BD PhaSeal™ System

The BD PhaSeal™ Closed System Transfer Device is the first and only CSTD cleared under the FDA's newly created product code, ONB: Closed Antineoplastic and Hazardous Drug Reconstitution and Transfer System. Based on:

• Nothing Out – No escape of hazardous drug or vapor concentration (leakproof & airtight)
• Nothing In – No transfer of environmental contaminants
• Prevention of Microbial Ingress

New FDA code clarifies misconceptions in the market place*

• Establishes a specific product code for CSTD’s indicated to reduce exposure to hazardous drugs
• Requires data to prove a system is closed for use with hazardous drugs
• Requires data to demonstrate reduction in healthcare worker exposure

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The Value of Protection

Healthcare workers who handle hazardous drugs, including nurses and pharmacists, may be subject to acute and long term health risks. Multiple studies show that exposure to some lifesaving drugs may lead to cancer, reproductive problems, genetic conditions and other serious concerns.

The Dangers Are Clear:

• Independent studies have documented hazardous drugs in the urine of healthcare workers³
• Exposure and uptake present serious hazards to health and safety

BD PhaSeal™ System Advantages:

• FDA cleared CSTD indicated to reduce exposure to hazardous drugs
  • Eliminates human uptake during preparation, administration and disposal
  • Prevents drug exposure
  • Reduces surface contamination

• FDA cleared to prevent microbial ingress*. As a result, peer reviewed studies have shown sterility of vial contents remain unaffected.
  • Cuts drug waste to enable savings
  • Protects the microbial state of the vial contents for up to 168 hours
  • Reduces the impact of drug shortages
  • Helps fund investments in healthcare worker safety

• Easy to use system compatible with all known hazardous drug vials to ensure compliance

 

 

* Data on file at BD.
1. Valanis BG, Vollmer WM, Labuhn KT et al. Acute symptoms associated with antineoplastic drug handling among nurses. Cancer Nurs. 1993; 16:288-95.
2. Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Healthcare Settings. National Institute for Occupational Safety and Health. DHHS (NIOSH) Publication No 2004-165; 2004.
3. Wick C, Slawson MH, Jorgenson JA, Tyler LS. Using a closed-system protective device to reduce personnel exposure to antineoplastic agents. Am J Health Syst Pharm. 2003;60(22):2314-20.

 

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