FDA Approves IST's ONE TRAY® for Extended 365-Day Storage for Surgical Use
The landscape of surgical facilities is about to change significantly with the recent announcement from Innovative Sterilization Technologies (IST). The U.S. Food and Drug Administration (FDA) has granted a second clearance for IST's ONE TRAY® sterilization container, allowing it to maintain its integrity for up to 365 days. This major development provides increased flexibility for hospitals and surgical centers facing dynamic workflows and ever-evolving needs.
Historically, the original clearance in 2006 allowed ONE TRAY® to effectively sterilize instruments at a temperature of 270°F (132°C) for a duration of four minutes. Notably, it initially set a maximum storage period of just 48 hours. With the new clearance obtained in 2025, IST has transformed the operating procedures for surgical facilities, allowing professionals to store sterilized instruments much longer—up to a full year, all while retaining the same rigorous sterilization parameters. The previous validated exposure time and dry duration have remained unchanged at four minutes and 15 minutes, respectively.
Barbara Ann Harmer, MHA, BSN, RN, Vice President of Clinical Services at IST, emphasized the importance of this extended storage period. She indicated that unforeseen challenges can arise in operating rooms, and having a flexible option to access sterilized instruments promptly can alleviate potential delays that significantly impact both medical staff and patients. "Surgical delays often ripple far beyond the operating room," said Harmer. This sentiment underscores the complexity and the pressures faced by surgical departments in a high-stress healthcare environment, where timely intervention is often directly linked to patient care outcomes.
The implications of this dual clearance extend beyond just convenience. In a time of increasing healthcare costs, and where facilities are required to do more with less, this enhancement represents a strategic movement towards improving operational efficiency. Tim Tzimas, the President and CEO of IST, articulated this necessity by noting, "The dual FDA clearances improve efficiency across the entire chain of custody in the sterilization process - an increasingly important factor as healthcare systems face mounting costs and staffing pressures."
Implementing the ONE TRAY® system allows surgical departments to optimize their inventory management and standardize sterilization processes seamlessly. The AFL-CIO and other healthcare advocacy bodies have recognized the need for flexibility and efficiency in healthcare settings. This recent clearance represents a holistic solution in the face of mounting clinical demands, potentially allowing facilities to standardize their procedures around a single reusable sealed container platform.
To further assist surgical facilities interested in adopting the newly cleared storage guidelines or to answer any questions regarding the practical applications of this FDA clearance, IST has made resources available through direct contact with Barbara Ann at [email protected] or by phone at 407-709-7209. Additionally, further information on the equipment specifications and guidelines can be found at onetray.com/ifucomparison, showcasing the significant advancements made by IST in sterilization technology.
Thus, with ONE TRAY®, surgical teams can anticipate a more streamlined workflow that not only preserves the quality of sterilized instruments but also significantly enhances operational flexibility. This progressive step towards extended storage assurances showcases IST's commitment to aiding healthcare facilities in managing complex surgical processes and ultimately improving patient care outcomes.
Historically, the original clearance in 2006 allowed ONE TRAY® to effectively sterilize instruments at a temperature of 270°F (132°C) for a duration of four minutes. Notably, it initially set a maximum storage period of just 48 hours. With the new clearance obtained in 2025, IST has transformed the operating procedures for surgical facilities, allowing professionals to store sterilized instruments much longer—up to a full year, all while retaining the same rigorous sterilization parameters. The previous validated exposure time and dry duration have remained unchanged at four minutes and 15 minutes, respectively.
Barbara Ann Harmer, MHA, BSN, RN, Vice President of Clinical Services at IST, emphasized the importance of this extended storage period. She indicated that unforeseen challenges can arise in operating rooms, and having a flexible option to access sterilized instruments promptly can alleviate potential delays that significantly impact both medical staff and patients. "Surgical delays often ripple far beyond the operating room," said Harmer. This sentiment underscores the complexity and the pressures faced by surgical departments in a high-stress healthcare environment, where timely intervention is often directly linked to patient care outcomes.
The implications of this dual clearance extend beyond just convenience. In a time of increasing healthcare costs, and where facilities are required to do more with less, this enhancement represents a strategic movement towards improving operational efficiency. Tim Tzimas, the President and CEO of IST, articulated this necessity by noting, "The dual FDA clearances improve efficiency across the entire chain of custody in the sterilization process - an increasingly important factor as healthcare systems face mounting costs and staffing pressures."
Implementing the ONE TRAY® system allows surgical departments to optimize their inventory management and standardize sterilization processes seamlessly. The AFL-CIO and other healthcare advocacy bodies have recognized the need for flexibility and efficiency in healthcare settings. This recent clearance represents a holistic solution in the face of mounting clinical demands, potentially allowing facilities to standardize their procedures around a single reusable sealed container platform.
To further assist surgical facilities interested in adopting the newly cleared storage guidelines or to answer any questions regarding the practical applications of this FDA clearance, IST has made resources available through direct contact with Barbara Ann at [email protected] or by phone at 407-709-7209. Additionally, further information on the equipment specifications and guidelines can be found at onetray.com/ifucomparison, showcasing the significant advancements made by IST in sterilization technology.
Thus, with ONE TRAY®, surgical teams can anticipate a more streamlined workflow that not only preserves the quality of sterilized instruments but also significantly enhances operational flexibility. This progressive step towards extended storage assurances showcases IST's commitment to aiding healthcare facilities in managing complex surgical processes and ultimately improving patient care outcomes.
Topics Health）
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