BD 515003 - BD PhaSeal Injector Luer Lock N35, 50/BX

BD 515003 - BD PhaSeal Injector Luer Lock N35, 50/BX

The BD 515003 - BD PhaSeal Injector Luer Lock (N35) is a highly specialized medical device designed as part of the BD PhaSeal system, a closed-system drug transfer device (CSTD) aimed at minimizing the risk of exposure to hazardous drugs. It is a crucial tool for healthcare professionals handling chemotherapy drugs, antibiotics, and other hazardous medications. This injector features a Luer lock connection that ensures secure and leak-proof attachment to other components within the system.

Product Overview and Design Features

• Luer Lock Connection: The Luer lock feature allows for a secure, standardized connection with syringes or other drug delivery systems, reducing the risk of leakage or accidental disconnection.
• Closed-System Drug Transfer: Designed to maintain a sealed system during drug transfer, the PhaSeal Injector prevents exposure to hazardous drugs, safeguarding healthcare workers and minimizing contamination.
• Ergonomic Design: The injector is designed to be easy to handle during drug preparation and administration, helping to reduce fatigue during repetitive tasks in clinical environments.
• Compatibility: The N35 injector is part of the larger BD PhaSeal system, ensuring compatibility with other PhaSeal components like vial adapters and infusion sets. This creates an integrated system for safe drug handling.

Intended Use in Medical Settings

The BD PhaSeal Injector Luer Lock (N35) is intended for use in various medical settings where hazardous drugs, particularly chemotherapeutic agents, are prepared and administered. The injector forms a critical part of the closed-system drug transfer device (CSTD) ecosystem, offering protection against hazardous drug exposure.

Key applications:

• Chemotherapy: Used extensively in oncology wards where nurses and oncologists prepare and administer cytotoxic drugs.
• IV Drug Preparation: Ideal for the preparation and delivery of intravenous medications, where contamination or accidental exposure poses risks.
• Hospital and Pharmacy Settings: Pharmacists who handle hazardous drugs during compounding or preparation use the BD PhaSeal system to maintain a safe, closed environment.

Benefits for healthcare professionals:

• Exposure Protection: The closed-system design helps reduce the risk of inhalation or direct contact with hazardous substances, promoting safety in the workplace.
• Prevention of Drug Waste: The sealed system minimizes drug spillage or leakage, ensuring that exact dosages are maintained without contamination.
• Ease of Use: The ergonomic design and standardized Luer lock connection make the product easy to use, ensuring both safety and efficiency during preparation and administration.

Certifications, Safety Standards, and Regulatory Approvals

The BD PhaSeal Injector Luer Lock (N35) meets all relevant safety and regulatory approvals:

• FDA Cleared: The product has been FDA-cleared for use in the United States as a medical device under the closed-system drug transfer classification.
• NIOSH Standards: The PhaSeal system adheres to NIOSH (National Institute for Occupational Safety and Health) guidelines for protecting healthcare workers from hazardous drug exposure.
• ISO 9001: The injector is manufactured under ISO 9001 standards, ensuring high quality and consistency in production.

These certifications affirm that the product meets the necessary health and safety standards required for handling hazardous drugs.

Comparison with Other Products

Heres a comparison of the BD 515003 PhaSeal Injector Luer Lock (N35) with other closed-system drug transfer devices available on the market:

Unique Features:

• Seamless Integration with BD PhaSeal System: Unlike other closed-system devices, the N35 injector is specifically designed to integrate seamlessly with the BD PhaSeal line, ensuring consistent performance.
• Luer Lock Precision: The Luer lock design provides enhanced stability and security, preventing accidental disconnection or drug leakage, a feature that is sometimes less refined in competitor products.

Common User Profile and Typical Scenarios

The BD PhaSeal Injector Luer Lock (N35) is primarily used by:

• Oncology Nurses and Pharmacists: These professionals are often involved in handling and administering hazardous chemotherapy drugs. The closed-system design provides crucial protection during drug preparation and injection.
• Pharmacists: In hospitals and compounding pharmacies, pharmacists use this injector as part of the drug compounding process, particularly when hazardous substances are involved.
• Healthcare Workers in Chemotherapy Units: Nurses working with chemotherapy patients rely on this system to administer toxic drugs without risking exposure to themselves or patients.

Typical scenarios include:

• Compounding Hazardous Drugs: Pharmacists preparing chemotherapy agents or other toxic drugs rely on the BD PhaSeal Injector to ensure a closed system.
• Oncology Treatments: Nurses administering chemotherapy or other IV drugs requiring closed-system handling use this product to safely deliver medications.

Best Practices for Using and Maintaining the Product

To ensure safe and effective use of the BD PhaSeal Injector Luer Lock (N35), follow these best practices:

• Aseptic Technique: Always use aseptic techniques to maintain sterility when preparing and administering medications. This reduces the risk of contamination or infection.
• Ensure Proper Sealing: Confirm that the Luer lock connection is tightly secured to prevent any leakage or accidental drug exposure.
• Handle with Care: Although the product is designed to reduce exposure, always handle hazardous drugs in a controlled environment, such as a negative-pressure room, if possible.
• Dispose of Safely: Once used, dispose of the injector according to your facilitys hazardous waste protocols. Do not attempt to reuse the injector.
• Regular Inspections: Check for any visible damage or wear before use to ensure the injector is in optimal condition.

By following these guidelines, healthcare professionals can ensure the safe, accurate, and efficient use of the BD PhaSeal Injector Luer Lock (N35), protecting both patients and staff from the risks associated with hazardous drug handling.