Cost-Effectively Comply With USP <800> CSTD Guidelines



In the most recent update to its comprehensive standards, USP’s proposed Chapter <800> (USP <800>) will for the first time require facilities to utilize CSTDs during administration to patients, while encouraging compounding facilities to utilize CSTDs during hazardous drug preparation. While the comprehensive USP <800> safe handling guidelines will have significant budgetary implications for healthcare facilities, implementing CSTDs can be one of the most cost-effective ways to start improving safety and compliance.

Of the handful of CSTDs on the market, ICU Medical's ChemoClave® CSTD and ChemoLock® CSTD systems offer a variety of cost-effective USP <800> compliant solutions.

Minimizing Costs of CSTDs Used In the Pharmacy

There are multiple ways in which health system pharmacy leaders can control the cost of implementing CSTDs. For hospitals and cancer centers compounding fewer than 30 HD preparations each day, manual (by hand) CSTD compounding technologies are generally the most cost-effective, while high-volume facilities compounding greater than 30 preparations per day can more effectively offset the cost of CSTDs by implementing automated compounding technologies featuring reusable CSTD components.

1. Implement the Lowest Cost CTSD

Low-volume pharmacies rely on manual CSTD compounding methods that require single-use CSTD components for each preparation. As a result, the first determinant of CSTD affordability for these facilities is the cost of the devices themselves. A comparison of total annual costs associated with implementing the various CSTDs is illustrated in Figure 1.

2. Utilize Multi-Packs and Specialty Kits for Volume-Based Savings

Facilities compounding high-volumes of HD each day are especially vulnerable to the costs associated with high supply usage; however, high volume pharmacies can help offset the costs of CSTD implementation by ordering commonly used items in multi-packs and kits. ChemoClave and ChemoLock CSTD multi-packs provide pharmacies with price discounts on frequently used components, including vial spikes and bag spikes. In addition to multi-pack volume discounts, the ChemoClave and ChemoLock systems allow pharmacies to design specialty kits that include all CSTD components needed for a specific, repeated preparation, all at a cost lower than the sum of the individual components if purchased separately.

3. Minimize Costs with Automated Compounding Technology

High-volume compounding facilities can also minimize CSTD costs by implementing automated compounding technology that integrates reusable CSTD components. Substituting reusable CSTD components for single-use components helps decrease the cost per mix as volumes of preparations of the same medication increase, eventually bringing costs per mix below that of manual, single-use methods (Figure 2). Currently, the only available automated drug compounding system that integrates CSTD technology is the Diana automated drug compounding system. The Diana system uses ChemoClave or ChemoLock CSTD components to minimize exposure to HDs and preserve drug sterility, while offering the clinical accuracy and ergonomic benefits of compounding automation.

Minimizing Costs of CSTDs Used in Nursing

USP <800> CSTD language is strongest in its guidance for CSTD use during patient administration. This new guidance mandates the use of CSTDs for the safe administration of HDs, stating “CSTDs must be used when administering HDs when the dosage form allows.” CSTDs used during the administration process take the form of bag spikes, administration sets, and other components that help maintain closed systems during both IV pump infusion and direct IV push delivery.

1. Avoid Replacing Administration Sets for Patients Receiving Multiple Drugs Per Treatment

Traditionally, when patients receive additional HDs during a single treatment, the previous drug bag is discarded along with the entire administration set. As a result, each additional drug delivery requires a new primary or secondary set along with the new drug bag. The ChemoClave and ChemoLock systems incorporate unique CSTD adapter technology to eliminate the need to replace primary pump set or secondary set tubing (Figure 3) for patients receiving multiple drugtherapies. For each primary and secondary set scenario, CSTD bag spikes can be safely disconnected from the closed male luer on the primary set adapter or ICU Medical secondary set. As a result, primary and secondary administration tubing can stay in place for a patient receiving multiple drug therapies in a single treatment, helping to minimize treatment costs and maximize workflow efficiencies.

2. Avoid Additional Components Required for Administration

CSTD systems with non-ISO standard luer connections may require the use of extra components or adapters in order to access ISO-standard luers on a patient’s IV line. These additional components increase costs and complexity for the nursing staff. In contrast, ICU Medical’s luer-based ChemoClave system can be connected to any needlefree connector, helping minimize costs by eliminating the need for any extra components during administration.


ICU Medical’s ChemoClave and ChemoLock systems offer the most comprehensive and cost-effective CSTD solutions for facilities of all sizes and compounding volumes. These CSTD systems also allow high-volume compounding pharmacies to experience the benefits of compounding automation while minizing overall CSTD costs. With unique components that allow for the preservation of administration tubing, ICU Medical CSTDs may help large health systems save up to an additional $264,000 per year by minimizing the tubing and components required for patients receiving multiple chemotherapy drugs per treatment. Ultimately, minimizing CSTD implementation costs with ICU Medical’s proven CSTD solutions can make it easier for healthcare workers at hospital pharmacies and cancer centers to comply with USP <800> safe handling guidelines while working to improve the health and wellbeing of patients fighting through some the most challenging times of their lives.

Clinical Evidence


  1. 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, 2011.