STERIS Corporation announces that it has received Food and Drug Administration (FDA) 510(k) clearance for the STERIS SYSTEM 1E(R) Liquid Chemical Sterilant Processing System.
The STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System is the successor to the company's SYSTEM 1 Sterile Processing System. The SYSTEM 1E is indicated for liquid chemical sterilization of cleaned, immersible and reusable critical and semi-critical heat sensitive medical devices in healthcare facilities.
"We are pleased that the Agency cleared SYSTEM 1E for marketing," commented Walt Rosebrough, STERIS president and CEO. "This is good news for our customers and we look forward to working with them as they continue their transition to acceptable alternative technologies. We remain committed to the outstanding level of service that our customers have come to expect from STERIS."
STERIS continues dialogue with the FDA to close out the remaining SYSTEM 1 issues and expects to announce a transition plan in the near future. STERIS is also committed to providing SYSTEM 1 customers with consumables, parts and service and accessories throughout the FDA authorized transition time period. The company will begin accepting orders for SYSTEM 1E as soon as the transition plan is announced, with delivery of the first units expected by the second quarter of fiscal year 2011.
Endoscopes and Lumened Instruments: New Studies Highlight Persistent Contamination Risks
May 7th 2025Two new studies reveal troubling contamination in both new endoscopes and cleaned lumened surgical instruments, challenging the reliability of current reprocessing practices and manufacturer guidelines.
Happy Hand Hygiene Day! Rethinking Glove Use for Safer, Cleaner, and More Ethical Health Care
May 5th 2025Despite their protective role, gloves are often misused in health care settings—undermining hand hygiene, risking patient safety, and worsening environmental impact. Alexandra Peters, PhD, points out that this misuse deserves urgent attention, especially today, World Hand Hygiene Day.