This account is based on interviews and written documentation provided by the hospitals, and has been approved for publication.
In an era where oncology healthcare workers face growing challenges, the implementation of Closed System Transfer Devices (CSTDs) is significantly enhancing their safety. This life saving technology has been adopted by many countries as a standard, however Germany has not yet mandated their use. Three German hospitals have pioneered the use of closed-system transfer devices (CSTDs) out of concern for their oncology team’s exposure to dangerous medications. They adopted EQUASHIELDs CSTDs to enhance their hazardous drug handling procedures, ensuring a safer and more efficient work environment. The hospitals documented the entire process and conducted in-depth interviews with the pharmacy manager to assess the efficacy of the system. This blog post explores the impact of EQUASHIELD’s Closed System Transfer Device (CSTD) on Ostalb hospitals over a 12-month period from January to December 2017, with an updated evaluation conducted in 2024.
Understanding the Risks in Oncology
Oncology healthcare professionals face the risk of exposure to hazardous antineoplastic drugs on a daily basis. The very nature of these cytotoxic drugs which makes them so effective in combating cancer cells also makes them dangerous to healthy cells.
Infusion therapy typically necessitates individual preparation for each patient before administration. The preparation process can lead to errors, spillages, needlestick injuries, aerosolization, and workplace contamination. Potential exposure poses significant health risks to workers throughout the entire lifecycle, from preparation through waste disposal. While patients receive concentrated doses of a limited number of Hazardous Medicinal Products (HMPs) for a defined period, workers may be exposed to small doses of a wide range of hazardous medicinal products over decades, with some experiencing daily exposure year after year.1
Exposure can occur via skin contact, ingestion, or inhalation of airborne particles. Short term health effects from minimal exposure to hazardous drugs over a long period include hair loss, taste disturbances, headaches, reproductive disorders, miscarriages, infections, and respiratory diseases. Often, the effects of exposure are long-term, not becoming evident for years or even generations of continuous exposure. Given that cancer can take decades to manifest, a diagnosis of breast cancer or leukemia in a nurse or pharmacist today might stem from workplace exposure to hazardous drugs starting in the 1980s. 2
These risks necessitate that health facilities treating cancer patients implement stringent safety precautions. Essential precautions include using personal protective equipment (PPE), following local regulations, and employing suitable solutions like CSTDs for handling chemotherapy drugs.
What are CSTDs?
According to the National Institute for Occupational Safety and Health (NIOSH), a CSTD (Closed System Transfer Device) is a drug transfer device that mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drugs or vapors outside of the system. CSTDs play a crucial role in ensuring safe drug compounding and administration by protecting healthcare practitioners from exposure via leaks, spills, and vapor release.
Improving Oncology Safety at Ostalb Hospitals
Ostalb Klinikum Mutlangen, along with two affiliated hospitals in Southwest Germany, were preparing and administering around 6,500 chemotherapy cycles and 20,000 cytostatic preparations annually. While many countries have established stricter protocols for managing hazardous drugs, Germany has not yet followed suit. Recognizing the paramount importance of staff safety, Ostalb hospitals chose to lead the way in Germany by pioneering the use of CSTDs. Before switching to EQUASHIELD, the pharmacy was not using a closed system for handling hazardous drugs.
The pharmacy manager was eager to transition to a safer system primarily due to exposure risks. In a dedicated effort to improve safety for their oncology healthcare workers, the hospitals decided to adopt CSTDs. They identified their criteria for choosing a CSTD brand as follows:
- A system consisting of defined connectors, Vial Adaptors, Syringe Adaptors, and Luer Lock components for administration
- A leak-proof device that can manage multiple membrane access
- A system that will reduce occurrences of accidental disconnections and spike falloffs
- A system that is practical to use and will not impede workflow of busy hospital staff
- A system that is clinically validated to effectively protect healthcare workers
The Decision Process
The primary reason for selecting a closed system transfer device was to protect the oncology staff from hazardous drug contamination. The hospitals also aimed to preserve medication integrity and streamline the compounding process. The Pharmacy Manager at the time recognized the critical importance of safeguarding Pharmacy Technicians in the hazardous drugs compounding department. The high volume of daily production and the gradual decline of focus throughout the day had led to needlestick injuries. Recognizing these hazardous incidents, she was committed to transition to a safer system for her team. She also felt a responsibility to protect the oncology nurses from exposure by residual chemicals on the outside of the prepared medications they were handling.
The concept of a closed system remained a critical topic of discussion within the team. However, until they discovered EQUASHIELD there had been no practical closed system available on the market that could effectively meet their stringent requirements for both safety and functionality. The decision process to switch to a closed system took approximately six months and involved convincing the hospital management of its benefits, which outweigh the costs, keeping the staff safe. The Ostalb hospitals assessed various CSTD brands and chose EQUASHIELD based on their clinically proven safety and efficacy, product reliability, and user-friendly design.
Implementing EQUASHIELD CSTDs
Staff Reactions Â
It took one week for the pharmacy technicians to adapt to the EQUASHIELD system. The adoption process was seamless and intuitive, allowing them to effortlessly learn how to use the products. After the training and clinical onboarding the staff quickly adapted and learned how easy and intuitive is to use EQUASHIELD CSTDs in their workflow. After this period, they expressed high satisfaction and a preference for this system over others.
The hospitals reported several significant improvements immediately after implementation:
- Improved safety for healthcare professionals
- Reduced risk when handling cytotoxic drugs, resulting in improved workflows and stress-free handling of patient doses
- Completely dry connections with no spills or drips
- No foaming during drug withdrawal
- Easier preparation when reconstituting lyophilized powders
- User friendly and fail proof application due to the red marked notches that indicate specifically how to apply it
Compatibility
The hospitals noted smooth integration. Components they use include syringe units, spike adaptors, luer lock adaptors, female connectors, and vial adaptors. They utilized a standard tubing system.
The hospitals have adopted EQUASHIELD for all cytotoxic preparations, including antibodies, finding it advantageous over the previous method of using specific equipment for each medication based on compatibility.
One-Year Evaluation
Overall Improvements
One year after adopting EQUASHIELD’s CSTDs, all three Ostalb hospitals witnessed significant improvements in multiple areas. EQUASHIELD’s CSTD system substantially reduced contamination in the pharmacy and hospital. Reduced preparation times resulted in significant time savings in daily production. The system’s user-friendly design, with intuitive handling and clear application markings, ensures reliable and fail proof administration. Administration times have been reduced, and repetitive motion injuries have been prevented. The customer service team is responsive and ensures quick delivery, usually within 3-4 days.
Evaluating Surface Contamination Reduction
Wipe sampling was performed at multiple locations within the hospital system at various time points following the EQUASHIELD implementation. Of the three types of drugs used for sampling—Cisplatin, Fluorouracil, and Cyclophosphamide—all trackers pointed to lower traces of drug residue, with the vast majority being under 0.2 ng per sample detection limits.
This reduction in contamination not only enhances the safety of pharmacists and nurses but also contributes to a clean and safe environment for support staff throughout the lifecycle of the medication.
Time Savings
In addition to improving safety, EQUASHIELD’s CSTD have also proven to be time savers in drug preparation. When calculating the time saved while preparing top chemotherapy agents used daily, it was identified that drug preparation times could be reduced significantly by using EQUASHIELD CSTD. In some cases, the time savings were as much as 3.5 minutes per dose. Cetuximab alone saved 455 minutes annually. Similarly, other medications such as Fluorouracil, Avastin, and Herceptin achieved significant time reductions. The annual time savings in drug preparation for each staff member across 29 evaluated drugs totaled over 3,856 minutes.
Evaluating EQUASHIELD 7 Years Later
Seven years after integrating EQUASHIELD’s CSTD system into their daily operations, the hospitals continue to see improvements in staff satisfaction, time savings, and contamination reduction. The Ostalb hospital’s experience has been positive since its implementation. They are satisfied with the premium safety standards and would never consider using an alternative system. Annual wipe tests confirm that the enhanced safety levels, achieved since adoption, are consistently maintained. The system’s ease of use and safety features have significantly improved the workflow in the pharmacy department. An unexpected benefit is that the exceptional safety standards make it significantly easier to retain and recruit new staff to the oncology department. As a result, staff turnover has decreased significantly for the past seven years.
Adopting EQUASHIELD’s closed system technology has brought significant benefits to Ostalb hospitals, enhancing safety, streamlining workflows, and boosting staff morale.
Navigating the New EU Directives on HMPs
The implementation of EQUASHIELD CSTDs has ensured hospital compliance with the latest EU directives on hazardous medicinal products (HMPs). The new regulations outline which medicines are considered carcinogenic, mutagenic, or reprotoxic potential. Under the new regulations, hospitals are required to use closed systems for the updated list of HMPs by April 2024. The EQUASHIELD system meets and exceeds these safety requirements, providing a safe and efficient solution for pharmacists and nurses.Â
If you’re interested in learning more about how EQUASHIELD can benefit your healthcare facility, please reach out to one of our experts here.
