Case Study: Implementing EQUASHIELD CSTDs in German Ostalb Hospitals

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  

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 
Hospitals implementing CSTD

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. 

Time savings in chemotherapy preparation with Equashield CSTDs

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. 

If you’re interested in learning more about how EQUASHIELD can benefit your healthcare facility, please reach out to one of our experts here.

Case Study: CSTD use in Veterinary Medicine  

Dogs get cancer at roughly the same rate as humans, with nearly half of dogs over the age of 10 developing cancer.1 Cancer is a common concern in small animals, and as our beloved companions, they deserve the highest standard of care. Recently, there has been a notable rise in the use of antineoplastic chemotherapy within small animal veterinary practice. This trend is primarily driven by a growing awareness among pet owners about tumor diseases, along with significant advancements in diagnostics and therapies for small animal oncology.  

While such therapies were initially carried out by large oncology centers, they are increasingly being offered by specialized small animal clinics.

Safety concerns  

Exposure Risks for Veterinarians and Pet Owners 

The use of cytostatic drugs poses an increased risk of exposure for veterinary staff and pet owners present during chemotherapy.  

Given that the substances involved possess mutagenic, teratogenic, and carcinogenic properties, and that it is difficult to define minimum quantities for these effects, it is crucial to minimize the risk of exposure for both veterinary personnel and pet owners. The risk of exposure on surfaces is further increased considering that most veterinary clinics do not employ primary engineering controls, such as safety cabinets or isolators. 

Research in human medicine indicates that there is no connection between the number of chemotherapy treatments administered at a facility and the degree of exposure risk.2 This means that even facilities performing a relatively small number of chemotherapy treatments must prioritize minimizing exposure risks and implementing suitable protective measures.  

The European College of Internal Medicine for Companion Animals has developed guidelines for the appropriate use of antineoplastic chemotherapeutic agents.3   

The compounding of intravenous infusion solutions for antitumor chemotherapy, along with the administration of chemotherapeutic agents, introduces distinct risks of contamination and exposure to cytostatic drugs. Veterinarians encounter significant exposure risks in these processes. 4 Key steps in the process include reconstituting the vial, accurately extracting the substance, and managing the infusion solution.  

Syringe unit with a closed syringe plunger prevents toxic aerosols from escaping.

Risks of Bacterial Contamination   

 Small animals need much less medication than humans, but the medications often come in standard-sized vials, resulting in significant waste. Traditional systems carry a high risk of microbial contamination, making multiple withdrawals unsafe, especially for immunosuppressed patients who are more vulnerable to sepsis. Additionally, many cytostatic drugs are costly, and disposing of unused substances is both expensive and harmful to the environment. 

Use of CSTDs for the Application of Cytostatic Drugs to Small Animals  

Utilizing a closed system transfer device (CSTD) mitigates both environmental and microbial contamination risks, protecting medical personnel and pet owners. 

Currently, only a limited selection of CSTDs are available on the market in small animal oncology.5 EQUASHIELD has undergone extensive testing in human oncology, clinically backed to be safe and easy to use. The use of CSTDs does not exempt the oncologist of the obligation to adhere to current legal regulations governing chemotherapy. Nonetheless, it is strongly advised for veterinarians to prioritize their own safety. 6 

Case Study: Oncology at the Kleintierzentrum Kinzigtal Small Animal Center 

This summary highlights the experiences of Kleintierzentrum Kinzigtal Small Animal Center, written by Dr. Jörg Schäffner, as they transitioned to EQUASHIELD CSTDs. For the complete article, please download here.

At the Kinzigtal Small Animal Center in Baden-WĂĽrttemberg, Germany, we regularly provide chemotherapy for various tumors, including lymphomas, mastocytomas, and epithelial tumors like prostate and anal sac carcinoma. Treatments often involve intravenous administration of cytostatic drugs such as vincristine, doxorubicin, and carboplatin, with a successful slow infusion method.  

Before the introduction of EQUASHIELD CSTDs, the conventional system left staff vulnerable to exposure. Before application, the calculated volume of a cytostatic drug was drawn from the sealed glass vial. Since multiple doses were often extracted from a single vial, this process introduced a risk of contamination for both the user and the surrounding environment. Another potential source of exposure and contamination arose when air was introduced to equalize the pressure between the vial and the syringe. Finally, there was the risk of needlestick injuries. 

Veterinarian administering cytotoxic drug chemotherapy to small animals

Introducing EQUASHIELD

Over the past year, we have effectively mitigated these risks by utilizing the closed EQUASHIELD system. Administering treatment to restless, unsedated animals requires a safe and user-friendly approach to effectively prevent contamination of medical staff, pet owners, and the surrounding environment. It is crucial for us to have a system that can accommodate the unpredictable movements of the patient, ensuring the safe and hazard-free administration of cytostatic medications. The self-locking vial adapter, which remains firmly connected to a vial once it has been opened, and the syringe unit  connected to the double-membrane closure system thus safely reduces both hazards. The sterilized air is introduced into the drug vial from the sealed chamber in the syringe unit to equalize pressure. 

As the syringe unit is locked to the Luer Lock Adaptor of the infusion system, there is no risk of disconnection and subsequent contamination even if the patient moves. The slow application is carried out in a stress-free and controlled manner. Even when the syringe unit plunger is pulled back, the pressure equalization system reduces the risk of environmental contamination from aerosols. After administering the cytostatic drug and flushing the infusion tubing, the entire system is safely removed and disposed of in designated waste containers. Using CSTDs minimizes the risk of bacterial contamination, allowing us to make multiple withdrawals from the vial while effectively addressing the issue of waste.

 

Veterinarian using EQUASHIELD CSTD

Veterinarian using EQUASHIELD CSTD

Concluding Thoughts

In our experience, the introduction of EQUASHIELD is a significant contribution to safe chemotherapy. Our consistent positive experiences with EQUASHIELD, characterized by intuitive and safe handling, along with significant time savings compared to other systems, validate the findings of a study from North America.7 EQUASHIELD reduces the risk of microbial contamination of opened cytostatic vials.7 For medical staff and pet owners, exposure risks have been effectively reduced.  Implementing EQUASHIELD has significantly improved occupational safety in our veterinary clinic.     Â