Immediate Use Steam Sterilization

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1 Immediate Use Steam Sterilization Know the facts. Aesculap Surgical Technologies Sterile Processing

2 Immediate Use Steam Sterilization (IUSS) What is Immediate Use Steam Sterilization? In 2011 the term FLASH sterilization was replaced with Immediate Use Steam Sterilization (IUSS). The term flash sterilization has historically been used to describe steam sterilization of unwrapped items intended to be used immediately.* A multitude of organizations drafted the IUSS statement below: Immediate use is broadly defined as the shortest possible time between a sterilized item s removal from the sterilizer and its aseptic transfer to the sterile field. Immediacy implies that a sterilized item is used during the procedure for which it was sterilized and in a manner that minimizes its exposure to air and other environmental contaminants. A sterilized item intended for immediate use is not stored for future use, nor held from one case to another. Immediacy, rather than being defined according to a specific time frame, is established through the critical analysis and expert collaboration of the health care team. - Per AAMI/AORN joint statement* Know the Facts Look to Aesculap The world leader in closed sterilization container systems for solutions on Terminal and IUSS sterilization. * Data on file

3 Aesculap - The Preferred Container System for Immediate Use Steam Sterilization and Traditional Terminal Sterilization Same Rigid Container System for Terminal or Immediate Use Steam Sterilization reduces errors Using the same containers for both Terminal and IUSS processing streamlines work flow and reduces errors allowing the SPD to deliver instruments on time to the OR. Transparent lids allow visual inspection of instruments without compromising sterile boundary Aesculap see-through PrimeLine TM Lids have an integrated reusable filter and form a closed container system (meeting Joint Commissions Guidelines regarding transport of IUSS items) which allows the OR staff to visually inspect the internal indicators and instrument set prior to opening in the OR. Containerized Orthopaedic and Spine sets minimize case delays and reduce IUSS rates due to tears in wrap Major Orthopaedic and Spine vendors have performed validation studies with Aesculap. Ask your local sales representative for an example list of companies and start converting to the Aesculap SterilContainer System today.

4 SterilContainer System Broad Portfolio for Immediate Use Steam Sterilization and Traditional Terminal Sterilization SterilContainer TM 2000 System Bottoms Aluminum Lids with single use or reusable filter PrimeLine TM Lids Offered in 6 colors and See-Through with integrated reusable filter Full Size JK440, JK441, JK442, JK444, JK446 JK485, JK486, JK487, JK488, JK489 JP001, JP002, JP003, JP004, JP005, JP006, JP007 Three-Quarter Size JK740, JK741, JK742, JK744 JK785, JK786, JK787, JK788, JK789 JP011, JP012, JP013, JP014, JP015, JP016, JP017 Half Size JK340, JK341, JK342, JK344, JK346 JK385, JK386, JK387, JK388, JK389 JP021, JP022, JP023, JP024, JP025, JP026, JP027 Extra Long Size JK443 JK490 Mini Size JK187, JK188 JK170, JK171, JK172, JK173, JK174 Wide Body Size JK817, JK821 JE601 The Aesculap SterilContainer System is FDA cleared for dynamic air removal (PreVac) Immediate Use Steam Sterilization 510(k) Number: K & K Indications for Use: The Aesculap SterilContainer is a reusable sterilization container system (consisting of a solid bottom, a perforated lid with filter retention plates and disposable paper filters, PrimeLine Lids with filter retention plates and reusable PTFE filters) intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container has been validated with stainless steel lumens, hinged, and knurled instruments (stainless steel lumens of greater than 3 mm inner diameter or less than 400 mm in length). This container system is compatible for use in pre-vacuum (steam) flash sterilization. The SterilContainer System includes accessories such as baskets, trays, and racks. * Please refer to for instructions for use. Please reference the SterilContainer catalog, DOC132 for ordering details. * Data on file

5 Know the Facts What is the difference between a traditional terminal cycle and an IUSS cycle? The medical industry and its professional organizations such as AORN and AAMI, utilize two types of steam sterilization cycles with the common understanding as stated below: Traditional Terminal Steam Cycle includes an exposure time and dry time. The instrument set is dry and stored for later use. IUSS has an exposure time and no or little dry time. The instruments remain wet which is acceptable since they will be used immediately. Why is the facility performing an IUSS cycle and where is that data? Facilities may employ IUSS to provide instruments to the OR for a surgical case already underway. As noted in the October 2012 issue of OR Manager, Joint Commission surveyors won t cite an organization for sterilizing instruments for immediate use. Rather, they will check that data is being collected on instances when immediate-use sterilization is used and then check to see if action is being taken based on the data. If surveyors don t find that, they may cite the organization under the performance improvement standards. * Aseptic presentation best practices AAMI and AORN state in their aseptic presentation practices to check for compromised package integrity and moisture. If either is found, consider the set contaminated, except for moisture in IUSS processed sets. Therefore the practice of running non-industry recognized cycles such as short or rapid cycles with 0 minute minimum dry/cool time, and storing instrument sets wet for later use contradicts the best practices of aseptic presentation. 1, 2 * Data on file 1 AAMI ST79: Section AORN 2012 Recommend Practice: Recommendation VI.d.2

6 All rights reserved. Technical alterations are possible. This leaflet may be used for no other purposes than offering, buying and selling of our products. No part may be copied or reproduced in any form. In the case of misuse we retain the rights to recall our catalogs and price lists and to take legal actions AESCULAP. ALL RIGHTS RESERVED. PRINTED IN THE USA. Aesculap is an equal opportunity employer Aesculap, Inc Corporate Parkway Center Valley, PA Phone Fax Aesculap, Inc. - a B. Braun company DOC1196 2M 11/14

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