 - Administration: Simulate administration by reconstituting drug followed by an IV push using a vial adapter, CSTD syringe adapter and administration set with a Y-site and CSTD port. Task 3 - Liquid Compounding: Simulate compounding medication with liquid drug using a vial adapter, CSTD syringe adapter and bag spike. This task is not outlined in the NIOSH protocol, however, was added to simulate a commonly performed task in the pharmacy. These tasks were performed multiple times utilizing different vial adapter technologies and an 18G needle and syringe. The desorption tubes were then sent to an independent laboratory for analysis. All results of propylene glycol detected will be averaged and reported. As Task 1 represents the most comprehensive compounding task, only task 1 was utilized with a 18G needle and syringe. The positive control was established by placing a 1ml drop of propylene glycol in the chamber and running the air flow for 5 minutes. # of Trials AIR FROM VIAL Task 1 Reconstitution Barrier Technology ChemoLock with Barrier ChemoLock with Air-Cleaning Needle and Syringe 4 2 Task 2 - Administration 2 0* N/A Task 3 - Liquid Compounding 4 2 N/A 3 *Administration task not necessary with a air-cleaning vial adapter 2. An air-cleaning technology that utilizes a.22 micron filter designed to equalize pressure in the vial and limit the escape of hazardous drug particles while allowing air to escape MICRON FILTER AIR FROM VIAL Air-Cleaning Technology The protocol was completed by three different pharmacists utilizing the established CSTD directions for use (DFU) to ensure the data submitted was not technique dependent, rather it represents common technique found in the pharmacy. Positive Control Needle and Syringe Task 1 Reconstitution Task 2 - Administration Task 3 - Liquid Compounding Negative Control ChemoLock with Barrier ChemoLock with Air-Cleaning Detection of Propylene Glycol outside of a Closed System Transfer Device ng Objective Task 1 - Reconstitution: Simulate reconstitution using a vial adapter, CSTD syringe adapter and bag spike Positive Control 18G Needle and Syringe Negative Control <25ng considered static non-detectible ChemoLock Vial Spike w/ ChemoLock Vial Spike w/ Barrier Technology Vented Technology Conclusions The test shows that all tasks using both the barrier and air-cleaning vial adaptor CSTD technologies pass the current NIOSH test protocol including the additional liquid drug compounding task. Therefore, pharmacies can standardize on a preferred vial adaptor technology that best fits their facilities needs when taking into account cost, workflow and ease of use. This performance test protocol reinforced the efficacy of using a CSTD to reduce potential hazardous drug exposure, especially when compared to using a traditional needle and syringe. While the purpose of the draft NIOSH performance test protocol is to test the capability of a CSTD to perform as such, it is important to remember that all current CSTDs on the market are FDA cleared and USP <800> compliant. REFERENCES 1 National Institute for Occupational Safety and Health (NIOSH): A Performance Test Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs. NIOSH Docket Number 288-A ChemoLock Barrier Vial Adaptor ChemoLock Air-Cleaning Vial Adaptor DISCLOSURE Andrew Szkiladz: Honoraria - ICU Medical; Fred Massoomi: Honoraria - ICU Medical; Shawn Hegner: Honoraria - ICU Medical 1 Accuracy Evaluation of the Diana Compounding Workflow System, Evaluating a Closed System Transfer Device Based on NIOSH Performance Test Protocol, NIOSH Docket Number 288-A. CDC : Szkiladaz et al. Presented at the Hematology/Oncology Pharmacy Association (HOPA) Conference, March * When using PlumSet with Clave secondary port and a closed system transfer device.

7 Improve efficiency with innovative technologies designed to complement the way you work today ICU Medical s oncology systems deliver everything you need to standardize your IV oncology workflow. Our Diana drug compounding workflow system combines both automation and IV workflow technologies with wireless pharmacist notification to let you remotely verify preparations on a handheld tablet. You can streamline the flow of medications and data from pharmacy to administration with smart pump programming technology and IV pumps with complete IV-EHR interoperability. Speed up the compounding process with remote pharmacist verifications and easy-to-use click to lock CSTD technology With Diana, you can maximize compounding efficiencies and safety by remotely verifying every mix without having to gown up and enter the cleanroom. Prepare medications more safely and efficiently using our ChemoLock CSTD that snaps together with an audible click to ensure a safe and secure connection. Improve nursing efficiency with infusion systems featuring closed air management and full IV-EHR interoperability Reduce the time it takes nurses to program pumps by up to 25% with smart pump programming, freeing up nurses to spend more time caring for patients. Eliminate manual steps traditionally required for EHR documentation with infusion documentation. Monitor alarms more efficiently and effectively with alarm forwarding. Air-In-Line Alarms Over the course of three administration cycles, the competitive pump registered a total of 21 air-in-line alarms while the Plum 360 registered zero alarms.1 Plum 360 Average 0 Plum 360 Total 0 Competitor Average 4.2 Competitor Total Number of Alarms JW Beared, Zehra Madhany, Healther Witek. The Role of Infusion Pump Technology in Optimizing Efficiency in Cancer Care Delivery, Save time by remotely reviewing preparation photos and data and verifying the mix on a handheld tablet display

8 Maximize profitability by improving reimbursements and lowering product implementation costs From preparation to administration, ICU Medical IV oncology technologies help you effectively and efficiently boost profitability. Our infusion systems become an extension of your EHR to help you maximize revenue capture and eliminate lost charges through accurate documentation. Our unique secondary delivery technology lets you purchase fewer devices to administer the same amount of medications, while our lower cost CSTDs are included on pre-assembled sets with bonded components to maximize safety and minimize set costs. 12% Improve financial performance by maximizing reimbursements with accurate infusion documentation and reducing chair time Reduction in chair time by concurrent medication delivery with Plum 360 Increase revenue capture with accurate infusion documentation of start/stop times. Purchase fewer devices and reduce operating expenses by delivering compatible medications via secondary set with the unique concurrent flow technology of the Plum 360. Improve patient turnaround time by reducing air-in-line alarms with the unique air management technology of the Plum 360. Minimize CSTD and IV set costs by reducing components at each step Offset administration costs while preventing accidental misuse and reducing set-up time with CSTDs requiring no extra parts or add-on components $500K $450K $435,473 $400K $393,978 $350K $300K Cost 10% Reduction in cost with multipacks The ChemoClave system, which meets the NIOSH definition of a closed system, was shown to cost up to $307,000 less to implement Reduce costs and packaging waste with options to purchase multipack CSTD components. $507,287 Total Annual Costs Associated with Implementing Competing CSTDs than competing systems * $239,020 $250K $200K $200,281 $150K $100K $50K $0 * Component cost may vary slightly due to manufacturing price changes, contract pricing, and/or volume discount pricing. Texium/SmartSite is marketed as a closed system, not a CSTD. 3 Barnachea L, Lee T, Gitler J, Saria M. Cost Determination Study of Closed System Transfer Devices (CSTD). Presented at the California Society of Health System Pharmacists (CSHP), November 4, PhaSeal EquaShield OnGuard Texium/ SmartSite ChemoClave

9 A commitment to exceptional ongoing technical support and clinical education Our commitment to you doesn t end with the purchase. We provide a dedicated support organization with a wealth of knowledge, resources, and technical training opportunities to help you maximize the value of your investment in ICU Medical products. When you choose ICU Medical, you are choosing a true partner who will be with you every step of the way, offering: > Best-in-class technical and clinical in-servicing > Dedicated field service engineers available > Personalized instructional materials 2018 ICU Medical Inc. P For safe and proper use, refer to the instructions for use