With increased levels of caution regarding occupational exposure to hazardous drugs (HDs), employee safety must be considered throughout the HD admixing and administration processes. Use of a closed system drug-transfer device (CSTD) can help ensure this goal is met; yet despite the benefits afforded by CSTDs, some organizations may still find themselves resistant to implementation due to barriers of cost, lack of comparative standards, and the ongoing changes in the regulatory landscape. Nonetheless, CSTDs are a proven technology that reduces the exposure to hazardous medications.
Sentara Healthcare is an integrated health system comprised of 12 hospitals and over 300 sites of care operating throughout Virginia and North Carolina. The pharmacy at Sentara RMH Medical Center, a 238-bed community hospital and regional cancer center in Harrisonburg, Virginia, was preparing to meet the challenge of USP <800> compliance. USP <800> recommends CSTD use for HD preparation and requires its use for administration; the December 1, 2019 enforcement date is quickly approaching. Sentara began using CSTDs in 2012, and by 2017 was considering a new vendor; therefore, pharmacy’s critical decision was not whether to implement a CSTD, but rather which CSTD to implement.
Wipe Analysis Aids in Decision-Making
Quantitative wipe sampling should be a part of any quality assurance program. Sentara RMH has conducted bi-annual chemotherapy wipe sampling analysis since 2014, which has facilitated practice change based on positive test results. Positive wipe sampling results as well as data tracking device failures prompted pharmacy to re-evaluate CSTD options. These findings also helped convince other stakeholders to support the vendor review. A task force was formed to evaluate the various CSTDs on the market, with the goals of ensuring staff safety and standardizing CSTD use throughout the health system.
CSTD Evaluation Guidelines
Our first priority was to narrow the search to products that offer complete containment of hazardous materials; however, there currently is no standard or protocol in place for direct comparison of CSTD containment. The NIOSH CSTD testing protocol is not yet finalized; therefore, the only standard available is the FDA 510K category for CSTDs. As such, we created an initial vendor list for the onsite evaluation that included CSTDs with the FDA 510K designation. In addition, we evaluated published studies to further examine HD containment methodologies and effectiveness.
Ease of Use
After researching CSTD functionality in other facilities, we noted that product selection was typically based on user feedback regarding ease of use, including simplicity, ergonomic comfort, and the number of components needed to complete a task. Ease of use is often directly connected to product compliance. Our task force identified a subgroup of products that met the goal of protecting our employees, based on user feedback from other Sentara facilities. Two sites were selected to trial three different products for a full day and then provide end-user feedback across multiple teams. As USP <800> requires a multidisciplinary, comprehensive plan, feedback should include nursing as well as pharmacy staff members.
Benefits of the Equashield CSTD
Equashield was chosen as Sentara RMH’s vendor for CSTD technology because it met our organization’s goals of protecting employees by exemplifying complete hazardous containment, while also being easy to use. The integrated syringe with pre-bonded components passed all leakage tests while also excelling in published efficiency studies.
In addition, both nursing and pharmacy users preferred this CSTD by a large margin because it required minimal training and offered exceptional efficiency and ease of use. In particular, pharmacy users noted the simple ergonomic connection process, the reduced number of components required, and its intuitive simplicity. Benefits cited by nursing included the easy connection process and the seamless integration of the technology into patient care activities. In addition, the Equashield CSTD is compatible with the multiple infusion technologies and sets utilized throughout our organization.
The CSTD was implemented system-wide by a pharmacy operations team over a period of 6 months. Because practice compliance can be a primary barrier to new technology adoptions, on-site vendor support was critical to utilization success. As experienced system users, Equashield representatives led both pharmacy and nursing training for each site. The staff appreciated the first-hand operational insight that the trainers were able to share with new users.
Inventory management of old devices proved to be a challenge. To reduce waste, Sentara scheduled one of the largest sites in the system to be the last to implement the new device, thus allowing for the utilization of the existing inventory.
Safe HD compounding is an integral part of hospital pharmacy operations. As such, implementing a CSTD provides peace of mind that staff performing drug compounding and administration are properly protected from HD exposure. A robust evaluation of available devices facilitated our selection of the Equashield CSTD, which significantly increases technician and nursing safety while ensuring ease of use.
Jamin Engel, PharmD, MBA, is the pharmacy manager at Sentara RMH Medical Center in Harrisonburg, Virginia. He received his Doctor of Pharmacy degree from VCU School of Pharmacy in 2008, and MBA from James Madison University in 2013.