Infection Control Today

JUN 2019

ICT delivers to infection preventionists & their colleagues in the operating room, sterile processing/central sterile, environmental services & materials management, timely & relevant news, trends & information impacting the profession & the industry

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12 www.infectioncontroltoday.com ICT June 2019 Acute care progress, here and now Be there when news happens. Infection Control Today's eNewsletter spotlights the week's biggest headlines. Our digital edition brings you infection control and disinfection news, education and information you can take anywhere. Subscribe today! InfectionControlToday.com/subscribe When loaned sets arrive, the containers should be thoroughly inspected for damage. If the containers are damaged (e.g., especially plastic containers), they should not be accepted, and the OR should be notifed. The predominant use of single-use wrappers has increased the potential for packaging integrity to be compromised. Commercially available single-use or reusable "corner protectors" can be used in place of a towel or tray liner between the tray and the wrapper. Corner protectors help prevent holes, rips, and tears in sterilization wraps caused by the weight of the set or by sharp corners or protruding "feet" on the bottom of the set. Some of these devices can resist fattening when placed under heavy trays. Using corner protectors does not negate the need to comply with the AAMI- and AORN-recommended 25-pound weight limit for sets. Such devices just provide added protection for specialty trays. Reusable corner protectors are multi-use and provide a greater level of protection. There are cost-saving opportunities over time in terms of generating less waste material and reducing labor and time for waste management and transport. For any type of corner protector, it is important to obtain and follow the manufacturer's written IFU, including the recommended sterilization cycle parameters for which the device has been validated and, for reusable corner guards, the recommended inspection procedures. Stacking sets is also an issue due to lack of space in storage areas. However, wrapped sets should only be stacked if recommended by the wrap manufacturer. This has led to facilities placing their loaner sets inside rigid containers. However, this is not in compliance with ANSI/ AAMI ST77:2013: Containment devices for reusable medical device sterilization. Annex A of this document explains that "It is the respon- sibility of the medical device manufacturer to provide validation for the sterilization of their devices. If a rigid sterilization container system is used for the validation, it should fall within the cleared indications for the specifc manufacturer's rigid sterilization container. Any parameter that extends beyond the acceptable criteria for sterilization, such as extended reprocessing time or a new medical device not previously cleared, should be identifed and may require additional 510(k) submissions." If a formal validation project is required (e.g., when the device and package modality—in this instance rigid sterilization container—do not fall within the rigid sterilization container indications for use), the medical device manufacturer should conduct the appropriate validation testing. T herefore, the loaned ins trument manufacturer should be validating if its sets can be effectively sterilized in a rigid container and if so, under what conditions? The rigid container being used at the facility must meet those requirements. In addition, not all loaned instrument manufacturers have performed this testing. If the IFU does not specify a rigid container can be used, it should not be used. Furthermore, some loaned instrument manufacturers specify specifc sets that can be placed in rigid containers, so do not assume all the loaned sets from a specifc manufacturer can be placed in a container. In summary, sterile processing personnel must do everything possible to ensure their packaging integrity is not compromised. There are many factors leading to damaged packaging however there are also many resolutions to this issue. If your loaned sets are validated for placement in a rigid container, that can solve the problem. If not, there are several other options to ensure the integrity of the packaging is not compromised. Nancy Chobin, RN, AAS, ACSP, CSPM, CFER, is a sterile processing consultant and educator. References: AAMI. Management of Loaned Critical and Semicritical Medical Devices That Require Sterilization or High-Level Disinfection. TIR63, 2014. ANSI/AAMI ST77: 2013 Containment devices for reusable medical device sterilization. The Basics of Sterile Processing, sixth edition. Chapter 1. Sterile Processing University. 2016.

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