A variety of life-saving equipment is sterilized with radiation. is an instructor for the industrial radiation course and has presented several webinars through ComplianceOnline related to environmental monitoring excursion, testing failures, PCD development and reusable device cleaning validations. Gerry is lead instructor for the AAMI industrial ethylene oxide sterilization course, One of its key advantages is that it allows already-packaged products to be sterilized. Radiation sterilization for medical devices (syringes, dressings etc.) She is also a member of the most of the sterilization related working groups and several of the groups related the processing of reusable medical devices. All Rights Reserved. © 2020 Association for the Advancement of Medical Instrumentation. Note: gamma, e-beam and x-ray radiation sterilization are in scope. Gamma Sterilization: An ionizing sterilization technique that involves exposing materials to gamma rays, most commonly Cobalt-60. She holds both a bachelor's degree and a master's degree in microbiology from the University of South Florida and has over thirty years of experience in the medical device industry. She is currently co-chair of the AAMI Industrial Ethylene Oxide Sterilization Working Group and a member of the U.S. Sub-TAG for Radiation sterilisation utilises ionising radiation to sterilise medical devices. Sterilizing medical products Radiation is a safe and cost-effective method for sterilizing single-use medical devices such as syringes and surgical gloves. Gerry O’Dell is a member of AAMI and actively participates in the sterilization standards committee activities. products — Radiation — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. This 3.5-day program covers principles, processes, industry best practices, and industry standards in radiation sterilization for medical devices. Gamma rays are attractive for use in commercial sterilization of materials of considerable thickness or volume, eg., packaged food or medical devices. Steam Heat Sterilization. FDA Medical Device Advisory Meeting. The autoclave, invented in 1879, combines heat and moisture with elevated pressure. Sterilization with ionizing radiation inactivates microorganisms very efficiently and, when used for product wrapping, ensures that healthcare products are safe and can be relied upon. (Credit: Sterigenics) Single-use medical devices, pharmaceuticals, components, and packaging that need to be sterile must be treated with an appropriate and validated technique. 4. The course includes electronic versions of the PowerPoint presentations and case studies, pertinent FDA documents, and additional references. In this particular case it is used for steam sterilization. However, since 1950, there has been an increase in medical devices and instruments made of materials (e.g., plastics) that require low-temperature sterilization. For virtual training courses, we request that you register at least one week in advance of the course start date to allow sufficient time for shipping of training materials and devices (Please allow two weeks for non-U.S. addresses). Johnson & Johnson as a manager of laboratory & sterilization services; the department charged with oversight of the sterilization program for J&J Medical in addition to providing laboratory testing services to several J&J companies. Heat sterilization of medical instruments is known to have been used in ancient Rome. Dates: January 19-22, 2021 Location: Virtual Description. Gerry O'Dell Consulting works to assist companies of all sizes to comply If you register within these time frames, AAMI cannot guarantee you will receive material prior to the start of the course but you will have access to digital versions of the materials. Processing with gamma irradiation yields quick turnaround time, easily penetrating packaging and product, and is ideal for many types of materials. Some of the topics covered are: FDA expectations regarding successful submissions, inspections, recalls, problem solving, and risk avoidance. Medical Device Sterilization Validation Steam Sterilization Dry-Heat Sterilization Gas Sterilization Sterilization by Ionizing Radiation Sterilization by Filtration Its usage has grown in recent decades as more facilities have been built, radiation resistant materials developed and dosage levels more tightly defined. More than 160 gamma irradiation plants around the world are operating to sterilize medical devices. 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