Tips for CSTD Use

February 2017 : Oncology Safety - Vol.14 No. 2 - Page #8
Category: Closed System Drug-Transfer Devices (CSTDs)

Present a Robust Case for Closed System Drug-Transfer Device (CSTD) Adoption.
When making the case to senior hospital administration for implementing a CSTD, it is imperative to focus on safety and USP <800> compliance. In the past, it was not unusual for financial considerations to prevent organizations from adopting CSTDs. Now, because USP <800> requires CSTDs for hazardous drug (HD) administration and recommends use during compounding, incorporating this important safety device into practice is no longer optional: as of July 1, 2018, the chapter will become enforceable.

USP <800>’s expectation for CSTD use is to drive adoption wherever possible. The chapter can help pharmacy and nursing make a strong case to senior leadership and finance to adopt CSTDs. In addition to emphasizing regulatory compliance, focus on the proven safety benefits of CSTD use for those staff compounding and administering HDs. Using a CSTD is simply the right thing to do to protect health care workers from the harmful effects of HD exposure.

Specify and Document CSTD Use.
USP <800> requires documentation of the acquisition, preparation, and dispensing of HDs.1 Policies and procedures should specify that whenever possible, CSTDs are to be used during compounding and administering hazardous medications. In addition, organizations should devise a method of documenting CSTD use. Documenting CSTD use within the EHR is ideal. It is important that organizations work with their EHR vendors to develop ways to ensure documentation in the compounding record.

Consider the Needs of Pharmacy and Nursing When Choosing a Device.
While USP <800> provides an effective argument for CSTD adoption, the chapter does not provide guidelines for choosing a device. CSTD selection must be a collaborative process to ensure the device chosen is workable for both the pharmacy and nursing teams. Considerations when evaluating CSTDs include ease of use, the number of components required, the amount of space required to store the devices, risk of repetitive strain injury, cost, and clinical effectiveness.

Experience has shown that ease of use and risk of repetitive strain injury are top priorities for pharmacy technicians. Repeating the same motion during compounding can be taxing on technicians’ hands and wrists. For example, when withdrawing large volumes of chemotherapy for reconstitution, it can be challenging to make the connection and establish a sufficient pressure differential to extract the drug and then push it into a vial. Nurses’ priorities for CSTDs include ease of use and the number of parts required. If a system requires the nurse to connect multiple pieces, it can become cumbersome and will likely increase administration time.

As part of the evaluation of clinical studies supporting individual CSTDs, consider the quality of the evidence provided. For example, is the device proven to be closed? Which definition is the vendor using to define a closed system? What evidence is available proving that the CSTD effectively decreases the exposure of hazardous medications to the user? Most CSTD vendors have performed their own studies that support use of the device. Can they also provide independently conducted studies that demonstrate the effectiveness of their device? The value of independent research, performed by a university or other third party, is preferable to studies funded by the CSTD manufacturers themselves.

Adopting a single device significantly improves CSTD pricing and contracting options. To meet that goal, working closely with the end users, nurses and pharmacy technicians, is critical. Utilizing a single device throughout the health system also increases standardization. Because pharmacy technicians and nurses have similar requirements for CSTDs, identifying a single device should be a relatively smooth process.

After a device has been chosen and implemented, it is important to remain aware of developments in the CSTD marketplace. As new CSTDs or product upgrades become available, nursing and pharmacy leadership should continue to examine all product options.

Develop a Plan for Compounding and Administering CSTD-Incompatible HDs.
Some HDs, such as ampules and certain corrosive agents, may be incompatible with CSTD use. Corrosive chemotherapy agents may be incompatible with the rubber used in the closed system. In these cases, the CSTD should not be used with this product during preparation or administration. Check with your CSTD vendor for specific information on incompatibility.

Vials with small neck diameters may also be an issue; although CSTD manufacturers provide vial access devices that allow access to small vial neck diameters, it is critical to verify that these devices create a secure connection. If the vial access device fits too loosely, it will be ineffective. This issue may arise when a hospital’s usual vial is backordered and an alternate vial with a smaller topper is substituted. In this situation, it is critical to ensure the vial access device fits securely before compounding begins. Looking to the future, it would be helpful if vendors could provide a broad mechanism to cover any vial, IV bag, or syringe topper.

There may be circumstances where technicians cannot use a CSTD during HD compounding, but nurses can utilize the device during HD administration. In such a case, the technician should include the CSTD for administration. Including information in the electronic compounding record and the medication administration record specifying when to use the CSTD is a best practice.


Caryn Domenici Belisle, RPh, MBA, is the director of pharmacy regulatory compliance, quality, and safety at Brigham and Women’s Hospital in Boston, Massachusetts. Caryn received her BS in pharmacy from the Massachusetts College of Pharmacy and her MBA from the University of Massachusetts. She is the current president of the Massachusetts Society of Health-System Pharmacists. Caryn’s areas of expertise include USP <797>, sterile product robotic and workflow technology, regulatory compliance, patient safety, and pharmacy operations.


Reference

  1. USP General Chapter <800>. http://www.usp.org/usp-nf/notices/general-chapter-hazardous-drugs-handling-healthcare-settings. Accessed January 19, 2017.

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