BD Receives FDA Clearance for First 1000mL Antimicrobial Irrigation System for Powered Surgical Lavage
核心洞察
BD (搜索) received 510(k) clearance from the FDA for Surgiphor™ 1000mL (搜索), marking the first and only 1000mL antimicrobial irrigation system specifically designed for powered lavage procedures.
The ready-to-use sterile solution eliminates the need for hospital staff to manually mix solutions, saving valuable operating room time while meeting global safety guidelines for surgical wound cleaning.
Surgiphor™ 1000mL (搜索) is compatible with commonly used powered lavage devices and includes versatile features like a powered-device adapter and Y-connector for seamless integration into existing OR workflows.
BD (搜索) (Becton, Dickinson and Company) has received 510(k) clearance from the U.S. Food and Drug Administration (搜索) for its Surgiphor™ 1000mL (搜索) antimicrobial irrigation system, establishing a new standard in surgical safety. The device represents the first and only 1000mL antimicrobial irrigation system specifically designed for powered lavage procedures, providing surgical teams with a consistent, OR-ready solution designed to improve patient care and operating room efficiency.
Revolutionary Design for Powered Irrigation
The Surgiphor™ 1000mL (搜索) system empowers clinicians to mechanically loosen and remove debris and microorganisms from wounds within powered irrigation workflows. By simplifying these complex procedures, the system delivers consistency, efficiency, and ease of use across a broad range of complex surgical procedures.
The device arrives ready-to-use and completely sterile, eliminating the need for hospital staff to mix solutions by hand. This innovation saves valuable time in the operating room while helping hospitals meet global safety guidelines for surgical wound cleaning.
"This FDA clearance reinforces BD (搜索)'s position as the global leader in surgical irrigation innovation," said Rian Seger, worldwide president of the BD Surgery business. "Surgiphor™ 1000mL (搜索) is a unique solution that provides the consistency and safety surgical teams expect from BD, allowing them to focus on what matters most: providing better, safer care for their patients."
Advanced Technical Features
Building on the adoption of the original Surgiphor™ system, the 1000mL configuration gives operating room teams a larger-volume option engineered to fit seamlessly into existing powered irrigation setups. The system is compatible with many commonly used powered lavage devices, allowing quick integration into current OR practice.
Key technical specifications include versatile interchangeability features with a powered-device adapter and Y-connector for simple switching between saline and Surgiphor™ solution, plus a twist cap for manual use when needed. The system incorporates optimized flow and ergonomics through integrated venting that promotes smooth, unrestricted flow, while a collapsible bottle supports efficient evacuation and handling.
Comprehensive Surgical Portfolio
The device features a terminally sterile PVP-I solution as part of the only surgical irrigation portfolio that provides terminally sterile PVP-I solutions in multiple sizes and delivery formats. The expanded Surgiphor™ portfolio now offers both manual and powered irrigation configurations, giving clinicians flexibility to match the needs of their workflow and patient population.
This latest addition to BD (搜索)'s surgical innovation portfolio demonstrates the company's commitment to advancing surgical safety through medical technology solutions that optimize clinical operations and improve patient care outcomes.