CDX Articles Archive | Page 2 of 2

Maximizing Efficiency and Safety in Healthcare: Real Life Case Studies on Cost Savings with Closed System Drug Transfer Devices (CSTDs)

Ilya Viten on February 5, 2024

CSTDs have been instrumental in transforming medication safety in healthcare facilities. As the industry increasingly focuses on the well-being of healthcare professionals, these devices are recognized for their role in optimizing resource management, reducing product waste, and addressing occupational health risks. According to NIOSH (National Institute for Occupational Safety and Health)¹, CSTDs ensure safe, contained drug transfers, minimizing exposure to hazardous drugs and offering significant financial benefits.

CSTDs: Boosting Occupational Safety and Cutting Costs in Pharmacy Compounding

In healthcare environments, especially during the compounding process, Closed System Drug Transfer Devices (CSTDs) play a crucial role in minimizing the risks of hazardous contamination. They establish a secure, airtight connection between drug vials, syringes, and IV bags, effectively preventing exposure to harmful aerosols and vapors. By incorporating physical barriers, CSTDs ensure the containment of hazardous drugs, thereby significantly reducing the risk of exposure to hazardous particles.

Research shows a reduction in contamination risk from 26.4% with standard isolators to 12.2% with CSTDs², enhancing safety measures for pharmacists, nurses, and other healthcare professionals.

To further illustrate the impact of CSTDs, this paper explores real-world case studies where pharmacies and compounding centers have successfully implemented these systems, leading to substantial financial savings alongside enhanced safety measures.

Relevant Cost Reductions Proven by Extended Beyond Use Date (BUD): Case Studies at Mount Sinai and Bronson Battle Creek

The implementation of Closed System Transfer Devices (CSTDs) in healthcare settings, particularly in outpatient cancer centers, has shown significant potential for cost savings by reducing medication wastage. Notable examples come from Mount Sinai Hospital – New York, USA and Bronson Battle Creek (BBC) Cancer Care Center – Michigan, USA.

At Mount Sinai Hospital, by extending the BUD (Beyond Use Date) of single-dose vials from 6 hours to 7 days, the hospital could significantly reduce the amount of discarded medication. This led to substantial savings for six agents, enough to offset the cost of using Equashield solution to comply with USP 800 standards.³ The figures were impressive, showing an annual cost reduction of $530,000, underscoring the economic advantages gained from incorporating the CSTDs.⁴

Similarly, Bronson Battle Creek Cancer Care Center (BBC) also implemented a CSTD, aiming to decrease waste and offset the cost of CSTDs implementation in a comprehensive cancer care center. The results demonstrated financial efficiency in reducing drug wastage, applicable in both large university hospitals and smaller community healthcare settings³.

Relevant Cost Reductions Proven by Extended Beyond Use Date (BUD): Case Studies

More Real-Life Examples: Demonstrating Financial Gains with CSTDs and Automated Drug Compounding

Recent research, including one conducted by the Pharmacy Department of the Centre Regional de Lutte Contre le Cancer Léon Bérard⁵, has shown that Equashield CSTDs (closed system transfer devices) minimize contamination risks compared to traditional methods, leading to safer work environments, reduced direct contact with hazardous drugs, and significant financial benefits⁶.

The study, “An economic evaluation of vial sharing of expensive drugs in automated compounding,”⁷ highlights the economic advantages of an innovative approach to drug compounding. By implementing an automated compounding process with a vial-sharing strategy, significant cost savings were achieved. This method, contrasting with traditional manual compounding, led to avoiding drug wastage during the automated process. The study revealed that over six months, the cost of drug wastage for 1001 preparations of rituximab, pemetrexed, bevacizumab, and trastuzumab combined, amounted to €34.133, €46.688, and €88.255 for different manual compounding scenarios. In contrast, the automated compounding with vial sharing resulted in substantial savings, with an estimated total cost reduction exceeding €280.000 between 2017 and 2021. This approach not only presents an economic advantage but also contributes to environmental sustainability by minimizing drug wastage. Additionally, automated compounding saves valuable staff time, enhancing overall efficiency alongside its other benefits.

Reducing Liability and Undesired Healthcare Costs in Drug Compounding

CSTDs (closed system transfer devices) have emerged as key players in mitigating potential liability and contributing to cost-effective practices. They provide a closed and secure environment, reducing exposure to hazardous drugs and minimizing potential financial burdens. A case study in Genoa⁸ found that using Equashield during drug compounding resulted in no detectable levels of gemcitabine, a cytostatic drug used in chemotherapy, highlighting both safety benefits and potential cost savings.

Before the implementation of Equashield II, the study found detectable levels of GEM contamination in various samples, including on operators’ gloves, suggesting that the preparation systems used at the time were not fully sealed. This was evident in the results, where GEM was detected in several samples, indicating a risk of occupational exposure to the drug.

Reducing Liability and Undesired Healthcare Costs in Drug Compounding

After the introduction of Equashield II, the study observed a significant change. The subsequent monitoring from 2020 to 2021 showed that gemcitabine was not present at detectable levels in any of the evaluated samples when using the Equashield II system. This contrasted with the results obtained using the TexiumTM/SmartSiteTM system, where GEM dispersion was still observed after compounding, with positive samples ranging from 9-23%.

The absence of detectable levels of GEM in samples when using Equashield II indicates that this CSTD was effectively able to eliminate spills and leakage during the compounding of gemcitabine, thereby significantly reducing the risk of contamination and exposure. This result underscores the effectiveness of Equashield II in creating a safer environment for healthcare workers by minimizing the potential for hazardous drug exposure during the compounding process.

By preventing exposure-related health problems, CSTDs such as Equashield help to reduce sick leave costs and potential legal consequences. As such, these devices play a vital role in protecting healthcare facilities against both safety and financial risks.

To conclude our exploration of real-life examples and case studies, let’s summarize the key advantages of CSTDs that have been consistently observed across various healthcare settings.

Summarizing the Success: Key Advantages of CSTDs in Pharmaceutical Compounding

The integration of CSTDs has significantly improved staff confidence in medication administration. Healthcare workers felt safer and more confident in handling hazardous drugs, knowing that the risk of exposure was minimized.

Streamlined operations

The use of CSTDs can lead to faster medication preparation and administration. These devices are designed to minimize connections and disconnections during compounding, ultimately saving valuable time and reducing costs.

Minimize the risk of exposure to hazardous drugs

CSTDs offer the potential to reduce direct exposure of healthcare workers to hazardous drugs by creating a closed environment. The impact is significant: one study found that contamination was reduced from 26.4% with traditional methods to 12.2% with CSTDs, resulting in reduced sickness absence and a safer workplace.⁹

Improved productivity

A study at Nebraska Methodist Hospital found that CSTDs significantly improved the time efficiency of compounding. The task was completed in 36.4 seconds with EQUASHIELD, one of the CSTDs evaluated, compared to 87.7 seconds with other CSTD brands and 63 seconds with traditional needle and syringe methods.¹⁰

Innovations Lead to Cost Savings in Drug Compounding: The Financial Impact of CSTDs and Automation

Reflecting on the case studies and real-life examples, it’s clear that the compounding of hazardous drugs is evolving with a focus on innovative solutions like Closed System Transfer Devices (CSTDs) and automated compounding systems. These technologies not only mitigate the risks associated with hazardous drugs but also lead to significant cost savings. For instance, the study “The Future of Hazardous IV Drug Preparation is Here” ¹¹ highlights that the use of automated systems can substantially reduce operational expenses. It’s estimated that savings from the reduced waste of partial vials can amount to $70.000 annually while avoiding medication errors can save approximately $18.720 per year. Additionally, the elimination of costs associated with CSTDs, estimated at $117.000 annually for both prescription and nursing doses, underscores the financial efficiency of these technologies. This trend towards automation and CSTDs is pivotal in enhancing healthcare safety and ensuring the financial viability of pharmacies.

Conclusive Insights: Embracing CSTDs and Automation for Safer, More Cost-Effective Drug Compounding

The series of case studies and real-life examples we’ve explored provide valuable insights into the evolving landscape of drug compounding, particularly with hazardous drugs. The key takeaway is the significant role of Closed System Transfer Devices (CSTDs) and automated compounding systems in driving cost savings and enhancing safety in healthcare settings.

Cost Savings through Extended BUD and Reduced Wastage

The cases of Mount Sinai Hospital and Bronson Battle Creek (BBC) demonstrate how extending the Beyond Use Dating (BUD) of single-dose vials, as enabled by CSTDs like Equashield, can lead to substantial cost savings. By minimizing medication wastage, these healthcare facilities have shown annual cost reductions, highlighting the economic benefits of CSTD implementation.

Enhanced Safety and Efficiency

The integration of CSTDs has been shown to not only improve safety by reducing contamination risks but also to enhance operational efficiency. This dual benefit is crucial in a healthcare environment where both safety and cost-effectiveness are paramount.

Innovative Approaches in Compounding

Studies like “An economic evaluation of vial sharing of expensive drugs in automated compounding” underline the financial and environmental advantages of innovative compounding methods. Automated compounding with vial sharing, in contrast to traditional manual methods, has resulted in significant time and cost savings while reducing drug wastage.

Mitigating Liability and Health Risks

CSTDs have also been instrumental in mitigating potential liability and health risks associated with the compounding and administration of hazardous drugs. By providing a safer working environment, they help reduce healthcare costs and potential legal consequences.

In conclusion, the adoption of CSTDs and automated compounding systems represents a strategic move towards more efficient, safe, and cost-effective drug compounding practices. These innovations not only enhance the safety of healthcare professionals but also offer substantial financial benefits, making them a valuable addition to any healthcare facility’s medication management strategy.

Discover the Financial and Safety Benefits of CSTDs

Tamar Apper on January 24, 2024

Closed System Transfer Devices (CSTDs) play a critical role in protecting the health of pharmacy staff during hazardous drug compounding. Each year, over 8 million healthcare professionals in the US and 12 million in Europe face the risk of exposure to hazardous drugs, a concern that has been extensively studied. ⁽¹⁾⁽²⁾ CSTDs, with their advanced design, serve as powerful barriers, preventing exposure to dangerous drugs and reducing contamination. They also minimize waste and enhance the well-being of the staff working in hospitals and pharmacies.   

In the following sections, we will explore the significant impact of CSTDs on the compounding process.

The Key Benefits of Using CSTDs in Pharmaceutical Compounding

A closed-system drug transfer device effectively minimizes contamination risks in healthcare settings.

Prioritizing Safety with Closed-System Transfer Devices

Closed System Transfer Devices (CSTDs) have become essential tools in drug compounding for both pharmacists and nurses, in order to address the issue of hazardous drug exposure. According to NIOSH, a CSTD mechanically prohibits the transfer of environmental contaminants into the system and the escape of hazardous drug or vapour concentrations outside the system.⁽³⁾ By creating an airtight connection between drug vials, syringes, and IV bags, they successfully prevent the release of harmful aerosols and vapours, significantly reducing the risks associated with direct contact, skin exposure, and inhalation. ⁽⁴⁾

More Occupational Safety with CSTDs

CSTDs employ various technologies, each offering different levels of safety. Physical barriers establish a closed system, containing hazardous drugs, while air-cleaning technology filters out particles from the air. ⁽⁵⁾ This rigorous containment strategy provides a protective environment for healthcare staff, minimizing the potential long-term health risks associated with hazardous drugs.

Reducing Contamination Risks and Occupational Exposure to Chemotherapy Drugs

One standout benefit of a closed-system drug transfer device is the significant reduction in contamination hazards for healthcare workers. Research shows a substantial decrease in hazardous drug exposure when CSTDs are the preferred medical devices in use, with a contamination rate of 12.24% compared to 26.39% with standard isolators. ⁽⁶⁾ By adopting CSTDs, pharmacists, nurses, clinicians, and other staff can enhance safety measures, creating a safer and more secure healthcare setting.

Contamination Control in Chemotherapy Drug Compounding: CSTDs vs. open systems

In this section, we will compare CSTDs with their market alternatives. We will shed light on their distinctive features and provide guidance on the most suitable choice for various drug-compounding scenarios.

CSTD products

These devices maintain a sealed environment throughout the drug preparation process. Equipped with vial adapters and other components, CSTDs ensure that hazardous drugs are contained, protecting pharmacy staff. Particularly for dangerous drugs, CSTD performance is invaluable, effectively preventing the release of aerosols or vapours.

Open Systems

Open systems possess a degree of permeability due to their inherent lack of a complete seal. They are simpler and often more affordable, making them suitable for drugs with a lower contamination risk. However, their protective capabilities do not match those of CSTDs.

In conclusion, CSTDs offer enhanced protection, especially for hazardous drugs. The choice between CSTDs or alternative solutions should be based on the nature of the drug (hazardous vs non-dangerous), potential staff risks, and regulatory standards, always with a focus on safe and secure compounding. When compounding hazardous drugs one should always use CSTDs as the devices are the only ones able to ensure safety during the process.

The Mastery of Contamination Prevention

In addition to their numerous benefits, CSTDs excel at preventing contamination. Their design provides a dual defence mechanism: they prevent environmental contaminants from entering the system and ensure that hazardous drug particles and vapours are securely sealed within. This robust shield significantly reduces the danger of accidental contamination, setting CSTDs apart in terms of efficiency and protection for healthcare professionals and patients alike.

How do CSTDs prevent drug spills and leakage?

Furthermore, CSTDs offer impeccable protection against drug spills and leakage. They accomplish this through a foolproof mechanism that restricts the entry of environmental contaminants and securely contains hazardous drugs or vapours. Once activated and sealed, the CSTD system prevents any inadvertent entry or exit, including bacteria or particulate matter. This level of precision safeguards the compounding process from unintended breaches, highlighting the unparalleled capability of CSTDs in ensuring the integrity of drug handling.

The Financial Benefits of Transfer Devices with Closed Systems

In the world of healthcare, financial considerations are just as important as security. That’s why we’re taking a closer look at the economic advantages of CSTDs. This section explores how CSTDs save money and reduce waste, highlighting the long-term financial benefits of investing in these devices in the healthcare sector.

Using a Drug Transfer Device Enables Cost Savings through Waste Reduction

Using CSTDs offers significant cost savings by minimizing drug waste. By providing protection against microbial growth, the use of the vial can be extended, allowing for longer periods of use beyond the original expiration date. Studies show that implementing CSTDs reduces drug waste by an average of 72.5%. ⁽⁷⁾  This not only conserves valuable medications but also has a positive environmental impact by reducing the disposal of hazardous drugs.

Optimizing Drug Compounding with CSTDs

Efficiency studies have demonstrated that the closed systems extend the sterility of single-use vials, enabling the practice of vial sharing which significantly cuts down the volume of drugs thrown away after just one use. Remarkably, studies highlighted that CSTDs can preserve vial sterility for as much as seven days, with contamination rates remaining negligible up to 30 days, leading to considerable financial savings due to reduced drug wastage ^(8).

These devices not only ensure precision in medication measurement and dispensing, leaving minimal residue, but their design also prevents any medication leaks and drips, maximizing every drop. The controlled air pressure and accurate dosing provided by CSTDs also play a crucial role in averting the risks associated with overfilling or underfilling vials, which further trims down waste. Such efficiency has been shown to provide substantial economic benefits. Cost savings from integrating CSTDs into healthcare practices range from 7-15% on overall drug and device expenses. This can translate into annual savings of around £480,000 by recovering an average of 57% of unused drugs from vials, with Hungarian hospitals reporting noteworthy savings, particularly with costly parenteral biological agents ⁽⁹⁾. Collectively, CSTDs make a compelling case not only for their role in reducing drug waste but also for optimizing healthcare resources through their economic use.

Enhancing Results by Integrating CSTDs with DVO

Combining CSTDs with Drug Vial Optimization (DVO) techniques provides a comprehensive approach to protection and efficiency. While CSTDs ensure a secure drug-handling environment, DVO maximizes medication extraction from vials with minimal residue. This combination not only protects healthcare professionals but also offers long-term financial benefits, establishing a sustainable and cost-effective solution for patient care and financial health.

Factors that influence the vial savings when compounding hazardous drugs with CSTDs and DVOs

Calculating vial savings during the preparation of cytostatic drugs with CSTDs and Drug Vial Optimization (DVO) depends on multiple variables, such as the drug specifics, equipment, and compounding procedures. Key considerations include:

Drug concentration: Higher concentrations may yield more doses per vial, enhancing DVO savings.

Vial size: Bigger vials could result in more savings by optimizing usage.

Vial cost: Selecting vials should be cost-effective, balancing the price per millilitre with potential waste.

Shelf life: Consider the drug’s stability post-mixing to prevent waste from expiring drugs.

Compounding efficiency: Properly trained staff using CSTDs and DVO can minimize errors and waste.

Regulatory adherence: Comply with all regulations to ensure safe compounding practices.

Demand analysis: High demand for a drug could mean significant savings through vial optimization.

DVO efficiency: The efficacy of the DVO technology used affects the amount of extractable doses.

Drug properties: Consider the compounding impact of drug characteristics like viscosity and solubility.

Staff education: Skilled staff using CSTDs and DVO technology can maximize their well-being at the workplace while increasing cost savings.

Long-Term Cost Savings: CSTDs vs. Alternative Solutions

In addition to the economic and sterility benefits presented earlier, CSTDs address also the financial consequences of contamination in healthcare settings. Exposure to hazardous drugs poses risks to healthcare professionals and patients, resulting in significant financial strains. These strains include costs associated with potential medical expenses due to staff harm, and the management of contamination fallout. Using CSTDs in drug compounding provides a key solution for such issues and ensures financial profitability in the long term.

The Ripple Effect: The Costs and Consequences of Staff Exposure to Hazardous Drugs

Human errors in healthcare settings can have detrimental effects on staff, leading to a series of costly repercussions. Immediate expenses include medical treatment, testing for exposure to hazardous drugs, and time off work. Furthermore, staff illnesses can result in workforce shortages, requiring the need for temporary hires and additional expenses. These issues disrupt operations and drive up costs. Additionally, if patients are adversely affected, legal and compensation expenses may arise. Given these financial strains, it is crucial to implement preventive strategies to address the broad impact of staff exposure incidents. ⁽¹⁰⁾

Mitigating Contamination Costs with CSTDs: A Proactive Approach

By using Closed-System Drug-Transfer Devices (CSTDs) to ensure a sealed environment during drug preparation and administration, the risk of staff contamination can be significantly reduced. This helps minimize immediate medical expenses related to exposure treatments, prevents operational disruptions, and eliminates the likelihood of legal and compensation claims. Implementing CSTDs demonstrates a proactive commitment to healthcare safety, protecting the well-being of healthcare professionals while also ensuring cost-effectiveness in operations.

Maximising Your CSTD Return on Investment by Investing in Staff Education

Investing in staff education for the proper use of Closed System Transfer Devices (CSTDs) is paramount in the healthcare sector, both for ensuring safety and enhancing financial outcomes. Effective training equips staff with the necessary skills to operate, maintain, and create efficient protocols for CSTDs, leading to fewer errors, reduced contamination risks, and improved chemotherapy administration. This not only advances patient care and satisfaction but also significantly increases return on investment (ROI) by minimizing costly mistakes such as drug spillage and avoiding needlestick injuries, which can cost between £10,000 to £620,000 alone, according to a report in Scotland.⁽¹¹⁾Hence, comprehensive training is a strategic investment that yields long-term financial benefits by optimizing medication use and reducing healthcare risks. Equashield provides free training for all healthcare professionals interested in improving occupational safety and well-being in hospitals and pharmacy environments.

Choosing the Right CSTD: Factors to Consider

Selecting the appropriate CSTD is not as simple as choosing any other item. Comparing CSTDs in a real-world setting requires thorough education for all staff involved in testing. Here are the key aspects to consider when selecting a CSTD:

Safety: When it comes to handling hazardous drugs, the safety of healthcare personnel is the top priority. Utilizing a completely closed CSTD is crucial to provide the utmost level of protection against the risks linked to exposure and contamination.

Compatibility: Ensure the CSTD is compatible with all tubing and pump equipment used in your facility.

Effectiveness: Evaluate the device’s ability to prevent work environment contamination and exposure to high vapour concentrations when disconnecting IV tubing after infusion.

Ease of use: Choose a device that is user-friendly and does not require extensive training.

Cost: Consider the device’s total cost of ownership and its fit within your facility’s budget.

Reliability: Select a device with a proven track record of success and reliability. Those designed with the closed-back syringe tend to be the safest and show the highest CSTD performance.

Ensuring Compatibility with Existing Regulations and Protocols

Before integrating a Closed System Transfer Device (CSTD) into your healthcare facility, it is crucial to ensure it aligns seamlessly with your country’s existing protocols and regulations. Different regions may have specific guidelines for medication safe handling and increased risk exposure. Verify that the chosen CSTD meets the regulatory requirements and healthcare protocols in your area. This step is vital for maintaining compliance, enhancing patient safety, and streamlining your drug transfer processes.

EQUASHIELD Changed the World For Me

Ilya Viten on November 13, 2023

Mark Stanfield has had a diverse career path, starting as a musician and later working in Hollywood producing television commercials. However, after the events of September 11, he felt a calling to make a difference in people’s lives and found his path as an oncology pharmacist.

In 2017, he was diagnosed with stage four lung cancer, which led him to question the safety of certain medical equipment at his workplace. Concerned about the potential harm to others, he embarked on a mission to improve safety in the medical field by identifying a closed system transfer device (CSTD) that effectively prevents vapor escape. He discovered that EQUASHIELD is the best CSTD to cover all routes of exposure. Despite his personal health struggles, Mark remains resolute in his commitment to fearlessly living life and promoting safe compounding practices for fellow healthcare professionals.

Mark’s full story

EQUASHIELD Syringe Unit

EQUASHIELD Pioneers AI in Production Lines

Tamar Apper on November 2, 2023

AI has been heralded as the future of production lines, providing a level of automation and control that is unparalleled- surpassing limited human visual perception by employing advanced image processing techniques. At EQUASHIELD, we take pride in our early adoption of AI technology. We have seamlessly integrated it into our automated warehouse, production lines, and packaging. This results in enhanced efficiency, improved product quality, and reduced waste.

The use of AI in the production lines at EQUASHIELD is an integral part of our success. The AI system ensures constant quality control and provides real-time status updates for each product throughout the automated assembly process, thanks to the integration of over 300 cameras across 500 stations. Cameras and sensors play a crucial role in facilitating the automated machine operations by providing valuable data including orientation, barcode reading, OCR (Object Character Recognition), and defect detection. This ensures a high level of consistency and accuracy in the production process, reducing costly errors, and minimizing the need for manual labor.

Revolutionizing Product Tracking and Packaging

Another one of the key benefits is the ability to extract vital information for product tracking and automatic packaging. The system reads UDIs (Unique Device Identification), prints checks, and conducts end-of-the-line blister checks to ensure that every product is flawless and ready for use. The cameras have superior zoom capabilities compared to the human eye, leading to enhanced flaw detection. This level of automation and quality control is crucial when it comes to medical products, where any flaw could have serious consequences for patient health.

Utilizing Predictive Maintenance to Reduce Waste and Save Time

At EQUASHIELD, the utilization of AI models is an ever-evolving process. We employ a wide range of models to enhance the image processing capabilities of our production lines. Predictive maintenance is another crucial application of AI. By collecting real-time data and employing data science algorithms, we can anticipate potential mechanical failures resulting from incorrect calibration of parameters such as temperature and torque resulting in reduction of production down time. Smart defect detection possesses a deep understanding of potential issues, promptly indicating and aiding technicians in resolving them effectively. As a result, the production lines considerably reduce product waste while identifying flaws in production. This has resulted in significant time and cost savings, as well as improved product reliability, customer satisfaction and retention.

By implementing automated quality control and real-time status updates, we ensure a consistent and accurate production process. Furthermore, the ability to extract crucial information for product tracking and enable automatic packaging adds an extra layer of quality assurance. With a range of AI models utilized in our production lines, we are at the forefront of the industry, continuously enhancing image processing capabilities and improving product quality. At EQUASHIELD we are proud to set a higher standard in the world of medical device manufacturing.

The use of AI in our production lines has a direct impact on the quality and reliability of our products. By ensuring constant quality control and reducing waste, we can confidently stand behind our products and guarantee their effectiveness for healthcare professionals. This level of precision and efficiency would not be achievable without the integration of AI technology, making EQUASHIELD a leader in revolutionizing medical device manufacturing. By continuously evolving and improving our production processes, we strive to provide the best possible products for the healthcare industry. So, our customers can have peace of mind knowing that they are using safe, reliable, and high-quality medical devices from EQUASHIELD.

FDA Clearance of EQUASHIELD® Syringe Unit for Full Volume Use

Ilya Viten on October 4, 2023

We are thrilled to announce that the EQUASHIELD® Syringe Unit has received additional FDA clearance for full volume use¹. This achievement marks a significant milestone for our company, as we celebrate our fifth consecutive year of being the most used CSTD in the USA. We firmly believe that our innovative product design will revolutionize the way hazardous drugs are handled, offering unparalleled safety and efficiency.

Compared to Other Syringes on the Market

Many institutions adhere to guidelines that limit the fill volume of standard syringes to three-quarters when handling hazardous drugs (OSHA, ASHP) to prevent loss of the plunger^2,3. Our EQUASHIELD® Syringe Unit, however, eliminates this risk, preventing vapor escape and plunger contamination. The design allows you to use the most accurate syringe size possible for compounding and administration⁴.

Introducing the Unique EQUASHIELD® Syringe Unit

EQUASHIELD® Syringe Unit, a barrier type CSTD, stands out from its competitors with its one-of-a-kind closed-back design and bonded connector. This innovative design effectively eliminates more routes of hazardous drug exposure than alternate systems, preventing vapor escape and plunger contamination. The encapsulated plunger of the EQUASHIELD® Syringe Unit cannot be detached from the barrel, ensuring the safe usage of the entire Syringe Unit volume.

Benefits of Full-Volume Use

Full-volume use of the EQUASHIELD® Syringe Unit has multiple benefits:

Cost reduction: Utilize fewer syringes for compounding and administering a dose, thanks to the full volume utilization of each syringe. In combination with the full volume use and largest EQUASHIELD® syringes being 35mL and 60mL, contribute to major cost savings compared to regular off the shelf syringes.
Reduced strain: Experience less strain due to minimized repetitive motion.
Save time: Compound and prepare doses more efficiently with fewer syringes, leading to significant time savings.
Waste reduction: Decrease waste in both compounding and administering doses with optimized syringe usage.

Consider the following example to illustrate the potential cost savings:

EQUASHIELD significantly reduces syringe usage, streamlining the process with just 1 Syringe Unit. In contrast to other CSTD’s that often require 2 syringes + 2 or more injectors/connectors for the most common drug. This streamlining ensures efficiency and cost-effectiveness in your drug handling practices.

A Safer and More Efficient Solution

The EQUASHIELD® Syringe Unit was created with your safety at the forefront of our minds. We understand the potential risks involved with handling hazardous drugs, and we believe that our unique design offers a safer solution. The FDA clearance is a testament to the commitment we have in ensuring our products are safe and reliable.

In addition to safety, the EQUASHIELD® Syringe Unit offers efficiency. By allowing full-volume use, we help streamline your processes, reducing waste and maximizing your resources. This results in a cost-effective solution for your medication compounding and administrating needs.

Embrace Safety and Efficiency with the EQUASHIELD® Syringe Unit

For over a decade, through our innovative design and commitment to safety, we have created a product that stands out in the industry. The EQUASHIELD® Syringe Unit is more than just a syringe; it’s a safe, efficient, and cost-effective solution for handling hazardous drugs. As we mark this FDA clearance, we look forward to continuing to provide you with the highest quality products that meet your needs.

CAR-T Cell Therapy and Gene Therapy: A Revolution in Cancer Treatment

Tamar Apper on September 18, 2023

The ongoing battle against cancer has seen a paradigm shift with the advent of CAR-T cell therapy, a revolutionary approach that utilizes the patient’s own immune system to fight cancer. This innovative treatment, coupled with gene therapy, is transforming the landscape of cancer care.

Unveiling CAR-T Cell Therapy

Chimeric Antigen Receptor T-cell (CAR-T) technique was designed to augment the body’s natural defenses by equipping T cells, the soldiers of the immune system, with engineered receptors known as CARs. These receptors enable the T cells to recognize and attack specific cancer cells, thereby providing a targeted approach to cancer treatment.

CAR-T cell therapy has proven to be a game-changer in treating certain types of blood cancers, such as B-cell acute lymphoblastic leukemia and diffuse large B-cell lymphoma, that had previously shown resistance to conventional treatments¹.

Manufacturing Process of CAR-T Cell Therapy

The production of CAR-T cells involves several intricate steps, each requiring meticulous precision to ensure the utmost safety and efficacy of the final product. The process commences with the collection of T cells from the patient’s blood through a procedure called leukapheresis, where a specialized machine separates the desired cells.

These collected cells, which play a crucial role in the immune system, are then transported to a laboratory, where they undergo a series of genetic modifications to express Chimeric Antigen Receptors (CARs) on their surface. This genetic engineering process involves precisely inserting the CAR gene into the T cells, allowing them to recognize and target specific cancer cells. Subsequently, the modified cells are cultured and expanded in the lab, undergoing rigorous quality control checks to ensure their purity, potency, and safety.

Once these quality standards are met, the final product, consisting of the genetically modified CAR-T cells, is prepared for infusion back into the patient, where they can potentially combat the cancer cells with enhanced specificity and effectiveness.

Contamination Risks in Cell Therapy Manufacturing: Safeguarding Patients and Preserving Quality

Contamination can occur at various stages of cell therapy manufacturing, such as during genetic modification, cell expansion, or product formulation. Even a small presence of external contaminants, such as microorganisms or particles, can undermine the therapeutic value of the treatment and pose significant risks to patients.

Complications arising from contamination may evade standard quality control measures, leading to the release of a contaminated batch. If administered to patients, this could result in adverse effects, reduced treatment effectiveness, or even serious harm. Moreover, such incidents could have far-reaching consequences for the manufacturer, including financial burdens, legal challenges, damage to reputation, and ethical concerns.

Role of Closed System Devices

CSTDs play an important role in the manufacturing and quality control processes of CAR-T cell therapy, improving sterility, decreasing batch failure rates and improving overall process efficiency. These devices prevent the introduction of contaminants into the system and restrict the escape of hazardous drugs or vapors, ensuring a safe and controlled working environment².

Throughout the therapy manufacturing process, from transportation to quality control, air removal, and sampling, Closed System Transfer Devices (CSTDs) play a role in reducing contamination risks. Let’s take a closer look at how these devices effectively safeguard the integrity of the therapy. CSTDs offer a controlled environment for testing and analysis. By maintaining a closed system, these devices minimize the chances of external contaminants infiltrating the samples, thereby ensuring accurate and reliable results. This is particularly crucial as even the slightest contamination can skew test outcomes and lead to erroneous conclusions.

By incorporating Closed System Transfer Devices (CSTDs), CAR-T companies can significantly reduce the potential for contamination throughout the manufacturing process of CAR-T cell therapy. These devices serve as a reliable defense mechanism, contributing to the safety, effectiveness, and integrity of the end product.

USP 800 Questions & Answers

Tamar Apper on August 24, 2023

Q: How does USP <800> refer to closed system transfer devices (CSTDs)?

A: CSTDs are referred to as a containment supplemental engineering control that provide adjunct controls to offer an additional level of protection during compounding or administration. Supplemental engineering controls may also facilitate enhanced occupational protection, especially when handling HDs outside of primary and secondary engineering controls.

Q: Does USP <800> acknowledge that all CSTDs will perform adequately?

A: No, USP <800> reveals that there is no certainty that all CSTDs will perform adequately. Therefore, users should carefully evaluate the performance claims associated with available CSTDs based on independent, peer-reviewed studies and demonstrated contamination reduction.

Q: Can hazardous drugs (HDs) vaporize at room temperature increasing risk of occupational exposure?

A: Yes, the Oncology Nursing Society (ONS) Toolkit for Safe Handling of Hazardous Drugs for Nurses in Oncology identifies 8 HDs with the potential to vaporize at room temperature including Carmustine, Cisplatin, Cyclophosphamide, Etoposide, 5-Florouracil, Ifosfamide, Nitrogen mustard and Thiptepa.

Q: Why does USP <800> indicate that it is important to contain HDs vapors?

A: USP <800> states that a potential opportunity of exposure during administration includes generating aerosols of HDs by various routes (Ex. Injection, irrigation, oral, inhalation or topical administration).

Q: Does USP <800> indicate that a CSTD can help contain HDs vapors when utilized?

A: Yes, USP <800> states that some CSTDs have been shown to limit the potential of generating aerosols during compounding.

Q: Does USP <800> still allow for the use of two tiers of containment (Ex. CSTD within a BSC) that is in a non-negative pressure room for facilities that prepare a low volume of HDs?

A: No, USP <800> states that a CSTD must not be used as a substitute for a containment primary engineering control (C-PEC) which must be in a room with negative pressure between 0.01 and 0.03 inches of water column relative to all adjacent areas.

Q: When does USP <800> indicate that a CSTD should be utilized?

A: USP <800> states that a CSTD should be used when compounding HDS when the dosage form allows. Furthermore, USP <800> states that a CSTD must be used when administering antineoplastic HDs when the dosage form allows.

Q: Do USP standards indicate how affixing a CSTD to a vial impact beyond use dating (BUD)?

A: No, USP <797> revisions and USP <800> do not state that attachment of a CSTD to a medication vial either reduces or prolongs the beyond use date (BUD) of a medication vial (single or multiple dose). Therefore, for medication vials with an attached CSTD, BUD remains unchanged from USP standards. USP, Joint Commission and other regulatory bodies also do not currently endorse the utilization of a CSTD for prolonging the BUD of single dose vials, which is also known as dose vial optimization (DVO) due to patient safety concerns.

Leveraging AI to Streamline Pharmacy Compounding: Enhancing Safety and Efficiency in Drug Preparation

Tamar Apper on August 9, 2023

Current State of Pharmacy Compounding Automation

In the rapidly evolving landscape of healthcare, the realm of pharmacy is undergoing a transformative shift with the advent of compounding automation. This paradigm shift is revolutionizing the way pharmacies function in the United States, leading to enhanced efficiency, improved accuracy, and increased safety. Pharmacy compounding, once a labor-intensive process requiring meticulous manual effort, is now becoming an automated operation, harnessing cutting-edge technology to streamline workflows and mitigate potential errors. This article delves into the current state of pharmacy compounding automation in the U.S., exploring its benefits, challenges, and the potential it holds for the future of pharmaceutical care. From reducing the risk of cross-contamination to ensuring precise dosage and formulation, automation is poised to redefine the standards of pharmacy compounding, making it a compelling topic of discussion in contemporary pharmaceutical discourse.

What are the main challenges?

Pharmacy compounding automation, while offering numerous benefits, does present its own set of challenges. The initial cost of adopting automated systems can be substantial and may deter some pharmacies, particularly smaller operations. Additionally, implementing these systems requires a significant amount of training and adaptation for the staff, potentially disrupting workflow during the transition period. Interoperability issues, where different systems fail to communicate effectively with each other, can also pose a challenge. However, the market is evolving rapidly to meet these challenges head-on. Numerous companies are developing more user-friendly interfaces, comprehensive training programs, and better integration capabilities to ensure smooth operation. Meanwhile, the long-term savings in terms of time, reduced wastage, and improved accuracy often outweigh the initial investment, making automation an increasingly viable option for pharmacies of all sizes.

Pharmacies play a critical role in providing safe and effective medications to patients. However, a study suggests that approximately 9 percent, or nearly 1 in 10, of IV preparations may contain errors, with the most common problem being incorrect ingredients and/or volumes. These errors have the potential to cause harm or even result in patient fatalities¹. One area where advancements in technology can significantly improve safety and efficiency is the pharmacy compounding process. By leveraging artificial intelligence (AI), pharmacies can streamline their operations while minimizing the risk of errors. This blog post will discuss how AI can help reduce human error and enhance accuracy and consistency in pharmacy compounding, as well as the essential role of Closed System Transfer Devices (CSTDs) in maintaining a contamination-free environment.

Harnessing AI to Reduce Human Error in Pharmacy Compounding

The integration of AI technology into pharmacy compounding processes offers several benefits, including:

Precision and Consistency: AI algorithms can precisely measure and dispense drug components, ensuring consistency and accuracy in the final product. This reduces the likelihood of dosage errors reaching the patient2.
Real-time Monitoring: AI-driven systems can continuously monitor the compounding process, detecting and correcting errors before they become a threat to patient safety.
Data Analysis and Learning: AI can analyze historical data to identify trends and patterns, enabling continuous improvement in the compounding process and reducing the risk of future errors.

While AI is already making a significant impact, its potential in the field of pharmacy is far from fully realized. Future developments could see AI being used to automate more complex tasks, further reducing the burden on human pharmacists and minimizing the risk of errors. For instance, we could see AI systems that can interpret complex prescription orders or even dispense medications autonomously.

By adopting AI-driven automation, pharmacies can significantly reduce the occurrence of human errors, leading to safer and more efficient compounding processes.

The Role of Closed System Transfer Devices (CSTDs) in Ensuring Safety and Sterility

While AI can greatly improve the accuracy and consistency of pharmacy compounding, maintaining a sterile and contamination-free environment is equally important. Closed System Transfer Devices (CSTDs) serve as an additional layer of protection against contamination, particularly when handling hazardous drugs.

CSTDs are specially designed drug-transfer devices that create a physical barrier between the drug, the environment, and healthcare workers. They are used to prevent the escape of hazardous drug vapors, aerosols, and droplets during compounding and administration³. By incorporating CSTDs into the pharmacy compounding process, pharmacies can:

Minimize Exposure Risks: CSTDs reduce the risk of healthcare workers and patients being exposed to hazardous drug particles, ensuring a safer working environment.
Maintain Sterility: CSTDs help maintain the sterility of compounded medications by preventing contaminants from entering the drug preparation process.
Complement AI-driven Systems: The integration of CSTDs with AI-driven automation systems can provide comprehensive protection against both dosage errors and contamination risks.

Embracing AI and CSTDs for a Safer Future in Pharmacy Compounding

By integrating artificial intelligence technology and Closed System Transfer Devices (CSTDs) into their compounding processes with products like the EQUASHIELD Pro, pharmacies can significantly enhance safety, efficiency, and accuracy. This powerful combination of cutting-edge technology and robust protective measures can help minimize the risk of medication errors, ensuring optimal patient care and public health outcomes.

Handling Hazardous Drugs in Veterinary Medicine: Promoting Safety with Closed System Transfer Devices

Tamar Apper on August 9, 2023

In the United States, it is estimated that there are over 100,000 veterinary healthcare workers, including veterinarians, veterinary technicians, and support staff, who play a crucial role in the care and treatment of animals¹. These professionals are often exposed to hazardous drugs, such as chemotherapy agents and immunosuppressive medications, which can pose significant occupational health risks. Long-term effects of such exposure can include skin and respiratory irritation, organ damage, and an increased risk of developing various cancers³ . Research on the demographic characteristics of veterinary healthcare workers indicates that most of these professionals are women and may be at a higher risk of reproductive toxicity due to hazardous drug exposure². It is essential for veterinary healthcare workers to be aware of these risks and implement safety measures to minimize exposure and protect their health. Safety measures include using personal protective equipment (PPE) and closed system transfer devices (CSTDs) when preparing and administering hazardous drugs.

Cancer in Pets is on the Rise

According to the American Veterinary Medical Association (AVMA), cancer is a leading cause of death in pets, accounting for almost 50% of all disease-related pet deaths annually5. The growing number of cases has been attributed to several factors, including increased life expectancy due to advancements in veterinary care, improved diagnostics, and greater awareness among pet owners. Among household pets, dogs have the highest incidence of cancer, with one in four dogs developing cancer at some point in their lives5. Cats also experience cancer, albeit at lower rates compared to dogs. This upward trend in cancer cases among pets highlights the need for continued research, early detection, and advanced treatment options to improve outcomes and enhance the quality of life for affected animals.

In this blog post, we will discuss the different types of hazardous drugs used in veterinary settings, detail the potential risks involved in handling these drugs, and provide a step-by-step guide for veterinarians to follow when handling hazardous drugs, focusing on the use of closed system transfer devices (CSTDs).

Hazardous Drugs in Veterinary Medicine

Hazardous drugs are medications that pose a potential risk to humans through exposure due to their inherent toxic properties. In veterinary medicine, hazardous drugs can include:

Chemotherapy agents used to treat various cancers in animals

Hormones and hormone antagonists

Immunosuppressive agents for managing autoimmune diseases and facilitating organ transplants

Antiviral medications

Certain antibiotics and antifungal agents

Potential Risks and Precautions

Veterinary healthcare professionals often handle hazardous drugs to treat a variety of medical conditions in animals. These professionals must understand the potential risks associated with handling these drugs and take necessary precautions to ensure their safety, as well as the safety of the animals they treat. Handling hazardous drugs can pose risks to veterinary healthcare professionals, including skin irritation, respiratory issues, and reproductive toxicity. Often, vets are compounding hazardous drugs without engineering controls, such as biological safety cabinets or compounding aseptic containment isolators. These veterinary healthcare providers may be at a higher risk for exposure to hazardous drugs and vapors.

To minimize these risks, it is essential to follow proper handling procedures, including:

Wearing appropriate personal protective equipment (PPE) such as gloves, gowns, and eye protection.
Utilizing engineering controls like biological safety cabinets or compounding aseptic containment isolators when possible.
Implementing safe work practices, such as avoiding hand-to-mouth contact and washing hands thoroughly after handling hazardous drugs.
Regularly training staff on safe handling practices and staying updated on the latest guidelines and recommendations.

The Role of Closed System Transfer Devices in Veterinary Medicine

CSTDs, such as EQUASHIELD CSTDs, play a crucial role in mitigating the risk of exposure to hazardous drugs during the preparation and administration process. These devices create a sealed barrier between the drug and the environment, preventing the escape of hazardous drug or vapors.

Clinical studies⁴ have shown that by incorporating CSTDs into their practice, veterinarians can:

Reduce the risk of exposure to hazardous drugs for themselves and their staff.
Minimize the risk of contamination during drug preparation and administration.
Improve the overall safety of handling hazardous drugs in veterinary settings.

A Step-by-Step Guide for Handling Hazardous Drugs

To ensure safety when handling hazardous drugs in veterinary medicine, follow these recommended steps:

Storage: Store hazardous drugs separately from other medications, ideally in a designated area with proper ventilation and limited access.
Preparation: Prepare drugs in a designated area, using engineering controls like biological safety cabinets. Institute safety measures such as using CSTDs and wearing appropriate PPE during preparation.
Administration: Administer drugs following the recommended route and dosage, ensuring the use of proper PPE and equipment, including CSTDs.
Disposal: Dispose of hazardous drug waste including used vials, syringes, and contaminated PPE, according to local, state, and federal regulations.

In conclusion, handling hazardous drugs in veterinary medicine requires diligence and adherence to proper safety protocols. By implementing safe handling practices, utilizing closed system transfer devices, like EQUASHIELD CSTDs, and staying informed about the latest guidelines and recommendations, veterinary healthcare professionals can enhance their safety and the safety of the animals they treat.

What is a Closed System Transfer Device (CSTD)?

Ilya Viten on August 9, 2023

According to the National Institute for Occupational Safety and Health (NIOSH), a CSTD 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 system1. These devices serve as a critical tool to prevent exposure to hazardous drugs, which can cause serious health effects in healthcare workers. The use of CSTDs has been mandated in several countries, including the United States, due to the high incidence of hazardous drug exposure among healthcare workers. In this article, we will explore the key features and regulatory requirements of CSTDs, and why they are essential in protecting healthcare workers from hazardous drug exposure.

Why are CSTDs so important?

Hazardous drugs, such as chemotherapy agents, antiviral medications, and immunosuppressive drugs pose significant health risks to medical personnel who handle them. These risks include skin irritation, allergic reactions, reproductive issues, and even the development of cancer². To minimize exposure to hazardous drugs and ensure the long-term health and safety of medical personnel, it is essential to implement best practices and safety measures.

What is the regulation status in the USA?

Specific requirements mandated by USP 800 guidelines include:

USP 800 is a set of guidelines³ developed by the United States Pharmacopeia (USP) and mandated by the Occupational Safety and Health Administration (OSHA) to prevent occupational exposure to hazardous drugs for healthcare workers. USP 800 aims to protect healthcare personnel, patients, and the environment by outlining safety standards for the handling and disposal of hazardous drugs in healthcare settings.

Proper use of personal protective equipment (PPE), such as gloves, gowns, masks, and eye protection.

Establishment of designated areas for receiving, storing, compounding, and administering hazardous drugs.

Implementation of engineering controls, including biological safety cabinets and compounding aseptic containment isolators.

Proper handling, decontamination, and disposal procedures for hazardous drugs and contaminated materials.

Specific requirements mandated by USP 797 guidelines include:

USP 797⁴ is a comprehensive set of standards designed to ensure safe compounding practices for sterile preparations. These regulatory requirements address critical aspects, including personnel qualifications, training, and hygiene; environmental quality and control; facilities and equipment; standard operating procedures (SOPs); and quality assurance and documentation. Personnel involved in sterile compounding must undergo proper training and demonstrate competency through written and practical assessments while adhering to strict hygiene protocols.

Personnel Qualifications and Training: Ensure that all staff involved in sterile compounding have appropriate training, demonstrate competency through assessments, and follow strict hygiene protocols.

Environmental Quality and Control: Maintain defined air quality standards using primary engineering controls, and regularly monitor the compounding environment to minimize contamination risks.

Facilities and Equipment: Design compounding areas that are segregated from other activities, with proper equipment such as laminar airflow workbenches or biological safety cabinets, and adhere to controlled temperature and humidity conditions.

Standard Operating Procedures (SOPs) and Quality Assurance: Develop and implement SOPs for all compounding activities, including preparation, labeling, storage, and disposal of compounded sterile preparations, and perform quality control measures such as sterility testing, endotoxin testing, and beyond-use dating.

Closed System Transfer Devices (CSTDs), such as EQUASHIELD’s CSTD product line, play a crucial role in reducing the risk of exposure and contamination while complying with USP 800 and USP 797 guidelines. EQUASHIELD CSTDs provide a physical barrier between the clinician and the hazardous drug, preventing the escape of hazardous drugs or vapors into the environment during compounding and administration processes.

When does exposure to hazardous drugs occur?

Exposure to hazardous drugs and their vapors occurs throughout the whole chain of drug handling, from receiving at the hospital warehouse until disposal. Compounding and administration constitute the major portion of the drug handling chain as more people are exposed, thereby increasing the risk of exposure.

Contamination with hazardous drugs can occur via several routes:

Oral – through ingestion
Inhalation – breathing in vapors
Dermal – contact

Different roles in handling hazardous drugs require specific recommendations:

Pharmacists and Pharmacy Technicians

1. Use closed-system transfer devices (CSTDs) during drug compounding to prevent the escape of hazardous drugs or vapors.

2. Work in a designated area with proper ventilation, such as a biological safety cabinet or compounding aseptic containment isolator.

3. Wear appropriate personal protective equipment (PPE), including gloves, gowns, masks, and eye protection.

4. Dispose of contaminated materials properly, following the facility’s hazardous waste disposal guidelines.

Nurses and Healthcare Providers

Utilize CSTDs during drug administration to minimize the risk of spills or leaks.

Wear PPE, such as gloves and gowns, while administering hazardous drugs and handling contaminated equipment.

Follow proper procedures for handling and disposing of hazardous drugs, including using puncture-resistant sharps containers for needles and syringes.

Educate patients and their families about the safe handling of hazardous drugs at home, including proper storage, administration, and disposal.

Environmental Services and Waste Management Staff

Wear appropriate PPE when cleaning areas where hazardous drugs are prepared or administered.

Follow facility-specific protocols for decontamination and cleaning procedures.

Dispose of hazardous drug waste according to local, state, and federal regulations.

Medical facilities and employers play a critical role in supporting these safety measures by providing adequate resources, including:

Regular training and education for all staff handling hazardous drugs, ensuring they are well-versed in safety protocols and procedures.
Supplying the necessary PPE and CSTDs for all personnel who handle hazardous drugs.
Implementing specialized ventilation systems and designated areas for drug preparation and administration.
Establishing clear guidelines and procedures for decontamination, cleaning, and waste disposal.

How can EQUASHIELD CSTDs help?

Pharmacists can protect themselves from hazardous drug exposure by implementing various safety measures, including the use of EQUASHIELD® Closed System Transfer Devices (CSTD). These devices are designed to create a physical barrier between the clinician and the hazardous drug, minimizing the risk of exposure during the compounding and administration process.

EQUASHIELD® CSTDs are unique in their ability to cover more routes of exposure than other solutions. Extensive clinical evaluation and studies⁴ have shown that standard syringes can become contaminated with hazardous drugs on surfaces exposed to the environment, potentially leading to vapor escape and plunger contamination. EQUASHIELD® addresses this issue with its closed-back syringe design, providing superior protection compared to alternative systems.

In conclusion, minimizing exposure to hazardous drugs is crucial for the long-term health and safety of medical personnel. By implementing best practices, using CTDS, appropriate PPE and equipment, and providing ongoing training and support, medical facilities can create a safer work environment for all staff members involved in handling hazardous drugs.

About

Order